U.S. flag An official website of the United States government
  1. Home
  2. Drug Databases
  3. OMUF

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.


 
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
Back to Top