OTC Monograph Number Search

What is an OTC Monograph?

Think of an OTC monograph as a rulebook for a specific category of OTC drugs. It establishes the guidelines under which a drug can be considered generally recognized as safe and effective (GRASE) for its intended use, without needing a full drug application approval process (NDA or ANDA).

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.

OTC Monograph Number Search

OTC Monograph Number

FDA OTC Monograph Title

M001

Antacid Products for Over-the-Counter Human Use

M002

Antiflatulent Products for OTC Human Use

M003

First Aid Antiseptic Drug Products for Over-the-Counter Human Use

M004

First Aid Antibiotic Drug Products for Over-the-Counter Human Use

M005

Topical Antifungal Drug Products for Over-the-Counter Human Use

M006

Topical Acne Drug Products for Over-the-Counter Human Use

M007

Laxative Drug Products for Over-the-Counter Human Use

M008

Antidiarrheal Drug Products for Over-the-Counter Human Use

M009

Antiemetic Drug Products for Over-the-Counter Human Use

M010

Nighttime Sleep Aid Drug Products for OTC Human Use

M011

Stimulant Drug Products for Over-the-Counter Human Use

M012

Cold, Cough, Allergy, Bronchodilator, and Antiasthmatic Drug Products for Over-the-Counter Human Use

M013

Internal Analgesic, Antipyretic, and Antirheumatic Drug Products for Over-the-Counter 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

M017

External Analgesic Drug Products for Over-the-Counter Human Use

M018

Ophthalmic Drug Products for Over-the-Counter Human Use

M019

Antiperspirant Drug Products for Over-the-Counter Human Use

M020

Sunscreen Drug Products for Over-the-Counter Human Use

M021

Anticaries Drug Products for Over-the-Counter Human Use

M022

Oral Healthcare Drug Products for Over-the-Counter Human Use

M023

Poison Treatment Drug Products for Over-the-Counter Human Use

M024

Anthelmintic Drug Products for Over-the-Counter Human Use

M025

Cholecystokinetic Drug Products for Over-the-Counter Human Use

M026

Deodorant Drug Products for Internal Use for Over-the-Counter Human Use

M027

Orally Administered Menstrual 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

M032

Drug Products for the Control of Dandruff, Seborrheic Dermatitis, and Psoriasis for Over-the-Counter Human Use

NM900

Non-Monograph Conditions NM900: Drug Products Containing Certain Active Ingredients Offered Over-the-Counter for Certain Uses

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