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 13 of 65 · 1,284 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Vascu-Pro T009CACTUS GRANDIFLORUS, HAMAMELIS VIRGINIANA, VALERIANA OFFICINALIS, ARTERIA SUIS, HEART (SUIS), ARNICA MONTANA, AURUM METALLICUM, BARYTA MURIATICA, CHOLESTERINUM, LECITHIN, MAGNESIA MURIATICA, OXALICUM ACIDUM, PHOSPHORUSGuangzhou Renuma Medical Systems Co., Ltd01d22fd6-7d2f-4448-81ff-c88baafc0af72026-01-09WarningsExact identifier
unii: 97C5T2UQ7J
Hepaticol Drops 5008HEPATICOL DROPSProfessional Complementary Health Formulas79ee9e37-7853-4560-a87d-cdaefb603bbb2026-01-08WarningsExact identifier
unii: 451W47IQ8X
Weight Management Formula 7534WEIGHT MANAGEMENT FORMULAProfessional Complementary Health Formulasf0406b63-7b97-4b2c-b976-75e8890818c62026-01-08WarningsExact identifier
unii: 451W47IQ8X
Acne Drops 2001ACNE DROPSProfessional Complementary Health Formulas340fc7dc-2aa4-411f-842b-4ce7046717222026-01-08WarningsExact identifier
unii: 451W47IQ8X
Herpetic Nosode 4012HERPETIC NOSODEProfessional Complementary Health Formulasa0e0fe46-5f78-4ac4-bcbe-08ee82a98d382026-01-08WarningsExact identifier
unii: COB9FF6I46
Radialgin 6002RADIALGINProfessional Complementary Health Formulas5e7ce7a0-9f43-4a69-89e9-a59692a8de412026-01-08WarningsExact identifier
unii: 451W47IQ8X
Viral Immune Stimulator 6017VIRAL IMMUNE STIMULATORProfessional Complementary Health Formulasf462cfb7-e1c3-4ded-9f79-f1983517fe152026-01-08WarningsExact identifier
unii: 451W47IQ8X
Pituitary Liquescence 3018PITUITARY LIQUESCENCEProfessional Complementary Health Formulasa32e9ea9-5ff9-4951-9244-7b3253456b5f2026-01-08WarningsExact identifier
unii: 451W47IQ8X
Gallbladder Drops 5006GALLBLADDER DROPSProfessional Complementary Health Formulasf07b10e1-00b1-47d7-b745-72165781c6d22026-01-08WarningsExact identifier
unii: 97C5T2UQ7J
Psorinum Combination 9237PSORINUM COMBINATIONProfessional Complementary Health Formulas8b2a133d-9681-4091-a6d1-4ecc4583626b2026-01-08WarningsExact identifier
unii: 451W47IQ8X
Adrenal Liquescence 3001ADRENAL LIQUESCENCEProfessional Complementary Health Formulas0388d3c7-4b3b-4e74-8c1b-9a2af2a4377d2026-01-08WarningsExact identifier
unii: 451W47IQ8X
Plus Rinse Emergency EyewashPURIFIED WATERINNOVATIVE SAFETY SUPPLY INC.b3f47d26-39e4-4aea-bb92-358def52b6522026-01-08WarningsExact identifier
unii: 059QF0KO0R
pH Neutral Emergency EyewashWATERINNOVATIVE SAFETY SUPPLY INC.29a1bd1e-d0dd-478f-e063-6394a90ab0aa2026-01-08WarningsExact identifier
unii: 059QF0KO0R
Anti-Constipation Drops 2077ANTI-CONSTIPATION DROPSProfessional Complementary Health Formulas55d105fe-5698-43a6-9252-eaa9b63299d02026-01-08WarningsExact identifier
unii: 451W47IQ8X
unii: 97C5T2UQ7J
Anxious Drops 2098ANXIOUS DROPSProfessional Complementary Health Formulasa5dc8619-074a-4c1f-8bb2-fea788f5aff12026-01-08WarningsExact identifier
unii: 451W47IQ8X
Spleen Thymus Liquescence 3023SPLEEN THYMUS LIQUESCENCEProfessional Complementary Health Formulasabe3c5c4-c5b4-47dd-afe3-b7858c82f7752026-01-08WarningsExact identifier
unii: 451W47IQ8X
POP Detox 6045POP DETOXProfessional Complementary Health Formulas48e7e23a-014c-4259-a2c9-37127da3ba032026-01-08WarningsExact identifier
unii: 97C5T2UQ7J
RET Bladder 7006RET BLADDERProfessional Complementary Health Formulasf1d354e7-3d72-40aa-aaf1-172cb39f07112026-01-08WarningsExact identifier
unii: 451W47IQ8X
Cataract Drops 2085CATARACT DROPSProfessional Complementary Health Formulas6040a096-ccdb-4e1e-a242-be29c3127f272026-01-08WarningsExact identifier
unii: 451W47IQ8X
Anti-Smoking II Drops 2008ANTI-SMOKING II DROPSProfessional Complementary Health Formulas8e64a0eb-4673-42e3-8387-7248d38557872026-01-08WarningsExact identifier
unii: C151H8M554

Reported adverse events (FAERS/openFDA)#

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