FDA.reportPublic FDA data

sofpironium 12.45 % (72 MG/ACTUAT) Topical Gel Pump, 60 Actuations

RxCUI
2689326
RxNorm name
sofpironium 12.45 % (72 MG/ACTUAT) Topical Gel Pump, 60 Actuations
Display name
sofpironium 12.45 % (72 MG/ACTUAT) Topical Gel Pump, 60 Actuations
Full name
sofpironium 12.45 % (72 MG/ACTUAT) Topical Gel Pump, 60 Actuations
Term type
SY
Status
DailyMed mapping
Updated
2026-06-04 23:39:05

RxNav Current And Historical NDCs#

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UNII Substances#

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openFDA label cross-check#

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Matched openFDA labels page 1 of 1 · 1 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
SofdraSOFPIRONIUM BROMIDEBotanix SB Inc.78f86f4f-658c-468b-bd54-49182ddcc7ac2025-09-22Warnings, Adverse reactionsExact identifier
rxcui: 2689326

Reported adverse events (FAERS/openFDA)#

Adverse event summaries are temporarily unavailable. Other product information remains available.

DailyMed RxNorm Mappings#

unique DailyMed labels mapped to this RxNorm concept page 1 of 1 · 1 matching rows.

Set ID, RxNorm mappings, Terms table
Set IDRxNorm mappingsTermsSPL versionLabelEffective
78f86f4f-658c-468b-bd54-49182ddcc7acsofpironium 12.45 % (72 MG/ACTUAT) Topical Gel Pump, 60 Actuations [PSN] · 60 ACTUAT sofpironium 72 MG/ACTUAT Topical Gel [SCD] · sofpironium 12.45 % (72 MG/ACTUAT) Topical Gel Pump, 60 Actuations [SY]36These highlights do not include all the information needed to use SOFDRA™ safely and effectively. See full prescribing information for SOFDRA. SOFDRA (sofpironium) topical gel, 12.45% Initial U.S. Approval: 202420250922