OTC Monograph Number Search

An OTC monograph number identifies the specific FDA monograph under which your OTC drug is marketed. It must be included in your FDA drug listing submission.

Drug Listing RequiredSPL FormatGRASE StatusSince 2009

OTC Monograph Number Search

OTC Monograph Number	FDA OTC Monograph Title
M001	Antacid Products for OTC Human Use
M002	Antiflatulent Products for OTC Human Use
M003	First Aid Antiseptic Drug Products for OTC Human Use
M004	First Aid Antibiotic Drug Products for OTC Human Use
M005	Topical Antifungal Drug Products for OTC Human Use
M006	Topical Acne Drug Products for OTC Human Use
M007	Laxative Drug Products for OTC Human Use
M008	Antidiarrheal Drug Products for OTC Human Use
M009	Antiemetic Drug Products for OTC Human Use
M010	Nighttime Sleep Aid Drug Products for OTC Human Use
M011	Stimulant Drug Products for OTC Human Use
M012	Cold, Cough, Allergy, Bronchodilator, and Antiasthmatic Drug Products for OTC Human Use
M013	Internal Analgesic, Antipyretic, and Antirheumatic Drug Products for OTC Human Use
M014	Topical Otic Drug Products for OTC Human Use
M015	Anorectal Drug Products for OTC Human Use
M016	Skin Protectant Drug Products for OTC Human Use
M017	External Analgesic Drug Products for OTC Human Use
M018	Ophthalmic Drug Products for OTC Human Use
M019	Antiperspirant Drug Products for OTC Human Use
M020	Sunscreen Drug Products for OTC Human Use
M021	Anticaries Drug Products for OTC Human Use
M022	Oral Healthcare Drug Products for OTC Human Use
M023	Poison Treatment Drug Products for OTC Human Use
M024	Anthelmintic Drug Products for OTC Human Use
M025	Cholecystokinetic Drug Products for OTC Human Use
M026	Deodorant Drug Products for Internal Use for OTC Human Use
M027	Orally Administered Menstrual Drug Products for OTC Human Use
M028	Wart Remover Drug Products for OTC Human Use
M029	Ingrown Toenail Relief Drug Products for OTC Human Use
M030	Corn and Callus Remover Drug Products for OTC Human Use
M031	Pediculicide Drug Products for OTC Human Use
M032	Drug Products for the Control of Dandruff, Seborrheic Dermatitis, and Psoriasis for OTC Human Use
NM900	Non-Monograph Conditions NM900: Drug Products Containing Certain Active Ingredients Offered OTC for Certain Uses

What is an OTC Monograph Number?

An OTC monograph is a rulebook for a category of OTC drugs establishing GRASE (generally recognized as safe and effective) guidelines without requiring NDA or ANDA approval.

The monograph number (e.g., M020 for sunscreen) identifies which monograph your product follows and must be included in your FDA drug listing in SPL format.

OTC monograph outlines: permitted active ingredients, uses/indications, dosage, route of administration, and labeling requirements.

What Does an OTC Monograph Include?

An OTC monograph outlines several key aspects of an OTC drug:

Active Ingredients: This specifies the permitted ingredients that can be used in the drug.
Uses (Indications): The monograph clearly defines the conditions or symptoms the drug is approved to treat.
Dosage: It outlines the safe and effective amount of drug to be taken.
Route of Administration: This specifies how the drug should be taken (e.g., orally, topically).
Labeling: The monograph dictates the required information that must be included on the drug label, ensuring consumers have clear instructions and warnings.
Testing: The monograph may also establish testing requirements to ensure the drug meets quality standards.

OTC Monograph Number: Keeping Track

Each OTC monograph is assigned a unique identification number, following the format “M” followed by three digits (e.g., M001, M020). This number helps identify the specific set of rules a particular OTC drug falls under.

Marketing with a Final Order? Include the OTC Monograph Number!

If you are marketing an OTC drug under a final order from the FDA, it’s essential to include the relevant OTC monograph number in the “Marketing Category” field of your drug listing. This helps ensure compliance and clarity for both consumers and regulatory bodies.

For example, if you have a sunscreen product marketed under OTC Monograph M020, you would list “M020” as the OTC monograph number on your drug listing.