FDA Registration for Acne Drug Products

Acne drug 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 listing.

OTC MonographDrug Facts Labeling21 CFR Part 207Since 2009

FDA Requirements for Acne Drug Products

Acne drug products are regulated as over-the-counter (OTC) drugs under FDA’s OTC Monograph system. The active ingredients permitted in OTC acne drug products include benzoyl peroxide (2.5–10%), salicylic acid (0.5–2%), and sulfur (3–10%).

All manufacturers of OTC acne drug products must: (1) Register their drug establishment with FDA, (2) Obtain an NDC Labeler Code, (3) List each acne product with FDA in SPL format with Drug Facts labeling.

FDA Drug Establishment Registration — required for manufacturers, repackers, re-labelers
NDC Labeler Code — unique identifier required for all acne drug products
Drug Listing in SPL Format — with Drug Facts panel uploaded
Annual Renewal — October 1–December 31 each year
GMP Compliance — 21 CFR Parts 210 & 211

Over-the-counter (OTC) acne products are regulated by the FDA through a monograph system. This means there are specific rules manufacturers must follow to ensure their products are safe and effective. These rules cover things like the types and concentrations of ingredients allowed in the product, as well as the labeling. There are five ingredients currently approved for OTC acne treatment: benzoyl peroxide, salicylic acid, sulfur, and combinations of resorcinol or resorcinol monoacetate with sulfur. These ingredients work in various ways to combat acne such as reducing the number of acne pimples, blackheads or whiteheads and and allows skin to heal.

Active Ingredients	OTC Monograph Number
Benzoyl peroxide, 2.5 to 10 percent	M006.10 (Part 333)
Resorcinol, 2 percent, when combined with sulfur	M006.10 (Part 333)
Resorcinol monoacetate, 3 percent, when combined with sulfur	M006.10 (Part 333)
Salicylic acid, 0.5 to 2 percent	M006.10 (Part 333)
Sulfur, 3 to 10 percent	M006.10 (Part 333)
Sulfur, 3 to 8 percent when combined with resorcinol or resorcinol monoacetate	M006.10 (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.

Acne Drug Products — FAQs

Common questions about FDA registration requirements for acne drug products.

Are acne products drugs or cosmetics?

Acne products containing active ingredients like benzoyl peroxide or salicylic acid are regulated as drugs, not cosmetics. Products making only cosmetic claims may be classified as cosmetics.

What is the OTC Monograph for acne products?

FDA OTC Acne Monograph specifies the permitted active ingredients, concentrations, indications, and labeling requirements for non-prescription acne drug products.

Do I need FDA registration to sell acne products in the USA?

Yes. If you manufacture an acne product, you must register your establishment with FDA and list the product before marketing in the USA.