Quick answers
- What is Sofpironium bromide used for?
- The FDA-approved label (Sofdra, Botanix SB Inc., September 22, 2025) says: “SOFDRA is indicated for the treatment of primary axillary hyperhidrosis in adults and pediatric patients 9 years of age and older. SOFDRA is an anticholinergic indicated for the treatment of primary axillary hyperhidrosis in adults and pediatric patients 9 years of age and older.” This page is not medical advice. Talk to your doctor or pharmacist before you start, stop or change any medicine.
- Does Sofpironium bromide have a boxed warning?
- No. None of the 1 FDA labels we found for this medicine has a boxed warning.
- Is there a shortage of Sofpironium bromide?
- No current shortage is listed by the FDA for the products of this medicine (FDA data from October 30, 2026).
- Has Sofpironium bromide been recalled?
- No recall linked to the products of this medicine appears in the FDA enforcement reports we use.
- Who makes Sofpironium bromide?
- 1 company lists prescription products of Sofpironium bromide in the FDA NDC Directory, including Botanix SB Inc..
What Sofpironium bromide is used for
Quoted from the “Indications and Usage” section of the FDA-approved label.
SOFDRA is indicated for the treatment of primary axillary hyperhidrosis in adults and pediatric patients 9 years of age and older. SOFDRA is an anticholinergic indicated for the treatment of primary axillary hyperhidrosis in adults and pediatric patients 9 years of age and older.
— FDA label: Sofdra, Botanix SB Inc., effective September 22, 2025. Read the full label on DailyMed →
This page is not medical advice. Talk to your doctor or pharmacist before you start, stop or change any medicine.
Boxed warning
A boxed warning (“black box”) is the FDA’s strongest warning on a drug label, for serious or life-threatening risks.
The label quoted above has no boxed warning.
Forms and how it is given
| Dosage forms | Gel |
|---|---|
| Route | Topical |
| Prescription products | 1 in the FDA NDC Directory |
| Brand names | Sofdra |
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.
- Botanix SB Inc.1 product
FDA approval history
- NDA: New Drug Application: how a new (usually brand-name) medicine is approved.
| Application | Sponsor | Approved | Later changes approved |
|---|---|---|---|
| NDA217347 SOFDRA | Botanix Sb | June 18, 2024 | — |
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) | 2689326, 2689332 |
|---|---|
| SPL set ID of the quoted label | 78f86f4f-658c-468b-bd54-49182ddcc7ac |
| FDA labels (SPL) | 1 |
| FDA applications | NDA217347 |
| Active ingredients (FDA) | SOFPIRONIUM |
Sources
- FDA-approved label on DailyMed (National Library of Medicine) — Sofdra, Botanix SB Inc., effective September 22, 2025; 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 →