• Decrease font size
  • Return font size to normal
  • Increase font size
U.S. Department of Health and Human Services

Regulatory Information

  • Print
  • Share
  • E-mail

OTC Panel Submissions (Indices Only): 13 - Oral Cavity

Public Administrative File
OTC Oral Health Care Drug Products
(Docket No. 81N-0033) 

VOLUME SUBMITTED BY TRADE NAME/ SUBJECT
130001 Monsanto Methyl Salicylate
130002 Henry Thayer Co.

Thayers Slippery

Elm Throat lozenges

130003 Lorvic Corp. Odara Solution
130004 Hoyt Orabase with Benzocaine
130005 Cox Drugs Formula “U”
130006

Denver  Chemical

Manufacturing  Co.

Pain-A-Lay
130007 Merrell-National Laboratories Cepacol Mouthwash/Gargle
130008 Merrell-National Laboratories Cepacol Throat Lozenges

130009

130010

130011

Merrell-National Laboratories Cepacol Anesthetic Troches
130012 Endo laboratories, Inc. Benocol
130013 Upjohn Oral Pentacresol
130014 Endo Laboratories, Inc. Lidocol
130015 Rystan Co., Inc. Chloresium

130016

130017

International Pharmaceutical Corp. Gly-oxide Liquid
130018 Endo Laboratories, Inc. Dyclocol

130019

130020

130021

130022

130023

130024

Richardson-Merrell, Inc.

Vicks Medi-Trating

Lozenges

Vicks Oracin Throat

Lozenges

130025 Church and Dwight Co., Inc. Arm and Hammer Baking Soda
130026 K.I.K. Cheramist

130027

130028

130029

Calgon Consumer Products Co., Inc. Sucrets Cough Control Lozenge

130030

130031

Calgon Consumer Products Co., Inc. Sucrets Sore Throat Lozenge

130032

130033

130034

130035

130036

Calgon Consumer Products Co., Inc. Sucrets Cold Decongestant
130037 Block Drug Co., Inc. Proxigel

130038

130039

130040

Block Drug Co., Inc. Chloraseptic
130041 Warren-Teed Di-O-Chrome

130042

130043

130044

130045

130046

130047

Warner-Lambert Co. Listerine Antiseptic
130048 Cooper Laboratories, Inc. Amosan

130049

130050

Ciba-Geigy Corp. Domiphen Bromide
130051 Ayerst laboratories Larylgan Throat Spray
130052 Julius Schmid, Inc. Comments

130053

130054

130055

Johnson and Johnson Micrin Plus Gargle and Rinse
130056 Purdue Frederick Co. Betadine
130057 Blair Laboratories, Inc. Isodine Concentrate
130058 E.R. Squibb and Sons, Inc.

Spec-T Decongestant Lozenges

Spec-T Cough Suppressant

Spec-T Anesthetic Lozenges

Spec-T Throat Spray

130059 Block Drug Co., Inc. Anesthetic, Aqueous and Concentrate Mouthwash, and Aerosol Spray
130060 Scott Laboratories, Inc. Scott’s Certified Peroxide of Hydrogen

130061

130062

Merrell-National Laboratories Anesthetic Gargle/Rinse/Spray

130063

130064

130065

Block Drug Co., Inc. Chloraseptic
130066 International Pharmaceutical Corp. Gly-oxide Liquid

130067

130068

130069

Merrell-National Laboratories

Cepacol Mouthwash/Gargle

Cepacol Lozenges

Cepacol Troches

Cepacol Discs

130070 E.R. Squibb and Sons, Inc.

Spec-T Sore Throat/Decongestant Lozenge

Spec-T Sore Throat/Cough Suppressant Lozenge

Spec-T Sore Throat/Anesthetic Lozenge

130071 Cooper Laboratories, Inc. Amosan
130072 Schmidt Laboratories Comments
130073 McKesson Laboratories Isodettes Throat Lozenges
130074 Warner-Lambert Co. Listerine Throat Lozenges
130075 Hynson, Westcott, and Dunning, Inc. Thantis Lozenges
130076 LaWall and Harrison Research laboratories, Inc. Troutman’s Cough Syrup
130077 Reed and Carnrick Pharmaceuticals Anesthetic Mouthwash
130078 Procter and Gamble Co. Scope Mouthwash and Gargle

130079

130080

Calgon Consumer Products Co., Inc. Sucrets Sore Throat Lozenges
130081 Reed and Carnrick Pharmaceuticals Anesthetic Mouthwash
130082 Whitehall  Laboratories Anbesol
130083 Reed and Carnrick Pharmaceuticals Benzocaine Spray
130084 International Pharmaceutical Corp. Gly-oxide Liquid
130085 Cooper Laboratories, Inc. Oral-B Antiseptic Drops
130086 The Proprietary Association Journal of Periodontal Research, Supplement No. 14, 1975
130087 Sterling Drug, Inc.

Campho-Phenique Liquid

Campho-Phenique Powder

130088 Ryatan Co., Inc.

Choresium - Data

Supplement to Volume 130015

130089

130090

Merrell-National Laboratories Cepacol - Addendum to Volume 130007
130091 Bernard L. Oser Associates, Inc. Statement Data to Volume 130042
130092 Warner-Lambert Co. Supplemental Data to Volume 130042
130093 Cooper Laboratories, Inc.. Supplemental Dat - “Actions of Oxygenating Agents on Oral Inflamations”
130094 Cooper Laboratories, Inc. Supplement to Volume 130085 - Oral-B Antiseptic Drops
130095 Richardson-Merrell, Onc. Vicks Throat Lozengers - Supplement to Volume 130019
130096 Warner-Lambert Co. Supplemental Data to Volume 130042
130097

Panelist

Martin J. Goldberg,

D.D.S.

Three Papers from V. Periodontology, Volumes 45-46
130098 Cooper Laboratories, Inc. Amosan - Upadate of Data and Information to Volumes 130048, 130071, 130085, and 130093
130099

Industry Liaison

Joseph D. Ambrozaitis,

D.D.S., Ph. D.

Bibliography: “A Review of mal Odor”

130100

130101

Sterling Drug, Inc. Campho-Phenique - Addendum to Volume 130087.
130102 Colgate-Palmolive Co. Benzethonium Chloride Mouthrinse
130103 The Proprietary Association Letter of June 26, 1976 and Position Paper - Rationale for Establishing Antiseptic Activity Mouthrinses
130104 Plough, Inc. Aspergum
130105 Sterling Drug, Inc. Campho- Phenique - Supplement to Volume 130087
130106 Richardson-Merrell, Inc. Cepacol Professional labeling for Mouthwash Gargle, Throat Lozenges, Anesthetic Troches
130107 Warner-Lambert Co. Listerine - Supplement to Volume 130042
130108 The Proprietary Association Letter on Mouth-odors
130109 American Association of Poison Control Centers Letter on Camphor
130110-A The Proprietary Association Statement on Combining Multiple Ingredients
130110-B The Proprietary Association Statement on the Evaluation of Mouthrinses
130111 Cooper Laboratories, Inc. Amosan - Supplemental Information to Volumes 130048, 130071, 130085 and 130093
130112 BASF Wyandotte Corp. Pluronic Polyols - Toxicity and irritation Data
130113 Richardson-Merrell, Inc. Metholated Cough Drops - Updating Information to Volume 130019
130114 Richardson-Merrell, Inc. Letter Relevant to the Panel’s In-vitro Guidelines for an Antiseptic/Antimicrobial Mouthwash
130115 Colgate-Palmolive Co. Benzethonium Chloride - Supplemental Data to Volume 130102
130116 Richardson-Merrell, Inc. Oracin Throat Lozenges - Supplemental Data to Volume 130020
130117 The Proprietary Association OTC Oral Topical Antiseptics
130118 Procter and Gamble Co. Addendum to Volume 130078 - Additional Data
130119 The Proprietary Association OTC Combinations
130120 Colgate-Palmolive Co. Benzethonium Chloride - Supplemental Data to Volume 130102
130121 Warner-Lambert Co. Addendum to Volume 130042
130122 Richardson-Merrell, Inc. Cepacol Concentrate - Labels for Dental Decanter and Gallon Bottle
130123 Cooper Laboratories, Inc. Oral B Antiseptic Drops - Supplemental Information to Volume 130048
130124 Richardson-Merrell, Inc. Menthol - Additional Data to Volume 130019
130125 Warner-Lambert Co. Listerine - Additional Data to Volume 130042
130126 Warner-Lambert Co. Listerine - Additional Data to Volume 130042
130127 Beecham Products Dyclonine Lozenges
130128 Beecham Products Dyclonine Lozenges
130129 Beecham Products Dyclonine Lozenges
130130-A Beecham Products Dyclonine Lozenges
130130-B Beecham Products Dyclonine Lozenges
130131 Norwich  Pharmacal Chloraseptic Products - Additional Data to Volume 130038
130132 The Proprietary Association The Effectiveness of Locally Applied Topical Anesthetics
130133 The Proprietary Association Guidelines for the Evaluation of Mouthwashes for the Reduction of Intrinsic Oral Malodor
130134 Procter and Gamble Co. Cetylpyridinium Chloride and Domiphen Bromide Data
130135 Warner-Lambert Co. Listerine Antiseptic
130136 Warner-Lambert Co. Listerine Antiseptic
130137 Warner-Lambert Co. Listerine Antiseptic
130138 Merrell-National Laboratories Cepacol Mouthwash/Gargle
130139 Cooper Laboratories, Inc. Amosan
130140 Warner-Lambert Co. Listerine Antiseptic - Volatile Oils/Topical
130141 The Proprietary Association In-vitro Evaluation of Antimicrobial Mouthrinses
130142 The Proprietary Association In-vitro Evaluation of Antimicrobial Mouthrinses - Volumes 1,2, and 3 - Comments to the panel’s Draft Report
130143 Beecham Products Sore throat Product Labeling
130144 Lever Brothers Co. In-vitro Antimicrobial Testing Guidelines
130145 Oral Products Hedonics “Bad Breath”
130146 Richardson-Merrell, Inc.  Oracin Throat Lozenges
130147 Ralph B. D’Agostino Statistical Evaluation of Studies on Cepacol and Scope
130148 Ralph B. D’Agostino Statistical Analysis of Listerine Antiseptic
130149 Division of Medical Sciences, National Research Council/National  Academy of  Sciences Drug Efficacy Study
130150 Merrell-National Laboratories Effects of Local Anesthetics on Tactile Sensitivity Thresholds for Cutaneous and Mucous Membranes
130151 Merrell-National Laboratories Cetylpyridinium Chloride/Sodium Fluoride Solution
130152 Cooper Laboratories, Inc. Amosan
130153 Marion  Laboratories Guidelines for Testing the Effectiveness of Locally Applied Topical Antiseptics Other Than Mouthrinses
130154 Hynson, Wescott, and Dunning, Inc. Thantis Lozenges (was 170040)
130155

Panelist

Arthur N. Bahn, Ph.D.

The Efficacy of Mouthwashes
130156 Warner-Lambert Co. Listerine
130157 Cooper Laboratories, Inc. Amosan
130158 Cooper Laboratories, Inc. Amosan
130159 Cooper Laboratories, Inc. “Absorption of Boron after Mouthwash Treatment with Bocosept”
130160 Procter and Gamble Co. Active Ingedients in Scope - Cetylpyridinium Chloride and Domiphen Bromide
130161 Procter and Gamble Co. Information Provided to Dr. D’Agostino for Statistical Evaluation
130162 The Proprietary Association Information Pertaining to a Presentation by the Proprietary Association to the Panel
130163 The Proprietary Association Effectiveness of Locally Applied Topical Antiseptics
130164 Warner-Lambert Co. Listerine Antiseptic - Drug vs Cosmetic Claims/Comment on Draft Report
130165 Merrell-National Laboratories Safety and Effectiveness of Cetylpyridinium Chloride
130166 Merrell-National Laboratories Safety and Effectiveness of Cetylpyridinium Chloride
130167 Merrell-National Laboratories Safety and Effectiveness of Cetylpyridinium Chloride
130168 Merrell-National Laboratories Safety and Effectiveness of Cetylpyridinium Chloride
130169 Merrell-National Laboratories Safety and Effetiveness of Cetylpyridinium Chloride
130170 Merrell-National laboratories Safety and Effectiveness of Cetylpyridinium Chloride
130171 Merrell-National Laboratories Safety and Effectiveness of Cetylpyridinium Chloride
130172 Warner-Lambert Co. Relationship between Plaque, Bacteria, and Oral Disease
130173

Walter J. Loesche,

D.M.D., Ph. D

In-vitro and In-vivo Testing of Antiseptic Mouthrinses
130174 Procter and Gamble Co. Dental Plaque - Gingivitis and Dental Caries
130175 Forsyth  Dental Center Methods for Measuring Plaque
130176 Purdue Frederick Co. Povidone-Iodine
130177 Whitehall Laboratories, Inc. Anbesol
130178 Louis P. Gangerosa, Sr., D.D.S. Comments
130179 Warner-Lambert Co. Listerine
130180 Plough, Inc. Topical Analgesics (Asprin) and Sore Throat
130181 Nathaniel H. Rowe, D.D.S. Comments - Dental Plaque
130182 The Proprietary Association Soft Tissue Responses to High Frequency Use of Experimental and Commercial Mouthwashes
130183 Purdue Frederick Co. Providone-Iodine - Testing
130184

Panelist

Arthur N. Bahn, Ph. D.

Minority Report, OTC advisory Panel on OTC oral Cavity Drug Products
130185 Irwin D. Mandel, D.D.S. Plaque and Dental Disease
130186 Cooper Laboratories, Inc. Amosan
130187 Procter and Gamble Co. Domiphen Bromide Alone and in Combination with Cetylpyridinium Chloride
130188 The Proprietary association Comments on the Information Copy of the panel’s Report
130189

Panelist

Walter E. Loch, M.D.

Comments on Monograph
130190 The Proprietary Association Comments on “Methods of Expressing Strength of Drugs”
130191 University Faculty Members Comments on Plague, Gingivitis, or Microbial Activity in the Mouth as Related to OTC Mouthwashes
130192 Panel Chairman Lawrences Cohen, Ph. D., M.D., D.D.S. Statement to the OTC Panel
130193 D. B. Smith, D.D.S. Clarification of Data in his Paper on Mouthwashs and Oral Cancer

Public Administrative File 
OTC Oral Health Care Drug Products 

(Docket No. 81N-0033)
Alphabetical Listing of References Cited in the Report

VOLUME CONTENTS
130194 A
130195 B
130196 C
130197 D-E
130198 F-G
130199 H-J
130200 K-L
130201 M-N
130202 O-R
130203 S
130204 T-Z
130205 Miscellaneous Uncited References A-G
130206 Miscellaneous Uncited references H-Z

Public Administrative File
OTC Oral Health Care Drug Products
(Docket No. 81N-0033)
Panel Administrator’s File

VOLUME CONTENTS
130PA1

Panel Administrator’s File

Volume I - General

1.1    Calls for Data

1.2    List of Panel Members and Liaisons

1.3    Curriculum Vitae for Panel Memebrs and Liaisons

1.4    General and Specific Charges to Panel

1.5    Index of Panel Submissions

130PA2

Panel Administrator’s File,

Volume II - Minutes of Panel Meetings

130PA3

Panel Administrator’s File,

Volume III - Correspondence File (1973-1982).

Top