OTC Monograph Drug Products — FDA

Over-the-counter drug products marketed under FDA monographs must comply with specific formulation, labeling, and registration requirements. LMG assists OTC drug manufacturers with full FDA compliance.

OTC Monograph ID M001 - M032CARES Act OTC ReformAnnual Registration

OTC Drug Product Services

LMG assists OTC drug manufacturers with FDA registration, OTC monograph compliance, drug listing, and label review for all monograph categories.

OTC Drug Listing & Registration

Complete establishment registration and drug listing services for OTC manufacturers. LMG prepares and submits all required SPL files using our proprietary software to ensure accurate electronic submissions to the FDA.

OTC Drug Facts Labeling

FDA-compliant Drug Facts panel preparation for OTC products. We format your labeling according to regulatory standards, ensuring all required information—active ingredients, uses, warnings, directions, and inactive ingredients—appears correctly.

OTC Monograph Compliance

Ensure your OTC drug products comply with applicable FDA monographs. We review formulations, labeling, and Drug Facts panels against current monograph requirements to verify regulatory compliance before market entry.

Private Label OTC Services

Specialized support for private label OTC products including labeler code assignment, product listing, and NDC labeling compliance. We handle the complete regulatory process for retailers and distributors entering the OTC market.

How It Works

We manage the entire process from start to finish — so you can focus on your business.

Monograph Assessment

We identify the applicable FDA OTC monograph for your product and confirm all formulation and labeling requirements.

Registration & Listing

We handle your drug establishment registration and complete drug listing submission for all OTC products.

Label Compliance Review

We review your drug facts panel and complete labeling against monograph and 21 CFR Part 201 requirements.

Ongoing Compliance

We monitor OTC monograph updates and OMOR requirements that affect your product category.

Frequently Asked Questions

Common questions about this FDA regulatory service.

What is an OTC monograph?

An FDA OTC monograph is a regulation that specifies the conditions under which certain OTC drug ingredients are generally recognized as safe and effective (GRASE). Products that conform to a monograph can be marketed without an NDA.

Do OTC monograph products need FDA registration?

Yes. Manufacturers, repackers, and relabelers of OTC monograph drug products must register their establishments with FDA and list their drug products — even though no NDA is required.

What changed under the CARES Act OTC reform?

The CARES Act (2020) modernized the OTC monograph system — replacing the traditional rulemaking process with administrative orders and establishing OTC Monograph Order Request (OMOR) fees.

What information is required on the drug facts panel?

The drug facts panel must include active ingredients with purposes, uses, warnings, directions, inactive ingredients, and other information — in the FDA-required format and order specified in 21 CFR Part 201.66.