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 | Type |
|---|---|---|---|
| Shingrix - GlaxoSmithKline Biologicals SA | GlaxoSmithKline Biologicals SA | 2026-08-31 | VACCINE LABEL |
| Shingrix - A-S Medication Solutions | A-S Medication Solutions | 2024-01-09 | VACCINE LABEL |
| Shingrix - A-S Medication Solutions | A-S Medication Solutions | 2021-04-15 | VACCINE LABEL |
DailyMed Package Descriptions#
| Package NDC | Product | Description | Form | Quantity | Strength | SPL version |
|---|---|---|---|---|---|---|
| 58160-828-03 | Shingrix | 0.5 mL in 1 VIAL | INJECTION, POWDER, LYOPHILIZED, | 5 mL | 50 ug in 0.5mL | 23 |
| 58160-828-03 | Shingrix | 0.5 mL in 1 VIAL | INJECTION, POWDER, LYOPHILIZED, | 10 mL | 50 ug in 0.5mL | 6 |
| 58160-828-01 | Shingrix | 0.5 mL in 1 VIAL | INJECTION, POWDER, LYOPHILIZED, | 1 mL | 50 ug in 0.5mL | 2 |
DailyMed Dashboard NDC Coverage#
| NDC | Dashboard title | SPL version | Validation | Dashboard ZIP |
|---|---|---|---|---|
| 58160-828 | SHINGRIX (ZOSTER VACCINE RECOMBINANT, ADJUVANTED) KIT [GLAXOSMITHKLINE BIOLOGICALS SA] | 19 | Unmatched | 20250327_0280849d-5c78-4a9d-8941-4eab429f6bd8.zip |
| 58160-828 | SHINGRIX (ZOSTER VACCINE RECOMBINANT, ADJUVANTED) KIT [A-S MEDICATION SOLUTIONS] | 6 | Unmatched | 20240110_279a251c-f4d0-4c47-b999-7ef1a45ac0d0.zip |
| 58160-828 | SHINGRIX (ZOSTER VACCINE RECOMBINANT, ADJUVANTED) KIT [A-S MEDICATION SOLUTIONS] | 2 | Unmatched | 20210416_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.
| Brand | Generic | Manufacturer | SPL set ID | Effective date | Available safety fields | Join |
|---|---|---|---|---|---|---|
| Spleen-Pro T018 | SPLEEN (SUIS), ARSENICUM ALBUM, CARBO VEGETABILIS, CEANOTHUS AMERICANUS, CHININUM SULPHURICUM, IGNATIA AMARA, IODIUM, NATRUM MURIATICUM, NITRICUM ACIDUM, PHOSPHORICUM ACIDUM, PHOSPHORUS | Guangzhou Renuma Medical Systems Co., Ltd | bc2b70bd-2a4a-46fb-b3d8-d69b61056b89 | 2017-10-26 | Warnings | 451W47IQ8X |
| Female Vitality T010 | CIMICIFUGA RACEMOSA, FUCUS VESICULOSUS, OOPHORINUM (SUIS), HYPOPHYSIS SUIS, THYROIDINUM (SUIS), GRAPHITES, LACHESIS MUTUS, NATRUM MURIATICUM, PULSATILLA (PRATENSIS), SEPIA | Guangzhou Renuma Medical Systems Co., Ltd | 694f0c36-b656-471a-9f38-2efb5193e05a | 2017-10-20 | Warnings | 451W47IQ8X |
| Sterile Water | WATER | Baxter Healthcare Corporation | ef3e79c5-3f58-4b36-a296-64b7d9a651c1 | 2017-10-17 | Warnings, Adverse reactions | 059QF0KO0R |
| Cardio Tonic | KALI MURIATICUM, KALI PHOSPHORICUM, PLANTAGO MAJOR, CACTUS GRANDIFLORUS, DIGITALIS PURPUREA, HEART (BOVINE), L-CARNITINE, L-VALINE, THYROIDINUM (SUIS), ABROTANUM (ARTEMISIA ABROTANUM), IODIUM, LECITHIN, SPIGELIA ANTHELMIA | BioActive Nutritional, Inc. | 2c252ba6-f147-4c22-b432-cd603a9623ac | 2017-08-14 | Warnings | CI71S98N1Z |
| Sodium Chloride | SODIUM CHLORIDE | Baxter Healthcare Company | 886f889b-f3cf-4197-b307-6cfa88c89436 | 2017-05-04 | 451W47IQ8X | |
| Eye Wash | WATER | CVS Pharmacy | 049cee29-7ec2-4d5b-8308-f522acde43a7 | 2017-03-29 | Warnings | 059QF0KO0R |
| ReHydration | ADENOSINUM CYCLOPHOSPHORICUM, COFFEA CRUDA, GLANDULA SUPRARENALIS SUIS, HYPOTHALAMUS (BOVINE), KALI PHOSPHORICUM, NATRUM MURIATICUM, SARSAPARILLA, SILICEA, TARAXACUM OFFICINALE, THYROIDINUM (BOVINE) | Energetix Corp | 9883c502-9782-451e-9eec-c54d7b054f31 | 2017-01-31 | Warnings | CI71S98N1Z 451W47IQ8X |
| Tox-Chord | ALFALFA, ALUMINA, BENZOICUM ACIDUM, CARBONEUM, CETRARIA ISLANDICA, FOLLICULINUM, FUCUS VESICULOSUS, FUMARICUM ACIDUM, HEPAR SUIS, KALI CARBONICUM, KREOSOTUM, NATRUM MURIATICUM, PARAFFINUM, PETROLEUM, PHOSPHORICUM ACIDUM, PHOSPHORUS, PIX LIQUIDA, PLANTAGO MAJOR, PLUMBUM METALLICUM, PULSATILLA (VULGARIS), RADIUM BROMATUM, RESORCINUM, SALOL, SILICEA, SYMPHYTUM OFFICINALE, TABACUM, TEREBINTHINA, THYROIDINUM (BOVINE), TRITICUM REPENS, ZINCUM OXYDATUM | Energetix Corp | 6b0d1628-b20d-426e-9c84-5cceadca3f45 | 2016-11-11 | Warnings | 451W47IQ8X |
| Cerebroforce | CAPSICUM ANNUUM, GINKGO BILOBA, GELSEMIUM SEMPERVIRENS, KALI PHOSPHORICUM, LYCOPODIUM CLAVATUM, PHOSPHORUS, ARSENICUM ALBUM | BioActive Nutritional, Inc | f998ed3f-56a5-4497-be5b-9a819fe8be69 | 2016-07-13 | Warnings | CI71S98N1Z |
| Sterile Water | WATER | Baxter Healthcare Company | 210dc9ab-d6ca-4552-ac19-1be17792d290 | 2016-05-31 | Warnings, Adverse reactions | 059QF0KO0R |
| Sodium Chloride | SODIUM CHLORIDE | Baxter Healthcare Corporation | 2a96096d-43cc-49b7-af53-b53c17f41001 | 2014-07-25 | Warnings, Adverse reactions | 451W47IQ8X |
| SODIUM CHLORIDE | SODIUM CHLORIDE | Baxter Healthcare Corporation | b3b4b176-41f0-4ca8-90d4-3fba5707564a | 2014-02-21 | 451W47IQ8X | |
| TIS-U-SOL | SODIUM CHLORIDE, POTASSIUM CHLORIDE, MAGNESIUM SULFATE, SODIUM PHOSPHATE, AND POTASSIUM PHOSPHATE | Baxter Healthcare Corporation | 9da4121f-d62d-4da4-8dfb-0494da16015f | 2014-02-21 | 451W47IQ8X 4J9FJ0HL51 | |
| Ringers | SODIUM CHLORIDE, CALCIUM CHLORIDE, POTASSIUM CHLORIDE, | Baxter Healthcare Corporation | e1953d54-818d-46a6-8532-518ebae6d84e | 2012-06-13 | 451W47IQ8X | |
| Lactated Ringers | SODIUM CHLORIDE, SODIUM LACTATE, POTASSIUM CHLORIDE, CALCIUM CHLORIDE | Baxter Healthcare Corporation | f09f80bf-2f8b-4420-865d-aec2d5e5cd4d | 2012-06-12 | 451W47IQ8X |
Reported adverse events (FAERS/openFDA)#
Adverse event summaries are temporarily unavailable. Other product information remains available.