Quick answers
- What is Botox?
- Botox is a brand name of Incobotulinumtoxina, a prescription medicine. The FDA NDC Directory lists 3 Botox products in 2 strengths and forms.
- Who makes Botox?
- Allergan holds the FDA application for Botox (BLA103000, approved December 9, 1991). 1 other company (repackagers or distributors) also list Botox products.
- Is there a generic or store brand of Botox?
- Yes. The FDA NDC Directory lists 5 other products with the same active ingredients, strength and form as a Botox product. Ask your pharmacist whether one is right for you.
- Has Botox been recalled?
- No recall linked to Botox products (by their NDC code or label) appears in the FDA enforcement reports we use.
What Botox is
Each Botox 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 (intradermal, intramuscular) | Botox | 4 products, 3 companies | DailyMed |
| botulinum toxin type a 200 USP units injection, powder, lyophilized, for solution (intradermal, intramuscular) | Botox | 1 product, 1 company | 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 | 3 |
Companies that list Botox
The company named on the package (holder, repackager or distributor), as listed in the FDA NDC Directory, with its number of Botox products.
- Allergan, Inc.2 products
- Sportpharm LLC1 product
Recalls
No recall linked to Botox 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.