Common products that are OTC drugs in the U.S.
- Sunscreens, including makeup and moisturizers with SPF
- Hand sanitizers and antibacterial soaps
- Antiperspirants
- Acne treatments, such as benzoyl peroxide or salicylic acid products
- Anti-dandruff shampoos
- Fluoride toothpaste
- Pain relief creams, medicated lip balms and skin protectants
Not sure whether yours is a cosmetic or a drug? See cosmetic or drug?
What an OTC drug needs
- Establishment registration for each facility that makes, repacks or relabels it, renewed every year between October 1 and December 31. Facilities outside the U.S. name a U.S. Agent.
- An NDC and drug listing for each product. See how NDCs work.
- An OTC monograph: most OTC drugs are sold under FDA's monographs, which set the allowed active ingredients, strengths and claims. Products outside a monograph need an approved application.
- A "Drug Facts" label in FDA's required format.
- Drug manufacturing rules (21 CFR Parts 210 and 211), including testing.
- FDA facility fees: OTC monograph drug facilities pay an annual fee to FDA, set every year.
Hand sanitizers: extra caution
FDA has found many imported hand sanitizers containing methanol or other contaminants, and has stopped shipments at the border. Use only allowed active ingredients at the right strength, test each batch, and keep the records.
Sunscreens: a common surprise
Sunscreens sold as cosmetics in the EU, Japan or Korea are OTC drugs in the U.S. The allowed UV filters are more limited, the Drug Facts label is required, and SPF claims must be supported by testing.
Questions
Can we register our sunscreen under MoCRA?
No. Products that are drugs follow drug registration and listing. If a product is both a cosmetic and a drug, drug rules apply.
Do we pay FDA a fee for OTC drugs?
Registration and listing are free, but OTC monograph drug facilities pay an annual facility fee to FDA. We tell you whether it applies to you.
Can Regovant register our OTC products?
Yes. Registration, labeler code and U.S. Agent service is $369 a year, and each drug listing is $169.
How Regovant can help
Regovant LLC registers drug establishments, obtains NDC labeler codes, lists products and acts as U.S. Agent for $369 a year, plus $169 per drug listing. See the drug registration service, all guides or prices.