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 12 of 65 · 1,284 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
0.9salineSODIUM CHLORIDEHuizhou Jinsheng Medical Technology Co., Ltd49e76aca-ca2b-3b95-e063-6394a90a875e2026-02-03WarningsExact identifier
unii: 451W47IQ8X
0.9%salineSODIUM CHLORIDEHuizhou Jinsheng Medical Technology Co., Ltd49e7b329-e4e5-6991-e063-6294a90ac8172026-02-03WarningsExact identifier
unii: 451W47IQ8X
NerveFixACONITUM NAPELLUS, BELLADONNA, CANTHARIS, FERRUM PHOSPHORICUM, KALI PHOSPHORICUM, MAGNESIA PHOSPHORICA, HYPERICUM PERFORATUM, SPIGELIA ANTHELMIANaturalCare92326b54-cac9-4fb2-ae48-120a0dcbbe562026-02-03WarningsExact identifier
unii: CI71S98N1Z
Adrenal SupportADRENALINUM, BERBERIS VULGARIS, ARGENTUM NITRICUM, NATRUM MURIATICUM, VANADIUM METALLICUM, OLEUM MORRHUAE, PETROLEUMNaturalCarecee52757-a86e-4251-b65f-954ac85f4e7e2026-01-30WarningsExact identifier
unii: 451W47IQ8X
Vital Female Sexual EnergyAGNUS CASTUS, ARNICA MONTANA, AVENA SATIVA, CAULOPHYLLUM THALICTROIDES, CINCHONA OFFICINALIS, DAMIANA, HYPOPHYSIS SUIS, L-ARGININE, NATRUM MURIATICUM, OOPHORINUM SUIS, PHOSPHORICUM ACIDUM, SABAL SERRULATA, SEPIA, THUJA OCCIDENTALISLiddell Laboratories, Inc.7b15d6fa-eb04-41d2-8a01-6e7408ccf4d32026-01-30WarningsExact identifier
unii: 451W47IQ8X
Additive Formula 3DEXTROSE MONOHYDRATE, TRISODIUM CITRATE DIHYDRATE, SODIUM CHLORIDE, SODIUM PHOSPHATE, MONOBASIC, MONOHYDRATE, CITRIC ACID MONOHYDRATE, AND ADENINETerumo BCT, Ltd9a5247a1-cc05-442d-b2d0-950f887f03c22026-01-30Warnings, Adverse reactionsExact identifier
unii: 451W47IQ8X
CVS ULTRA FINE MOISTURIZING SALINE MISTNASAL MISTCVS44821c47-63f9-5d0a-e063-6394a90a555d2026-01-29WarningsExact identifier
unii: 451W47IQ8X
Varicose VeinsELAPS CORALLINUS, CROTALUS HORRIDUS, BRYONIA, CALC. FLUOR., CARDUUS MAR., CHOLESTERINUM, CINCHONA, DIGITALIS, HAMAMELIS, HYDROFLUORICUM ACIDUM, LACHESIS, LYCOPODIUM, NAJA, PULSATILLA, VIPERA BERUS, ZINC. MET., AESCULUS HIPP., ECHINACEANewton Laboratories, Inc.91e8e37c-c654-6df9-e053-2995a90aafe12026-01-29WarningsExact identifier
unii: 97C5T2UQ7J
Sodium ChlorideSODIUM CHLORIDENephron Pharmaceuticals Corporationa4edf2d5-a9ff-30d4-e053-2995a90a56502026-01-26Warnings, Adverse reactionsExact identifier
unii: 451W47IQ8X
INSULIN DILUTING MEDIUM FOR KirstyWATERBiocon Biologics Inc.3db1d482-7e1f-aec6-79ef-3f305b4d82772026-01-20Warnings, Adverse reactionsExact identifier
unii: 059QF0KO0R
Sodium ChlorideSODIUM CHLORIDEProPharma Distribution48d73434-e65b-dc98-e063-6294a90affa22026-01-20Adverse reactionsExact identifier
unii: 451W47IQ8X
Equate Comfort Flow Sinus washSINUS WASHWALMART INC9e911eef-ca99-9902-e053-2a95a90aab0e2026-01-19WarningsExact identifier
unii: 451W47IQ8X
EQUATE PREMIUM SALINESODIUM CHLORIDE 0.65%Walmart Stores, Inc.1e17f022-f513-140d-e063-6394a90a379e2026-01-19WarningsExact identifier
unii: 451W47IQ8X
Sodium chlorideSODIUM CHLORIDEFresenius Kabi USA, LLCd98bf9f7-30ec-4927-a577-cabad192cb182026-01-19Warnings, Adverse reactionsExact identifier
unii: 451W47IQ8X
Sodium Chloride HypertonicitySODIUM CHLORIDECVS Pharmacy9245d842-7f78-42d8-83ba-8eb9ec8dbc0d2026-01-15WarningsExact identifier
unii: 451W47IQ8X
Sodium Chloride HypertonicitySODIUM CHLORIDECVS PHARMACYd5cc6cd1-ddf8-4f5b-a021-204cdda0db942026-01-15WarningsExact identifier
unii: 451W47IQ8X
Walgreens Sterile Soothing Eye WashPURIFIED WATERWalgreensa62e3294-abd6-48dc-81b1-62a809bdc9682026-01-14WarningsExact identifier
unii: 059QF0KO0R
Constipation ReliefALUMINUM OXIDE, BRYONIA ALBA ROOT, SODIUM CHLORIDE, GRAPHITE, SILICON DIOXIDEHomeocare Laboratories62374240-cd14-44e2-9405-5f8996faf0472026-01-12WarningsExact identifier
unii: 451W47IQ8X
LuffaLUFFA, HYDRASTIS CANADENSIS, MERCURIUS SULPH. RUB, ALLIUM CEPA, NATRUM MURITICUM, PHOSPHORUS, EUPATORIUM PERF, STICTAMarco Pharma International LLC.7dbb79de-c3f5-4245-884a-a6bd29bb861c2026-01-12WarningsExact identifier
unii: 451W47IQ8X
HeilenGALIUM APARINE, AGNUS CASTUS, APIS MELLIFICA, CAPSICUM ANNUUM, CHELIDONIUM MAJUS, TARAXACUM OFFICINALE, URTICA DIOICA, XANTHOXYLUM FRAXINEUM, FUCUS VESICULOSUS, KALI PHOSPHORICUM, MAGNESIA PHOSPHORICA, NATRUM PHOSPHORICUM, SARSAPARILLA (SMILAX REGELII), UBIDECARENONUM, CALCAREA CARBONICA, GRAPHITES, LYCOPODIUM CLAVATUM, ANACARDIUM ORIENTALE, COLCHICUM AUTUMNALE, NUX VOMICA, PHYTOLACCA DECANDRA, PULSATILLA (PRATENSIS), HISTAMINUM HYDROCHLORICUMHeilenef3f66f9-47bc-4fce-8950-ed2319bc30d62026-01-12WarningsExact identifier
unii: CI71S98N1Z

Reported adverse events (FAERS/openFDA)#

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