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 11/12/2021
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

Note: If you need help accessing information in different file formats, see Instructions for Downloading Viewers and Players.
Language Assistance Available: Español | 繁體中文 | Tiếng Việt | 한국어 | Tagalog | Русский | العربية | Kreyòl Ayisyen | Français | Polski | Português | Italiano | Deutsch | 日本語 | فارسی | English