FDA.reportPublic FDA data

NDC 58160-723 - Arexvy

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
58160-723
Package NDCs from labels
58160-723-03
Manufacturer
GlaxoSmithKline Biologicals SA
Effective date
2026-07-27
Current FDA listing
Not matched in FDA.report NDC product tables

DailyMed Labels#

Label, Manufacturer, Effective date table
LabelManufacturerEffective dateType
Arexvy - GlaxoSmithKline Biologicals SAGlaxoSmithKline Biologicals SA2026-07-27VACCINE LABEL

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
58160-723-03Arexvy0.5 mL in 1 VIALINJECTION, POWDER, LYOPHILIZED,5 mL120 ug in 0.5mL10

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
58160-723AREXVY (RESPIRATORY SYNCYTIAL VIRUS VACCINE RECOMBINANT, ADJUVANTED) KIT [GLAXOSMITHKLINE BIOLOGICALS SA]5Unmatched20250112_1e50f275-002e-413f-a840-66ee3cb3740c.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 58 of 59 · 1,178 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Kids ReliefARSENICUM ALBUM, KALI PHOSPHORICUM, MERCURIS SOLUBILIS, NATRUM SULPHURICUM, HEPAR SULPHURIS CALCAREUM, ARUM TRIPHYLLUMHomeolab International (Canada) inc18a6f6d4-cdfd-4bf7-8cb2-831033c1d9652019-10-23WarningsExact identifier
unii: CI71S98N1Z
Plasma-Lyte ASODIUM CHLORIDE, SODIUM GLUCONATE, SODIUM ACETATE, POTASSIUM CHLORIDE AND MAGNESIUM CHLORIDEBaxter Healthcare Corporation6ec9e61c-2c26-402f-8604-f446b2e340582019-08-05Warnings, Adverse reactionsExact identifier
unii: 451W47IQ8X
Potassium Chloride in Dextrose and Sodium ChloridePOTASSIUM CHLORIDE, DEXTROSE MONOHYDRATE AND SODIUM CHLORIDEBaxter Healthcare Companyc553fed1-3de5-4826-8eff-633b5923bf0b2019-02-21Warnings, Adverse reactionsExact identifier
unii: 451W47IQ8X
Potassium Chloride in Sodium ChloridePOTASSIUM CHLORIDE AND SODIUM CHLORIDEBaxter Healthcare Companybecc7410-0a25-49f5-b0c3-240078479dc82019-01-11Warnings, Adverse reactionsExact identifier
unii: 451W47IQ8X
EZ-Detox Super Drainage FormulaAESCULUS HIPPOCASTANUM BARK,ANTIMONY TRISULFIDE,SILVER NITRATE,ARNICA MONTANA,BERBERIS VULGARIS WHOLE,ACTIVATED CHARCOAL,CEANOTHUS AMERICANUS WHOLE,CHOLESTEROL,CINCHONA BARK,CYNARA SCOLYMUS LEAF,EQUISETUM ARVENSE TOP,CONYZA CANADENSIS,FUCUS VESICULOSUS,GINKGO,HAMAMELIS VIRGINIANA LEAF,CHAMAELIRIUM LUTEUM ROOT,GOLDENSEAL,ARCTIUM LAPPA ROOT,LESPEDEZA CAPITATA FLOWERING TOP,RANUNCULUS BULBOSUS,DAIKON,ROBINIA PSEUDOACACIA BARK,TARAXACUM PALUSTRE ROOT,VIBURNUM PRUNIFOLIUM BARK,VITIS VINIFERA WHOLEHomeocare Laboratories5a07e95d-08a8-4a54-bd04-3679a7b856c82018-12-31WarningsExact identifier
unii: 97C5T2UQ7J
Skin Klear Acne ReliefTRIBASIC CALCIUM PHOSPHATE, FUMARIA OFFICINALIS FLOWERING TOP, ARCTIUM LAPPA ROOT, SODIUM CHLORIDE, SAPONARIA OFFICINALIS ROOT, SILICON DIOXIDE, SOLIDAGO VIRGAUREA FLOWERING TOP, SULFUR, VIOLA TRICOLORHomeocare Laboratories65afbc20-611b-4bc4-a151-c633bec66a822018-12-31WarningsExact identifier
unii: 451W47IQ8X
Leg Cramps ReliefCUPRIC ARSENITE, COPPER, POTASSIUM PHOSPHATE, DIBASIC, LACTIC ACID, L-,MAGNESIUM PHOSPHATE, TRIBASIC, PENTAHYDRATEHomeocare Laboratoriese34601fb-2bd8-498a-9910-d82410e930362018-12-31WarningsExact identifier
unii: CI71S98N1Z
Muscular Pain ReliefARNICA MONTANA, COPPER, POTASSIUM PHOSPHATE, DIBASIC, LACTIC ACID, DL-,MAGNESIUM PHOSPHATE, DIBASIC TRIHYDRATEHomeocare Laboratories7ef95005-8cd2-4d7d-af73-4d3dd47128db2018-12-26WarningsExact identifier
unii: CI71S98N1Z
H.M.D.ALLIUM SAT, AVENA, BERBER VULG, LAPPA, PHYTOLACCA, SOLIDAGO, ALUMINA, ARG NIT, BARYTA CARB, BERYLLIUM, CADMIUM MET, CURPRUM MET, FLUORICUM ACIDUM, INDIUM, IODIUM, LITHIUM CARB, MERC SOLUB, NICCOLUM CARB, NITROGENUM OXYGENATUM, PLUMB MET, SELENIUM, STRONTIUM CARB, TITANIUM, ARSENICUM ALB, NAT MUR, NUX VOMZorex International8c53091a-904d-4756-93e4-17143c5b48e92018-12-21WarningsExact identifier
unii: 451W47IQ8X
Vitality FemaleARALIA QUINQUEFOLIA, AVENA SATIVA, BERBERIS VULGARIS, CAUSTICUM, GRAPHITES, LACHESIS MUTUS, NATRUM MURIATICUM, PHOSPHORICUM ACIDUM, PHOSPHORUS, SEPIANatural Creations, Inc679ba86d-bf84-4ded-b0bf-d55a0df9faa42018-12-21WarningsExact identifier
unii: 451W47IQ8X
StressARALIA QUIN, PASSIFLORA, SCUTELLARIA, VALERIANA, ARSENICUM ALB, AUR MET, CALC CARB, COFFEA CRUDA, IGNATIA, KALI PHOS, LYCOPUS, PHOSPHORUS, STAPHYSAGRIAZorex Internationald0527396-7b7f-4252-be0f-d3aa74c25e0e2018-12-21WarningsExact identifier
unii: CI71S98N1Z
Hydrate IIBERBER AQUI, BETA VULG, BOLDO, CARDUUS MAR, CHELIDONIUM MAJ, HORDEUM VULGARE, IRIS VERS, ROSMARINUS, TARAXACUM, AVENA, ELEUTHEROCOCCUS SENTICOSUS, XANTHOXYLUM, EQUISETUM HYEM, HYPERICUM, ULMUS FULV, GETTYSBURG AQUA, GLYCYRRHIZA, WILDBAD AQUA, CARLSBAD AQUA, ATP, HYDROGEN, NAT MUR, OXYGEN, SILICEA, WIESBADEN AQUAZorex Internationale5f53495-3b75-4d7c-89af-23058fb6fd052018-12-21WarningsExact identifier
unii: 451W47IQ8X
Dynamic Eyewash with EyecupWATERDynamic Safety International7d3af0f4-0e1f-9ea5-e053-2991aa0af7a22018-12-17WarningsExact identifier
unii: 059QF0KO0R
WinCo Foods Saline Nasal ReliefSODIUM CHLORIDEWinCo Foods, LLC1280fee4-e763-49ba-8722-8cdb8157f1a42018-08-02WarningsExact identifier
unii: 451W47IQ8X
Bio Rock WaterROCK WATERBioActive Nutritional, Inc.178bd16d-0d4f-49d8-866b-8ab3a3c6889d2018-07-30WarningsExact identifier
unii: 059QF0KO0R
Sodium ChlorideSODIUM CHLORIDEBaxter Healthcare Corporation05dee566-7b82-4216-8a6b-765d2b4d9dc72018-07-17Warnings, Adverse reactionsExact identifier
unii: 451W47IQ8X
HA HPBELLADONNA, BRYONIA (ALBA), GELSEMIUM SEMPERVIRENS, GLONOINUM, MELILOTUS OFFICINALIS, NUX VOMICA, SILICEA, SPIGELIA ANTHELMIABioActive Nutritional, Inc.30f6c191-ce6e-438c-9601-74f5e8b61f962018-07-06WarningsExact identifier
unii: 451W47IQ8X
Metabolic SupportFUCUS VESICULOSUS, AGNUS CASTUS, CHELIDONIUM MAJUS, LYCOPODIUM CLAVATUM, NATRUM MURIATICUM, NUX VOMICA, PHYTOLACCA DECANDRA, KALI PHOSPHORICUM, MAGNESIA PHOSPHORICA, CARBO VEGETABILIS, GRAPHITES, CALCAREA CARBONICA, NATRUM PHOSPHORICUM, HYPOPHYSIS SUIS, PLACENTA TOTALIS SUIS, THYROIDINUM (SUIS)BodyLogicMD of Fort Lauderdalec2a1bd6d-c595-402f-a3bc-23f64c949d782018-06-08WarningsExact identifier
unii: CI71S98N1Z
unii: 451W47IQ8X
Sodium ChlorideSODIUM CHLORIDEBaxter Healthcare Corporation181705c7-40e4-4d7d-b9ea-ada99380e7a92018-05-23Warnings, Adverse reactionsExact identifier
unii: 451W47IQ8X
Sodium ChlorideSODIUM CHLORIDEBaxter Healthcare Corporation7c72520e-de3c-493d-8aea-11933376d9682018-04-02Warnings, Adverse reactionsExact identifier
unii: 451W47IQ8X

Reported adverse events (FAERS/openFDA)#

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