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 27 of 76 · 1,503 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Sodium Chloride Normal SaltSODIUM CHLORIDEMethod Pharmaceuticalsce84727a-3677-4bf0-e053-2995a90a3ec82025-10-21WarningsExact identifier
unii: 451W47IQ8X
Potassium chloridePOTASSIUM CHLORIDEMacleods Pharmaceuticals Limitede0562a05-4359-4256-87e3-fcde65a008cd2025-10-18Warnings, Adverse reactionsExact identifier
unii: 660YQ98I10
WalgreensSODIUM CHLORIDEWalgreen Company21dfc2cf-65ae-c3fb-e063-6294a90a0a942025-10-17Exact identifier
unii: 451W47IQ8X
Mold Relief FormulaKALI MURIATICUM, GELSEMIUM, KALI BICHROMICUM, SABADILLA, HISTAMINUM, MOLD MIX.Integrative Healing Institute, LLC067ee707-7219-4370-9cdd-08888f45b5e52025-10-17WarningsExact identifier
unii: 660YQ98I10
Seasonal Allergy FormulaHYDRASTIS CANADENSIS, KALI MURIATICUM, GELSEMIUM SEMPERVIRENS, KALI BICHROMICUM, SABADILLA, HISTAMINUM, HOUSE DUST, GRASS MIX, TREES MIX, WEEDS MIXIntegrative Healing Institute, LLC1d4deee9-5452-421b-a107-ab150d1f62142025-10-17WarningsExact identifier
unii: 660YQ98I10
KLOR-CON MPOTASSIUM CHLORIDECardinal Health 107, LLCee3a1815-7325-4838-9764-fe1db68877b62025-10-17Warnings, Adverse reactionsExact identifier
unii: 660YQ98I10
Homeopathic Tea Tree Oil LiceEUCALYPTUS GLOBULUS, NATRUM MURIATICUMDOLGENCORP, LLC0a0c2db2-7eeb-909c-e063-6394a90a7a902025-10-15WarningsExact identifier
unii: 451W47IQ8X
Saline AmpoulesSODIUM CHLORIDE 0.9%Trifecta Pharmaceuticals USA, LLC.ee18ef7c-bb5d-30ec-e053-2a95a90a964e2025-10-13WarningsExact identifier
unii: 451W47IQ8X
Potassium ChloridePOTASSIUM CHLORIDEStrides Pharma Science Limitedf4e36462-3522-4130-8785-6c18871d29842025-10-10Warnings, Adverse reactionsExact identifier
unii: 660YQ98I10
EQUATE SALINE PACKETSNASAL CLEANING SALTWALMART INC9e905ecb-d4d5-514a-e053-2a95a90adfbb2025-10-08WarningsExact identifier
unii: 451W47IQ8X
EQUATE NETI POT SINUS WASHNASAL WASHWALMART INC9e90c1c1-4dcd-106e-e053-2995a90afd152025-10-08WarningsExact identifier
unii: 451W47IQ8X
GURUNANDA NASAL SALINENASAL WASHGURUNANDA LLC2b4d78ae-b587-6dfe-e063-6394a90a88762025-10-08WarningsExact identifier
unii: 451W47IQ8X
Sodium chlorideSODIUM CHLORIDEBecton Dickinson and Companyca3355f2-2cf0-4f58-bed5-0c4c0a7d35112025-10-08Warnings, Adverse reactionsExact identifier
unii: 451W47IQ8X
Potassium ChloridePOTASSIUM CHLORIDENorthstar Rx LLCfbed8c29-b3f1-4e53-b290-6f717290cecf2025-10-07Warnings, Adverse reactionsExact identifier
unii: 660YQ98I10
Homeopathic Calm DropsARSENIC TRIOXIDE 30C, MATRICARIA CHAMOMILLA12X, ARABICA COFFEE BEAN 30X, POTASSIUM CARBONATE30C, STRYCHNOS IGNATII SEED30X, LACHESIS MUTA VENOM12X, PHOSPHORIC ACID 3X, ANEMONE PULSATILLA 12C, VALERIAN 30C, ACONITUM NAPELLUS 6X, CHLORIDE ION 12X, STRYCHNOS NUX-VOMICA SEED 30CHISTORICAL REMEDIES LLP.69c35bc2-b9a0-4bb4-a56d-0e2d1c3f79582025-10-07WarningsExact identifier
unii: 451W47IQ8X
Homeopathic Moon dropsARSENIC CATION 30X, MATRICARIA CHAMOMILLA 6X, ARABICA COFFEE BEAN 12X, GELSEMIUM SEMPERVIRENS ROOT 12X, STRYCHNOS IGNATII SEED 30X, LYCOPODIUM CLAVATUM SPORE 30X, SODIUM CHLORIDE 30X, STRYCHNOS NUX VOMICA SEED 30X, VALERIAN 12C,Historical Remedies LLP0e7972a5-a930-4a52-8896-02ce810fa90b2025-10-07WarningsExact identifier
unii: 451W47IQ8X
Tri-Relief AntifungalSODIUM CHLORIDE, SILICON DIOXIDE, AND THUJA OCCIDENTALIS LEAFY TWIGForces of Nature6fe97b54-8aa3-4d86-9055-0629589a416b2025-10-06WarningsExact identifier
unii: 451W47IQ8X
VirexADENOVIREN NOSODE, ASCLEPIAS TUBEROSA, CALCAREA ARSENICICA, CAMPHORA, COXSACKIE A2 NOSODE, COXSACKIE A3 NOSODE, COXSACKIE A4 NOSODE, COXSACKIE A5 NOSODE, COXSACKIE A7 NOSODE, COXSACKIE B1 NOSODE, COXSACKIE B3 NOSODE, COXSACKIE B4 NOSODE, COXSACKIE B5 NOSODE, CYTOMEGALOVIRUS NOSODE, ECHINACEA PURPUREA, EPSTEIN-BARR VIRUS NOSODE, EUPHRASIA OFFICINALIS, INFLUENZINUM, LAC VACCINUM, MORBILLINUM, NATRUM MURIATICUM, PHYTOLACCA DECANDRA, THUJA OCCIDENTALIS, TRIFOLIUM PRATENSE, VARIOLINUMNutritional Specialties, Inc.4baa5c95-79a6-4ae8-a8c4-1edbf308f92c2025-10-03WarningsExact identifier
unii: 451W47IQ8X
POTASSIUM CHLORIDEPOTASSIUM CHLORIDEPD-Rx Pharmaceuticals, Inc.cc15ef60-6956-4d34-b86d-72cdd0c0c0bb2025-10-02Warnings, Adverse reactionsExact identifier
unii: 660YQ98I10
Potassium Chloride Extended-releasePOTASSIUM CHLORIDE EXTENDED-RELEASEGranules Pharmaceuticals Inc.b3d4d5b5-2898-ae3d-e053-2a95a90a6d042025-09-30Warnings, Adverse reactionsExact identifier
unii: 660YQ98I10

Reported adverse events (FAERS/openFDA)#

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