FDA.reportPublic FDA data

NDC 58160-855-01 - Arepanrix

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
58160-855
Requested NDC
58160-855-01
Package NDCs from labels
58160-855-01, 58160-855-19
Manufacturer
GlaxoSmithKline Biologicals SA
Effective date
2026-04-28
Current FDA listing
Not matched in FDA.report NDC product tables

DailyMed Labels#

Label, Manufacturer, Effective date table
LabelManufacturerEffective dateType
Arepanrix - GlaxoSmithKline Biologicals SAGlaxoSmithKline Biologicals SA2026-04-28VACCINE LABEL
AS03 - GlaxoSmithKline Biologicals SAGlaxoSmithKline Biologicals SA2025-12-31VACCINE LABEL

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
58160-855-192024-02-10C16284748780-11030e365-6622-111a-e063-dadaa90a10e2f136b41b-56f3-43a9-9d6a-61b2afca5b4a
58160-855-192024-01-30C16284748780-11030e365-6622-111a-e063-dadaa90a10e2f136b41b-56f3-43a9-9d6a-61b2afca5b4a

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
58160-855-01AS032.5 mL in 1 VIALINJECTION, SOLUTION2.53
58160-855-19AS0310 in 1 CARTONINJECTION, SOLUTION103

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
58160-855AS03 INJECTION, SOLUTION [GLAXOSMITHKLINE BIOLOGICALS SA]2Current NDC, Legacy NDC, 2 package rows20240210_f136b41b-56f3-43a9-9d6a-61b2afca5b4a.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 40 of 76 · 1,503 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Sodium Chloride Normal SaltSODIUM CHLORIDECitragen Pharmaceuticals Inc82c29f1d-a018-7483-e053-2a91aa0a8f7e2025-01-30WarningsExact identifier
unii: 451W47IQ8X
Bestmade Natural Products BM63CEANOTHUS, KALI MUR, KALI ARS, OOPHRINUM, SELENIUM, THALLIUM, WEISBADENBestmade Natural Products2cea4552-3700-3da3-e063-6294a90a14b52025-01-30WarningsExact identifier
unii: 059QF0KO0R
unii: 660YQ98I10
Bestmade Natural Products BM68PHOSPHORUS, ARG NIT, GELSEMIUM, NAT MUR, KALI BROM, BARYTA CARBBestmade Natural Products2cec9c90-2e61-f005-e063-6294a90a87532025-01-30WarningsExact identifier
unii: 451W47IQ8X
Bestmade Natural Products BM79CARDUUS MAR, HYDRASTIS, KALI MUR, PHYTOLACCIN, POLYGONUM, RUTABestmade Natural Products2cf029ac-5560-84fb-e063-6294a90a06202025-01-30WarningsExact identifier
unii: 660YQ98I10
RecovatoneGLYCYRRHIZA GLABRA, KALI MURIATICUM, KALI PHOSPHORICUM, IODIUM, ZINCUM GLUCONICUM, PHOSPHORUS, ASCORBICUM ACIDUM, CALCIUM GLUCONATE, L-ARGININE, L-CARNITINE, L-ORNITHINE, MAGNESIA MURIATICA, MAGNESIUM GLUCONICUM DIHYDRICUM, MANGANESE GLUCONATE, NATRUM MURIATICUM, COBALT GLUCONATE, COPPER GLUCONATE, CREATINE, L-GLUTAMINE, L-LEUCINE, L-VALINE, POTASSIUM GLUCONATE, SELENIUM DIOXIDE, ADRENALINUM, BORON, CALCAREA PHOSPHORICA, FERRUM SULPHURICUM, MOLYBDENUM, NICCOLUM METALLICUM, SELENIUM METALLICUM,Energique, Inc.8ca76872-a187-4fd8-8daf-9ee351bdf3462025-01-28WarningsExact identifier
unii: 451W47IQ8X
unii: 660YQ98I10
WHP HeadacheATROPA BELLADONNA - BRYONIA ALBA ROOT - SODIUM CHLORIDE - STRYCHNOS NUX-VOMICA SEEDWashington Homeopathic Products06d25564-4c7e-0b3a-e063-6294a90a38bf2025-01-28WarningsExact identifier
unii: 451W47IQ8X
Kali Muriaticum Kit RefillPOTASSIUM CHLORIDEWashington Homeopathic Products099223af-a3f6-c370-e063-6394a90aa17f2025-01-28WarningsExact identifier
unii: 660YQ98I10
Fever-InfectionCHAMOMILLA, ECHINACEA HYDRASTIS CANADENSIS, ACONITUM NAPELLUS, ARSENICUM ALBUM, BELLADONNA, BRYONIA, CAMPHORA, CINA, CINCHONA OFFICINALIS, EUPATORIUM PERFOLIATUM, FERRUM PHOSPHORICUM, GELSEMIUM SEMPERVIRENS, HEPAR SULPHURIS CALCAREUM, IGNATIA AMARA, NATRUM MURIATICUM, NUX VOMICA, PHOSPHORUS, PULSATILLA, SALIX NIGRA, VERATRUM VIRIDE, INFLUENZINUMNewton Laboratories, Inc.9d762268-8c30-8a86-e053-2a95a90a419c2025-01-27WarningsExact identifier
unii: 451W47IQ8X
Histastat PollenBAPTISIA TINCTORIA, ECHINACEA (ANGUSTIFOLIA), ADRENALINUM, ALLIUM CEPA, AMBROSIA ARTEMISIAEFOLIA, ARSENICUM ALBUM, EUPHRASIA OFFICINALIS, HISTAMINUM HYDROCHLORICUM, NATRUM MURIATICUM, NATRUM SULPHURICUM, NUX VOMICA, PHOSPHORUS, PULSATILLA (PRATENSIS), SABADILLA, SINAPIS NIGRA, SOLIDAGO VIRGAUREA, SULPHUR, WYETHIA HELENIOIDESEnergique, Inc.5a94659f-b62a-41d8-81c0-87a68c02606d2025-01-27WarningsExact identifier
unii: 451W47IQ8X
Bestmade Natural Products BM55DAPHNE INDICA, NATRUM PHOS, SILICA MARINA, TABACUMBestmade Natural Products2c751942-5b36-8558-e063-6294a90af87a2025-01-24WarningsExact identifier
unii: 70WT22SF4B
Bestmade Natural Products BM59CALC CARB, DULCAMARA, HEPAR SULPH, LYCOPODIUM, NAT MUR, SULPHUR, THUJA OCCBestmade Natural Products2c763956-a1de-c8df-e063-6294a90a5c812025-01-24WarningsExact identifier
unii: 451W47IQ8X
Equate Sterile Saline MistSODIUM CHLORIDEWALMART INC.275ada29-8904-fe1e-e063-6394a90abe592025-01-24WarningsExact identifier
unii: 451W47IQ8X
Glucose and Sodium ChlorideDEXTROSE ANHYDROUS AND SODIUM CHLORIDEBaxter Healthcare Corporation1ba918d0-13d0-48bc-8742-658fc0eb47b62025-01-24Exact identifier
unii: 451W47IQ8X
Sodium ChlorideSODIUM CHLORIDEBaxter Healthcare Corporation93aeac13-41de-4452-9f38-d6b4f38ada302025-01-24Exact identifier
unii: 451W47IQ8X
Bestmade Natural Products BM33ACID FOLICD10, ACID PHOSD4, ARSENIC ALBD4, AVENA SATD3, BETA VULGD5, CHINA OFFD12, FERR METD5, NATRUM MURD5Bestmade Natural Productsef2beaff-5c94-de60-e053-2995a90ad7962025-01-23WarningsExact identifier
unii: 451W47IQ8X
Bestmade Natural Products BM38BERB, AQUID2, GRAPHITESD18, HYDROCOTYLED2, KALI BROMD7, KALI IODATD7, NATRUM PHOSD12, SULPHUR IODATD7Bestmade Natural Productsef43430f-c002-fde5-e053-2995a90aca5e2025-01-23WarningsExact identifier
unii: 70WT22SF4B
Bestmade Natural Products BM50BARYTA CARB, CALC PHOS, FERRUM PHOS, KALI PHOS, MAGNESIA PHOS, NATRUM PHOS, PITUITRINUMBestmade Natural Products2c648fa0-e1e8-e3e7-e063-6294a90ad1b82025-01-23WarningsExact identifier
unii: 70WT22SF4B
Bestmade Natural Products Kali Mur (Lactose-Free)KALI MURIATICUMBestmade Natural Products2c4ae2c0-6ba0-e1dc-e063-6294a90a03652025-01-22WarningsExact identifier
unii: 660YQ98I10
Bestmade Natural Products Nat Mur (Lactose-Free)NATRUM MURIATICUMBestmade Natural Products2c4b8827-e724-858a-e063-6394a90a3b4e2025-01-22WarningsExact identifier
unii: 451W47IQ8X
Bestmade Natural Products Nat Phos (Lactose-Free)NATRUM PHOSPHORICUMBestmade Natural Products2c4bbfdd-dc0e-74f5-e063-6294a90ad0c72025-01-22WarningsExact identifier
unii: 70WT22SF4B

Reported adverse events (FAERS/openFDA)#

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