FDA Registration for Antiperspirant Drug Products

Antiperspirant products containing aluminum salts 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 Antiperspirant Drug Products

Antiperspirant products are regulated as OTC drugs by FDA. The OTC Antiperspirant Monograph permits aluminum salts (aluminum chlorohydrate, aluminum zirconium tetrachlorohydrex) as active ingredients.

Note: Deodorant products without antiperspirant claims and active ingredients are cosmetics, not drugs. A combination antiperspirant-deodorant is regulated as a drug.

FDA Drug Establishment Registration
NDC Labeler Code
Drug Listing with Drug Facts labeling
Annual renewal October 1–December 31

The Food and Drug Administration (FDA) has established an OTC monograph specifically for antiperspirant drugs. This monograph outlines the ingredients and labeling requirements to ensure these products are safe and effective. The allowed active ingredients are various aluminum salts, with concentration limits. Additionally, the monograph dictates what information must be included on the label, such as the product’s identity as an antiperspirant and its active ingredients. This regulation helps ensure that antiperspirants sold over-the-counter meet specific quality and safety standards.

Active Ingredients	OTC Monograph Number
(a) Aluminum chloride up to 15 percent, calculated on the hexahydrate form, in an aqueous solution nonaerosol dosage form	M019.10 (Part 350)
(b) Aluminum chlorohydrate up to 25 percent	M019.10 (Part 350)
(c) Aluminum chlorohydrex polyethylene glycol up to 25 percent	M019.10 (Part 350)
(d) Aluminum chlorohydrex propylene glycol up to 25 percent	M019.10 (Part 350)
(e) Aluminum dichlorohydrate up to 25 percent	M019.10 (Part 350)
(f) Aluminum dichlorohydrex polyethylene glycol up to 25 percent	M019.10 (Part 350)
(g) Aluminum dichlorohydrex propylene glycol up to 25 percent	M019.10 (Part 350)
(h) Aluminum sesquichlorohydrate up to 25 percent	M019.10 (Part 350)
(i) Aluminum sesquichlorohydrex polyethylene glycol up to 25 percent	M019.10 (Part 350)
(j) Aluminum sesquichlorohydrex propylene glycol up to 25 percent	M019.10 (Part 350)
(k) Aluminum zirconium octachlorohydrate up to 20 percent	M019.10 (Part 350)
(l) Aluminum zirconium octachlorohydrex gly up to 20 percent	M019.10 (Part 350)
(m) Aluminum zirconium pentachlorohydrate up to 20 percent	M019.10 (Part 350)
(n) Aluminum zirconium pentachlorohydrex gly up to 20 percent	M019.10 (Part 350)
(o) Aluminum zirconium tetrachlorohydrate up to 20 percent	M019.10 (Part 350)
(p) Aluminum zirconium tetrachlorohydrex gly up to 20 percent	M019.10 (Part 350)
(q) Aluminum zirconium trichlorohydrate up to 20 percent	M019.10 (Part 350)
(r) Aluminum zirconium trichlorohydrex gly up to 20 percent	M019.10 (Part 350)

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.

Antiperspirant Drug Products — FAQs

Common questions about FDA registration requirements for antiperspirant drug products.

Is an antiperspirant a drug or cosmetic?

Antiperspirants (reducing sweating) are OTC drugs. Deodorants (masking odor) are cosmetics. Combination products are drugs.

What aluminum salts are permitted in OTC antiperspirants?

Aluminum chlorohydrate, aluminum zirconium tetrachlorohydrex gly, and other aluminum salts are permitted at concentrations specified in the OTC Monograph.