FDA.reportPublic FDA data

BOTOX Cosmetic

Product NDC
0023-3919
11-digit product format
000233919
Labeler code
0023
Product ID
0023-3919_265710db-c7b9-42ff-9fc8-c24a936c1d87
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
onabotulinumtoxinA
Dosage form
INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION
Route
INTRAMUSCULAR
Labeler
Allergan, Inc.
Application
BLA103000
Marketing category
BLA
Marketing start
2008-07-15
Substance
BOTULINUM TOXIN TYPE A
Active strength
50 [USP'U]/1
Pharmacologic classes
Acetylcholine Release Inhibitor [EPC], Acetylcholine Release Inhibitors [MoA], Neuromuscular Blockade [PE], Neuromuscular Blocker [EPC]
NDC exclude flag
No
Listing certified through
2027-12-31
Current FDA listing
Yes

Additional Listing Data#

Finished product
Yes
Brand name base
BOTOX Cosmetic
Listing expiration
2027-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
BOTULINUM TOXIN TYPE A50 [USP'U]/1

Harmonized UNII identifiers#

UNII identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
E211KPY694Internal UNII lookup

Harmonized RxCUI identifiers#

RxCUI identifiers page 1 of 1 · 4 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
860192Internal RxNorm lookup
1726293Internal RxNorm lookup
1726296Internal RxNorm lookup
1726313Internal RxNorm lookup

Harmonized SPL set identifiers#

SPL set identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
485d9b71-6881-42c5-a620-a4360c7192abAvailable on FDA.report

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
2a92e090-adb9-48d2-ae5f-5956e4b6ad90Product name120231024
525448fb-6d30-4c07-bb80-9a8499bd8113Product name120230627
0cf2215a-e8b6-4688-9989-d0fcd154e4b8Product name120170725
8c498f95-3b71-4acf-9882-f567b5cc4a2aProduct name120160208
e9681bd0-ddf1-421f-88c4-4337e89d5421Product name120160208
a42a1284-ee26-4b9f-a2b3-1ba05f250710Product name120151202

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
0023-3919-50BOTOX Cosmetic1 in 1 VIAL, GLASSINJECTION, POWDER, LYOPHILIZED,154
0023-3919-50BOTOX Cosmetic1 in 1 CARTONINJECTION, POWDER, LYOPHILIZED,154
0023-3919-51BOTOX Cosmetic1 in 1 VIAL, GLASSINJECTION, POWDER, LYOPHILIZED,154
0023-3919-51BOTOX Cosmetic1 in 1 CARTONINJECTION, POWDER, LYOPHILIZED,154

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
0023-3919-50EA - Each0023-391951957bfd-b856-467a-a7ea-e1109d192ed512012-07-24

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
botulinum toxin type AACTIVE INGREDIENTE211KPY694BOTOX COSMETIC (ONABOTULINUMTOXINA) INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION [ALLERGAN, INC.]21
botulinum toxin type AACTIVE MOIETYE211KPY694BOTOX COSMETIC (ONABOTULINUMTOXINA) INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION [ALLERGAN, INC.]21
Albumin HumanINACTIVE INGREDIENTZIF514RVZRBOTOX COSMETIC (ONABOTULINUMTOXINA) INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION [ALLERGAN, INC.]21
Sodium ChlorideINACTIVE INGREDIENT451W47IQ8XBOTOX COSMETIC (ONABOTULINUMTOXINA) INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION [ALLERGAN, INC.]21

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
0023-3919BOTOX COSMETIC (ONABOTULINUMTOXINA) INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION [ALLERGAN, INC.]52Current NDC, Legacy NDC, 4 package rows20241031_485d9b71-6881-42c5-a620-a4360c7192ab.zip

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 · 3 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
application number: BLA103000
BOTOX CosmeticONABOTULINUMTOXINAAllergan, Inc.485d9b71-6881-42c5-a620-a4360c7192ab2024-10-18Boxed warning, Warnings, Adverse reactionsExact identifier
application number: BLA103000
ndc (product): 0023-3919
BOTOXONABOTULINUMTOXINAAllergan, Inc.33d066a9-34ff-4a1a-b38b-d10983df33002023-11-18Boxed warning, Warnings, Adverse reactionsExact identifier
application number: BLA103000

Purple Book Biologic Products#

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

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
1726313BOTOX Cosmetic 100 UNT InjectionPSN485d9b71-6881-42c5-a620-a4360c7192ab54
1726296BOTOX Cosmetic 50 UNT InjectionPSN485d9b71-6881-42c5-a620-a4360c7192ab54
860192onabotulinumtoxinA 100 UNT InjectionPSN485d9b71-6881-42c5-a620-a4360c7192ab54
1726293onabotulinumtoxinA 50 UNT InjectionPSN485d9b71-6881-42c5-a620-a4360c7192ab54
1726313onabotulinumtoxinA 100 UNT Injection [Botox Cosmetic]SBD485d9b71-6881-42c5-a620-a4360c7192ab54
1726296onabotulinumtoxinA 50 UNT Injection [Botox Cosmetic]SBD485d9b71-6881-42c5-a620-a4360c7192ab54
860192onabotulinumtoxinA 100 UNT InjectionSCD485d9b71-6881-42c5-a620-a4360c7192ab54
1726293onabotulinumtoxinA 50 UNT InjectionSCD485d9b71-6881-42c5-a620-a4360c7192ab54
1726313Botox Cosmetic 100 UNT InjectionSY485d9b71-6881-42c5-a620-a4360c7192ab54
1726296Botox Cosmetic 50 UNT InjectionSY485d9b71-6881-42c5-a620-a4360c7192ab54

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionMarketing startMarketing endSampleExclude flagStatus
0023-3919-50000233919501 VIAL, GLASS in 1 CARTON (0023-3919-50) / 1 INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION in 1 VIAL, GLASS2008-07-150000-00-00NoNoCurrent
0023-3919-51000233919511 VIAL, GLASS in 1 CARTON (0023-3919-51) / 1 INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION in 1 VIAL, GLASS2008-07-150000-00-00YesNoCurrent