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U.S. Department of Health and Human Services

Regulatory Information

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OTC Panel Submissions (Indices Only): Comment Files for Panel Submissions

Number

Subject Matter/Docket No.
01

Antacid

75N-0357

02

Antimicrobial I

5N-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

6N-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 Contraceptive

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

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