The short answer
The difference is one word: sweat. A deodorant fights odor and is a cosmetic. An antiperspirant reduces sweating and is an OTC drug. Most “antiperspirant deodorants” are both.
| Requirement | What it means | Who |
|---|---|---|
| Facility registration (MoCRA) | Facilities that manufacture or process cosmetics for the US register with FDA and renew every two years | The manufacturing facility |
| Product listing | Each product is listed with its ingredients, and updated every year | The Responsible Person |
| Label | English label: identity, net quantity, ingredients in descending order, name and place of business, warnings, and a contact for adverse event reports | The brand |
| Antiperspirant = OTC drug | Adds drug registration, listing (NDC), Drug Facts and monograph compliance | The brand / manufacturer |
| Safety substantiation | Records showing the product is safe as used | The Responsible Person |
| Adverse event reporting | Serious adverse events reported to FDA within 15 business days | The Responsible Person |
Side by side
| Deodorant | Antiperspirant (or AP/deo) | |
|---|---|---|
| Legal status | Cosmetic | OTC drug (+ cosmetic) |
| Registration | MoCRA facility registration | Drug establishment registration |
| Listing | MoCRA product listing | Drug listing with an NDC |
| Label | Cosmetic label with ingredient list | Drug Facts: active ingredient first, then inactive ingredients |
| Claims | Odor, freshness, fragrance | Reduces underarm wetness / perspiration, as the monograph allows |
The claims trap
“Natural” deodorant brands often run into trouble with claims like “stops sweat”, “keeps you dry”, “detoxifies” or “prevents infection”. FDA decides a product's status by its intended use, shown by label, website and advertising claims. A drug claim on a product that does not meet drug requirements makes it an unapproved drug.
Combined products
FDA's guidance says products that are both cosmetics and drugs must meet both sets of rules. The label combines them: active ingredients first as “Active Ingredients”, then the cosmetic ingredients as “Inactive Ingredients”.
Example
A personal care company in Thailand sells a natural crystal deodorant and an aluminum-based antiperspirant stick. The deodorant is registered and listed under MoCRA and only talks about odor and freshness. The antiperspirant is made in a registered drug establishment, listed with an NDC, and carries a Drug Facts label.
What FDA does — and does not do — for cosmetics
FDA does not approve cosmetic products or their labels before they are sold (color additives are the exception). Registration and listing are not an approval, so never write “FDA approved” or “FDA certified” on a cosmetic label or website. Under MoCRA, the brand carries the responsibility: it must be able to show the product is safe as used, and FDA can inspect records, ask for safety information and, in serious cases, suspend a facility's registration or order a recall.
At the US border, FDA reviews imported cosmetics and can detain a shipment that appears adulterated or misbranded — for example a wrong or missing English label, an unapproved color, a prohibited ingredient or drug claims. Detained goods must be brought into compliance, exported or destroyed, so it pays to fix problems before the first shipment.
Small businesses: what MoCRA exempts
MoCRA exempts certain small businesses from facility registration, product listing and GMP. The exemption does not cover products that regularly touch the eye's mucous membrane, injected products, products for internal use, or products meant to change appearance for more than 24 hours. Labeling, safety substantiation and adverse event reporting are not on the exempt list — and many US retailers and marketplaces ask for registration and listing anyway.
Step by step: selling your deodorant or antiperspirant in the US
- 1Decide: cosmetic, drug or bothYour claims and ingredients decide it. A drug needs drug registration, listing and Drug Facts labeling.
- 2Register the manufacturing facilityUnder MoCRA, and renew every two years. Foreign facilities name a U.S. Agent.
- 3List every productThe Responsible Person lists each product with its ingredients and updates the listing every year.
- 4Make the label US-readyEnglish text, ingredient list, warnings, contact for adverse events — and the product-specific points above.
- 5Keep safety records and an adverse event processSafety substantiation on file; serious adverse events reported within 15 business days.
Checklist
- Each product classed as deodorant (cosmetic) or antiperspirant (drug)
- Deodorant: MoCRA registration, listing, odor-only claims
- Antiperspirant: drug registration, NDC listing, Drug Facts, monograph compliance
- Website and marketplace claims match the product's status
- Safety records and adverse event process in place
Tell us your products — we send your MoCRA and FDA requirements in writing, free.
Frequently asked questions
Is deodorant regulated as a cosmetic?
Yes. A product that only reduces or masks body odor is a cosmetic, so the MoCRA requirements apply: facility registration, product listing, a compliant cosmetic label, safety records and adverse event reporting.
Why is antiperspirant a drug?
An antiperspirant reduces sweating — it affects a body function — so it is an OTC drug. FDA gives antiperspirant-deodorants as an example of products that are both cosmetics and drugs.
What label does an antiperspirant need?
A Drug Facts label, with the active ingredient (for example an aluminum compound) listed first, followed by the cosmetic ingredients as inactive ingredients, plus the directions and warnings required for the product.
Can a natural deodorant say “stops sweat”?
No — unless it is a compliant antiperspirant drug. Claims to stop or reduce sweating are drug claims. A cosmetic deodorant can talk about odor, freshness and fragrance.
Who is the Responsible Person under MoCRA?
The manufacturer, packer or distributor whose name appears on the label. The Responsible Person lists the products, keeps safety records and reports serious adverse events to FDA within 15 business days.
Are small cosmetic businesses exempt from MoCRA?
Certain small businesses are exempt from facility registration, product listing and GMP — but not for products that touch the eye’s mucous membrane, injected products, products for internal use or products that change appearance for more than 24 hours. Labeling, safety records and adverse event reporting still apply.
Sources
- FDA — Modernization of Cosmetics Regulation Act of 2022 (MoCRA) (content current as of Oct 29, 2026)
- FDA — Summary of Cosmetics Labeling Requirements
- FDA — Is It a Cosmetic, a Drug, or Both? (Or Is It Soap?)
Dates, fees and regulation numbers checked against FDA and Federal Register sources on November 8, 2026. This article is general information, not legal advice.