FDA.reportPublic FDA data

onabotulinumtoxinA 100 UNT Injection [Botox]

RxCUI
860195
RxNorm name
onabotulinumtoxinA 100 UNT Injection [Botox]
Display name
onabotulinumtoxinA 100 UNT Injection [Botox]
Full name
onabotulinumtoxinA 100 UNT Injection [Botox]
Term type
SBD
Status
DailyMed mapping
Updated
2026-06-04 23:38:53

Purple Book Biologic Products#

BLA, Proprietary name, Proper name table
BLAProprietary nameProper nameLicense typeStatusLatest source
103000Botox CosmeticonabotulinumtoxinA351(a)Rx2026-06-01

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 · 2 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
BOTOXONABOTULINUMTOXINASportpharm LLCa6f42753-d31e-4b23-8da0-4b990fee4b382026-02-02Boxed warning, Warnings, Adverse reactionsExact identifier
rxcui: 860195
BOTOXONABOTULINUMTOXINAAllergan, Inc.33d066a9-34ff-4a1a-b38b-d10983df33002023-11-18Boxed warning, Warnings, Adverse reactionsExact identifier
rxcui: 860195

DailyMed RxNorm Mappings#

Set ID, RxNorm string, TTY table
Set IDRxNorm stringTTYSPL versionLabelEffective
33d066a9-34ff-4a1a-b38b-d10983df3300onabotulinumtoxinA 100 UNT Injection [Botox]SBD61These highlights do not include all the information needed to use BOTOX ® safely and effectively. See full prescribing information for BOTOX. BOTOX ® (onabotulinumtoxinA) for injection, for intramuscular, intradetrusor, or intradermal use Initial U.S. Approval: 198920231118
33d066a9-34ff-4a1a-b38b-d10983df3300Botox 100 UNT InjectionPSN61These highlights do not include all the information needed to use BOTOX ® safely and effectively. See full prescribing information for BOTOX. BOTOX ® (onabotulinumtoxinA) for injection, for intramuscular, intradetrusor, or intradermal use Initial U.S. Approval: 198920231118
33d066a9-34ff-4a1a-b38b-d10983df3300Botox 100 UNT InjectionSY61These highlights do not include all the information needed to use BOTOX ® safely and effectively. See full prescribing information for BOTOX. BOTOX ® (onabotulinumtoxinA) for injection, for intramuscular, intradetrusor, or intradermal use Initial U.S. Approval: 198920231118
a6f42753-d31e-4b23-8da0-4b990fee4b38Botox 100 UNT InjectionSY1These highlights do not include all the information needed to use BOTOX ® safely and effectively. See full prescribing information for BOTOX. BOTOX ® (onabotulinumtoxinA) for injection, for intramuscular, intradetrusor, or intradermal use Initial U.S. Approval: 198920260202
a6f42753-d31e-4b23-8da0-4b990fee4b38onabotulinumtoxinA 100 UNT Injection [Botox]SBD1These highlights do not include all the information needed to use BOTOX ® safely and effectively. See full prescribing information for BOTOX. BOTOX ® (onabotulinumtoxinA) for injection, for intramuscular, intradetrusor, or intradermal use Initial U.S. Approval: 198920260202
a6f42753-d31e-4b23-8da0-4b990fee4b38Botox 100 UNT InjectionPSN1These highlights do not include all the information needed to use BOTOX ® safely and effectively. See full prescribing information for BOTOX. BOTOX ® (onabotulinumtoxinA) for injection, for intramuscular, intradetrusor, or intradermal use Initial U.S. Approval: 198920260202