Quick answers
- What is Incobotulinumtoxina used for?
- The FDA-approved label (Botox, Sportpharm LLC, February 2, 2026) says: “BOTOX is an acetylcholine release inhibitor and a neuromuscular blocking agent indicated for: Treatment of overactive bladder (OAB) with symptoms of urge urinary incontinence, urgency, and frequency, in adults who have an inadequate response to or are intolerant of an anticholinergic medication Treatment of urinary incontinence due to detrusor overactivity associated with a neurologic condition [e.g., spinal cord …” This page is not medical advice. Talk to your doctor or pharmacist before you start, stop or change any medicine.
- Does Incobotulinumtoxina have a boxed warning?
- Yes. The FDA label for Botox has a boxed warning (“WARNING: DISTANT SPREAD OF TOXIN EFFECT”), the FDA’s strongest warning. Read it on the full label and ask your pharmacist.
- Is there a shortage of Incobotulinumtoxina?
- No current shortage is listed by the FDA for the products of this medicine (FDA data from October 30, 2026).
- Has Incobotulinumtoxina been recalled?
- No recall linked to the products of this medicine appears in the FDA enforcement reports we use.
- Who makes Incobotulinumtoxina?
- 8 companies list prescription products of Incobotulinumtoxina in the FDA NDC Directory, including Merz Pharmaceuticals, LLC, Allergan, Inc. and Merz North America, Inc..
What Incobotulinumtoxina is used for
Quoted from the “Indications and Usage” section of the FDA-approved label.
BOTOX is an acetylcholine release inhibitor and a neuromuscular blocking agent indicated for: Treatment of overactive bladder (OAB) with symptoms of urge urinary incontinence, urgency, and frequency, in adults who have an inadequate response to or are intolerant of an anticholinergic medication Treatment of urinary incontinence due to detrusor overactivity associated with a neurologic condition [e.g., spinal cord …
— FDA label: Botox, Sportpharm LLC, effective February 2, 2026. Read the full label on DailyMed →
The FDA has 9 labels for products of this medicine (different makers and forms); uses can differ between them. Check the label that comes with your own medicine.
This page is not medical advice. Talk to your doctor or pharmacist before you start, stop or change any medicine.
Conditions named on the label
These condition names appear word for word in the label’s “Indications and Usage” text (matched with a reviewed table). Each page lists hospitals whose own websites name the condition.
Related medical specialties
Boxed warning
A boxed warning (“black box”) is the FDA’s strongest warning on a drug label, for serious or life-threatening risks.
This label has a boxed warning. Its heading: WARNING: DISTANT SPREAD OF TOXIN EFFECT
. Read it on the full label →
9 of 9 FDA labels for this medicine have a boxed warning.
Forms and how it is given
Companies that list this medicine
Labelers in the FDA NDC Directory: the company named on the package (maker or distributor), with the number of prescription products.
- Merz Pharmaceuticals, LLC5 products
- Allergan, Inc.4 products
- Merz North America, Inc.3 products
- Ipsen Biopharmaceuticals, Inc.2 products
- Sportpharm LLC1 product
- Evolus, Inc.1 product
- Galderma Laboratories, L.P.1 product
- Revance Therapeutics, Inc.1 product
FDA approval history
- BLA: Biologics License Application: how a biologic medicine (made from living cells) is approved.
| Application | Sponsor | Approved | Later changes approved |
|---|---|---|---|
| BLA103000 BOTOX, BOTOX COSMETIC | Allergan | December 9, 1991 | 59, latest October 18, 2024 2024: Labeling · 2024: Labeling · 2024: Labeling |
| BLA125274 DYSPORT | Ipsen Biopharm Ltd | April 29, 2009 | 12, latest September 21, 2023 2023: Labeling · 2023: Efficacy · 2020: Efficacy |
| BLA125360 Xeomin | Merz Pharms | July 30, 2010 | 24, latest June 25, 2026 2026: Efficacy · 2026: Labeling · 2026: Labeling |
| BLA761085 JEUVEAU | Evolus Inc | February 1, 2019 | 1, latest July 12, 2019 2019: Labeling |
| BLA761127 DAXXIFY | Revance Therapeutics, Inc. | September 7, 2022 | 1, latest August 11, 2023 2023: Efficacy |
Shortage status
The FDA drug shortage list does not show these products.
Recalls
No recall linked to these products (by their NDC code) appears in the FDA enforcement reports.
Official identifiers
| RxCUI (RxNorm) | 860192, 860195, 897366, 897368, 1000107, 1009456, 1009459, 1726293, 1726296, 1726313 … (+10) |
|---|---|
| SPL set ID of the quoted label | a6f42753-d31e-4b23-8da0-4b990fee4b38 |
| FDA labels (SPL) | 9 |
| FDA applications | BLA103000, BLA125274, BLA125360, BLA761085, BLA761127 |
| Active ingredients (FDA) | BOTULINUM TOXIN TYPE A |
Sources
- FDA-approved label on DailyMed (National Library of Medicine) — Botox, Sportpharm LLC, effective February 2, 2026; via openFDA, FDA data exported October 30, 2026, retrieved October 31, 2026
- 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 recall enforcement reports (openFDA) — U.S. Food and Drug Administration (FDA), FDA data exported October 27, 2026, retrieved October 31, 2026
- Drug shortages (openFDA) — U.S. Food and Drug Administration (FDA), FDA data exported October 30, 2026, retrieved October 31, 2026
openFDA data is provided by the FDA as is; it may be incomplete. Always rely on the label that comes with your medicine. FDA Enforcement Report search →