Quick answers
- What is BOTOX Cosmetic?
- BOTOX Cosmetic is a brand name of Incobotulinumtoxina, a prescription medicine. The FDA NDC Directory lists 2 BOTOX Cosmetic products in 2 strengths and forms.
- Who makes BOTOX Cosmetic?
- Allergan holds the FDA application for BOTOX Cosmetic (BLA103000, approved December 9, 1991).
- Is there a generic or store brand of BOTOX Cosmetic?
- Yes. The FDA NDC Directory lists 9 other products with the same active ingredients, strength and form as a BOTOX Cosmetic product. Ask your pharmacist whether one is right for you.
- Has BOTOX Cosmetic been recalled?
- No recall linked to BOTOX Cosmetic products (by their NDC code or label) appears in the FDA enforcement reports we use.
What BOTOX Cosmetic is
Each BOTOX Cosmetic product as listed in the FDA NDC Directory, by active ingredient, strength and form, with its official label. “Same medicine, other names” counts the other products with exactly the same active ingredients, strength and form (generic versions, store brands and other brands); inactive ingredients can differ.
Incobotulinumtoxina · prescription medicine
| Strength and form | Product names | Same medicine, other names | Label |
|---|---|---|---|
| botulinum toxin type a 100 USP units injection, powder, lyophilized, for solution (intramuscular) | BOTOX Cosmetic | 5 products, 4 companies | DailyMed |
| botulinum toxin type a 50 USP units injection, powder, lyophilized, for solution (intramuscular) | BOTOX Cosmetic | 4 products, 2 companies | DailyMed |
Its page lists every product and company, the FDA label’s uses and boxed warning, approvals, shortages and recalls: Incobotulinumtoxina →
FDA approval
- BLA: Biologics License Application: how a biologic medicine (made from living cells) is approved.
| Application | Holder | First approved | Products |
|---|---|---|---|
| BLA103000 | Allergan | December 9, 1991 | 2 |
Companies that list BOTOX Cosmetic
The company named on the package (holder, repackager or distributor), as listed in the FDA NDC Directory, with its number of BOTOX Cosmetic products.
- Allergan, Inc.2 products
Recalls
No recall linked to BOTOX Cosmetic products (by their NDC code or label) appears in the FDA enforcement reports.
Sources
- NDC Directory (openFDA) — U.S. Food and Drug Administration (FDA), FDA data exported October 30, 2026, retrieved October 31, 2026
- Drugs@FDA (openFDA) — U.S. Food and Drug Administration (FDA), FDA data exported October 30, 2026, retrieved October 31, 2026
- Drug labeling (SPL, openFDA) — U.S. Food and Drug Administration (FDA), FDA data exported October 30, 2026, retrieved October 31, 2026
- Drug recall enforcement reports (openFDA) — U.S. Food and Drug Administration (FDA), FDA data exported October 27, 2026, retrieved October 31, 2026
- NADAC (National Average Drug Acquisition Cost) 2026 — Centers for Medicare & Medicaid Services (CMS), data.medicaid.gov, list of November 4, 2026, retrieved November 7, 2026
Which names get a brand page: a name the NDC Directory lists for a medicine, held by one company (the FDA application holder, or the company named on most of its products), that is not just a description, and that is not the only product of its medicine.