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 66 of 76 · 1,503 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Sodium ChlorideSODIUM CHLORIDEFresenius Kabi USA, LLC51da05ce-e3c4-4ef5-a845-dc869152e17f2022-10-24Warnings, Adverse reactionsExact identifier
unii: 451W47IQ8X
Potassium ChloridePOTASSIUM CHLORIDEZydus Pharmaceuticals (USA) Inc.31e02249-7984-4b8f-9e37-2b79b708ac082022-10-18Warnings, Adverse reactionsExact identifier
unii: 660YQ98I10
Potassium ChloridePOTASSIUM CHLORIDEZydus Lifesciences Limited099c3a36-f460-4191-80e5-0c4153a5c7132022-10-18Warnings, Adverse reactionsExact identifier
unii: 660YQ98I10
Eye washPURIFIED WATERMcKessonbd089fde-24ba-4de5-e053-2995a90a39bb2022-10-18WarningsExact identifier
unii: 059QF0KO0R
Potassium ChloridePOTASSIUM CHLORIDEBluePoint Laboratories73c911bb-4d39-4793-acba-90ed4b0eff462022-10-17Warnings, Adverse reactionsExact identifier
unii: 660YQ98I10
Bach Original Flower Remedies Rock WaterWATERNelson Bach USA Limitedea242559-1618-3354-e053-2a95a90a1a952022-10-03WarningsExact identifier
unii: 059QF0KO0R
Dr Talbots Infgant Gas Colic ReliefCARBO VEGETABILIS 12X,CHAMOMILLA 12X,FOENICULUM VULGARE 12X,LYCOPODIUM 30X,NUX MOSCHATA 12X,RAPHANUS SATIVUS 12X,ZINGIBER OFFICINALE 12X,KALI MURIATICUM 6X,MAGNESIA PHOSPHORICA 12X,NATRUM PHOSPHORICUM 6XTalbot's Pharmaceuticals Family Products,LLC.e8bee190-04b2-4be6-e053-2a95a90a30a02022-09-28WarningsExact identifier
unii: 660YQ98I10
unii: 70WT22SF4B
Dr Talbots Infant Tummy Ache ReliefCALENDULA OFFICINALIS 12X,CARBO VEGETABILIS 12X,LYCOPODIUM 30X,FOENICULUM VULGARE 12X,NUX MOSCHATA 12X,ZINGIBER OFFICINALE 12X,KALI MURIATICUM 6X,MAGNESIA PHOSPHORICA 12X,NATRUM PHOSPHORICUM 6XTalbot's Pharmaceuticals Family Products,LLC.e9c24994-b935-36e6-e053-2a95a90a78df2022-09-28WarningsExact identifier
unii: 660YQ98I10
unii: 70WT22SF4B
Sterile WaterWATERMedical Purchasing Solutions, LLCe90b47e3-9636-b9ee-e053-2a95a90ad48c2022-09-19Warnings, Adverse reactionsExact identifier
unii: 059QF0KO0R
REFRESH OPTIVE AdvancedCARBOXYMETHYLCELLULOSE SODIUM, GLYCERIN, POLYSORBATE 80Allergan, Inc.ebd0839e-2e1d-4e0e-986c-19f1f5c763582022-09-15WarningsExact identifier
unii: 6OZP39ZG8H
Dr Talbots Infant Mucus Cold ReliefEUPATORIUM PERF 12X,HEPAR SULPHURIS CALCAREUM 12X,KALI BICHROMICUM 12X,MARRUBIUM VULGARE 12X,PHOSPHORUS 30X,PULSATILLA 12X,RUMEX CRISPUS 12X,SAMBUCUS NIGRA 12X,CALCAREA SULPHURICA 12X,FERRUM PHOSPHORICUM 12XTalbots Pharmaceuticals Family Products, LLC.e8917c54-f4c2-3427-e053-2995a90adbf22022-09-13WarningsExact identifier
unii: 660YQ98I10
Dr Talbots Infant Pain Inflamtion ReliefARNICA 12X,BELLIS PERENNIS 12X,CALENDULA OFFICINALIS 12X,CHAMOMILLA 12X,COFFEA CRUDA 12X,HYPERICUM 12X,MILLEFOLIUM 12X,FERRUM PHOSPHORICUM 12X,KALI MURIATICUM 6X,MAGNESIA PHOSPHORICA 6XTalbots Pharmaceuticals Family Products, LLC.e892c0cb-03b4-52da-e053-2995a90a08782022-09-12WarningsExact identifier
unii: 660YQ98I10
Dr Talbots Infant Daily Allergy ReliefALLIUM CEPA 12X,ARALIA RACEMOSA 12X,EUPHRASIA OFFICINALIS 12X,GALPHIMIA GLAUCA 12X,HISTAMINUM HYDROCHLORICUM 12X,LUFFA OPERCULATA 12X,PULSATILLA 12X,SOLIDAGO 12X,NATRUM MURIATICUM 6XTalbot's Pharmaceuticals Family Products,LLC.e8bdcc8a-c947-ff5d-e053-2a95a90a3b922022-09-12WarningsExact identifier
unii: 451W47IQ8X
REFRESH OPTIVE AdvancedCARBOXYMETHYLCELLULOSE SODIUM, GLYCERIN, AND POLYSORBATE 80Allergan, Inc.aaa943e4-7c38-4c5a-b7c0-5a656d8cafc02022-09-01WarningsExact identifier
unii: 6OZP39ZG8H
HerplexANATHERUM MURICATUM, CLEMATIS ERECTA, MEZEREUM, PHYTOLACCA DECANDRA, RANUNCULUS BULBOSUS, RHUS TOX, THUJA OCCIDENTALIS, NATRUM MURIATICUM, SEPIANashco Products LLC6a1322c7-7767-4569-aa22-9d2e363312832022-08-30WarningsExact identifier
unii: 451W47IQ8X
POTASSIUM CHLORIDEPOTASSIUM CHLORIDEDr. Reddys Laboratories, Inc.dda82a38-0c08-4947-99b7-915c2949bf162022-08-29Warnings, Adverse reactionsExact identifier
unii: 660YQ98I10
Kids Cold and Cough Nighttime Grape FlavorONION, CHAMOMILE, ARABICA COFFEE BEAN, CALCIUM SULFIDE, GOLDEN SEAL, SODIUM CHLORIDE, PHOSPHORUS, PULSATILLA VULGARIS TOP, SULFURHyland's Consumer Health Inc.e676dbb7-212f-47e3-e053-2995a90af4e12022-08-17WarningsExact identifier
unii: 451W47IQ8X
Kids Cold and Cough Daytime Grape FlavorONION, CALCIUM SULFIDE, GOLDEN SEAL, SODIUM CHLORIDE, PHOSPHORUS, PULSATILLA VULGARIS WHOLE, SULFURHyland's Consumer Health Inc.e65f14cb-5a8e-0ad5-e053-2a95a90a6f5d2022-08-16WarningsExact identifier
unii: 451W47IQ8X
Sterile Saline Kids Mist PediaMedsSODIUM CHLORIDEASCENT CONSUMER PRODUCTS, INC.e5c5b580-1d9f-3081-e053-2995a90a80312022-08-08WarningsExact identifier
unii: 451W47IQ8X
Sterile Saline Kids Mist SinuCleanse BreatheSODIUM CHLORIDEASCENT CONSUMER PRODUCTS, INC.e5c5c313-046f-b0a7-e053-2a95a90a2a072022-08-08WarningsExact identifier
unii: 451W47IQ8X

Reported adverse events (FAERS/openFDA)#

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