NDC 58160-815-01 - TWINRIX
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
- 58160-815
- Requested NDC
- 58160-815-01
- Package NDCs from labels
- 58160-815-43, 58160-815-52, 58160-815-01
- Manufacturer
- GlaxoSmithKline Biologicals SA
- Effective date
- 2026-05-14
- Current FDA listing
- Not matched in FDA.report NDC product tables
DailyMed Labels#
| Label | Manufacturer | Effective date | Type |
|---|---|---|---|
| TWINRIX - GlaxoSmithKline Biologicals SA | GlaxoSmithKline Biologicals SA | 2026-05-14 | VACCINE LABEL |
| TWINRIX - A-S Medication Solutions | A-S Medication Solutions | 2023-12-09 | VACCINE LABEL |
| National Council for Prescription Drug Programs indexing - billing unit | National Council for Prescription Drug Programs | 2013-03-03 | Indexing - Billing Unit |
FDA-Initiated Inactive NDC Indexing#
DailyMed Package Descriptions#
| Package NDC | Product | Description | Form | Quantity | Strength | SPL version |
|---|---|---|---|---|---|---|
| 58160-815-43 | TWINRIX | 1 mL in 1 SYRINGE | INJECTION, SUSPENSION | 1 | 34 | |
| 58160-815-52 | TWINRIX | 10 in 1 CARTON | INJECTION, SUSPENSION | 10 | 34 |
DailyMed Dashboard NDC Coverage#
| NDC | Dashboard title | SPL version | Validation | Dashboard ZIP |
|---|---|---|---|---|
| 58160-815 | TWINRIX (HEPATITIS A AND HEPATITIS B (RECOMBINANT) VACCINE) INJECTION, SUSPENSION [GLAXOSMITHKLINE BIOLOGICALS SA] | 31 | Current NDC, Legacy NDC, 2 package rows | 20250426_18e8f9fc-4d62-4d30-4ab7-bac03336171e.zip |
DailyMed Billing Units#
| Package NDC | Billing unit | Product NDC | DailyMed indexing SPL | SPL version | Effective |
|---|---|---|---|---|---|
| 58160-815-01 | ML - Milliliter | 58160-815 | 79a62666-e61f-4634-bb9d-391a857ac929 | 1 | 2013-03-03 |
| 58160-815-05 | ML - Milliliter | 58160-815 | 3c471fe2-8626-49b2-aae2-df1498272405 | 1 | 2016-01-13 |
| 58160-815-11 | ML - Milliliter | 58160-815 | d3547a57-b73b-4bf3-86cd-e9ce7ab5c05e | 1 | 2013-02-13 |
| 58160-815-32 | ML - Milliliter | 58160-815 | ab485cc7-d968-4b1a-a574-90c6e747884d | 1 | 2013-03-03 |
| 58160-815-34 | ML - Milliliter | 58160-815 | e6a16786-5348-4fec-bbbd-af112333be9a | 1 | 2016-01-13 |
| 58160-815-43 | ML - Milliliter | 58160-815 | 14301346-3bcd-4a08-aa21-dc0193c71ba6 | 1 | 2013-03-03 |
| 58160-815-52 | ML - Milliliter | 58160-815 | eaa2da79-0201-432c-b977-758ec7f11d13 | 1 | 2013-02-13 |
DailyMed Socrata Ingredients#
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 |
|---|---|---|---|---|---|---|
| Sinusforce-HP | ARSENICUM ALBUM, HEPAR SULPHURIS CALCAREUM, KALI BICHROMICUM, LYCOPODIUM CLAVATUM, MERCURIUS SOLUBILIS, NATRUM MURIATICUM, PHOSPHORUS, PULSATILLA (PRATENSIS), SEPIA | BioActive Nutritional, Inc. | 53c96680-210b-4426-8b41-3b9a882848dd | 2026-08-20 | Warnings | 451W47IQ8X |
| Mag-AL Plus | ALUMINUM HYDROXIDE, MAGNESIUM HYDROXIDE, AND SIMETHICONE | PAI Holdings, LLC dba PAI Pharma | 896ab07a-1b40-43ab-8589-3be86b1c4198 | 2026-08-19 | Warnings | 5QB0T2IUN0 |
| CVS Saline | NASAL | CVS PHARMACY | f02c41b0-c78e-41cd-aa4a-2756bbe92087 | 2026-08-19 | Warnings | 451W47IQ8X |
| CVS Health Extra Strength Antacid | ALUMINUM HYDROXIDE AND MAGNESIUM CARBONATE | CVS PHARMACY | 8629529e-4363-4d37-9ae0-27193868df32 | 2026-08-19 | Warnings | 5QB0T2IUN0 |
| Dextrose and Sodium Chloride | DEXTROSE MONOHYDRATE AND SODIUM CHLORIDE | Fresenius Kabi USA, LLC | df18a603-ca12-4b26-83b5-9dd07b6453ab | 2026-08-18 | Warnings, Adverse reactions | 451W47IQ8X |
| DELFLEX | DEXTROSE MONOHYDRATE, SODIUM CHLORIDE, SODIUM LACTATE, CALCIUM CHLORIDE, MAGNESIUM CHLORIDE | Fresenius Medical Care Renal Therapies Group, LLC | bbc5b820-4973-11e2-a192-0002a5d5c51b | 2026-08-18 | Warnings, Adverse reactions | 451W47IQ8X |
| DELFLEX | DEXTROSE MONOHYDRATE, SODIUM CHLORIDE, SODIUM LACTATE, CALCIUM CHLORIDE, MAGNESIUM CHLORIDE | Fresenius Medical Care Renal Therapies Group, LLC | c29bdfa0-4976-11e2-939b-0002a5d5c51b | 2026-08-18 | Warnings, Adverse reactions | 451W47IQ8X |
| DELFLEX | DEXTROSE MONOHYDRATE, SODIUM CHLORIDE, SODIUM LACTATE, CALCIUM CHLORIDE, MAGNESIUM CHLORIDE | Fresenius Medical Care Renal Therapies Group, LLC | 515dcee0-3e34-11e2-a25f-0800200c9a66 | 2026-08-18 | Warnings, Adverse reactions | 451W47IQ8X |
| Medpride First Aid | BACITRACIN ZINC NEOMYCIN SULFATE POLYMYXIN B SULFATE | Shield Line LLC | 5ba3e703-7873-4724-a0bf-bb22d8a25748 | 2026-08-18 | Warnings | 057Y626693 |
| First Aid Antibiotic and Burn Relief | BACITRACIN ZINC, NEOMYCIN SULFATE, POLYMYXIN B, PRAMOXINE HYDROCHLORIDE | Amazon.com Services LLC | 3459a453-0a94-4122-adad-bb120daecd9e | 2026-08-18 | Warnings | 057Y626693 |
| BM BM63 DROPS | CEANOTHUS, KALI ARSEN, KALI MUR, SELENIUM, THALLIUM, WIESBADEN | BM Private Limited | 59006d82-610a-2e08-e063-6394a90af1ed | 2026-08-14 | Warnings | 059QF0KO0R |
| BM BM173 DROPS | ECHINACEA, EUPHRASIA, NATRUM MUR, RHUS TOX, SILICEA, SULPHUR, URTICA UREN | BM Private Limited | 59036ca4-e7bb-bbe7-e063-6394a90a410a | 2026-08-14 | Warnings | 451W47IQ8X |
| CVS Health Extra Strength Heartburn Relief Antacid Original Flavor | ALUMINUM HYDROXIDE AND MAGNESIUM CARBONATE | CVS Pharmacy,Inc. | 5c32d90b-68a0-4acf-94b6-d02037cea376 | 2026-08-13 | Warnings | 5QB0T2IUN0 |
| Natural Lift Lack of energy - Fatigue | AVENA SATIVA 9C, GELSEMIUM SEMPERVIRENS 9C, PANAX GINSENG 3C, NATRUM MURIATICUM 9C | SEVENE USA | 551194c4-dfd8-c42d-e063-6294a90aecee | 2026-08-13 | Warnings | 451W47IQ8X |
| BM BM59 DROPS | CALC CARB, DULCAMARA, HEPAR SULPH, LYCOPODIUM, NAT MUR, SULPHUR, THUJA OCC | BM Private Limited | 58ef0755-c2cd-b7c2-e063-6294a90a2707 | 2026-08-13 | Warnings | 451W47IQ8X |
| Dealmed Triple Antibiotic | BACITRACIN ZINC, NEOMYCIN SULFATE, POLYMYXIN B SULFATE | Dealmed Medical Supplies, LLC. | b3f1e834-4e8f-49f6-af0d-38097ae4f928 | 2026-08-13 | Warnings | 057Y626693 |
| CVS PHARMACY Extra Strength Cherry Flavor | ALUMINUM HYDROXIDE AND MAGNESIUM CARBONATE | CVS Pharmacy,Inc. | cf7ae053-fa8d-4e6e-af4f-b846699aaf24 | 2026-08-13 | Warnings | 5QB0T2IUN0 |
| triple antibiotic pain relief | BACITRACIN, NEOMYCIN, POLYMYXIN B, PRAMOXINE HCL | Walgreen Company | f0fa2822-02a2-49e5-ad47-aa7e9cc2da71 | 2026-08-11 | Warnings | 057Y626693 |
| Adrenal-Tone | ADRENALINUM, AVENA, GINKGO, GLYCYRRHIZA, KALI PHOS, NAT MUR, NUX VOMICA, PHOSPHORICUM AC, PITUITARUM POSTERIUM, SARSAPARILLA, THYROIDINUM, VERATRUM ALB, ZINC MET. | Energetix Corporation | 1ea4abb3-3a02-4d5c-baeb-d903b0febbb5 | 2026-08-11 | Warnings | 451W47IQ8X |
| Adrenapath | CARDUUS MARIANUS, CHELIDONIUM MAJUS, ECHINACEA (ANGUSTIFOLIA), GLANDULA SUPRARENALIS SUIS, NATRUM MURIATICUM, PHOSPHORICUM ACIDUM, PITUITARUM POSTERIUM (BOVINE), THYROIDINUM (BOVINE) | Energetix Corporation | c300b8f5-4334-4597-a303-8200cbc117d1 | 2026-08-11 | Warnings | 451W47IQ8X |
Reported adverse events (FAERS/openFDA)#
Adverse event summaries are temporarily unavailable. Other product information remains available.