17

OTC - PANEL SUBMISSIONS - INDICES ONLY

COMMENT FILES FOR PANEL SUBMISSIONS

01 Antacid

75N-0357

02 Antimicrobial I

75N-0183

03 Internal Analgesic

77N-0094

04 Cough-Cold

76N-0052

76N-052B Bronchodilators

76N-052C Anticholinergics & Expectorants

76N-052G General Comments & Combinations

76N-052H Antihistamines

76N-052N Nasel Decongestants

76N-052T Antiussives

05 Sleep-Aids

75N-0244

06 Topical Analgesic

77N-0334 Topical Otics

78N-0021 Skin Protectants

78N-0038 Sunscreen

78N-0301 External Analgesic

07 Antimicrobial II

80N-0476 Topical Antifungal

81N-0114 Topical Acne

08 Dentifrices and Dental Care Agents

78N-0196 Oral Mucosal Injury

80N-0042 Anticaries

80N-0228 Oral Discomfort

09 Laxatives

78N-0036

78N-036A Antiemetic

78N-036D Antidiarrheal

78N-036E Emetic

78N-036L Laxative

10 Ophthalmic

80N-0145

11 Contraceptives and Other Vaginal Drug Products

80N-0280 Contraceptives

82N-0291 Vaginal

12 Memorrhoidal (Anorectal)

80N-0050

13 Oral Cavity

81N-0033

14 Antiperspirant

75N-0003 Zirconium

78N-0064 Antiperspirant

15 Vitamin and Mineral

78N-0024

16 Misc External

75N-0176 Request for Data and Information

75N-0183 Mercury-containing Drug Products for Topical Antimicrobial OTC Human

Use

75N-0183 Alcohol Drug Products for Topical Antimicrobial OTC Human Use

75N-0183 Diaper Rash

78N-0021 Astringent Drug Products

78N-0021 Diaper Rash

78N-0021 Externally Administered Fever Blister Drug Products

78N-0021 Insect Bite Neutralizer

78N-0021 Poison Ivy, Oak, and Sumac Prevention DRUG pRODUCTS

78N-0065 Skin Bleaching

78N-0301 Astringent Drug Products

78N-0301 Diaper Rash

78N-0301 Externally Administered Fever Blister Drug Products

78N-0301 Insect Bite Neutralizer

78N-0301 Male Genital Desensitizing

78N-0301 Poison Ivy, Oak, and Sumac Prevention Drug Products

80N-0146 Nailbiting and Thumbsucking Deterrent

80N-0227 Camphorated Oil

80N-0238 Wart Remover

80N-0348 Ingrown Toenail

80N-0357 Hair Grower and Sebum Hair Loss

80N-0476 Diaper Rash

81N-0122 Corn and Callus Remover

81N-0144 Topically Applied Hormone-containing Drug Products

82N-0054 Boil Ointment

82N-0214 Dandruff, Seborrheic Dermatitis and Psoriasis

17 Misc Internal

75N-0176 Request for Data and Information

77N-0094 Quinine for Treatment of Nocturnal Leg Muscle Cramps

79N-0176 Stomach Acidifiers

79N-0177 Sweet Spirits of Nitre

79N-0368 Cholecystokinetic Drugs

79N-0378 Anthelmintic Drugs

79N-0379 Exocrine Pancreatic Insufficiency Drugs

80N-0395 Hypophospatemia and Hyperphosphatemia Drug Products

80N-0419 Aphrodisiac Drug Products

81N-0022 Weight Control

81N-0027 Smoking Deterrent

81N-0040 Insect Repellent

81N-0050 Acute Toxic Ingestion

81N-0060 Orally Administered Treatment for Fever Blisters

81N-0064 Deodorant Drug Products for Internal Use

81N-0106 Digestive Aid

82N-0165 Menstrual Drug Products

82N-0166 Overindulgence in Alcohol & Food

82N-0168 Benign Prostatic Hypertrophy

18 Stimulants

75N-0244

19 Tropical Antibiotics (Antimicrobial II)

76N-0482

ACTION COMPLETED ON THE COMMENT FILES

TITLE CFR PART NO.

01 Antacid & Antiflatulent 331 & 332

75N-0357

05 Sleep-Aids 310.519

75n-0244 Daytime Sleep-Aids

14 Antiperspirnat 310.510

75N-0003 Zirconium

15 Vitamin and Mineral Withdrawn

78N-0024

16 Misc External 310.526

80N-0227 Camphorated Oil

17 Misc Internal 310.525

79N-0177 Sweet Spirits of Nitre 357

79N-0368 Cholecystokinetic Drugs

O-T-C ANTACID DATA SUBMISSIONS

VOLUME #	COMPANY	PRODUCTS
01	Plough Inc.	Dl-Gel liquid tablets
02	Smith, Miller, & Parch Inc.	Alzinex tablets magma
03	American Cyannaid Co.	Aciban Antacid tablets
04/05	Ayerst Laboratories Inc.	Riopan susp. Chew tablets
06	Whitehall Labs	Bisodol tablets powder Bisodol plus with Belladonne plus tablets
07/08	A.H. Robins Co.	Silain tablets Silain-gel tablets liquid
09	A.H. Robins Co.	Robalate liquid tablets
10	Lewis Howe Co.	Tums liquid
11	Arch Labs	Dicarbosil No. 2 Liquid
12	Lewis Howe Co.	Milk of Magnesia
13 & 52	Wyeth Lab.	A-M-T susp. Aludrox susp. Tablets Amphojel susp w/ mineral oil tablets, 300 mg. susp. 0.6 gm. tablets Basaljel Phosphaljel
14	Riker	Titralac tablets liquid tablets for Military
15	Sterling Drug	Aluminum Hydroxide
16	Sterling Drug	Magnesium Trisililicate
17	Sterling Drug	Calcium Carbonate
18	Sterling Drug	Antacids
19	Phillips, Chas. H.	Phillips 203
20	Winthrop Products Inc.	Creamalin gel. tablets Pepsamar Tablets gel.
21	Winthrop Lab.	Creamalin liquid
22	Winthrop Lab.	Creamalin ESP liquid tablets
23	Winthrop Lab.	Tricreamalata liquid tablets

VOLUME #	COMPANY	PRODUCTS
24	Winthrop Lab.	Wingel tablets liquids
25	Breon Lab Inc.	Al-Caroid tablets powder
26	Phillips, Ches. N. Co.	Phillips’ Milk of Magnesia Phillips’ Milk of Magnesia tab.
27	Sterling Drug Inc.	Sal Andrews
28	Sterling Drug	Fizrin
29	Sterling Drug	Haley’s M-O Regular & flavored Mil-Par
30/31	Lewis Howe Co.	Tums Tums Cherry Tums Orange Tums Lemon Tums Wintergreen
31	Arch Labs.	Dicarbosil
32	Allen Pharmacy Boericke & Ranyon Boericke & Tafel Bullard Co. Case Labs. Inc., G.M. Faraday Labs. Inc. G.M. Case Labs Gibbs Medicine Co. T.R. Henry Lab. Inc.	Flik Comb. tablet #9 Comb. tablet #33 Comb. tablet #249 Alpha #46 tablet Anti-acid tablets Carbo-Pancreatin Pepsin tablets Comb. tablets #117 Digestive compound tablets Digestive mixture Flik tablets Antacid tablets Antiacid tablets Push powder Formula 1447

VOLUME #	COMPANY	PRODUCTS
32	Savoy Drug & Chem’l Co. (for Vita Tone Co.) Schosburg, House of Scott Labs. Inc.	Anacid tablets Special formula Special formula Schomburg powder Citrate of Magnesia
32 & 105	Mallinckrodt Chem’l Works	Krem tablets
33	Vitamininerais Inc.	VM 21
34	Marion Lab.	Gavisoon foamtate
35/37	Vick Chemical Co.	Vanamail Antacid tablet liquid
38	Warren-Teed	Ratio tablets
39	Humphreys Pharmacal Inc.	Papsomax powder
40	Garfield & Co.	Soidlitz powders
41	Beecham Inc.	Eno
42	C.S. Dent & Co.	Bell-ans
43	Barnhoft Labs. Formulations Inc. Phillips-Roxane	Giycinate tablets Amaze Aids Aluminum Hydroxide Antacid 34 Hykasil Cream Magnesia and Alumina oral susp. Milk of Magnesia
43 & 45	Bowman Pharmaceuticals Inc.	Digestrogen tabs.
45	Bowman Pharmaceuticals Inc.	Antacid tabs. #2 Tabs Bowcid Liquid Milk of Magnesia Magnasil w/ Calcium Carbonate Milk og Magnesia Sode Mint 5 gr. white Sodium Bicarbonate 5 gr. White Sodium Bicarbonate 5 gr. Pink
50	Rorer Inc.	Maalox
51	Rorer Inc.	Camalox susp. tablet
52	Wyeth Lab.	A-N-T susp.
52 & 13	Wyeth Lab.	A-N-T susp. Aludrox susp. tablets Amphojel susp w/mineral oil tablets Amphojel susp tablets Basaljel Phosphaljel

VOLUME #	COMPANY	PRODUCTS
53/58	Merreil-National Labs.	Dalcid
59	Merreil-National Labs.	Kolantyl Kolantyl tabs wafers
60	Miles Lab. Inc.	Alka Seltzer
61	Upjohn Co.	Alkets
62	Medical Chemicals Co.	Medicil Madulox
62	E.R. Squibb	Milk of Magnesia tablet liquid Mint-o-Mag
63	FDA Library	Antacid literature search
64/70	Miles Lab. Inc.	Alka-Seltzer
71/73	Warner-Lambert	Rolaids
74/76	Warner-Lambert	Rolaids liquid
77/79	Warner-Lambert	Broomo Seltzer
80	Warner-Lambert	Macotin
81	Warner-Lambert	Gelusil Lac.
82	Warner-Lambert	Gelusil N liquid
83	Warner-Lambert	Gelusil N tablets
84	Warner-Lambert	Gelusil tablets
85	Warner-Chilcott	Gelusil Flavor Pak
86	Warner-Lambert	Gelusil liquid
87	Church & Delight	Sodium Bicarbonate
88	lCl American Inc.	Mylanta tablets liquid Mylanta II tablets liquid
89	Plough Inc.
90	Kremer Urban Co.	Kudrox tablets liquid
91	Sterling Drug	Phillips Milk of Magnesia
92	Fugi Chem. Ind.	Neusilin A B
93	Chattem Drug & Chem. Co.	Dihydroxyaiuminum Sodium Carbonate
94	Chattern Drug & Chem. Co.	Algyn & Dihydroxyaiuminum Aminoacetate
95	Wyeth	Aludrox Amphojel A-M-T Basaljel Phosphajel
95	UDGA Inc.	UDGA tablets
95	Reid Provident Labs.	Eugel tablets susp.
95	Miles	Riopan Gel.
96/98	Miles	Alka - 2
99	Vitaminerals Inc.	VM # 21
100	Wyeth Lab.	Aludrox etal
101	Tutag Co. S.J.	Escot capsules
102	Dr. Lamar	Silicates
103	Mithchum-Thayer Inc.	Amitone tablets
103	Ayerst	Riopan
104	Forest Labs Inc.	Mucogel O.C. Muco-25
105	Mallinckrodt	Krem
106	Tutag Co.	Escot Capsules
107	UpJohn Co.	Malcotabs Malcogel
108	UpJohn Co.	Anachloric A tablets
109	Beecham	Tartrates
110	UpJohn Co.	Citrocarbonate

Amended -- 9/72

020001

ANTIMICROBIAL DATA SUBMISSIONS

VOLUME #	COLOR	COMPANY	PRODUCT
1-8	Brown (or clear)	Givuidan Corp.	G-l (hexachlorophene)
9-13	Green	Sterling Drug	Zephiran Aqueous and Zobenol Aqueous
14	Green	Sterling Drug	Soapure and Sarene
15	Green	Sterling Drug	Mediquick
16	Green	Sterling Drug	Roccal
17-18	Green	Sterling Drug	Benzalkonium Chloride
19-20	Green	Sterling Drug	Hexachlorophene
21	Green	Sterling Drug	Zephiran Tincture and Zobenol Tincture
22	Green	Sterling Drug	Campho-Phenique
23-28	Green	Sterling Drug	PhisoHex, Fisohex and Phiso Scrub
29	Green	Sterling Drug	Zephiran Towellettes
30	Black	Chesebrough-Ponds Inc.	Vaseline First Aid Carbolate Petrolium Jelly
31	Grey	Monsanto	Trichlocarban in bar soap
32	Blue	R. Schattner Co.	Phenolic Compounds
33-40	Black	Ciba-Geigy	Irgasan DP-300
41-43	Brown	Norwich Pharmacal	Unguentine
44-46	Black	Armour Dial Inc.	Hexachlorophene and Trichlocarbon
47	Red	Vestal Labs	Septisal
48	Red (or Blue)	Fine Organics Inc.	Temasept (Tribromsalan)
49	Grey	Campana Corp.	Cuticura Medicated Soap
50	Grey	Rilox Co.	Geneva Ointment
51	Black	Colgate Palmolive	Wash’n Dri Washkins for Babies
52	Black	Colgate Palmolive	Washkins (hospital pack)
53	Black	Colgate Palmolive	Wash’n Dri (professional)
54	Black	Colgate Palmolive	Dermassage Lotion
55	Black	Colgate Palmolive	Tackel Gel
56	Black	Armour Dial	Tribrosalan
57	Black	Smith, Kline and French	Pragmatar
58	Black	Smith, Kline and French	Acnomel Cream, Cake
59	Blue	Nitine Inc.	Nitex
60	Clear	Oxford Chemicals	Hexachlorophene
61	Brown	Anti-infective Literature Search,	FDA Library
62	Brown	Ayerst Laboratories	Dermoplast Aerosol
63	Clear	Defense Med. Purchase Descriptions-Detergent	Providene Iodine
64	Brown	U.S. Borax	MD-7, Tomac, Luron
65-66	Brown	Miscellaneous Submissions
67	Brown	Ferro Corp.	Ottasept
68	Tan	Phenix	Phenix Fungicide
69-70	Blue	Armour Dial	Hexachlorophene
71	Red	West Chemical	Iodophers

Amended---9/72

ANTIMICROBIAL DATA SUBMISSIONS

VOLUME #	COLOR	COMPANY	PRODUCT
1-8	Brown (or clear)	Givuidan Corp.	G-l (hexachlorophene)
9-13	Green	Sterling Drug Inc.	Zephiran Aqueous and Zobenol Aqueous
14	Green	Sterling Drug	Soapure and Sarene
15	Green	Sterling Drug	Mediquick
16	Geen	Sterling Drug	Roccal
17-18	Green	Sterling Drug	Benzalkonium Chloride
19-20	Green	Sterling Drug	Hexachlorophene
21	Green	Sterling Drug	Zephiran Tincture and Zobenol Tincture
22	Green	Sterling Drug	Campo-Phenique
23-28	Green	Sterling Drug	PhisoHex, Fisohex and Phiso Scrub
29	Green	Sterling Drug	Zephiran Towellettes
30	Black	Chesebrough-Ponds Inc.	Vaseline First Aid Carbolate Petrolium Jelly
31	Grey	Monsanto	Trichlocarban in bar soap
32	Blue	R. Schatttner Co.	Phenolic Compounds Oraderm lip Lotion Chloraderm Liquid
33-40	Black	Ciba-Geigy	Irgasan DP-300
41-43	Brown	Norwich Pharmacal	Unguentine
44-46	Black	Armour Dial Inc.	Hexachlorophene and Trichlocarban
47	Red	Vestal Labs Dis Chemical Corp	Septisol
48	Red (or Blue)	Fine Organics Inc.	Temasept (Tribromsalan)
49	Grey	Campana Corp.	Cuticura Medicated Soap
50	Grey	Rilox Co.	Geneva Ointment
51	Black	Colgate Palmolive	Wash’n Dri Washkins for Babies
52	Black	Colgate Palmolive	Washkins (hospital pack)
53	Black	Colgate Palmolive	Wash’n Dri (professinal)
54	Black	Colgate Palmolive	Dermassage Lotion
55	Black	Colgate Palmolive	Tackel Gel
56	Black	Armour Dial	Tribromsalan
57	Black	Smith, Kline and French	Pragmatar
58	Black	Smith, Kline and French	Acnomel Cream, Cake
59	Blue	Nitine Inc.	Nitex
60	Clear	Oxford Chemicals Disconsolidated Food Corp	Hexachlorophene
61	Brown	Anti-infective Literature Search	FDA Library
62	Brown	Ayerst Laboratories	Dermoplast Aerosol
63	Clear	Defense Med. Purchase Descriptions	Detergent, Providone, Iodine
64	Brown	U.S. Borax	MD-7, Tomac, Luron
65-66	Brown	Miscellaneous Submissions
67	Brown	Ferro Corp.	Ottasept
68	Tan	Phenix	Phenix Fungicide
69-70	Blue	Armour Dial	Hexachlorophene
71	Red	West Chemical	Iodophors
72	Brown	Chesebrough Ponds Inc.	Virac Topical Germacide
73	Tan	R.T. Vanderbilt	Vancide
74-76	Brown	Plough Inc.	Solarcaine
77-79	Brown	Plough Inc.	Maxana Medicated Powder
80-82	Blue	Merck, Sharp & Dohme	ST 37 Antiseptic
83	Black	Proctor and Gamble	Safeguard
84	Brown	C.R. Canfield & Co.	Sebacide
85	Tan	High Chemical Company	Klorlyptus
86	Blue	Merck, Sharp & Dohme	Approve
87-91	Black (looseleaf)	Miles Labs	Bactine
92	Clear	C.R. Canfield	Sebacide
93	Black	UpJohn Co.	Mercresin
94	Brown	Plough, Inc.	Clean’n Treat
95	Clear	Marika	Verdi Lotion
96	Clear	Armour Dial	Dial and Safeguard Supp.
97	Clear	Sterling Drug	PhisoHex
98	Brown	Purdue Frederick	Betadine Cleanser
99	Brown	Purdue Frederick	Betadine Antiseptic
100	Brown	Purdue Frederick	Betadine Aerosol Spray
101	Brown	Purdue Frederick	Betadine Ointment
162	Brown	Sterling DRUG	Tribromosalicylanilide
103	Brown	Armour Dial, Inc.	Hexachlorophene
104	Brown	CIBA-GEIGY	Irgasan DP 300 Triclosan
105	Brown	Pfister	Tribromosalicylanilide
106	Brown	FDA Literature Search Supplement #1	Dichloro-m-Xylenol O-Phenyl-Phenol Pyrithione Zinc
107	Blue	Lever Brothers	Tribromsalan
108-113	Red or Yellow	Lever Brothers	Tribromsalan
114	Yellow (3 copies only) 1. Mrs. Bruch 2. Dr. Epstein 3. Dr. Kinoshita	Lever Brothers	Tribromsalan
115	Blue	FDA Literature Search Supplement #2	Quaternary Ammonium Compounds
116	Clear	Ciba Geigy	Irgasan DP-300
117	Black	Colgate	P-300 Soap Bar
118	Black	Colgate	P-300 Soap Bar
119	Blue	Purdue Frederick	Betadine Providone-iodine
120	Black	Sherwin Williams	Tribromosalicylanilide
121	Blue	Merck, Sharp & Dohme (IND # 6355)	5-Chloro-2 (2.4 Dichloro-Phenoxy) Phenol
122	Yellow or Red	Lever Brothers	Tribromsalan
123	Black	Armour Dial Inc.	Triclocarban Summary Report
124	Black	Armour Dial Inc.	Triclocarban Raw Data
125			3 Volumes combined in one
126	Brown	Armour Dial Inc.	Jacket (except Dr. Kinoshita’s)
127	Brown	Armour Dial Inc.	Triclocarbon
128	Black	Parke Davis	Benzethonium Chloride (Phemerol)
129	Clear	Smith, Kline & French	Pragmator (Labeling Change)
130	Clear	FDA	FDA Health Practices and Opinions Study
131	Yellow	West Chemical	Ionol (BHT)
132	Yellow	Fine Organics Inc.	TBS
133	Clear or Clear	Proctor & Gamble	1972-73 Antibacterial animal studies Preliminary Report TCC, TFC, BSA, HCP
134	Green	Sterling Drug	Zephiran Cl.
135	Gray	Norwich Pharmacal	Unquentine
136	Blue	Sterling Drug	Tribromo Salicylanilide
137	Blue	Sterling Drug	Tribromo Salicylanilide
138	Green	FDA Literature Search Supplement #2 (abstracts)	Quaternary Ammonium Compound
139	Brown	Procter & Gamble	91 Day, Rat Feeding Study with HCl, TBS, TCC, TFC
140	Gray	West Chemical	Iodophors
141	Gray	lCl America	Hibitane (chlorhexidine Gluconate) submission dated 10-13-72 to BD-120
142	Black	CIBA-GEIGY	Irgasan DP-300
143	Gray	Sterling Drug	Methylbenzethonium chloride
144	Red	FDA	Article on “Triple Dyd” (Dr. Lockhart)
145	Gray	Chesebrough Pond, Inc.	Addendum to VIRAC
146	Black	Rystan	Sodium Propioxiate Chlorophyll
147	Gray	R. Schattner Company	(Prophyllin) Chloraderm (invivo data)
148	Yellow	Procter & Gamble Company	28 Day Rabbitt Study HCP, BSA, TCC, TFC
149	Yellow	Jerry M. Rice, Ph.D Ncl	Letter to Dr. Francis Margulli, FDA Toxicity & Carcinogenicity of PVP
150	Yellow	Peter S. Herman, MBBS, MSC, CSPR; University of Sherbrooke Quebec, Canada	Letter to Mary Bruch Executive Secretary, OTC Panel
151	Yellow	Sterling Drug Inc.	Individual Brain Weights of rats TBS Study
152	Yellow	Chesebrough Ponds, Inc.	Virac Supplemental Information (New PDR Section)
153	Black	Ciba-Geigy Corp.	Irgasan CF3 Cloflucarban Additional Safety Data
154	Black	Ciba-Geigy Corp.	Iragasan CF3 Cloflucarban Additional Safety Data
155	Yellow	Colgate-Palmolive Company	Letter to Panel Chairman re: TBS
156	Various Colors	Ferro Corp.	Additional test data on Otrasept
157	Red	West Chemical	Additional data on Iodophors
158	Blue	FDA	Cross Index to Submission
159	Clear (and Blue)	The Purdue Frederick Co.	Additional Data on Betadine
160	Clear	Ferro Corp. Ottawa Chemical Div.	Additional Data on p-chloro-xylenol
161	Red	West Chemical Products Inc.	Additional Data on Iodophors
162	Brown	Huntington Laboratories Inc.	Iodophors
163	Brown	Sterling Drug Inc.	Additional Data on TBS
164	Yellow	Letters from various dermatologists	re: TBS
165	Brown	Monsanto	TCC
166	Black	Ciba-Geigy Corp.	Iragasan (CF 3) Additional Data
167	Black	Ciba-Geigy Corp.	Iragasan (DP 300) Additional Data
168	Black	Ciba-Geigy Corp.	Iragasan (DP 300) Additional Data
169	Red	Lever Brothers Co.	TBS Additional Data
170	Blue	Lever Brothers Co.	Irgasan (DP 300)
171	Yellow	Winthrop Laboratories	Comments on Proposed Definitions and Guidelines
172	Brown	Fine Organics	TBS Additional Data (Summary)
173	Clear	Fine Organics	TBS Additional Data
174	Blue	Sterling	Phisohex-Final Report Infant Monkey Study
175	Black	Chesebrough-Ponds, Inc.	Additional Data; Vasoline Carbolated Petroleum Jelly
176	Blue	W. Mitchel Sams, Jr., M.D. Prof. And Head Division of Dermatology University of Colorado Med. Center Denver, Colorado	Letter regarding TBS
177	Blue	West Chemical Products, Inc.	Comments on Panels Proposed Definitions
178		FDA	Misc. Reports (Proctor and Gamble NDA)
179		Onyx Chemical Company Jersey City, NJ 07302	Toxicity data on Quaternary Ammonium Compounds
180	Yellow	Colgate-Palmolive	Additional data on Dermassage - Comments on Oxyquinoline Sulfate as an active ingredient
181	Red	West Chemical Products, Inc.	Iodine Bibliography
182	Black	Colgate-Palmolive	Additional animal safety data on Irgasan, HCP & TBS
183	Black	Colgate-Palmolive
184	Black	Colgate-Palmolive
185	Black	Colgate-Palmolive
186			Misc. FDA Reports
187		Fine Organics	90 Day Subacute Rat Study on TBS
188		Bristal-Myers Co.	Presentation on Skin Antiseptics
189		Monsanto	TCC Reproduction Study
190		FDA	Additional data on Phenol
191		FDA	Misc. Uncited Ref.

Topical Antimicrobial Drug Products for OTC Human Use Establishment of a Monograph and Reopening of Administrative Record

Docket No. 75N-0183

Volume

02APA1

In the FEDERAL REGISTER of September 7, 1982 (47 FR 39406), the administrative record for the OTC topical antimicrobial drug products rulemaking was reopened to include a statement on OTC Drug Products for the Treatment of Diaper Rash by the Advisory Review Panel on OTC Miscellaneous External Drug Products. To avoid duplication, the Public Administrative File for that statement appears as part of the administrative file for the OTC external analgesic drug products rulemaking (Docket No. 78N-0301) that was also reopened on September 7, 1982 (47 FR 39412).

The material included in the topical antifungal rulemaking is identified in OTC Volume 06BPA6 in the external analgesic administrative file.

DATA AND INFORMATION

Volume	Submittted by	Trade Name	Ingredients Listed
030001	Plough, Inc. Memphis, Tenn.	St. Joseph Aspirin for Children	Aspirin
030002	Plough, Inc.	St. Joseph Aspirin	Aspirin
030003	A.H. Robins Co. Richmond, VA	Arthralgen Tablets	Sallcylamide Acetaminophen
030004	A.H. Robins Co.	Pabalate Tablets	Sodium Sallcylate (PABA) Sodium Aminobenzoate
030005 030006 030007	Warner Lambert Co. Morris Plains, N.Y.	Bromo Seltzer	Acetaminophen Phenacetin Potassium bromide Caffeine Sodium bicarbonate Citric acid
030008 to 030015	Miles Laboratories Inc. Elkhart, Indiana	Alka-Seltzer	Aspirin Mono-calcium phosphate Sodium bicarbonate Citric acid
030016 to 030029	McNeil Laboratories, Inc. Camp Hill Road Fort Washington, PA 19034	Tylenol Tablets	Acetaminophen
030030 to 030032	McNeil	Tylenol Elixir	Acetaminophen
030033 to 030035	McNeil	Tylenol Chewable Tablets	Acetaminophen
030036	McNeil	Tylenol Drops	Acetaminophen
030037	Abbott Laboratories North Chicago, Ill 60064	Children’s Chewable Tab.	Aluminum Aspirin
030038	Smith Kline & French Lab. 15000 Spring Carden St. Philadelphia, Pa 19101	Ecotrin, enteric coated	Aspirin
030039	The Dow Chemical Co. Research Center P.O. Box 10 Zionsville, Indiana 46077	Tenlap Elixir	Acetaminophen
030040	The Dow Chemical Co.	Phensal Tablets	Aspirin Phenacetin Caffeine
030041	Plough, Inc. Memphis, Texas 38101	Aspergum	Aspirin
030042	Warren-Teed Pharm. Inc. Columbus, Ohio 43215	Magan Tablets	Magnesium Salicylate
030043	Whitehall Laboratories Inc. 685 Thrid Avenue New York, N.Y. 10017	Duplexin Tablets	Dihydroxy Aluminum Sodium Carbonate Magnesium Carbonate Aspirin Phenacetin Caffeine
030044	Whitehall Labs Inc.	Arthritis Pain Formula	Micronized Aspirin Dried Aluminum Hydroxide gel Magnesium Hydroxide
030045	Whitehall Labs	Anacin	Aspirin Caffeine
030046	Whitehall Labs	Saloxium Tablet	Salicylsalicylic Acid (Salsalate)
030047	VSV Pharmaceutical Corp. 1 Scarsdalle Road Tuckahoe, New York 10707	Liquiprin Suspension	Acetaminophen
030048	USV	Femicin Tablets	Acetaminophen Saliylamide Caffeine Pyrilamine Maleate Homatropine Methylbromide
030049	USV	Comeback Tablets	Acetaminophen Salicylamide Caffeine
030050	Dorsey Laboratories Box 83288 Lincoln, Nebraska 68501	Calurin Tablets	Calcium Carbaspirin
030051	Dorsey	Cama Inlay Tabs	Aspirin (10 grains) Magesium hydroxide Aluminum hydroxide dried gel
030052	Dorsey	Chexit Tablets	Phenylpropanaolamine hydrochloride Pheniramine maleate Phrilamine maleate Dextromethorphan hydrobromide Terpin hydrate Acetaminophen
030053	Dorsey	Pabirin Tablets	Aspirin Aminobenzomic acid dried aluminum hydroxide gel
030054	Dorsey	Triaminicin Tablets	Phenylpropanolamine hydrochloride Pheniramine maleate Pyrilamine maleate Aspirin Acetaminophen Caffeine Ascorbic acid
030055	Dorsey	Tussagesic Tablets/Suspension	Phenylpropanolamine hydrochloride Pheniramine maleate Pyrilamine maleate Dextromethorphan hydrobromide Terpin hydrate Acetaminophen
030056	Dorsey	Ursinus Inlay Tabs	Calcium Carbaspirin Phenylpropanolamine hydrochloride Phyrilamine maleate
030057	Mead Johnson Research Center Evansville, Indiana 47721	Tempra Drops,Syrup, Tablet	Acetaminophen (Drops) (Syrup) (Tablets)
030058	Block Drug Company Inc.	BC Powder	Aspirin Salicylamide Caffeine
		BC Tablet	Aspirin Salicylamide Caffeine
030059	William H. Rorer Inc. Fort Washington, Pa 19034	Ascriptin Tablet	Aspirin Magnesium Hydroxide Aluminum Hydroxide
030060	Monsanto Industrial Chemicals Co. 800 N. Lindbergh Boulevard St. Louis, Missouri 63166	Salicylamide	(No dosage form)
030061	Monsanto	Aspirin	(No dosage form)
030062	Monsanto	Phenacetin	(No dosage form)
030063	J. Maxwell Little, Ph.D. Professor & Chairman Dept. Of Pharmacology Bowman Gray School of Medicine	Headache Powders	Phenacetin Caffeine Citric acid Potassium chloride Lactose Aspirin
030064	Sterling Drug Inc. 90 Park Avenue New York, N.Y. 10016	Bayer Aspirin tablets Bayer Children’s Aspirin Bayer Timed-Release Measurin Tablets Cortal para Ninos Fizrin	Aspirin Aspirin Aspirin Aspirin Aspirin Aspirin Sodium Bicarbonate Sodium Carbonate Citric Acid
030065	Sterling	Mejoral Cafenol Tablet Cafiaspirina Tablet	Aspirin Caffeine Aspirin Caffeine Aspirin Caffeine
030066	Sterling	Midol	Aspirin Cinnamedrin hydrochloride Caffeine
030067	Sterling	Vanquish	Aspirin Acetaminophen Caffeine Dried Aluminum hydroxide gel Magnesium hydroxide
030068	Sterling	Cope	Aspirin Caffeine Methapyrilene fumarate Magnesium hydroxide Dried Aluminum hydroxide gel
030069 to 030072	Bristol-Myers Products New York, New York	Bufferin Arthritis Strength Bufferin Excedrin Excedrin P.M. Disolve	Aspirin Magnesium Carbonate Dihydroxyaluminum aminoacetate Aspirin Magnesium carbonate Dithydroxyaluminum aminoacetate Aspirin Acetaminophen Caffeine Salicylamide Aspirin Salicylamide Acetaminophen Methapyrilene fumarate Aspirin Sodium bicarbonate Powdered citric acid Monocalcium phosphate
030073	Sandoz Pharmaceuticals	Fiogesic Tablets	Calcium carbaspirin Phenylpropanolamine hydrochoride Pheniramine maleate Pyrilamine maleate
030074	E.R. Squibb & Sons Inc.	Aspirin Tablets Trigesic Tablets Valadol Liquid Valadol Tablets Valadol Chewable Tablets	Aspirin Acetaminophen Caffeine Acetylsalicylic acid Acetaminophen Acetaminophen Acetaminophen
030075	Templetons Inc. Buffalo, New York	Templeton’‘s T-R-C’s	Aspirin Caffeine
030076	Fountain Labs, Inc.	PANO	Aspirin Caffeine
030077	The Purdue Frederick Co.	Arthropan Liquid	Choline Salicylate
030078	Federal Register Notice of April 20, 1972 and NAS/NRC Reports	Surfacaine Suppositories Bufferin Tablets Trigesic Tablets Nebs Tablets Apamide Tablets Metalid Tablets Duplexin Tablets Nysacetol Tablets Tylenol Elixir Tempra Drops, Syrup Tralgon Elixir Tylenol Tablets Arthropan Liquid Actasal Pediatric Drops Defencin Tablets	Cyclomethycaine Aspirin Aluminum Glycinate Magnesium Carbonate Acetaminophen Aspirin Caffeine Acetaminophen Acetaminophen Acetaminophen Dihydroxyaluminum Sodium Carbonate Magnesium Carbonate Aspirin Phenacetin Caffeine Acetaminophen Acetaminophen Acetaminophen Acetaminophen Acetaminophen Choline Salicylate Choline Salicylate Glycerylguaiacolate Aspirin Phenyltoloxamine Dihydrogen Citrate
030079	The Upjohn Company	Aspirin Tablets	Aspirin
030080		P-A-C Compound Tablets, Capsules	Phenacetin Aspirin Caffeine
030081		Acetonyl Effervescent Salt	Aspirin
030082		Salicionyl Effervescent Salt	Sodium Salicylate Sodium Bicarbonate
030083 to 030086	Warner-Chilcott Laboratories	Sinutab	Acetaminophen Phenacetin Phenylpropanolamine HCl Phenylpropanolamine Citrate
		Sinutab ll	Acetaminophen Phenacetin Phenylpropanolamine HCl
030087 030088 to 030090	Norwich Pharmacal Co.	Aspirin Nebs Tablets Nebs Elixir	Aspirin Acetaminophen Acetaminophen
030091 (labels only)	Eneglotaria Medicine Co. of Pureto Rico	Pediascirin Syrup	Acetaminophen
	L.W. Estes Co., Inc.	Estes Nu-Ral Tablets	Aspirin Caffeine
	The Rilox Co.	Baltar’s Medium	Sodium Salicylate Potassium Iodide Cascara Sagrade
	R.L. Gaddy Pharmacist	EZ-IT Tablets	Aspirin Phenacetin Caffeine
030092	McMurray & Pendergast for Cooper Labs. Inc.	Persistin	Salicylsalicylic acid Aspirin
030093 (labels only)	Curtis Drug Co.	Curtis A-R Pain Relief	Sodium Sallcylate Sodium Para Aminobenzoate Vitamin C (Ascorbic Acid) Vitamin B (Thiamin Hydrochloride) Vitamin B (Riboflavin)
	Berry & Withington Co.	Sodium Salicylate Aspirin Buffered Aspirin Aspirin Compound No.2	Aspirin Glycline, Aluminum Hydroxide Magnesium Carbonate Aspirin Penacetin Caffeine
030093 (cont.)	Republic Drug Co.	A.P.C. Tablets	Aspirin Phenacetin Caffeine
		A.P.C. with Codeline Aspirin Buffered Aspirin Superin Tapanol	Aspirin Phenacetin Caffeine Codeine Phosphate Aspirin Aluminum Hydroxide Glycine Magnesium Carbonate N-Acetyl-p-aminophenol Salicylamide Aspirin Caffeine Acetaminophen
	Boericke & Tafel	Boericke & Runyon Tablets No. 200	Acetanilid Caffeine Sodium Bicarbonate Calomel Iris Versicolor Nux Vomica
	Boericke & Tafel	B & R Tablet No. 171A	Henatyne (represents Acetylsalicylic 1/10 gr. And Magnesium Oxide 2/10 gr.) Acetylsalicylic Acid Macrotin Bryonin
	Lewis’ Mfg. Co.	Dr. Lewis’ Preparation for Rheumatism	Sodium Salicylate
030094	Prepared bt Lee M. Quon, OTC Staff	Comparative Toxicity of Phenacetin and Acetaminophen
030095	Miles Laboratories	Prepared by Allen R. Cooke, M.D. The Role of Acid in the Pathogenesis of Aspirin Induced Gastronintestinal Erosions and Hemorrhage
030096	T.E. Watson Co. American Felsol Co. Division	Felsol Powders Felsol Tablets	Antipyrine Iodopyrine Citrated Caffeine
030097	Edgar Larsen	Hoover Powders	Acetanilid Caffeine Sodium Bicarbonate
030098	T.E. Watson Co.		Antipyrine
030099	T.E. Watson Co.		Antipyrine
030100	T.E. Watson Co.		Antipyrine
030101	T.E. Watson Co.		Antipyrine
030102	Sterling Drug Inc.	Vanquish addition	Acetaminophen literature
030103	Bristol-Myers Co.	Remarks concerning the safety and effectiveness of Caffeine in combination with aspirin-order analgesic with special reference to Excedrin
030104	Miles Laboratories Inc.	Alka Seltzer-Safety And Effectiveness of a Buffered Sodium Acetylsalicylate Solution
030105 to 030112	Miles Laboratories Inc.	References for Volume 030104
030113	Bristol-Myers Products	Presentation to the Panel on Bufferin and Excedrin
030114 and 030115	Bristol-Myers Products	Excedrin P.M.	Aspirin Salicylamide Acetaminophen Methapyrilene Fumarate
030116	Plough, Inc.	Aspergum - Additional data
030117	Bristol-Myers Products	Duration of Action Bufferin compared to standard aspirin
030118	Plough, Inc.	Aspergum - additional data #2
030119	Smith Kling & French Laboratories	Ecotrin - additional data
030120	T.E. Watson Co.	Felsol (Additional Data)	Antipyrine
030121 to 030124	Miles Laboratories	Alka-Seltzer (Additional Data)
030125 to 030127	Whitehall Laboratories	Anacin Arthritis Pain Formula (Additional Data Prepared by Clinical Resources, Inc.)
030128	McNeil Laboratories, Inc.	Acetaminophen	Acetaminophen (additional data)
030129	Whitehall Laboratories	Additional data	Micronized Aspirin
030130	Ciba-Geigy Corp.	General Comments on Buffered Analgesics
030131	Endo Laboratories, Inc.	Percogesic Dilone	Acetaminophen Phenyltoloxamine citrate Acetaminophen Phenyltoloxamine citrate Caffeine
030132	Miles Labs., Inc.	References for Alka-Seltzer
030133	Sterling Drug Inc.	Additional Information
030134	Burroughs Wellcome Co.	Additional Information
030135	Warner-Lambert Res. Inst.	Additional Information on Bromo-Seltzer	Acetaminophen Sodium bicarbonate Citric Acid
030136 to 030138	Bristol-Myers Products	Bufferin	Additional information
030139	Bristol-Myers Products	Bufferin	Additional Information
030140	Eli Lilly & Co.	Aspirin Suppositories	Aspirin
030141	Glenbrook Laboratories, Division of Sterling Drug, Inc.	Information on Acetaminophen
030142	Plough, Inc.	Additional inforamtion on St. Joseph Aspirin for Children
030143 and 030144	American Home Products and Bristol-Myers Products	Joint presentation to the 24th Panel meeting “arthritis in the label”
030145	T.E. Watson Co.	Felsol Powder and Tablet	additional information
030146	S.B. Penick & Co.	Salicylamide bibliography
030147	Miles Laboratories Inc.	Additional data on Alka-Seltzer
030148	Bristol-Myers Products	Crystal size data on aspirin
030149	Sterling Drug Inc.	Dr. Fallier’s presentation on 9/25/74
030150	OTC Division	General data collection
030151	McNeil Laboratories	Abstract of Study by Drs. Cooper and Beaver
030152	Reprints and bibliography on analgesic nephropathy
030153	Bristol-Myers	Excedrin	Additional data
030154	Endo	Percogesic	Acetaminophen
030155			phenyltoloxamine
030156	Whitehall Laboratories	Saloxium,	additional data
030157	Warner-Lambert Company	Bromo-Seltzer	additional data
030158	Glenbrook Laboratories Division of Sterling Drug, Inc.	Information, and reprints, on aspirin
030159	Primer on the Rheumatic Diseases, Prepared by a Committee of the American Rheumatism Association Section of the Arthritis Foundation, 1973
030160	Bristol-Myers	Neolin	Aspirin Magnesium carbonate Calcium carbonate
030161	McNeil Laboratories, Inc.	Acetaminophen	Pediatric dose comments, data
030162	Miles Laboratories, Inc.	Alka-Seltzer	Additional information
030163	Endo Laboratories, Inc.	Percogesic	Additional information
030164	Burroughs Wellcome Co. Block Drug Co., Inc. The Proprietary Assn. Plough, Inc. Vick Divisions Reseach/Vick Chemical Co. Bristol-Myers Products
030165	Endo Laboratories	Percogesic	additional information presented at the November 22, 1976 meeting.
030166	Glenbrook Laboratories, Division of Sterling Drug, Inc.
030167	Miles Laboratories, Inc.
030168	American Home Products Corp.
030169	Various memoranda of discussions and evaluations of Percogesic
030170	Miles Laboratories		Supplemental Data on Alka-Seltzer, dated October 30, 1974, Master List of References
030171
030172	Negative responses to request for data--38 companies
030173	Summary minutes of Panel meetings #1-#28
030174	Bibiography, 1972 compiled by FDA Medical Library
030175	FDA-OTC Literature Search	Abstract Bibiography	Aspirin, 1972
030176	FDA-OTC Literature Search	Abstract Bibliography	Phenacetin, 1972
030177	FDA-OTC Literature Search	Abstract Bibliography	Caffeine, 1972
030178	FDA-OTC Literature Search	Abstract Bibliography	Internal Analgesics other than aspirin, phenacetin, caffeine, 1972
030179	Federal Trade Commission	Comments on preliminary Draft #6
030180	The Propietary Association, position statement for discussion of labeling at the August 21-23, 1976 meeting
030181	Various Submissions, Memoranda, etc. regarding aspirin, phenacetin
030182	Various Submissions, Memoranda, etc. regarding acetaminophen, antipyrine, caffeine

CCABA SUBMISSION CHART

Volume Number	Submittor	Subject
040001 to 040004	Merck Chem. Division Thomas Davis	Noscapine
040005	Chesebrough-Ponds	Pertussin
040006 to 040009	McNeil Laboratories Patrick H. Seay, Ph.D.	Co-Tylenol Cold Formula Tablets
040010	Monsanto	Methapyrilene Hcl
040011	Creomulsion Co.	Creomulsion
040012 to 040018	Pennwalt	Allerest
040019	Smith Kline & French	Ornex
040020 to 040021	Smith Kline & French	Benzedrex
040021	Smith Kline & French	Ornacol
040022	Ludens	Cough Drops
040023 to 040025	Calgon Consumer Products Jane Howell	Sucrets
040026	A.H. Robins Co. Robitussin	Glyceryl guaiacolate
040027	Pennwalt	Sinarest Tablets
040028
040029 to 040046	Johnson & Johnson	Sine-aid
040032	USV Pharmaceutical Corp.	Liquiprin
040047 to 040055	Vicks Chemical Co.	Nyquil Nighttime Cold Medicine
040056 to 040060 040060A	Vicks Chemical Co.	Vicks Vapor Rub
040061 to 040063	Vicks Chemical Co.	Vicks Cough Drop
040063	USV Pharmaceutical Corp.	Vaponefrin/Asthmanefrin
040064	Vicks Chemical Co.	Vicks Cough Syrup
040065 to 040066	Vicks Chemical Co.	Vick Inhaler
040067	Vicks Chemical Co.	Vick Cough Silencer Formula 44D Cough Syrup
040068	Vicks Chemical Co.	Formula 44D Cough Syrup
040069 to 040070	Vicks Chemical Co.	Sinex Nasal Spray
040071 to 040072	Vicks Chemical Co.	Formula 44D Cough Discs
040073 to 040079	Vicks Chemical Co.	Formula 44 Cough Mixture
040080	Father John Medicine Gerald Donehue	Cough Syrup
040081 to 040083	Schering Corp. Ken Brilhart	Coricidin Chlor-Trimeton Afrin
040084	Hoffman-LaRoche	Romilar Syrup
040085	Hoffman-LaRoche	Romilar Expectorant
040086	Hoffman-LaRoche	Romilar HB Tablets
040087	Hoffman-LaRoche	Romilar CF Syrup
040088	Hoffman-LaRoche	Romilar CF Capsules
040089	Hoffman-LaRoche	Romilar Cough and Cold Capsules
040090	Hoffman-LaRoche	Children’s Romilar Syrup
040091	Hoffman-LaRoche	Romilar CF 8-Hr. Syrup
040092	Hoffman-LaRoche	Romilar Cough Discs
040093	Hoffman- LaRoche	Romilar Chewable Cough Tablets
040094	Hoffman-LaRoche	Romilar III
040095	Chesebrough-Ponds	Pertussin Wild Berry Cough Syrup
040096	Chesebrough-Ponds	Pertussin Medicated Vaporizer
040097	Chesebrough-Ponds	Pertussin Plus Nighttime Cold Medicine
040098	Knoll Pharm. Co.	Verequad
040099	USV Pharmaceutical Corp.	Arrestin
040100	USV Pharmaceutical Corp.	Vaponefrin/Asthmanefrin
040102	Abbott Laboratories	Quelidrine Cough Syrup
040103	Abbott Laboratories	Calcidrine Syrup
040104	A.H. Robins Co.	Robitussets Troches
040105	A.H. Robins Co.	Robitussin PE Syrup
040106	A.H. Robins Co.	Robitussin DM Syrup
040107	Ciba-Geigy Corp.	Otrivin Nasel Solution and Spray
040108	LaWall & Harrison Donald Abbott	Troutman’s Cough Syrup
040109	The Dow Chemical Co.	2/G
040110	The Dow Chemical Co.	Novahistine-Elixir
040111	The Dow Chemical Co.	Novahistine
040112	The Dow Chemical Co.	2 G/DM
040113	The Dow Chemical Co.	Novahistine Expectorant
040114	The Dow Chemical Co.	Novahistine - Special Study Addendum
040115	The Dow Chemical Co.	Novahistine Fortia
040116	Ives Labs. Inc.	Cerose DM
040117	Ives Labs. Inc.	Cerose
040118	The Mentholatum Co.	Mentholatum Ointment
040119	Whitehall Labs. Inc.	Dondrill Anticough Tablets
040120	Whitehall Labs. Inc.	Dristan Capsules
040121	Whitehall Labs. Inc.	Primatene Asthma Tablets (P)
040122	Whitehall Labs. Inc.	Primatene Asthma Tablets (M)
040123	Whitehall Labs. Inc.	Dristan Nasal Mist and Vapor Spray
040124	Whitehall Labs. Inc.	Clear and dry Tablets
040125	Whitehall Labs. Inc.	Dristan Cough Formula Liquid
040126	Whitehall Labs. Inc.	Dristan Decongestant Tablets
040127	Whitehall labs. Inc.	Primetime and Bronitin Mist
040128	Whitehall labs. Inc.	Bronitin Tablets
040129	Ives Labs. Inc.	Cerose Compond
040130	Ives Labs. Inc.	Cetro-Cirose
040131	Warner-Lambert Co.	Listerine Cough Control Lozenge
040132	Warner-Lambert Co.	Super Anahist Decongestant Nasal Spray
040133	Warner-Lambert Co.	Big 4 Cough Formula
040134	Warner-Lambert Co.	Listerine Antiseptic Lozenge
040135	Warner-Lambert Co.	Smith Brothers Cough Discs
040136	Warner-Lambert Co.	Hall’s Cough Tablets
040137	Warner-Lambert Co.	Listerine Cold Tablets
040138	Warner-Lambert Co.	Super Anahist Decongestant Tablets
040139	Ciba-Geigy	Privine Nasal Solution and Spray
040140	The Dow Chemical Co.	Novahistine Melet
040141	Plough, Inc.	St. Joseph’s Cough Syrup for Children
040142 to 040146	Merck/Calgon Consumer Products	Sucrets Cold Decongestant Formula
040147	Dorsey Laboratories	Dorcol Pediatric Cough Syrup
040148	Dorsey Laboratories	Dor-C Tablets
040149	Dorsey Laboratories	Chexit Tablets
040150	Dorsey Laboratories	Triaminic Expectorant
040151	Dorsey Laboratories	Triaminic Syrup
040152	Dorsey Laboratories	Triaminicin Nasal Spray
040153	Dorsey Laboratories	Triaminicin Tablets
040154	Dorsey Laboratories	Triaminicol Cough Syrup
040155	Dorsey Laboratories	TussagesicR Tablets and Suspension
040156	Dorsey Laboratories	Ursinus Inlay Tabs
040157	Merck Sharp & Dohme	Capsules & Elixer Propadrine
040158	Merck Sharp & Dohme	Capsules & Elixer Propadrine
040159	Sterling Drug, Inc.	Deka Cough Syrup
040160	Sterling Drug, Inc.	Neo-Synephrine Elixir
040161	Sterling Drug, Inc.	Breacol Cough Medicine
040162	Sterling Drug, Inc.	Bronkaid Mist
040163	Sterling Drug, Inc.	Breacol with Prylon Cough Medicine
040164	Sterling Drug, Inc.	Synephicol Cough Syrup
040165	Sterling Drug, Inc.	Recindal Cough Medicine
040166	Sterling Drug, Inc.	Bronkotabs Bronkotabs HAFS Bronkolixer Bronkaid Tabs
040167	Sterling Drug, Inc.	NTR, NTZ, NRT Nose Drops and Nasal Spray
040168	Sterling Drug, Inc.	Neo-Synephrine Nose Drops & Nasal Spray
040169	Sterling Drug, Inc.	Neo-Synephrine Asafen Synephricol
040170	FDA Library	Bibliography
040171	Chesebrough-Ponds	Pertussin Cold-Team-24
040172	Norwich Pharmacal Co.	Quadrin
040173	Norwich Pharmacal Co.	Elixir Terpin Hydrate
040174	Norwich Pharmacal Co.	Baby Cough Syrup
040175	Searle Laboratories	Amodrine
040176	Pfizer Inc.	Coryban-D Nasal Spray
040177	Pfizer Inc.	Coryban-D Cough Syrup
040178 to 040189	Pfizer Inc.	Coryban-D Cold Capsules
040190	The UpJohn Co.	Cheracol, Cheracol D Cheracol Bilingual
040191	The UpJohn Co.	Orthoxicol (Orthoxine Cough Syrup)
040192 to 040193	Miles labs.	Alka Seltzer
040194 to 040197	A.H. robins Co.	Dimetane Elixir (Brompheniramine)
040198	The UpJohn Co.	Pyrroxate Cap. And Tablets
040199 to 040200	Warner-Chilcott	Tedral Tedral Anti-H Tedral susp.
040201	UpJohn Co.	Emeracol
040202	UpJohn Co.	Terpin Hydrate and Codeine Elixir
040203	Block Drug Co.	BC All Clear
040204	Key Pharm. Inc. M. Friedland	Key Tusscapine
040205	Sandoz Pharmaceuticals Div. Of Sandoz-Wander	Fiogesic Tablets
040206