FDA.reportPublic FDA data

NDC 49281-541-78 - Fluzone Quadrivalent Northern Hemisphere

This NDC is not currently matched to an FDA NDC product listing in FDA.report, but it is a valid NDC-form code. FDA.report is showing the available DailyMed label context for the product root.

Product NDC
49281-541
Requested NDC
49281-541-78
Package NDCs from labels
49281-541-78, 49281-541-15
Manufacturer
Sanofi Pasteur Inc.
Effective date
2025-07-11
Current FDA listing
Not matched in FDA.report NDC product tables

DailyMed Labels#

Label, Manufacturer, Effective date table
LabelManufacturerEffective dateType
Fluzone Quadrivalent Northern Hemisphere - Sanofi Pasteur Inc.Sanofi Pasteur Inc.2025-07-11VACCINE LABEL

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
49281-541-15Fluzone Quadrivalent Northern Hemisphere1 in 1 PACKAGEINJECTION, SUSPENSION125
49281-541-78Fluzone Quadrivalent Northern Hemisphere5 mL in 1 VIAL, MULTI-DOSEINJECTION, SUSPENSION525

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
INFLUENZA A VIRUS A/CALIFORNIA/7/2009 X-179A (H1N1) ANTIGEN (FORMALDEHYDE INACTIVATED)ACTIVE INGREDIENTXQO8062U6RFLUZONE QUADRIVALENT (INFLUENZA A VIRUS A/CALIFORNIA/7/2009 X-179A (H1N1) ANTIGEN (FORMALDEHYDE INACTIVATED), INFLUENZA A VIRUS A/SWITZERLAND/9715293/2013 NIB-88 (H3N2) ANTIGEN (FORMALDEHYDE INACTIVATED), INFLUENZA B VIRUS B/PHUKET/3073/2013 ANTIGEN (FORMALDEHYDE INACTIVATED), AND INFLUENZA B VIRUS B/BRISBANE/60/2008 ANTIGEN (FORMALDEHYDE INACTIVATED)) INJECTION, SUSPENSION [SANOFI PASTEUR INC.]1
INFLUENZA A VIRUS A/SWITZERLAND/9715293/2013 NIB-88 (H3N2) ANTIGEN (FORMALDEHYDE INACTIVATED)ACTIVE INGREDIENT0S33AL4WWPFLUZONE QUADRIVALENT (INFLUENZA A VIRUS A/CALIFORNIA/7/2009 X-179A (H1N1) ANTIGEN (FORMALDEHYDE INACTIVATED), INFLUENZA A VIRUS A/SWITZERLAND/9715293/2013 NIB-88 (H3N2) ANTIGEN (FORMALDEHYDE INACTIVATED), INFLUENZA B VIRUS B/PHUKET/3073/2013 ANTIGEN (FORMALDEHYDE INACTIVATED), AND INFLUENZA B VIRUS B/BRISBANE/60/2008 ANTIGEN (FORMALDEHYDE INACTIVATED)) INJECTION, SUSPENSION [SANOFI PASTEUR INC.]1
INFLUENZA B VIRUS B/BRISBANE/60/2008 ANTIGEN (FORMALDEHYDE INACTIVATED)ACTIVE INGREDIENTW45Z4CJE2JFLUZONE QUADRIVALENT (INFLUENZA A VIRUS A/CALIFORNIA/7/2009 X-179A (H1N1) ANTIGEN (FORMALDEHYDE INACTIVATED), INFLUENZA A VIRUS A/SWITZERLAND/9715293/2013 NIB-88 (H3N2) ANTIGEN (FORMALDEHYDE INACTIVATED), INFLUENZA B VIRUS B/PHUKET/3073/2013 ANTIGEN (FORMALDEHYDE INACTIVATED), AND INFLUENZA B VIRUS B/BRISBANE/60/2008 ANTIGEN (FORMALDEHYDE INACTIVATED)) INJECTION, SUSPENSION [SANOFI PASTEUR INC.]1
INFLUENZA B VIRUS B/PHUKET/3073/2013 ANTIGEN (FORMALDEHYDE INACTIVATED)ACTIVE INGREDIENTB93BQX9789FLUZONE QUADRIVALENT (INFLUENZA A VIRUS A/CALIFORNIA/7/2009 X-179A (H1N1) ANTIGEN (FORMALDEHYDE INACTIVATED), INFLUENZA A VIRUS A/SWITZERLAND/9715293/2013 NIB-88 (H3N2) ANTIGEN (FORMALDEHYDE INACTIVATED), INFLUENZA B VIRUS B/PHUKET/3073/2013 ANTIGEN (FORMALDEHYDE INACTIVATED), AND INFLUENZA B VIRUS B/BRISBANE/60/2008 ANTIGEN (FORMALDEHYDE INACTIVATED)) INJECTION, SUSPENSION [SANOFI PASTEUR INC.]1
INFLUENZA A VIRUS A/CALIFORNIA/7/2009 X-179A (H1N1) HEMAGGLUTININ ANTIGEN (FORMALDEHYDE INACTIVATED)ACTIVE MOIETYC8E791RO82FLUZONE QUADRIVALENT (INFLUENZA A VIRUS A/CALIFORNIA/7/2009 X-179A (H1N1) ANTIGEN (FORMALDEHYDE INACTIVATED), INFLUENZA A VIRUS A/SWITZERLAND/9715293/2013 NIB-88 (H3N2) ANTIGEN (FORMALDEHYDE INACTIVATED), INFLUENZA B VIRUS B/PHUKET/3073/2013 ANTIGEN (FORMALDEHYDE INACTIVATED), AND INFLUENZA B VIRUS B/BRISBANE/60/2008 ANTIGEN (FORMALDEHYDE INACTIVATED)) INJECTION, SUSPENSION [SANOFI PASTEUR INC.]1
INFLUENZA A VIRUS A/SWITZERLAND/9715293/2013 NIB-88 (H3N2) HEMAGGLUTININ ANTIGEN (FORMALDEHYDE INACTIVATED)ACTIVE MOIETYN5LV3U272GFLUZONE QUADRIVALENT (INFLUENZA A VIRUS A/CALIFORNIA/7/2009 X-179A (H1N1) ANTIGEN (FORMALDEHYDE INACTIVATED), INFLUENZA A VIRUS A/SWITZERLAND/9715293/2013 NIB-88 (H3N2) ANTIGEN (FORMALDEHYDE INACTIVATED), INFLUENZA B VIRUS B/PHUKET/3073/2013 ANTIGEN (FORMALDEHYDE INACTIVATED), AND INFLUENZA B VIRUS B/BRISBANE/60/2008 ANTIGEN (FORMALDEHYDE INACTIVATED)) INJECTION, SUSPENSION [SANOFI PASTEUR INC.]1
INFLUENZA B VIRUS B/BRISBANE/60/2008 HEMAGGLUTININ ANTIGEN (FORMALDEHYDE INACTIVATED)ACTIVE MOIETY166D8OWM7BFLUZONE QUADRIVALENT (INFLUENZA A VIRUS A/CALIFORNIA/7/2009 X-179A (H1N1) ANTIGEN (FORMALDEHYDE INACTIVATED), INFLUENZA A VIRUS A/SWITZERLAND/9715293/2013 NIB-88 (H3N2) ANTIGEN (FORMALDEHYDE INACTIVATED), INFLUENZA B VIRUS B/PHUKET/3073/2013 ANTIGEN (FORMALDEHYDE INACTIVATED), AND INFLUENZA B VIRUS B/BRISBANE/60/2008 ANTIGEN (FORMALDEHYDE INACTIVATED)) INJECTION, SUSPENSION [SANOFI PASTEUR INC.]1
INFLUENZA B VIRUS B/PHUKET/3073/2013 HEMAGGLUTININ ANTIGEN (FORMALDEHYDE INACTIVATED)ACTIVE MOIETY9HB0XUS9TMFLUZONE QUADRIVALENT (INFLUENZA A VIRUS A/CALIFORNIA/7/2009 X-179A (H1N1) ANTIGEN (FORMALDEHYDE INACTIVATED), INFLUENZA A VIRUS A/SWITZERLAND/9715293/2013 NIB-88 (H3N2) ANTIGEN (FORMALDEHYDE INACTIVATED), INFLUENZA B VIRUS B/PHUKET/3073/2013 ANTIGEN (FORMALDEHYDE INACTIVATED), AND INFLUENZA B VIRUS B/BRISBANE/60/2008 ANTIGEN (FORMALDEHYDE INACTIVATED)) INJECTION, SUSPENSION [SANOFI PASTEUR INC.]1
FORMALDEHYDEINACTIVE INGREDIENT1HG84L3525FLUZONE QUADRIVALENT (INFLUENZA A VIRUS A/CALIFORNIA/7/2009 X-179A (H1N1) ANTIGEN (FORMALDEHYDE INACTIVATED), INFLUENZA A VIRUS A/SWITZERLAND/9715293/2013 NIB-88 (H3N2) ANTIGEN (FORMALDEHYDE INACTIVATED), INFLUENZA B VIRUS B/PHUKET/3073/2013 ANTIGEN (FORMALDEHYDE INACTIVATED), AND INFLUENZA B VIRUS B/BRISBANE/60/2008 ANTIGEN (FORMALDEHYDE INACTIVATED)) INJECTION, SUSPENSION [SANOFI PASTEUR INC.]1
OCTOXYNOL-9INACTIVE INGREDIENT7JPC6Y25QSFLUZONE QUADRIVALENT (INFLUENZA A VIRUS A/CALIFORNIA/7/2009 X-179A (H1N1) ANTIGEN (FORMALDEHYDE INACTIVATED), INFLUENZA A VIRUS A/SWITZERLAND/9715293/2013 NIB-88 (H3N2) ANTIGEN (FORMALDEHYDE INACTIVATED), INFLUENZA B VIRUS B/PHUKET/3073/2013 ANTIGEN (FORMALDEHYDE INACTIVATED), AND INFLUENZA B VIRUS B/BRISBANE/60/2008 ANTIGEN (FORMALDEHYDE INACTIVATED)) INJECTION, SUSPENSION [SANOFI PASTEUR INC.]1
THIMEROSALINACTIVE INGREDIENT2225PI3MOVFLUZONE QUADRIVALENT (INFLUENZA A VIRUS A/CALIFORNIA/7/2009 X-179A (H1N1) ANTIGEN (FORMALDEHYDE INACTIVATED), INFLUENZA A VIRUS A/SWITZERLAND/9715293/2013 NIB-88 (H3N2) ANTIGEN (FORMALDEHYDE INACTIVATED), INFLUENZA B VIRUS B/PHUKET/3073/2013 ANTIGEN (FORMALDEHYDE INACTIVATED), AND INFLUENZA B VIRUS B/BRISBANE/60/2008 ANTIGEN (FORMALDEHYDE INACTIVATED)) INJECTION, SUSPENSION [SANOFI PASTEUR INC.]1

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 3 of 13 · 251 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
NeurotoxAGARICUS MUSCARIUS, COCCUS CACTI, CONIUM MACULATUM, LYCOPODIUM CLAVATUM, PHOSPHORUS, ALUMINIUM METALLICUM, ANTIMONIUM CRUDUM, ARGENTUM METALLICUM, ARSENICUM ALBUM, AURUM METALLICUM, BARYTA CARBONICA, BERYLLIUM METALLICUM, BISMUTHUM METALLICUM, BORON, BROMIUM, CADMIUM METALLICUM CERIUM METALLICUM, CESIUM CHLORIDE, CHROMIUM, COBALTUM METALLICUM, CUPRUM METALLICUM, DYSPROSIUM METALLICUM, ERBIUM METALLICUM, EUROPIUM METALLICUM, FERRUM METALLICUM, GADOLINIUM METALLICUM, GERMANIUM SESQUIOXIDE, HOLMIUM METALLICUM,BioActive Nutritional, Inc.73fb4038-40b5-4b5b-8ded-f510d0411c952026-01-21WarningsExact identifier
unii: AU5C98U4BB
INSULIN DILUTING MEDIUM FOR KirstyWATERBiocon Biologics Inc.3db1d482-7e1f-aec6-79ef-3f305b4d82772026-01-20Warnings, Adverse reactionsExact identifier
unii: 059QF0KO0R
Walgreens Sterile Soothing Eye WashPURIFIED WATERWalgreensa62e3294-abd6-48dc-81b1-62a809bdc9682026-01-14WarningsExact identifier
unii: 059QF0KO0R
Bio ImmuneCHELIDONIUM MAJUS, LOBELIA INFLATA, RUMEX CRISPUS, SAMBUCUS NIGRA, SENEGA OFFICINALIS, SPONGIA TOSTA, TARAXACUM OFFICINALE, MYRISTICA SEBIFERA, STICTA PULMONARIA, SULPHUR, USTILAGO MAIDIS, POLYPORUS OFFICINALIS, CANDIDA ALBICANS, CARDUUS MARIANUS, CROTALUS HORRIDUS, SCROPHULARIA NODOSA, AGARICUS MUSCARIUS, BOVISTA, SECALE CORNUTUM, ANAS BARBARIAE, HEPATIS ET CORDIS EXTRACTUM, ANTHRACINUM, ARSENICUM ALBUM, BAPTISIA TINCTORIA, BERBERIS VULGARIS, BOTULINUM, BRYONIA (ALBA), CAMPHORA, CINCHONA OFFICINALIS,Energique, Inc.fc837264-8edd-4234-a4c7-d699fcf1b8a02026-01-08WarningsExact identifier
unii: AU5C98U4BB
Plus Rinse Emergency EyewashPURIFIED WATERINNOVATIVE SAFETY SUPPLY INC.b3f47d26-39e4-4aea-bb92-358def52b6522026-01-08WarningsExact identifier
unii: 059QF0KO0R
pH Neutral Emergency EyewashWATERINNOVATIVE SAFETY SUPPLY INC.29a1bd1e-d0dd-478f-e063-6394a90ab0aa2026-01-08WarningsExact identifier
unii: 059QF0KO0R
INFL CombinationACONITUM NAPELLUS, ADENOVIREN NOSODE, BRYONIA (ALBA), EUCALYPTUS GLOBULUS, EUPATORIUM PERFOLIATUM, GELSEMIUM SEMPERVIRENS, INFLUENZINUM, IPECACUANHA, KREOSOTUM, VERATRUM VIRIDEDeseret Biologicals, Inc.5ce3ab98-f4b2-4845-bfa4-af0a017bb6352026-01-05WarningsExact identifier
unii: AU5C98U4BB
VACC HCANTIMONIUM TARTARICUM, ARSENICUM ALBUM, BRYONIA (ALBA), ECHINACEA (ANGUSTIFOLIA), GELSEMIUM SEMPERVIRENS, HEPAR SUIS, HISTAMINUM HYDROCHLORICUM, HYOSCYAMUS NIGER, INFLUENZINUM, LEDUM PALUSTRE, MERCURIUS SOLUBILIS, MEZEREUM, NICOTINAMIDUM, HUMAN CORONAVIRUS (RNA), SENEGA OFFICINALIS, SILICEA, SPIGELIA ANTHELMIA, SULPHUR, THUJA OCCIDENTALIS, ZINCUM METALLICUMDeseret Biologicals, Inc.16d782b2-1bef-45e5-8a1d-721b1ffe56312026-01-05WarningsExact identifier
unii: AU5C98U4BB
Immune SupportACONITUM NAPELLUS, ARGENTUM NITRICUM, ARNICA MONTANA, ARSENICUM ALBUM, ASTRAGALUS MEMBRANACEUS, BAPTISIA TINCTORIA, BRYONIA (ALBA), CALENDULA OFFICINALIS, CORTISONE ACETICUM, ECHINACEA (ANGUSTIFOLIA), EUPATORIUM PERFOLIATUM, EUPHORBIUM OFFICINALIS, GELSEMIUM SEMPERVIRENS, HEPAR SULPHURIS CALCAREUM, INFLUENZINUM, LACHESIS MUTUS, MERCURIUS CORROSIVUS, PHOSPHORUS, PHYTOLACCA DECANDRA, PULSATILLA (PRATENSIS), PYROGENIUM, RHUS TOX, SANGUINARIA CANADENSIS, SPLEEN (SUIS), SULPHUR, THUJA OCCIDENTALIS, THYMUS,Deseret Biologicals, Inc.8b5a4609-184d-4a43-823a-91024d9dc0c12026-01-02WarningsExact identifier
unii: AU5C98U4BB
Eye CleanEYE WASHHART Health41f53e2e-c2bc-4bf1-a541-3bcb2cf630022025-12-31WarningsExact identifier
unii: 059QF0KO0R
teeth and gumsCALC FLUORICA, CALC PHOS, FERRUM PHOS, KALI PHOS, MAG PHOS, MALUS PUMILA, FLOS, ROCK WATER, ULEX EUROPAEUS, FLOSSiddha Flower Essences LLC926c79d5-d270-4c0d-aca9-b58571c24f3a2025-12-31WarningsExact identifier
unii: 059QF0KO0R
lung and sinusCALC PHOS, FERRUM PHOS, GENTIANELLA AMARELLA, FLOS, KALI MUR, KALI PHOS, KALI SULPH, ROCK WATER, ROSE CANINA, FLOSSiddha Flower Essences LLC9f7c949f-21bc-473c-ab8d-24837893fccc2025-12-31WarningsExact identifier
unii: 059QF0KO0R
Quality Choice Eye WashWATERChain Drug Marketing Assoc., Inc.1fb8a109-351b-7039-e063-6394a90a73112025-12-30WarningsExact identifier
unii: 059QF0KO0R
Rite Aid Eye WashPURIFIED WATERRite Aid28a18e04-d735-a511-e063-6394a90af6bb2025-12-30WarningsExact identifier
unii: 059QF0KO0R
Respiforce IECHINACEA (ANGUSTIFOLIA), LOMATIUM DISSECTUM, MYRRHA, NASTURTIUM AQUATICUM, TABEBUIA IMPETIGINOSA, HYDRASTIS CANADENSIS, PROPOLIS, BRYONIA (ALBA), EUPATORIUM PERFOLIATUM, FERRUM PHOSPHORICUM, GELSEMIUM SEMPERVIRENS, IPECACUANHA, MERCURIUS CORROSIVUS, PYROGENIUM, INFLUENZINUMBioActive Nutritional, Inc.7dca20cc-91ae-4f20-896d-10365b82711b2025-12-30WarningsExact identifier
unii: AU5C98U4BB
OCUFRESHWATEROptics Laboratory Inc.b8e477a9-66b9-496b-92fb-3d4bbd7b36b52025-12-29WarningsExact identifier
unii: 059QF0KO0R
Kollourion Eyesalve EyewashPURIFIED WATER 98.3%Miracle Eye Pharmaceuticalsb56d2ab9-169b-b490-e053-2a95a90a80b32025-12-28WarningsExact identifier
unii: 059QF0KO0R
Sterile WaterWATERProPharma Distribution386a0a2f-4ff7-f128-e063-6294a90a7d4d2025-12-18Warnings, Adverse reactionsExact identifier
unii: 059QF0KO0R
Firstep FirstflushEYEWASHEncon Safety Products, Inc.a44beb26-79ae-98bd-e053-2995a90a9b742025-12-09WarningsExact identifier
unii: 059QF0KO0R
Triple Flu DefenseACONITUM NAPELLUS, ANAS BARBARIAE, HEPATIS ET CORDIS EXTRACTUM, ANTIMONIUM CRUDUM, BRYONIA (ALBA), EUPATORIUM PERFOLIATUM, GELSEMIUM SEMPERVIRENS, INFLUENZINUM, IPECACUANHA, KALI BICHROMICUM, NUX VOMICA, PHOSPHORUS, PHYTOLACCA DECANDRANenningers Naturals, LLC43bbed35-e351-409a-b6b6-7da1959634bf2025-11-25WarningsExact identifier
unii: AU5C98U4BB

Reported adverse events (FAERS/openFDA)#

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