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 |
|---|---|---|---|---|---|---|
| V HP | ANAS BARBARIAE, HEPATIS ET CORDIS EXTRACTUM, ARSENICUM ALBUM, BELLADONNA, BRYONIA (ALBA), CARCINOSIN, ECHINACEA (ANGUSTIFOLIA), EUPATORIUM PERFOLIATUM, GELSEMIUM SEMPERVIRENS, LYCOPODIUM CLAVATUM, NATRUM MURIATICUM, PHOSPHORICUM ACIDUM, PHOSPHORUS, PYROGENIUM, RHUS TOX, SULPHUR | Energique, Inc. | ea12ca3b-19e0-4d4a-9514-4d28d214e1e7 | 2026-06-12 | Warnings | 451W47IQ8X |
| Sodium Chloride | SODIUM CHLORIDE | Cardinal Health 107, LLC | 107af8bc-b6af-4b85-8c8a-ea757dcef1da | 2026-06-12 | Adverse reactions | 451W47IQ8X |
| BM BM70 DROPS | ANTIM CURD, FERR MET, PHOSPHORUS, SULPHUR, WIESBADEN, THUJA, VERATRUM ALB | BM Private Limited | 53fa21d9-1f80-2e69-e063-6394a90ab9f3 | 2026-06-11 | Warnings | 059QF0KO0R |
| Jacksons Cell Salts DIGESTIVE BALANCE | NAT MUR, NAT PHOS, NAT SULPH | Zettl Health Inc. | 54018d0e-372f-8afc-e063-6394a90aeb15 | 2026-06-11 | Warnings | 451W47IQ8X |
| Mag-Al Plus | ALUMINUM HYDROXIDE, MAGNESIUM HYDROXIDE, AND SIMETHICONE | Cardinal Health 107, LLC | 08df7403-9ee3-4a43-a151-c1a6ef7a7549 | 2026-06-10 | Warnings | 5QB0T2IUN0 |
| GUNA-ALLERGY T | AMMONIUM CARBONATE - APIS MELLIFERA - ARSENIC TRIOXIDE - BLATTA ORIENTALIS - CUPRIC ACETATE - DRIMIA MARITIMA BULB - EPINEPHRINE - GALPHIMIA GLAUCA FLOWERING TOP - HISTAMINE DIHYDROCHLORIDE - LUFFA OPERCULATA - MANGANESE GLUCONATE - ONION - SCHOENOCAULON OFFICINALE SEED - SODIUM CHLORIDE - SUS SCROFA ADRENAL GLAND - SUS SCROFA BRONCHUS - SUS SCROFA NASAL MUCOSA - | Guna spa | fddba85e-2bec-468f-a01a-b71a3aeed9d3 | 2026-06-10 | Warnings | 451W47IQ8X |
| BM BIO28 ALCOHOL | CALC SULPH, CALC FLUOR, CALC PHOS, FERR PHOS, KALI MUR, KALI PHOS, KALI SULPH, MAG PHOS, NAT PHOS, NAT SULPH, NAT MUR, SILICEA | BM Private Limited | 53d1c51a-77eb-bb3c-e063-6394a90aab3f | 2026-06-09 | Warnings | 451W47IQ8X |
| BM BIO16 | CALC PHOS, FERR PHOS, KALI PHOS, MAG PHOS, NAT MUR. | Total Operations Management LLC DBA:Bestmade Natural Products Micro | 53d2c34e-fa4d-9240-e063-6294a90a28da | 2026-06-09 | Warnings | 451W47IQ8X |
| BM BIO20 | CALC FLUOR, CALC SULF, KALI SULF, NAT MUR, NAT SULF | Total Operations Management LLC DBA:Bestmade Natural Products Micro | 53d48847-c0bf-1334-e063-6294a90acf7e | 2026-06-09 | Warnings | 451W47IQ8X |
| BM BM68 | ARGENTUM NIT, BARYTA CARB, DULCAMARA, GELSEMIUM, KALI BROM, NAT MUR, CAUSTICUM | BM Private Limited | 53d52b7e-1e84-d4d3-e063-6294a90a9efc | 2026-06-09 | Warnings | 451W47IQ8X |
| Apizelen | GERMANIUM METALLICUM, ALFALFA, ARALIA QUINQUEFOLIA, AVENA SATIVA, BETA VULGARIS, CALENDULA OFFICINALIS, CHELIDONIUM MAJUS, ECHINACEA (ANGUSTIFOLIA), NATRUM MURIATICUM, PALOONDO, PHYTOLACCA DECANDRA, TARAXACUM OFFICINALE, TRIFOLIUM PRATENSE, URTICA DIOICA, VISCUM ALBUM, COBALT ACETATE, COBALT GLUCONATE, COPPER GLUCONATE, CUPRUM ACETICUM, GLUTATHIONE, MAGNESIUM GLUCONICUM DIHYDRICUM, GANODERMA LUCIDUM, UBIDECARENONUM, ARGENTUM METALLICUM | BioActive Nutritional, Inc. | 471a7fab-1ef1-4d13-a28e-75f9762a711a | 2026-06-08 | Warnings | 451W47IQ8X |
| XIMONTH Fungi Free Bee Venom Nail Soothing Serum | GLYCERIN | Shantou Ximonth Biotechnology Co., Ltd. | 53bab969-8407-6334-e063-6294a90aa5d1 | 2026-06-08 | Warnings | 059QF0KO0R |
| BM Nat Mur | NATRIUM MURIATICUM | Total Operations Management LLC DBA:Bestmade Natural Products Micro | 53baa9ce-5ce6-7bba-e063-6294a90a517a | 2026-06-08 | Warnings | 451W47IQ8X |
| Triple Antibiotic First Aid Antibiotic plus Pain Relief | BACITRACIN ZINC, NEOMYCIN SULFATE, POLYMYXIN B SULFATE, PRAMOXINE HCL | Aldermed Inc. | 5bfc7776-1030-48ba-9df4-897c4984c9e6 | 2026-06-08 | Warnings | 057Y626693 |
| Triple Antibiotic Plus Pain Relief | BACITRACIN ZINC, NEOMYCIN SULFATE, POLYMYXIN B SULFATE, AND PRAMOXINE HYDROCHLORIDE | Sun Pharmaceutical Industries, Inc. | 4545c043-8e8e-4288-b4d8-e6ec9d72f979 | 2026-06-04 | Warnings | 057Y626693 |
| BM Nat Mur Icing Sugar | NATRUM MURIATICUM ICING SUGAR | Total Operations Management LLC DBA:Bestmade Natural Products Micro | 5356d350-1325-7299-e063-6294a90a96a0 | 2026-06-03 | Warnings | 451W47IQ8X |
| Triple Antibiotic | BACITRACIN ZINC, NEOMYCIN SULFATE, AND POLYMYXIN B SULFATE | Sun Pharmaceutical Industries, Inc. | d77239e6-5e81-439a-b0cd-f8be59169442 | 2026-06-02 | Warnings | 057Y626693 |
| First Aid Antibiotic | BACITRACIN ZINC, NEOMYCIN, POLYMYXIN B | HyVee Inc | 3ac9f0fc-e08c-49d9-9079-3ba0393c612b | 2026-06-02 | Warnings | 057Y626693 |
| Triple Antibiotic Plus Pain Relief | BACITRACIN, NEOMYCIN, POLYMYXIN B, PRAMOXINE HCL | HyVee Inc | 69a4b642-b7ec-43cc-aa57-6858da0b3d63 | 2026-06-02 | Warnings | 057Y626693 |
| ACID GONE ANTACID | ALUMINUM HYDROXIDE AND MAGNESIUM CARBONATE | Major Pharmaceuticals | 3d353a92-92f1-4304-8895-31d39dccd88c | 2026-06-01 | Warnings | 5QB0T2IUN0 |
Reported adverse events (FAERS/openFDA)#
Adverse event summaries are temporarily unavailable. Other product information remains available.