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 2 of 13 · 252 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
VAXBAPTISIA TINCTORIA, ECHINACEA (ANGUSTIFOLIA), TABEBUIA IMPETIGINOSA, TRIFOLIUM PRATENSE, ARNICA MONTANA, CALENDULA OFFICINALIS, CHELIDONIUM MAJUS, LEPTANDRA VIRGINICA, LIGUSTICUM PORTERI, LOMATIUM DISSECTUM, MYRRHA, NASTURTIUM AQUATICUM, PHYTOLACCA DECANDRA, TARAXACUM OFFICINALE, TRIGONELLA FOENUM-GRAECUM, URTICA DIOICA, HYDRASTIS CANADENSIS, ASTRAGALUS MEMBRANACEUS, PROPOLIS, GLANDULA SUPRARENALIS SUIS, THYMUS (SUIS), ARSENICUM ALBUM, BELLADONNA, CHAMOMILLA, LYCOPODIUM CLAVATUM, RHUS TOX, SILICEA,BioActive Nutritional, Inc.faa4a678-321a-4982-a5d4-01b713e6862d2026-06-08WarningsExact identifier
unii: 2225PI3MOV
Bacteriostatic WaterBACTERIOSTATIC WATERHospira, Inc.87d6e9dc-fe3b-4593-ac9a-d7493d1959c72026-05-22Warnings, Adverse reactionsExact identifier
unii: 059QF0KO0R
WHITENING SUNSCREENANTI WRINKLEWHITENING SUNSCREENANTI WRINKLEShantou Oushiya Biotechnology Co.,Ltd524384e9-b3f8-4c13-e063-6394a90a89732026-05-20WarningsExact identifier
unii: 059QF0KO0R
Viri SodeCYTOMEGALOVIRUS NOSODE, HERPES SIMPLEX I AND II NOSODE, INFLUENZINUM, RUBELLA NOSODE, HEPATITIS A NOSODE, HEPATITIS B NOSODE, HEPATITIS C NOSODE, EPSTEIN-BARR VIRUS NOSODE, HERPES ZOSTER NOSODENutritional Specialties, Inc.8fb280d9-b79f-4b44-a534-89ddda0c27782026-05-18WarningsExact identifier
unii: AU5C98U4BB
Viri SodeCYTOMEGALOVIRUS NOSODE, HERPES SIMPLEX I NOSODE, HERPES SIMPLEX II NOSODE, INFLUENZINUM (2024-2025), RUBELLA NOSODE, HEPATITIS A NOSODE, HEPATITIS B NOSODE, HEPATITIS C NOSODE, EPSTEIN BARR VIRUS NOSODE, HERPES ZOSTER NOSODENutritional Specialties, Inc.cab3c0e1-6358-45e9-ac26-a51b4d4a7af82026-05-12WarningsExact identifier
unii: AU5C98U4BB
Sodium PhosphatesSODIUM PHOSPHATE, MONOBASIC, MONOHYDRATE AND SODIUM PHOSPHATE, DIBASIC, ANHYDROUSHospira, Inc.6f044d16-295e-43ff-72a3-b045c387bc5c2026-05-11Warnings, Adverse reactionsExact identifier
unii: 22ADO53M6F
Sterile WaterWATERHospira, Inc.3a6422e1-feee-4095-8883-2b0837039e6e2026-05-07Warnings, Adverse reactionsExact identifier
unii: 059QF0KO0R
Multi FlowerAESCULUS CARNEA, FLOS, AESCULUS HIPPOCASTANUM, FLOS, AGRIMONIA EUPATORIA, FLOS, BROMUS RAMOSUS, FLOS, CALLUNA VULGARIS, FLOS, CARPINUS BETULUS , FLOS, CASTANEA SATIVA, FLOS, CENTAURIUM UMBELLATUM, FLOS, CERATOSTIGMA WILLMOTTIANUM, FLOS, CICHORIUM INTYBUS, FLOS, CLEMATIS VITALBA, FLOS, CLEMATIS VITALBA, FLOS, FAGUS SYLVATICA, FLOS, GENTIANELLA AMARELLA, FLOS, HELIANTHEMUM NUMMULARIUM, FLOS, ILEX AQUIFOLIUM, FLOS, IMPATIENS GLANDULIFERA, FLOS, LARIX DECIDUA, FLOS, LONICERA CAPRIFOLIUM, FLOSEnergique, Inc.09c059e7-f748-402c-8447-af5b61169c582026-05-06WarningsExact identifier
unii: 059QF0KO0R
Influenzinum 200CINFLUENZINUM (2024-2025)Energique, Inc.926ad570-498b-4c1c-8524-25af07f3a3052026-05-06WarningsExact identifier
unii: AU5C98U4BB
Dibasic Sodium Phosphate, Monobasic Potassium Phosphate and Monobasic Sodium PhosphateDIBASIC SODIUM PHOSPHATE, MONOBASIC POTASSIUM PHOSPHATE AND MONOBASIC SODIUM PHOSPHATERising Pharma Holdings, Inc.b01eac95-dbe3-4b21-a922-187e0fc8ad232026-04-07Adverse reactionsExact identifier
unii: 22ADO53M6F
KIDS TOOTHPASTE, FOR CAVITY PROTECTIONKIDS TOOTHPASTE FOR CAVITY PROTECTIONShulisa (Foshan) Daily ChemicalIndustry Co., Ltd4e8fab9e-f05c-5e2f-e063-6294a90aecf92026-04-03WarningsExact identifier
unii: 059QF0KO0R
VIR CombinationADENOVIREN NOSODE, CYTOMEGALOVIRUS NOSODE, HERPES SIMPLEX VIRUS 1 DNA, HERPES SIMPLEX VIRUS 2 DNA, EPSTEIN-BARR VIRUS NOSODE, HEPATITIS B NOSODE, HERPES SIMPLEX I, HERPES SIMPLEX II NOSODE, HUMAN HERPESVIRUS 6A, INFLUENZINUMDeseret Biologicals, Inc.17769d8c-78d8-4232-b62d-52dc868f3cdb2026-03-27WarningsExact identifier
unii: AU5C98U4BB
VIR CombinationADENOVIREN NOSODE, CYTOMEGALOVIRUS NOSODE, HERPES SIMPLEX VIRUS 1 AND 2 DNA, EPSTEIN-BARR VIRUS NOSODE, HEPATITIS B NOSODE, HERPES SIMPLEX I AND II NOSODE, HUMAN HERPESVIRUS 6A, HUMAN HERPESVIRUS 6B, INFLUENZINUMDeseret Biologicals, Inc.a667977c-376b-4891-8005-b58d679ff2cb2026-03-26WarningsExact identifier
unii: AU5C98U4BB
PHOSPHA 250 NEUTRALDIBASIC SODIUM PHOSPHATE, MONOBASIC POTASSIUM PHOSPHATE AND MONOBASIC SODIUM PHOSPHATERising Pharma Holdings, Inc.9432adfc-6add-4ab4-ae93-2e2daf348be22026-03-25Adverse reactionsExact identifier
unii: 22ADO53M6F
Sterile WaterWATERHospira, Inc.2b9ea23a-f9e9-48a8-25b7-519e3bbd68282026-03-18Warnings, Adverse reactionsExact identifier
unii: 059QF0KO0R
Lymph Tonic IIIADENOSINUM TRIPHOSPHORICUM DINATRUM, ARNICA MONTANA, BOLDO, CALCAREA IODATA, CALCAREA PHOSPHORICA, CARCINOSIN, ECHINACEA (ANGUSTIFOLIA), GERMANIUM SESQUIOXIDE, HAMAMELIS VIRGINIANA, HEPAR SULPHURIS CALCAREUM, INFLUENZINUM (2024-2025), NAJA TRIPUDIANS, NATRUM SULPHURICUM, PHYTOLACCA DECANDRA, PINUS SYLVESTRIS, PYROGENIUM, SULPHUR, THYROIDINUM (SUIS), UBIDECARENONUMBioActive Nutritional, Inc.14f87aa6-2005-4939-a612-1162bbc5462b2026-03-18WarningsExact identifier
unii: AU5C98U4BB
TINTED SUNSCREEN FOUNDATIONTINTED SUNSCREEN FOUNDATIONGuanghzou AiXin Biotech Co Ltd396393c4-b50c-3877-e063-6294a90a0e9b2026-03-17WarningsExact identifier
unii: 059QF0KO0R
2-Pack Facial Serum2-PACK FACIAL SERUMGuangzhou Ariel Biotech Co., Ltd.27c7f645-cfb3-6db1-e063-6394a90a42ff2026-03-06WarningsExact identifier
unii: 059QF0KO0R
InfluensegGELSEMIUM SEMPERVIRENS, SAMBUCUS NIGRA, GALPHIMIA GLAUCA, CAUSTICUM, EUPATORIUM PERFOLIATUM, IPECACUANHA, ACONITUM NAPELLUS, KALI BICHROMICUM, AVENA SATIVA, INFLUENZINUM (2024-2025), LOBELIA PURPURESCENS, ANAS BARBARIAE, HEPATIS ET CORDIS EXTRACTUM, ECHINACEA (ANGUSTIFOLIA), CANCHALAGUANucleic Products, LLC6d673ec9-fdb3-48a0-9a4f-bb65e290f9a42026-02-27WarningsExact identifier
unii: AU5C98U4BB
ENT SupportARGENTUM NITRICUM, ASPERGILLUS NIGER, CANDIDA ALBICANS, EUPHORBIUM OFFICINARUM, GALLICUM ACIDUM, HEPAR SULPHURIS CALCAREUM, INFLUENZINUM (2024 - 2025), LUFFA OPERCULATA, MERCURIUS IODATUS RUBER, MUCOR RACEMOSUS, MUTABILE BACILLUS (BACH), PULSATILLA (PRATENSIS), SINUSITISINUMDeseret Biologicals, Inc.fd8675cb-33c7-49bb-a035-f7c7881115f22026-02-23WarningsExact identifier
unii: AU5C98U4BB

Reported adverse events (FAERS/openFDA)#

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