FDA.reportPublic FDA data

Fluzone (Influenza Vaccine)

Manufacturer
Bamboo US BidCo LLC
Effective date
2026-06-10
Label type
VACCINE LABEL
Version
2
Source
daily-update
Hydrated at
2026-06-12 05:10:19

Label at a glance#

ProductFLUZONE TRIVALENT NORTHERN HEMISPHERE
Active ingredientINFLUENZA A VIRUS A/VICTORIA/4897/2022 IVR-238 (H1N1) ANTIGEN (FORMALDEHYDE INACTIVATED), INFLUENZA A VIRUS A/CROATIA/10136RV/2023 X-425A (H3N2) ANTIGEN (FORMALDEHYDE INACTIVATED), INFLUENZA B VIRUS B/MICHIGAN/01/2021 ANTIGEN (FORMALDEHYDE INACTIVATED)
Label structure2 sections

Label contents#

Full prescribing information#

PRINCIPAL DISPLAY PANEL - 0.5 mL Syringe Label

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

Influenza Vaccine

Fluzone ®
Rx only

2025-2026 Formula

No Preservative
For IM Use

0.5 mL Single-Dose

Mfd by: Sanofi Pasteur Inc.

PRINCIPAL DISPLAY PANEL - 0.5 mL Syringe LabelPRINCIPAL DISPLAY PANEL - 0.5 mL Syringe Label

PRINCIPAL DISPLAY PANEL - 0.5 mL Syringe Package

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

2025-2026

Formula

Influenza Vaccine
Fluzone ®

Rx only

For Intramuscular Use
For 6 months of age and older
10 single-dose prefilled syringes 0.5 mL each

sanofi

PRINCIPAL DISPLAY PANEL - 0.5 mL Syringe PackagePRINCIPAL DISPLAY PANEL - 0.5 mL Syringe Package

Product Linked Resources#

Resource, Code type, Value table
ResourceCode typeValueEquivalent identifiersSource image
BarcodeDataBar Limited(01)00349281425882GTIN-14: 00349281425882
GTIN-12: 349281425882
UPC-A: 349281425882
EAN-13: 0349281425882
GTIN storage (14 digits): 00349281425882		5fe0ce14-bc11-4b43-b002-7efdca0d3003-03.jpg
Data codeData Matrix9342865fe0ce14-bc11-4b43-b002-7efdca0d3003-04.jpg
Data codeData MatrixGTIN EXP LOT 5fe0ce14-bc11-4b43-b002-7efdca0d3003-03.jpg

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
726062af-1135-4707-a1d7-57256991bbf9Product name220250226
19c71a3d-ed9c-166b-a7e5-38c250c35631Product name120140508

Products#

Every source-derived product name is available through these pages.

DailyMed product names page 1 of 1 · 13 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
83703-08383703-083-88, 83703-083-50

Ingredients#

Every source-derived ingredient row is available through these pages.

DailyMed ingredient rows page 1 of 1 · 8 matching rows.

Name, UNII, Kind table
NameUNIIKind
OCTOXYNOL-97JPC6Y25QSIACT
SODIUM PHOSPHATE, DIBASIC, ANHYDROUS22ADO53M6FIACT
SODIUM PHOSPHATE, MONOBASIC, ANHYDROUSKH7I04HPUUIACT
WATER059QF0KO0RIACT
FORMALDEHYDE1HG84L3525IACT
INFLUENZA A VIRUS A/VICTORIA/4897/2022 IVR-238 (H1N1) ANTIGEN (FORMALDEHYDE INACTIVATED)AU5C98U4BBACTIM
INFLUENZA A VIRUS A/CROATIA/10136RV/2023 X-425A (H3N2) ANTIGEN (FORMALDEHYDE INACTIVATED)HQW9FZS4YKACTIM
INFLUENZA B VIRUS B/MICHIGAN/01/2021 ANTIGEN (FORMALDEHYDE INACTIVATED)FF9YP4D23CACTIM

Source Document#

Source XML

Older Hydrated Versions#

Version, Effective date, Source table
VersionEffective dateSourceHydrated
12026-02-02full-release2026-06-01 02:52:24

Reported adverse events (FAERS/openFDA)#

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