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 35 of 65 · 1,284 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
D-78HYPERICUM PERFORATUM, LACHESIS MUTA VENOM, LYTTA VESICATORIA, ECHINACEA ANGUSTIFOLIA, SODIUM CHLORIDE, AND PLANTAGO MAJORDNA Labs, Inc.d62673a9-8a67-4580-a8bf-25f85960a5552025-01-13WarningsExact identifier
unii: 451W47IQ8X
D-86ARNICA MONTANA, SILICON DIOXIDE, SODIUM CHLORIDE, LEAD ACETATE ANHYDROUS, SELENICEREUS GRANDIFLORUS STEM, TRIBASIC CALCIUM PHOSPHATE, AND POTASSIUM IODIDEDNA Labs, Inc.54fa62d3-c129-4826-a794-f3dcc6b855bf2025-01-13WarningsExact identifier
unii: 451W47IQ8X
D-98STRYCHNOS NUX-VOMICA SEED, MATRICARIA CHAMOMILLA, ANEMONE PRATENSIS, SODIUM CHLORIDE, CALCIUM SULFIDE, GOLD, DAPHNE MEZEREUM BARK, PLATINUM, AND BERBERIS VULGARIS ROOT BARKDNA Labs, Inc.9b39b277-9eb2-44c9-9c0c-a8680a50e18d2025-01-13WarningsExact identifier
unii: 451W47IQ8X
D-129SODIUM CHLORIDEDNA Labs, Inc.ef130f08-1c34-4774-9298-2d1997e631fc2025-01-13WarningsExact identifier
unii: 451W47IQ8X
D-50HORSE CHESTNUT, CITRULLUS COLOCYNTHIS FRUIT PULP, BLACK COHOSH, SODIUM CHLORIDE, STRYCHNOS NUX-VOMICA SEED, PHYTOLACCA AMERICANA ROOT, AND STRONTIUM CARBONATEDNA Labs, Inc.df118b9b-dee7-4555-bcae-751007c1fd2c2025-01-13WarningsExact identifier
unii: 451W47IQ8X
D-68CROTON OIL, DAPHNE MEZEREUM BARK, SODIUM CHLORIDE, AND TOXICODENDRON PUBESCENS LEAFDNA Labs, Inc.01ae098b-aadd-4edc-bf73-6bc60903e7792025-01-13WarningsExact identifier
unii: 451W47IQ8X
D-76LOBELIA INFLATA, STRYCHNOS IGNATII SEED, AVENA SATIVA FLOWERING TOP, DIBASIC POTASSIUM PHOSPHATE, SELENICEREUS GRANDIFLORUS STEM, GLUTAMINE, TAURINE, AND THIAMINE HYDROCHLORIDEDNA Labs, Inc.ea7aadf5-0ee2-4b0a-9ba8-0a5d98944bd12025-01-13WarningsExact identifier
unii: CI71S98N1Z
D-54DIBASIC POTASSIUM PHOSPHATE, SEPIA OFFICINALIS JUICE, LYCOPODIUM CLAVATUM SPORE, PHOSPHORUS, GELSEMIUM SEMPERVIRENS ROOT, ATROPA BELLADONNA, ARSENIC TRIOXIDE, AND SEMECARPUS ANACARDIUM JUICEDNA Labs, Inc.68a206a8-6f66-4957-843c-4c4c0636e78f2025-01-13WarningsExact identifier
unii: CI71S98N1Z
D-53AMMONIUM BROMIDE, BROMINE, CALCIUM SULFIDE, POTASSIUM BROMIDE, RHODODENDRON TOMENTOSUM LEAFY TWIG, SODIUM BROMIDE, SODIUM CHLORIDE, AND BOS TAURUS PLACENTADNA Labs, Inc.3787d569-ee4d-41de-9519-73c11b626b382025-01-13WarningsExact identifier
unii: 451W47IQ8X
D-126DIBASIC POTASSIUM PHOSPHATEDNA Labs, Inc.ec9b7232-d9c9-4ad8-bad6-830bcc073cc72025-01-13WarningsExact identifier
unii: CI71S98N1Z
D-51ATROPA BELLADONNA, IODINE, LYCOPUS VIRGINICUS, SODIUM CHLORIDE, HEKLA LAVA, AND CALCIUM HEXAFLUOROSILICATEDNA Labs, Inc.9928dd54-bd3a-47cb-bde5-4bebab3db6832025-01-13WarningsExact identifier
unii: 451W47IQ8X
D-85HYDRANGEA ARBORESCENS ROOT, SAW PALMETTO, CORN SILK, ELYMUS REPENS ROOT, AGATHOSMA CRENULATA LEAF, SODIUM PHOSPHATE, DIBASIC, HEPTAHYDRATE, AND DIBASIC POTASSIUM PHOSPHATEDNA Labs, Inc.83f43207-76bb-4fc0-b3fc-45614da43e232025-01-13WarningsExact identifier
unii: CI71S98N1Z
D-138GARLIC, VISCUM ALBUM FRUITING TOP, OLEA EUROPAEA FLOWER BUD, PRUNUS DULCIS FLOWER, PYRIDOXINE HYDROCHLORIDE, CYANOCOBALAMIN, FOLIC ACID, POTASSIUM IODIDE, AND CHOLESTEROLDNA Labs, Inc.3f17a0a3-7eff-477a-a21f-fc3f94f0a8ec2025-01-13WarningsExact identifier
unii: 97C5T2UQ7J
D-112LACHESIS MUTA VENOM, SILICON DIOXIDE, SODIUM CHLORIDE, RANUNCULUS BULBOSUS, ACONITUM NAPELLUS, ACTIVATED CHARCOAL, NITROGLYCERIN, OYSTER SHELL CALCIUM CARBONATE, CRUDE, ANEMONE PRATENSIS, PLANTAGO MAJOR, ARSENIC TRIOXIDE, AND MAGNESIUM PHOSPHATE, DIBASIC TRIHYDRATEDNA Labs, Inc.8d517ef2-3a1e-4393-9452-a4cd0f0a3bca2025-01-13WarningsExact identifier
unii: 451W47IQ8X
D-65ARSENIC TRIOXIDE, BERBERIS AQUIFOLIUM ROOT BARK, OYSTER SHELL CALCIUM CARBONATE, CRUDE, GRAPHITE, CENTELLA ASIATICA, AND SODIUM CHLORIDEDNA Labs, Inc.94d4b66a-f995-4516-bdcf-2152c2a624dd2025-01-13WarningsExact identifier
unii: 451W47IQ8X
D-88COCCULUS INDICUS, NATRUM MURIATICUM, HELONIAS DIOICA, CALCAREA PHOSPHORICUM, IGNATIA AMARA, MAGNESIA PHOSPHORICUM, CIMICIFUGA RACEMOSA, PASSIFLORA INCARNATA, VALERIANA OFFICINALIS, SEPIA, KALIUM PHOSPHORICUM, ZINCUM METALLICUM, PITUITARY, ADRENAL, OVARIANDNA Labs, Inc.1eefff9c-d86c-44ef-b968-9a8c5a9c54032025-01-13WarningsExact identifier
unii: CI71S98N1Z
unii: 451W47IQ8X
D-120CALCIUM FLUORIDE, BISMUTH SUBNITRATE, ZINC, MERCURIC CHLORIDE, TOXICODENDRON PUBESCENS LEAF, ANTIMONY TRISULFIDE, BARIUM CARBONATE, ECHINACEA ANGUSTIFOLIA, IODINE, PHOSPHORIC ACID, POTASSIUM CARBONATE, DIBASIC POTASSIUM PHOSPHATE, AND THUJA OCCIDENTALIS LEAFY TWIGDNA Labs, Inc.9525c016-f0dd-43fd-a4e9-062075107eec2025-01-13WarningsExact identifier
unii: CI71S98N1Z
D-133CALCIUM FLUORIDE, SILICON DIOXIDE, TRIBASIC CALCIUM PHOSPHATE, CALCIUM SULFATE ANHYDROUS, FERROSOFERRIC PHOSPHATE, POTASSIUM CHLORIDE, DIBASIC POTASSIUM PHOSPHATE, POTASSIUM SULFATE, MAGNESIUM PHOSPHATE, DIBASIC TRIHYDRATE, SODIUM PHOSPHATE, DIBASIC, HEPTAHYDRATE, SODIUM CHLORIDE, AND SODIUM SULFATEDNA Labs, Inc.a250b7e9-7fd2-4cb0-82f3-baa089d174412025-01-13WarningsExact identifier
unii: CI71S98N1Z
unii: 451W47IQ8X
Premixed saline packetsSODIUM CHLORIDE, SODIUM BICARBONATEShenzhen Kerui lntl Trading Co., Ltd0d11e07b-c137-6efc-e063-6394a90a6bba2025-01-09WarningsExact identifier
unii: 451W47IQ8X
STERILE WATERSTERILE WATERHF Acquisition Co. LLC, DBA HealthFirst74ed2a6f-824c-a1ff-e053-2a91aa0a57c02025-01-09Warnings, Adverse reactionsExact identifier
unii: 059QF0KO0R

Reported adverse events (FAERS/openFDA)#

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