FDA.reportPublic FDA data

60 ACTUAT sofpironium 72 MG/ACTUAT Topical Gel [Sofdra]

RxCUI
2689332
RxNorm name
60 ACTUAT sofpironium 72 MG/ACTUAT Topical Gel [Sofdra]
Display name
60 ACTUAT sofpironium 72 MG/ACTUAT Topical Gel [Sofdra]
Full name
60 ACTUAT sofpironium 72 MG/ACTUAT Topical Gel [Sofdra]
Term type
SBD
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#

OpenFDA label data provides additional search and identifier links. DailyMed’s Structured Product Label is the canonical label on FDA.report. Matching records are deduplicated before they are shown below.

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: 2689332

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-bd54-49182ddcc7acSofdra 12.45 % (72 MG/ACTUAT) Topical Gel Pump, 60 Actuations [PSN] · 60 ACTUAT sofpironium 72 MG/ACTUAT Topical Gel [Sofdra] [SBD] · 60 ACTUAT Sofdra 72 MG/ACTUAT Topical Gel [SY] · Sofdra 12.45 % (72 MG/ACTUAT) Topical Gel Pump, 60 Actuations [SY]46These 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