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 44 of 76 · 1,503 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
POTASSIUM CHLORIDEPOTASSIUM CHLORIDEHF Acquisition Co LLC, DBA HealthFirst9508355e-e1ed-412b-e053-2a95a90aac8e2025-01-08Warnings, Adverse reactionsExact identifier
unii: 660YQ98I10
POTASSIUM CHLORIDEPOTASSIUM CHLORIDEHF Acquisition Co LLC, DBA HealthFirst951ffdc3-d54f-d5e1-e053-2a95a90a79e62025-01-08Warnings, Adverse reactionsExact identifier
unii: 660YQ98I10
Sterile WaterSTERILE WATER FOR INJECTIONMedefil, Inc.99e99a50-82d5-aff6-e053-2a95a90a8c562025-01-08Warnings, Adverse reactionsExact identifier
unii: 059QF0KO0R
BACTERIOSTATIC WATERBACTERIOSTATIC WATERHF Acquisition Co LLC, DBA HealthFirst99b0ef9b-600a-40dc-e053-2a95a90aa07e2025-01-08Warnings, Adverse reactionsExact identifier
unii: 059QF0KO0R
0.9% SODIUM CHLORIDE0.9% SODIUM CHLORIDEHF Acquisition Co LLC, DBA HealthFirst8dfb05c0-77e8-2fa1-e053-2a95a90a3d332025-01-08Adverse reactionsExact identifier
unii: 451W47IQ8X
STERILE WATERSTERILE WATERHF Acquisition Co LLC, DBA HealthFirst99b1cb12-0b2d-0c0f-e053-2a95a90ac3b62025-01-08Warnings, Adverse reactionsExact identifier
unii: 059QF0KO0R
SODIUM CHLORIDESODIUM CHLORIDEHF Acquisition Co LLC, DBA HealthFirst998a2a47-5c79-2efd-e053-2995a90a8fac2025-01-08Adverse reactionsExact identifier
unii: 451W47IQ8X
SODIUM CHLORIDESODIUM CHLORIDEHF Acquisition Co LLC, DBA HealthFirst7da788fc-3481-527f-e053-2a91aa0af6ac2025-01-08Adverse reactionsExact identifier
unii: 451W47IQ8X
Dextrose and Sodium ChlorideDEXTROSE MONOHYDRATE AND SODIUM CHLORIDEBECTON DICKINSON AND COMPANYc1d0f42e-3494-4217-8f86-e9f34d930e822025-01-07Warnings, Adverse reactionsExact identifier
unii: 451W47IQ8X
Shingles RemedyCROTON TIGLIUM, NATRUM MURIATICUM, PLANTAGO MAJOR, RHUS TOX, SARSAPARILLASilver Star Brands5d65c997-f5dc-4dee-e053-2a91aa0ac3192025-01-01WarningsExact identifier
unii: 451W47IQ8X
Mucus-Clear Jr. NighttimeCHAMOMILLA, CINA, KALI BIC, KALI CARB, KALI MUR, PULSATILLASilver Star Brands830e4796-5371-f681-e053-2991aa0a8e832025-01-01WarningsExact identifier
unii: 660YQ98I10
Mucus Clear Allergy ReliefALLIU CEPA, CALC PHOS, EUPHRASIA, IGNATIA, KALI MUR, NAT MUR, NUX VOM, PULSATILLA, SILICASilver Star Brandsf49bdcc1-1939-6dc2-e053-2995a90a0a3b2025-01-01WarningsExact identifier
unii: 451W47IQ8X
unii: 660YQ98I10
Sweat-LessARG NIT, CASTOREUM, HUMULUS, IODUM, KALI PHOS, NAT MURSilver Star Brands4053d10b-4b06-291b-e054-00144ff88e882025-01-01WarningsExact identifier
unii: 451W47IQ8X
NativeRemedies Triple Complex Brain TonicCALC PHOS, KALI PHOS, NAT MUR.Silver Star Brandsf76eaf46-4a80-31a9-e053-6394a90a542d2025-01-01WarningsExact identifier
unii: 451W47IQ8X
Mucus-Clear NighttimeHEPAR SULPH, KALI BIC, KALI CARB, KALI MUR, NUX VOMSilver Star Brands826c01f3-a8b6-48c7-e053-2a91aa0a3ce12025-01-01WarningsExact identifier
unii: 660YQ98I10
Mucus Clear Cough and Cold ReliefARG MET, ARSENICUM ALB, BAPTISIA, BRYPNIA, CAUSTICUM, DULCAMARA, ECHINACEA ANGUSTIFOLIA, ECHINACEA PURP, KALI BIC, KALI MUR, MERC CORROS, PHOS, PULSATILLA NUTT, SENEGA, ZINC PIC, ZINC VAL.Silver Star Brandsf4378d84-73d5-2170-e053-2a95a90a41c62025-01-01WarningsExact identifier
unii: 660YQ98I10
Mucus-ClearKALI BIC, KALI MUR, KALI SULPHSilver Star Brandsc895c490-7ca1-dee6-e053-2995a90a21262025-01-01WarningsExact identifier
unii: 660YQ98I10
Headache EaseAUR MET, BELLADONNA, BRYONIA, GELSEISUM, IGNATIA, KALI PHOS, NAT MUR, NUX VOM, SEPIASilver Star Brandsc689fb16-6200-ac94-e053-2995a90a703d2025-01-01WarningsExact identifier
unii: 451W47IQ8X
AllergiClear-MADRENALINUM, CALCAREA FLUORICA, CALCAREA PHOSPHORICA, EUPHRASIA OFFICINALIS, HISTAMINUM HYDROCHLORICUM, KALI MURIATICUM, NATRUM MURIATICUM, SILICEASilver Star Brands9d36096b-022f-5cfa-e053-2995a90a381f2025-01-01WarningsExact identifier
unii: 451W47IQ8X
unii: 660YQ98I10
Mucus-Clear Jr.ALLIUM CEPA, FERRUM PHOS, KALI BIC, KALI CARB, KALI MURSilver Star Brands83098e43-d89d-21ff-e053-2991aa0affde2025-01-01WarningsExact identifier
unii: 660YQ98I10

Reported adverse events (FAERS/openFDA)#

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