FDA.reportPublic FDA data

onabotulinumtoxinA 100 UNT Injection [Botox Cosmetic]

RxCUI
1726313
RxNorm name
onabotulinumtoxinA 100 UNT Injection [Botox Cosmetic]
Display name
onabotulinumtoxinA 100 UNT Injection [Botox Cosmetic]
Full name
onabotulinumtoxinA 100 UNT Injection [Botox Cosmetic]
Term type
SBD
Status
DailyMed mapping
Updated
2026-06-04 23:38:56

Purple Book Biologic Products#

BLA, Proprietary name, Proper name table
BLAProprietary nameProper nameLicense typeStatusLatest source
103000Botox CosmeticonabotulinumtoxinA351(a)Rx2026-07-01

RxNav Current And Historical NDCs#

RxNav current and historical NDC rows page 1 of 1 · 0 matching rows.

No records found.

UNII Substances#

UNII substance links page 1 of 1 · 0 matching rows.

No records found.

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
BOTOX CosmeticONABOTULINUMTOXINAAllergan, Inc.485d9b71-6881-42c5-a620-a4360c7192ab2024-10-18Boxed warning, Warnings, Adverse reactionsExact identifier
rxcui: 1726313

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
485d9b71-6881-42c5-a620-a4360c7192abBOTOX Cosmetic 100 UNT Injection [PSN] · onabotulinumtoxinA 100 UNT Injection [Botox Cosmetic] [SBD] · Botox Cosmetic 100 UNT Injection [SY]354These highlights do not include all the information needed to use BOTOX Cosmetic safely and effectively. See full prescribing information for BOTOX Cosmetic. BOTOX ® Cosmetic (onabotulinumtoxinA) for injection, for intramuscular use Initial U.S. Approval: 198920241018