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 41 of 76 · 1,503 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Bestmade Natural Products Bio1CALC PHOS, FERR PHOS, KALI PHOS, NAT MURBestmade Natural Productse9fb280b-2f79-f268-e053-2995a90a732c2025-01-22WarningsExact identifier
unii: 451W47IQ8X
Bestmade Natural Products Bio2KALI PHOS, MAG PHOS, NAT MUR, NAT SULFBestmade Natural Productse9fc4f2f-a699-163f-e053-2995a90ab1fe2025-01-22WarningsExact identifier
unii: 451W47IQ8X
Bestmade Natural Products Bio4CALC FLUOR, KALI MUR, NAT MUR, SILICEABestmade Natural Productsea224687-106e-3821-e053-2995a90aa69c2025-01-22WarningsExact identifier
unii: 451W47IQ8X
unii: 660YQ98I10
Bestmade Natural Products Bio5FERR PHOS, KALI MUR, NAT MUR, KALI SULPHBestmade Natural Productsea22e5e7-491a-91ac-e053-2a95a90a44142025-01-22WarningsExact identifier
unii: 451W47IQ8X
unii: 660YQ98I10
Potassium Chloride ERPOTASSIUM CHLORIDE ERDirect_Rxf988aa11-60ef-411e-e053-6294a90a522a2025-01-22Warnings, Adverse reactionsExact identifier
unii: 660YQ98I10
Bestmade Natural Products Bio6FERR PHOS, KALI MUR, MAG PHOS, NAT MUR, NAT SULPHBestmade Natural Productsea233792-038f-39e7-e053-2995a90a20ad2025-01-22WarningsExact identifier
unii: 451W47IQ8X
unii: 660YQ98I10
Bestmade Natural Products Bio7CALC PHOS, FERR PHOS, KALI PHOS, NAT PHOS, NAT SULPHBestmade Natural Productsea23afe1-4e46-01ba-e053-2995a90acc6f2025-01-22WarningsExact identifier
unii: 70WT22SF4B
POTASSIUM CHLORIDEPOTASSIUM CHLORIDEDirect_Rx946b9568-671d-172a-e053-2a95a90ac8272025-01-22Warnings, Adverse reactionsExact identifier
unii: 660YQ98I10
Bestmade Natural Products BM7ECHINACEAD5, GRAPHITESD10, HYDROCOTYLED3, KALI MURD6, PETROLEUMD12, SULPHURD7, VIOLA TRICOLORD5Bestmade Natural Productsec16dd97-9407-5aef-e053-2a95a90af5b02025-01-22WarningsExact identifier
unii: 660YQ98I10
Bestmade Natural Products Bio9FERR PHOS, KALI MUR, KALI PHOS, MAG PHOSBestmade Natural Productsea4dbb5b-9a48-0710-e053-2995a90ae3882025-01-22WarningsExact identifier
unii: 660YQ98I10
Bestmade Natural Products Bio10CALC PHOS, FERR PHOS, KALI MURBestmade Natural Productsea63db39-136e-6098-e053-2995a90aa6182025-01-22WarningsExact identifier
unii: 660YQ98I10
Bestmade Natural Products Bio11FERR PHOS, KALI MUR, KALI SULF, NAT MUR, NAT SULFBestmade Natural Productseaa202d7-4297-57ba-e053-2995a90a02952025-01-22WarningsExact identifier
unii: 451W47IQ8X
unii: 660YQ98I10
Bestmade Natural Products Bio12FERR PHOS, NAT MUR, KALI PHOS, MAG PHOSBestmade Natural Productseab251db-c69a-572d-e053-2a95a90ab3a02025-01-22WarningsExact identifier
unii: 451W47IQ8X
Bestmade Natural Products Bio13CALC PHOS, KALI SULF, KALI PHOS, NAT MURBestmade Natural Productseab2e339-c9e9-3048-e053-2995a90ae1492025-01-22WarningsExact identifier
unii: 451W47IQ8X
Bestamade Natural Products Bio15CALC PHOS, KALI PHOS, FERR PHOS, KALI SULF, MAG PHOSBestmade Natural Productseab3b43c-b506-277b-e053-2a95a90a68682025-01-22WarningsExact identifier
unii: 70WT22SF4B
Bestmade Natural Products Bio16CALC PHOS, FERR PHOS, KALI PHOS, MAG PHOS, NAT MURBestmade Natural Productseac26053-7c65-7c56-e053-2995a90a8e642025-01-22WarningsExact identifier
unii: 451W47IQ8X
Bestmade Natural Products Bio17CALC FLUOR, KALI PHOS, FERR PHOS, KALI MURBestmade Natural Productseac2ec50-08e3-1923-e053-2a95a90aca1a2025-01-22WarningsExact identifier
unii: 660YQ98I10
Bestmade Natural Products Bio20CALC FLUOR, CALC SULF, KALI SULF, NAT MUR, NAT SULFBestmade Natural Productseb3b0d9d-5f1c-8a3b-e053-2a95a90a0e1f2025-01-22WarningsExact identifier
unii: 451W47IQ8X
Bestmade Natural Products Bio24CALC PHOS, FERR PHOS, KALI PHOS, MAG PHOS, NAT PHOSBestmade Natural Productseb3ca8fa-bbd7-556f-e053-2995a90ab3c62025-01-22WarningsExact identifier
unii: 70WT22SF4B
Bestmade Natural Products Bio27MAG PHOS, CALC PHOS, KALI PHOS, CALC FLUORBestmade Natural Productseb420652-ec68-6b46-e053-2995a90af98c2025-01-22WarningsExact identifier
unii: 451W47IQ8X

Reported adverse events (FAERS/openFDA)#

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