Regulatory Information
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 |
