OTC Monographs@FDA
OTC Monographs@FDA provides a resource for the public to view proposed, final, and interim final orders for OTC monograph drugs. OTC Monographs@FDA also facilitates the submission of comments and data from the public for proposed and interim final administrative orders, except if otherwise specified.
Some final orders incorporate by reference material that is available for inspection at FDA. For further information about inspecting incorporated material, contact druginfo@fda.hhs.gov.
OTC Monographs
Administrative Orders
| Order ID | Order Title | Status | Comments Due |
|---|---|---|---|
| OTC000001 | Over-the-Counter Monograph M002: Antiflatulent Products for Over-the-Counter Human Use | Final Order | N/A |
| OTC000002 | Over-the-Counter Monograph M010: Nighttime Sleep-Aid Drug Products for Over-the-Counter Human Use | Final Order | N/A |
| OTC000003 | Over-the-Counter Monograph M014: Topical Otic Drug Products for Over-the-Counter Human Use ` | Final Order | N/A |
| OTC000004 | Over-the-Counter Monograph M030: Corn and Callus Remover Drug Products for Over-the-Counter Human Use | Final Order | N/A |
| OTC000005 | Over-the-Counter Monograph M016: Skin Protectant Drug Products for Over-the-Counter Human Use | Final Order | N/A |
| OTC000006 | Over-the-Counter Monograph M020: Sunscreen Drug Products for Over-the-Counter Human Use | Final Order | N/A |
| OTC000007 | Non-Monograph Conditions NM900: Drug Products Containing Certain Active Ingredients Offered Over-the-Counter for Certain Uses | Final Order | N/A |
| OTC000008 | Amending Over-the-Counter Monograph M020: Sunscreen Drug Products for Over-the-Counter Human Use | Proposed Order | 12/27/2021 |
| OTC000009 | Over-the-Counter Monograph M015: Anorectal Drug Products for Over-the-Counter Human Use | Final Order | N/A |
| OTC000010 | Over-the-Counter Monograph M028: Wart Remover Drug Products for Over-the-Counter Human Use | Final Order | N/A |
| OTC000011 | Over-the-Counter Monograph M029: Ingrown Toenail Relief Drug Products for Over-the-Counter Human Use | Final Order | N/A |
| OTC000012 | Over-the-Counter Monograph M031: Pediculicide Drug Products for Over-the-Counter Human Use | Final Order | N/A |
| OTC000013 | Over-the-Counter Monograph M006: Topical Acne Drug Products for Over-the-Counter Human Use | Final Order | N/A |
| OTC000014 | Over-the-Counter Monograph M009: Antiemetic Drug Products for Over-the-Counter Human Use | Final Order | N/A |
| OTC000015 | Over-the-Counter Monograph M019: Antiperspirant Drug Products for Over-the-Counter Human Use | Final Order | N/A |
| OTC000016: | Over-the-Counter Monograph M026: Deodorant Drug Products for Internal Use for Over-the-Counter Human Use | Final Order | N/A |
| OTC000017 | Over-the-Counter Monograph M005: Topical Antifungal Drug Products for Over-the-Counter Human Use | Final Order | N/A |
| OTC000018 | Over-the-Counter Monograph M024: Anthelmintic Drug Products for Over-the-Counter Human Use | Final Order | N/A |
| OTC000019 | Over-the-Counter Monograph M025: Cholecystokinetic Drug Products for Over-the-Counter Human Use | Final Order | N/A |
| OTC000020 | Over-the-Counter Monograph M027: Orally Administered Menstrual Drug Products Over-the-Counter Human Use | Final Order | N/A |
| OTC000021 | Over-the-Counter Monograph M032: Drug Products for the Control of Dandruff, Seborrheic Dermatitis, and Psoriasis for Over-the-Counter Human Use | Final Order | N/A |
| OTC000022 | Over-the-Counter Monograph M008: Antidiarrheal Drug Products for Over-the-Counter Human Use | Final Order | N/A |
| OTC000023 | Over-the-Counter Monograph M018: Ophthalmic Drug Products for Over-the-Counter Human Use | Final Order | N/A |