FDA Registration for Acne Cream Products
Acne cream products containing benzoyl peroxide, salicylic acid, or sulfur are regulated as OTC Monograph drugs by FDA — requiring drug establishment registration, NDC labeler code, and Drug Facts labeling.
OTC MonographDrug Facts Labeling21 CFR Part 207Since 2009
FDA Requirements for Acne Cream Products
Acne cream products are a specific formulation of OTC acne drug products. Benzoyl peroxide (2.5%–10%) is the most common active ingredient in OTC acne creams.
All manufacturers of acne cream products must register with FDA as drug establishments, obtain an NDC labeler code, and list each product with Drug Facts labeling.
- FDA Drug Establishment Registration
- NDC Labeler Code
- Drug Listing in SPL format with Drug Facts panel
- Annual renewal October 1–December 31
- GMP compliance 21 CFR Parts 210 & 211
Acne Cream Products — FAQs
Common questions about FDA registration requirements for acne cream products.
Is acne cream considered a drug?
Yes. Acne creams containing active drug ingredients (benzoyl peroxide, salicylic acid) are OTC drugs regulated by FDA.
What benzoyl peroxide concentration is allowed in OTC acne creams?
Benzoyl peroxide at 2.5%–10% is permitted in OTC acne drug products under FDA Monograph.
Ready to Register Your Acne Cream Products?
LMG handles drug establishment registration, OTC drug listing, and NDC labeler code for acne cream products manufacturers worldwide.
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