NDC 49281-405-88 - FLUZONE High-Dose

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: 49281-405
Requested NDC: 49281-405-88
Package NDCs from labels: 49281-405-88, 49281-405-65
Manufacturer: Sanofi Pasteur Inc.
Effective date: 2023-04-05
Current FDA listing: Not matched in FDA.report NDC product tables

DailyMed Labels#

Label, Manufacturer, Effective date table
Label	Manufacturer	Effective date	Type
FLUZONE High-Dose - Sanofi Pasteur Inc.	Sanofi Pasteur Inc.	2023-04-05	VACCINE LABEL

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDC	Effective	Action	Document	Indexing SPL	Related label
49281-405-65	2025-09-16	C162847	48780-1	2cef2736-a426-d83d-e063-dadaa90ab31f	These highlights do not include all the information needed to use Fluzone ® High-Dose safely and effectively. See full prescribing information for Fluzone High-Dose. Fluzone High-Dose (Influenza Vaccine) Suspension for Intramuscular Injection 2019-2020 Formula Initial U.S. Approval: 2009
49281-405-65	2025-01-30	C162847	48780-1	2cef2736-a426-d83d-e063-dadaa90ab31f	These highlights do not include all the information needed to use Fluzone ® High-Dose safely and effectively. See full prescribing information for Fluzone High-Dose. Fluzone High-Dose (Influenza Vaccine) Suspension for Intramuscular Injection 2019-2020 Formula Initial U.S. Approval: 2009

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
49281-405	FLUZONE HIGH-DOSE (INFLUENZA A VIRUS A/MICHIGAN/45/2015 X-275 (H1N1) ANTIGEN (FORMALDEHYDE INACTIVATED), INFLUENZA A VIRUS A/SINGAPORE/INFIMH-16-0019/2016 IVR-186 (H3N2) ANTIGEN (FORMALDEHYDE INACTIVATED), AND INFLUENZA B VIRUS B/MARYLAND/15/2016 BX-69A (A B/COLORADO/6/2017-LIKE VIRUS) ANTIGEN (FORMALDEHYDE INACTIVATED)) INJECTION, SUSPENSION [SANOFI PASTEUR INC.]	10	Legacy NDC	20230428_81758772-80b1-4e76-8f50-e68d1fb4e9ee.zip

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDC	Billing unit	Product NDC	DailyMed indexing SPL	SPL version	Effective
49281-405-65	ML - Milliliter	49281-405	bdc23921-ba2f-4689-97b5-aad587a0cbcc	1	2019-08-06
49281-405-88	ML - Milliliter	49281-405	560c2594-221d-4cf3-abe1-dad855ca8361	1	2019-08-06

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 · 17 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
Aspartame/MSG Detox	CHELIDONIUM MAJUS, ARNICA MONTANA, PHYTOLACCA DECANDRA, NITRICUM ACIDUM, NUX VOMICA, PHOSPHORICUM ACIDUM, BISPHENOL A (BPA), DEXTROSE, MALTODEXTRIN, SUCRALOSE, ASPARTIC ACID, DIKETOPIPERAZINE, DOPAMINE HYDROCHLORIDE, FORMALINUM, FORMICUM ACIDUM, L-PHENYLALANINE, METHYL ALCOHOL, MONOSODIUM GLUTAMATE	Deseret Biologicals, Inc.	a1dc1bf3-db71-4550-a975-4f146fb94005	2025-03-11	Warnings	Exact identifier unii: 1HG84L3525
Oratox	FUCUS VESICULOSUS, LYMPH NODE (SUIS), MEDULLA OSSIS SUIS, THYMUS (SUIS), THYROIDINUM (SUIS), CALCAREA MURIATICA, IODIUM, NATRUM FLUORATUM, NATRUM MURIATICUM, SELENIUM METALLICUM, VANADIUM METALLICUM, ARGENTUM METALLICUM, AURUM METALLICUM, CUPRUM METALLICUM, EUGENOL, FORMALINUM, LIDOCAINE, MERCURIUS SOLUBILIS, MOLYBDENUM METALLICUM, NICCOLUM METALLICUM, PALLADIUM METALLICUM, STANNUM METALLICUM, TITANIUM METALLICUM, ZINCUM METALLICUM	Deseret Biologicals, Inc.	b78d8991-ffbe-4b11-b9b9-8fe432bed8aa	2024-10-23	Warnings	Exact identifier unii: 1HG84L3525
Metox	ALLIUM SATIVUM, BERBERIS VULGARIS, GLYCYRRHIZA GLABRA, LAPPA MAJOR, STILLINGIA SYLVATICA, TRIFOLIUM PRATENSE, ASCORBICUM ACIDUM, CYSTEINUM, L-METHIONINE, PHYTOLACCA DECANDRA, THYROIDINUM (SUIS), CARBOLICUM ACIDUM, FORMALINUM, LYCOPODIUM CLAVATUM, NATRUM MURIATICUM, NUX VOMICA, BORON, ARSENICUM ALBUM, ALUMINUM METALLICUM, ANTIMONIUM CRUDUM, ARGENTUM METALLICUM, MERCURIUS SOLUBILIS, PLUMBUM METALLICUM, LANTHANUM METALLICUM, NIOBIUM METALLICUM, NIOBIUM,	Deseret Biologicals, Inc.	ddaedfad-c7d1-4aeb-a52e-dce5c1b45c92	2024-10-22	Warnings	Exact identifier unii: 1HG84L3525
Household Detox	PTELEA TRIFOLIATA, ALLIUM SATIVUM, PETROLEUM, CARBONEUM SULPHURATUM, ALUMINA, BENZINUM, BISPHENOL A, CARBOLICUM ACIDUM, FORMALINUM, GLYPHOSATE, METHYLPARABEN, NAPHTHALINUM, PARAFFINUM, PHENACETINUM, SODIUM CARBOXYMETHYL CELLULOSE, FOLLICULINUM, ANTIPYRINUM, DIOXIN, DIETHYLSTILBESTROL, TEFLON	Deseret Biologicals, Inc.	7e32c1f4-c88e-43d0-9f6c-de736d358d46	2024-09-27	Warnings	Exact identifier unii: 1HG84L3525
FNG	BERBERIS VULGARIS, COCHLEARIA ARMORACIA, ECHINACEA (ANGUSTIFOLIA), LOMATIUM DISSECTUM, MYRRHA, HYDRASTIS CANADENSIS, PROPOLIS, GLANDULA SUPRARENALIS SUIS, TABEBUIA IMPETIGINOSA, THYMUS (SUIS), FORMALINUM, CARBOLICUM ACIDUM, FERRUM METALLICUM, IRIDIUM METALLICUM, LYCOPODIUM CLAVATUM, PHOSPHORICUM ACIDUM, PULSATILLA (PRASTENSIS), SELENIUM METALLICUM, ZINCUM METALLICUM, ADENOSINUM TRIPHOSPHORICUM DINATRUM, METHYLCOBALAMIN, SARCOLACTICUM ACIDUM, MUCOR RACEMOSUS, ALTERNARIA TENUIS NEES, ASPERGILLUS NIGER,	Deseret Biologicals, Inc.	fd32287e-af1a-45d3-b82a-5cc004db6bc9	2024-09-27	Warnings	Exact identifier unii: 1HG84L3525
Dairy Allergen Mix	ADENOSINUM TRIPHOSPHORICUM DINATRUM, BENZOICUM ACIDUM, CHOLINUM, CINNAMIC ACID, EUGENOL, FOLIC ACID, FORMALINUM, HISTAMINUM HYDROCHLORICUM, L-ASPARAGINE (MONOHYDRATE), LAC DEFLORATUM, LAC VACCINUM, MENADIONE, OOPHORINUM (SUIS), PETROSELINUM SATIVUM, PHENYL ISOTHIOCYANATE, QUERCETIN, RUTIN, SACCHARUM LACTIS, ILEUM (SUIS), JEJUNUM (SUIS), STOMACH (SUIS), COUMARINUM, FOLLICULINUM, GABA (GAMMA-AMINOBUTYRIC ACID), SARCOLACTICUM ACIDUM, LAC CANINUM, LAC FELINUM, LAC HUMANUM, PIPERINE, CALCAREA CARBONICA,	Deseret Biologicals, Inc.	e03d8463-287a-4509-a9f4-0ad38a98377c	2024-09-11	Warnings	Exact identifier unii: 1HG84L3525
Bio Glyoxal Phase	ARNICA MONTANA, BAPTISIA TINCTORIA, ECHINACEA (ANGUSTIFOLIA), SANGUINARIA CANADENSIS, EUPATORIUM PERFOLIATUM, EUPHORBIUM OFFICINARUM, DOPAMINE HYDROCHLORIDE, PHYTOLACCA DECANDRA, ACONITUM NAPELLUS, ARGENTUM NITRICUM, ARSENICUM ALBUM, BRYONIA (ALBA), GELSEMIUM SEMPERVIRENS, MERCURIUS CORROSIVUS, PHOSPHORUS, PULSATILLA (PRATENSIS), RHUS TOX, SULPHUR, THUJA OCCIDENTALIS, CORTISONE ACETICUM, ACETALDEHYDE, FORMALINUM, HEPAR SULPHURIS CALCAREUM, LACHESIS MUTUS, ZINCUM METALLICUM	Deseret Biologicals, Inc.	d43db203-7756-43a5-bd68-aa070d429f60	2024-05-09	Warnings	Exact identifier unii: 1HG84L3525
BP Reg	ALLIUM SATIVUM, ADRENALINUM, ARTERIA SUIS, CORTISONE ACETICUM, THYROIDINUM (SUIS), VENA SUIS, FORMALINUM, KALI CHLORICUM, ALPHA-LIPOICUM ACIDUM, AURUM METALLICUM, CACTUS GRANDIFLORUS, CHOLESTERINUM, COUMARINUM, EPHEDRA VULGARIS, GLONOINUM, LACHESIS MUTUS, RAUWOLFIA SERPENTINA, STRONTIUM CARBONICUM, SULPHUR, VERATRUM ALBUM, PROTEUS (VULGARIS)	Deseret Biologicals, Inc.	f99833d8-d637-4c63-afe8-25eb2f05de6a	2024-05-08	Warnings	Exact identifier unii: 1HG84L3525
Vascuflow	MELATONIN, L-ARGININE, L-CITRULLINE, UBIDECARENONUM, SQUALENE, CALCAREA CARBONICA, CHOLESTERINUM, COUMARINUM, FORMALINUM, GELSEMIUM SEMPERVIRENS, ALPHA-LIPOICUM ACIDUM, MERCURIUS CORROSIVUS, PLUMBUM METALLICUM, PANTOTHENIC ACID, GLONOINUM, LYCOPODIUM CLAVATUM, PHOSPHORUS, BERBERIS VULGARIS, RED YEAST RICE, NITRIC OXIDE, PROTEUS (MORGANI), RHUS TOX	Deseret Biologicals, Inc.	1ca5d57d-7cf0-4b9a-afa0-767dca99864d	2024-04-02	Warnings	Exact identifier unii: 1HG84L3525
Formaldehyde	FORMALINUM	Deseret Biologicals, Inc.	9d0bf1f5-43cb-47d2-8d95-ae5dd77c8f74	2024-02-19	Warnings	Exact identifier unii: 1HG84L3525
A05 HEAVY ANTITOX	ALLIUM CEPA, ALLIUM SATIVUM, ALUMINIUM METALLICUM, APIS MELLIFICA, ARGENTUM METALLICUM, AURUM METALLICUM, BELLADONNA, BERBERIS VULGARIS, CADMIUM METALLICUM, CHELIDONIUM MAJUS, CUPRUM METALLICUM, FAGUS SYLVATICA, FORMALINUM, FORMICUM ACIDUM, HYPERICUM PERFORATUM, ICHTHYOLUM, MERCURIUS CORROSIVUS, MERCURIUS SOLUBILIS, NICCOLUM METALLICUM, PLUMBUM METALLICUM, SELENIUM METALLICUM, SILICEA, SOLIDAGO VIRGAUREA, STANNUM METALLICUM, THIOSINAMINUM	Apex Energetics Inc.	b9bdc39e-8ebf-615c-e053-2a95a90afe1b	2024-01-08	Warnings	Exact identifier unii: 1HG84L3525
Oligo Bio Iodine	CHELIDONIUM MAJUS, IODIUM, LYCOPUS VIRGINICUS, GINKGO BILOBA, PINUS SYLVESTRIS, FUCUS VESICULOSUS, SPONGIA TOSTA, GERMANIUM SESQUIOXIDE, HYPOPHYSIS SUIS, THYROIDINUM (SUIS), CYSTEINUM, MANGANESE GLUCONATE, ALPHA-KETOGLUTARICUM ACIDUM, CALCAREA CARBONICA, FERRUM IODATUM, FUMARICUM ACIDUM, KALI IODATUM, NATRUM OXALACETICUM, PULSATILLA (VULGARIS), ARGENTUM METALLICUM, AURUM METALLICUM, CUPRUM METALLICUM, EUGENOL, FORMALINUM, LIDOCAINE, MERCURIUS SOLUBILIS, MOLYBDENUM METALLICUM, NICCOLUM METALLICUM,	BioActive Nutritional, Inc.	2f4f53a9-6294-4014-9898-72023b9506f5	2023-12-01	Warnings	Exact identifier unii: 1HG84L3525
Formalinum	FORMALDEHYDE	Boiron	87376732-58e9-40af-e053-2a91aa0a58f5	2023-11-13		Exact identifier unii: 1HG84L3525
Oligo Bio Iodine	CHELIDONIUM MAJUS, IODIUM, LYCOPUS VIRGINICUS, GINKGO BILOBA, PINUS SYLVESTRIS, FUCUS VESICULOSUS, SPONGIA TOSTA, GERMANIUM SESQUIOXIDE, HYPOPHYSIS SUIS, THYROIDINUM (SUIS), CYSTEINUM, MANGANESE GLUCONATE, ALPHA-KETOGLUTARICUM ACIDUM, CALCAREA CARBONICA, FERRUM IODATUM, FUMARICUM ACIDUM, KALI IODATUM, NATRUM OXALACETICUM, PULSATILLA (VULGARIS), ARGENTUM METALLICUM, AURUM METALLICUM, CUPRUM METALLICUM, EUGENOL, FORMALINUM, LIDOCAINE, MERCURIUS SOLUBILIS, MOLYBDENUM METALLICUM, NICCOLUM METALLICUM,	BioActive Nutritional, Inc.	90e3028e-9e1e-4887-8b7c-f712bf67cd52	2023-11-07	Warnings	Exact identifier unii: 1HG84L3525
Allermilk	TARAXACUM OFFICINALE, HYDRASTIS CANADENSIS, BENZOICUM ACIDUM, CHOLINUM, CINNAMIC ACID, EUGENOL, FOLIC ACID, HISTAMINUM HYDROCHLORICUM, L-ASPARAGINE (MONOHYDRATE), MENADIONE, OOPHORINUM (SUIS), PHENYL ISOTHIOCYANATE, PIPERINE, PROGESTERONE, QUERCETIN, RUTIN, SACCHARUM LACTIS, TYRAMINE, XANTHINE, COUMARINUM, FOLLICULINUM, FORMALINUM, GABA (GAMMA-AMINOBUTYRIC ACID), VANILLYLAMINE, APIOLUM	Deseret Biologicals, Inc.	c13cbfb9-1c1f-43b5-b218-e58c3c521f93	2023-01-12	Warnings	Exact identifier unii: 1HG84L3525
Addiclenz	BETA VULGARIS, BOLDO, CHELIDONIUM MAJUS, PETROSELINUM SATIVUM, TARAXACUM OFFICINALE, ARSENICUM ALBUM, BISPHENOL A, COBALTUM METALLICUM, CUPRUM METALLICUM, GLYPHOSATE, IODIUM, LYCOPODIUM CLAVATUM, PHOSPHORICUM ACIDUM, SELENIUM METALLICUM, ZINCUM METALLICUM, ASPARTAME, BENZALKONIUM CHLORIDE, FORMALINUM, METHYLENE CHLORIDE, METHYL PARABEN, PROPYL PARABEN, SODIUM BENZOATE, SODIUM CITRATE, TITANIUM DIOXIDE, ZINCUM OXYDATUM	Deseret Biologicals, Inc.	e39235ea-2a2f-44a7-92d6-fb1d428ebabd	2022-05-12	Warnings	Exact identifier unii: 1HG84L3525
Additox	TRIFOLIUM PRATENSE, XANTHOXYLUM FRAXINEUM, PHYTOLACCA DECANDRA, ARSENICUM ALBUM, BELLADONNA, CHELIDONIUM MAJUS, LYCOPODIUM CLAVATUM, PHOSPHORICUM ACIDUM, ASPARTAME, BENZALKONIUM CHLORIDE, FORMALINUM, METHYLENE CHLORIDE, METHYLPARABEN, PROPYLPARABEN, SODIUM BENZOATE, SODIUM CITRATE, TITANIUM DIOXIDE, ZINCUM OXYDATUM	BioActive Nutritional, Inc.	319ee2fe-58e3-495e-bf0d-df201f6fbb1c	2018-07-18	Warnings	Exact identifier unii: 1HG84L3525

Reported adverse events (FAERS/openFDA)#

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