Prescription medicine
Sofpironium Brand names: Sofdra
Sofpironium (Sofdra) is a prescription medicine with an FDA approval on record since 2024. No generic is listed in FDA's NDC Directory.
- No generic listed
Check it at the source: the sofpironium FDA label on DailyMed (effective September 22, 2025, Botanix SB Inc.); the NDA 217347 record on Drugs@FDA; every sofpironium label on DailyMed.
Highlights of the record
FDA label of September 22, 2025; NDC Directory, Drugs@FDA and Orange Book, October 8, 2026
Used for
From the label: indications and usageSOFDRA is indicated for the treatment of primary axillary hyperhidrosis in adults and pediatric patients 9 years of age and older.
Forms and strengths
- 87 mg/.67ml
Gel.
On the market
- Earliest approval on file
- June 18, 2024 Sofdra, Botanix Sb; Drugs@FDA’s file, where older or withdrawn approvals can be missing
- Generic approvals
- No generic approved
- Labelers listed (NDC)
- 1 of which 0 under generic applications, 1 under brand applications, repackagers included
- Last listed patent
- May 22, 2040 Sofdra gel; not a generic launch date
Supply and safety
- Pharmacy cost (NADAC)
- Not in the survey
- Shortage (FDA)
- No current entry
- Recalls by its makers (FDA)
- No recall recorded
- FAERS reports
- 227 through July 30, 2026
What is sofpironium used for?
From the label: indications and usageSOFDRA 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 ( 1 ).
Source: FDA drug label (Sofdra), Botanix SB Inc., effective September 22, 2025 (SPL set 78f86f4f-658c-468b-bd54-49182ddcc7ac), via openFDA; the full label on DailyMed
What does the patient leaflet for sofpironium say first?
The FDA-approved Medication Guide or Patient Information that comes with the medicine, in its own words.
From the patient leaflet: What should I avoid while using SOFDRA?SOFDRA may cause you to have blurred vision that is temporary. If you develop blurred vision, call your healthcare provider, stop using SOFDRA and do not drive, operate machinery, or do hazardous work until your vision is clear. SOFDRA is flammable. Avoid fire, flame, and smoking during and right after applying SOFDRA to your skin.
From the patient leaflet: How should I store SOFDRA?Store SOFDRA upright at room temperature between 68°F to 77°F (20°C to 25°C). SOFDRA is flammable. Keep SOFDRA away from heat or flame. Keep SOFDRA and all medicines out of the reach of children.
Source: FDA drug label (Sofdra), Botanix SB Inc., effective September 22, 2025 (SPL set 78f86f4f-658c-468b-bd54-49182ddcc7ac), via openFDA; the full label on DailyMed
Is there a generic for sofpironium (Sofdra)?
No generic sofpironium is approved (Drugs@FDA, October 8, 2026).
The Orange Book lists 21 patents for Sofdra gel: the compound patent runs to May 22, 2040. A patent or exclusivity date is not the date a generic goes on sale: court cases and settlements move it either way.
- 2024 earliest approval on file
- 2040 last listed patent
Source: Drugs@FDA, FDA NDC Directory and the Orange Book (openFDA bulk files, October 8, 2026)
What do FAERS reports show for sofpironium?
The FDA Adverse Event Reporting System holds 227 reports that list sofpironium among the medicines taken, through July 30, 2026, each a report of something that happened, not proof the medicine caused it; 0 are coded as a death and 5 as a hospital stay. Counts follow how widely a medicine is used and watched, and they are not a measure of how risky it is.
The most reported reactions
Source: FDA Adverse Event Reporting System (FAERS) via openFDA, reports through July 30, 2026
What next?
- Sofpironium side effects
- the label's list beside FAERS reports
- Check an interaction
- what two or more labels say about each other