FDA Registration for OTC Stimulant Drug Products
OTC stimulant products containing caffeine for temporary alertness are regulated as OTC Monograph drugs by FDA — requiring drug establishment registration, NDC labeler code, and Drug Facts labeling.
FDA Requirements for OTC Stimulant Drug Products
OTC stimulant drug products (alertness aids) are regulated by FDA. Caffeine (100–200mg per dose) is the only active ingredient permitted under the FDA OTC Stimulant Monograph.
- FDA Drug Establishment Registration
- NDC Labeler Code
- Drug Listing with Drug Facts labeling
- Annual renewal October 1–December 31
There is a specific FDA monograph for OTC stimulant drugs. This regulation outlines the ingredients and labeling requirements for these products. The only approved stimulant for OTC use is caffeine, which can help restore mental alertness or wakefulness during fatigue or drowsiness. The labeling must clearly state this purpose and include warnings about potential risks. Interestingly, the monograph prohibits combining caffeine with other stimulants like ephedrine due to safety concerns.
| Active Ingredients | OTC Monograph Number |
|---|---|
| Caffeine | M011.10 (Part 340) |
These are not complete lists of ingredients in the FDA OTC drug monograph. The status of ingredients in the OTC monograph may change. Please contact the FDA for updated information.
OTC Stimulant Drug Products — FAQs
Are caffeine tablets regulated as drugs?
What is the permitted OTC caffeine dose?
Ready to Register Your OTC Stimulant Products?
LMG handles drug establishment registration, OTC drug listing, and NDC labeler code for otc stimulant products manufacturers worldwide.
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