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

OTC Monograph ID	OTC Monograph Title
M002	Antiflatulent Products for OTC Human Use
M010	Nighttime Sleep Aid Drug Products for OTC Human Use
M014	Topical Otic Drug Products for OTC Human Use
M015	Anorectal Drug Products for Over-the-Counter Human Use
M016	Skin Protectant Drug Products for Over-the-Counter Human Use
M020	Sunscreen Drug Products for Over-the-Counter Human Use
M028	Wart Remover Drug Products for Over-the-Counter Human Use
M029	Ingrown Toenail Relief Drug Products for Over-the-Counter Human Use
M030	Corn and Callus Remover Drug Products for OTC Human Use
M031	Pediculicide Drug Products for Over-the-Counter Human Use

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