FDA.reportPublic FDA data

NDC 58160-828 - Shingrix

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
58160-828
Package NDCs from labels
58160-828-03, 58160-828-01
Manufacturer
GlaxoSmithKline Biologicals SA
Effective date
2026-08-31
Current FDA listing
Not matched in FDA.report NDC product tables

DailyMed Labels#

Label, Manufacturer, Effective date table
LabelManufacturerEffective dateType
Shingrix - GlaxoSmithKline Biologicals SAGlaxoSmithKline Biologicals SA2026-08-31VACCINE LABEL
Shingrix - A-S Medication SolutionsA-S Medication Solutions2024-01-09VACCINE LABEL
Shingrix - A-S Medication SolutionsA-S Medication Solutions2021-04-15VACCINE LABEL

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
58160-828-03Shingrix0.5 mL in 1 VIALINJECTION, POWDER, LYOPHILIZED,5 mL50 ug in 0.5mL23
58160-828-03Shingrix0.5 mL in 1 VIALINJECTION, POWDER, LYOPHILIZED,10 mL50 ug in 0.5mL6
58160-828-01Shingrix0.5 mL in 1 VIALINJECTION, POWDER, LYOPHILIZED,1 mL50 ug in 0.5mL2

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
58160-828SHINGRIX (ZOSTER VACCINE RECOMBINANT, ADJUVANTED) KIT [GLAXOSMITHKLINE BIOLOGICALS SA]19Unmatched20250327_0280849d-5c78-4a9d-8941-4eab429f6bd8.zip
58160-828SHINGRIX (ZOSTER VACCINE RECOMBINANT, ADJUVANTED) KIT [A-S MEDICATION SOLUTIONS]6Unmatched20240110_279a251c-f4d0-4c47-b999-7ef1a45ac0d0.zip
58160-828SHINGRIX (ZOSTER VACCINE RECOMBINANT, ADJUVANTED) KIT [A-S MEDICATION SOLUTIONS]2Unmatched20210416_e9ba0102-8cbb-4c4c-810e-292119095a8a.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 28 of 65 · 1,284 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
EXTRANEALICODEXTRIN, SODIUM CHLORIDE, SODIUM LACTATE, CALCIUM CHLORIDE, MAGNESIUM CHLORIDEVantive US Healthcare LLC2b327b13-a0e9-4b2c-9875-4470998e2e302025-05-07Exact identifier
unii: 451W47IQ8X
DIANEAL LOW CALCIUM WITH DEXTROSESODIUM CHLORIDE, SODIUM LACTATE, CALCIUM CHLORIDE, MAGNESIUM CHLORIDE AND DEXTROSEVantive US Healthcare LLCb2b780d3-26ac-4e7c-a0f2-78991bee32a82025-05-07Exact identifier
unii: 451W47IQ8X
VirimmuneACONITUM NAPELLUS, ALLIUM CEPA, ALLIUM SATIVUM, ARSENICUM ALBUM, BAPTISIA TINCTORIA, CHELIDONIUM MAJUS, ECHINACEA (ANGUSTIFOLIA), GELSEMIUM SEMPERVIRENS, GINKGO BILOBA, HAMAMELIS VIRGINIANA, INFLUENZINUM (2024-2025), MERCURIUS VIVUS, MORBILLINUM, NATRUM MURIATICUM, NUX VOMICA, SELENIUM METALLICUM, VISCUM ALBUMDeseret Biologicals, Inc.ac036ad8-6f48-4c15-b021-dc9bbb7e642e2025-05-06WarningsExact identifier
unii: 451W47IQ8X
Jacksons Cell Salts KALI PHOS 6X 10KALI PHOSPHORICUMZettl Health Inc.3467dac6-887e-3677-e063-6294a90a21bb2025-05-05WarningsExact identifier
unii: CI71S98N1Z
Gout Relief 3310-SCELERY SEED MEDICAGO SATIVA WHOLEBispit Canada Ltd.346f68ea-73aa-99c6-e063-6394a90af5d52025-05-05WarningsExact identifier
unii: 451W47IQ8X
Seasonal Allergy ReliefONION, SODIUM CHLORIDE, HISTAMINE DIHYDROCHLORIDE, CUCUMBER, GALPHIMIA GLAUCA FLOWERING TOP, AND STRYCHNOS NUX-VOMICA SEEDHyland's Inc.101e6b80-cdae-49e5-acfb-f056448856ec2025-04-30WarningsExact identifier
unii: 451W47IQ8X
Kali Phos 6XPOTASSIUM PHOSPHATE, DIBASICHyland's Inc.dbfe86e8-c06f-2a84-e053-2a95a90a1f3d2025-04-30WarningsExact identifier
unii: CI71S98N1Z
Sinus Wash PacketSODIUM BICARBONATE, SODIUM CHLORIDEBETTER LIVING BRANDS LLC33ee7b77-0871-4df8-e063-6394a90ac4792025-04-29WarningsExact identifier
unii: 451W47IQ8X
Sodium chlorideSODIUM CHLORIDEFresenius Kabi USA, LLC6d43fa91-0940-437f-ba70-b2d3f977593e2025-04-25Warnings, Adverse reactionsExact identifier
unii: 451W47IQ8X
Potassium PhosphatesPOTASSIUM PHOSPHATESFresenius Kabi USA, LLC357c3020-ea6f-4401-a2e7-cebb82b031442025-04-15Warnings, Adverse reactionsExact identifier
unii: CI71S98N1Z
unii: 4J9FJ0HL51
Nat Mur 6XSODIUM CHLORIDEHyland's Inc.dcf0e2ac-3b69-3ae4-e053-2a95a90aaf412025-04-10WarningsExact identifier
unii: 451W47IQ8X
Bestmade Natural Products BM68 PelletsPHOSPHORUS, ARG NIT, GELSEMIUM, NAT MUR, KALI BROM, BARYTA CARBBestmade Natural Products32423a04-31d1-7477-e063-6394a90aecac2025-04-08WarningsExact identifier
unii: 451W47IQ8X
Bestmade Natural Products Kali Phos 8xKALI PHOSPHORICUMBestmade Natural Products31e0616f-d471-fb29-e063-6294a90a30692025-04-03WarningsExact identifier
unii: CI71S98N1Z
Bestmade Natural Products Nat Mur 8xNATRUM MURIATICUMBestmade Natural Products31e0e16d-e4df-cd9a-e063-6394a90abcc12025-04-03WarningsExact identifier
unii: 451W47IQ8X
Eye WashWATERCMC Group Inc.6158a1f5-a6bc-4a3e-9d1d-0a310d9dc5612025-04-02WarningsExact identifier
unii: 059QF0KO0R
Kidneyforce-HPARNICA MONTANA, AURUM METALLICUM, CACTUS GRANDIFLORUS, CALCAREA CARBONICA, NATRUM MURIATICUM, NUX VOMICA, PHOSPHORUS, SOLIDAGO VIRGAUREABioActive Nutritional, Inc.0c0f0c0c-10c2-47eb-aad6-bbffb6e167992025-04-02WarningsExact identifier
unii: 451W47IQ8X
Sodium ChlorideSODIUM CHLORIDE TABLETBelleview Bioscience LLC31195e8f-d4de-9e37-e063-6294a90a41562025-03-24WarningsExact identifier
unii: 451W47IQ8X
Bestmade Natural Products BIO13 Lactose FreeCALC PHOS KALI SULPH, KALI PHOS, NAT MURBestmade Natural Products303590c5-8a66-aafc-e063-6294a90a1a4e2025-03-23WarningsExact identifier
unii: CI71S98N1Z
unii: 451W47IQ8X
Bestmade Natural Products BIO15 Lactose FreeCALC PHOS, KALI PHOS, FERR PHOS, KALI SULPH, CALC SULPH, MAG PHOSBestmade Natural Products30365dcf-1e90-f81a-e063-6294a90a24f82025-03-23WarningsExact identifier
unii: CI71S98N1Z
Bestmade Natural Products BIO17 Lactose FreeCALC FLUOR, KALI PHOS, KALI MURBestmade Natural Products3036e6be-efc7-7b2b-e063-6294a90a3fdc2025-03-23WarningsExact identifier
unii: CI71S98N1Z

Reported adverse events (FAERS/openFDA)#

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