FDA Registration for Antifungal Drug Products
OTC antifungal products containing clotrimazole, miconazole nitrate, or tolnaftate are regulated as OTC Monograph drugs by FDA — requiring establishment registration and drug listing.
FDA Requirements for OTC Antifungal Drug Products
OTC antifungal drug products are regulated under FDA’s OTC Monograph system. Permitted active ingredients include clotrimazole (1%), miconazole nitrate (2%), and tolnaftate (1%).
- FDA Drug Establishment Registration
- NDC Labeler Code
- Drug Listing with Drug Facts labeling
- Annual renewal October 1–December 31
Over-the-counter (OTC) antifungal products are topical medications regulated by the FDA for self-treatment of fungal infections. There’s a specific monograph, M005, outlining which ingredients are safe and effective at certain concentrations. These ingredients include clotrimazole, miconazole, tolnaftate, and various undecylenates.
| Active Ingredients | OTC Monograph Number |
|---|---|
| Clioquinol 3 percent | M005.10 (Part 333) |
| Haloprogin 1 percent | M005.10 (Part 333) |
| Miconazole nitrate 2 percent | M005.10 (Part 333) |
| Povidone-iodine 10 percent | M005.10 (Part 333) |
| Tolnaftate 1 percent | M005.10 (Part 333) |
| Undecylenic acid, calcium undecylenate, copper undecylenate, and zinc undecylenate may be used individually or in any ratio that provides a total undecylenate concentration of 10 to 25 percent | M005.10 (Part 333) |
| Clotrimazole 1 percent | M005.10 (Part 333) |
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.
Antifungal Drug Products — FAQs
Are OTC antifungal products regulated as drugs?
What antifungal ingredients are permitted OTC?
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LMG handles drug establishment registration, OTC drug listing, and NDC labeler code for antifungal drug products manufacturers worldwide.
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