NDC 85534-0046-01 - Butalbital, Acetaminophen, Caffeine
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
- 85534-0046
- Requested NDC
- 85534-0046-01
- Package NDCs from labels
- 85534-0046-0, 85534-0046-1, 85534-0046-2, 85534-0046-3, 85534-0046-4, 85534-0046-5, 85534-0046-6, 85534-0046-7, 85534-0046-8, 85534-0046-01
- Manufacturer
- HAWAII REPACK, INC.
- Effective date
- 2026-07-17
- Current FDA listing
- Not matched in FDA.report NDC product tables
DailyMed Labels#
| Label | Manufacturer | Effective date | Type |
|---|---|---|---|
| BUTALBITAL, ACETAMINOPHEN AND CAFFEINE TABLETS, USP 50 mg/325 mg/40 mg | HAWAII REPACK, INC. | 2026-07-17 | HUMAN PRESCRIPTION DRUG LABEL |
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 |
|---|---|---|---|---|---|---|
| equate dual pain reliever | ACETAMINOPHEN, IBUPROFEN | WALMART INC. | 09dc976b-6065-4aad-9d57-0fe5e88a722a | 2025-12-15 | Warnings | 362O9ITL9D |
| Pain Reliever | ACETAMINOPHEN | WALGREENS | 40a1b354-9b2e-1cf3-e063-6394a90af113 | 2025-12-13 | Warnings | 362O9ITL9D |
| topcare childrens pain and fever | ACETAMINOPHEN | Topco Associates LLC | 911492d5-e065-4b8f-b2dc-cb6a6678d0ae | 2025-12-13 | Warnings | 362O9ITL9D |
| Cold and Flu maximum strength | ACETAMINOPHEN, DEXTROMETHORPHAN HBR, GUAIFENESIN, PHENYLEPHRINE HCL | Rite Aid Corporation | ac01206f-a717-4c0b-8a03-fab0a4fd154b | 2025-12-12 | Warnings | 362O9ITL9D |
| Acetaminophen 250 mg and Ibuprofen 125 mg | ACETAMINOPHEN 250 MG AND IBUPROFEN 125 MG TABLETS | MARKSANS PHARMA LIMITED | 46121a30-1361-4f2b-9f3f-3cedabd66c33 | 2025-12-12 | Warnings | 362O9ITL9D |
| Sinus Severe | ACETAMINOPHEN, GUAIFENESIN, PHENYLEPHRINE HCL | Strategic Sourcing Services LLC | dcb80dd5-465d-4792-947a-3044e25a5284 | 2025-12-12 | Warnings | 362O9ITL9D |
| Pain Reliever, Extra Strength, 24-7 Life by 7-Eleven | ACETAMINOPHEN TABLET | Lil' Drug Store Products, Inc. | 45c397bd-a1ff-1246-e063-6394a90ac54a | 2025-12-12 | Warnings | 362O9ITL9D |
| Acetaminophen and Ibuprofen | ACETAMINOPHEN AND IBUPROFEN | DISCOUNT DRUG MART, INC. | f9dfeb0e-0d4d-7348-e053-6394a90a8aef | 2025-12-12 | Warnings | 362O9ITL9D |
| Acetaminophen and Ibuprofen | ACETAMINOPHEN AND IBUPROFEN | Bionpharma Inc. | 04ccc4b2-0cfd-3012-e063-6394a90afa79 | 2025-12-12 | Warnings | 362O9ITL9D |
| Pain Reliever PM, Extra Strength, 24-7 Life by 7-Eleven | ACETAMINOPHEN, DIPHENHYDRAMINE HCL TABLET, FILM COATED | Lil' Drug Store Products, Inc. | 45c7c11b-d627-aee8-e063-6294a90a401d | 2025-12-12 | Warnings | 362O9ITL9D |
| Severe Congestion Relief Maximum Strength Sinus | ACETAMINOPHEN, GUAIFENESIN, PHENYLEPHRINE HCL | Wal-Mart Stores Inc | 59918b8b-5c91-468f-834e-66020dc1ae12 | 2025-12-12 | Warnings | 362O9ITL9D |
| GERM HP | APIS MELLIFERA, ARSENIC TRIOXIDE, ATROPA BELLADONNA, MATRICARIA RECUTITA, LACHESIS MUTA VENOM, MERCURIUS SOLUBILIS, PULSATILLA VULGARIS, TOXICODENDRON PUBESCENS LEAF, SILICON DIOXIDE | Natural Creations, Inc. | 15dc5391-0e6e-45d9-8ac7-142333a90716 | 2025-12-12 | Warnings | ETJ7Z6XBU4 |
| Daytime Cold and Flu Relief | ACETAMINOPHEN, DEXTROMETHORPHAN HBR, PHENYLEPHRINE HCL | SALADO SALES INC. | 8f66f5bc-7c77-420b-9feb-911c980fbfdc | 2025-12-12 | Warnings | 362O9ITL9D |
| Germasode | ARNICA MONTANA, ECHINACEA ANGUSTIFOLIA, ARSENICUM ALBUM, BELLADONNA, BERBERIS VULGARIS, BORRELIA, CHLAMYDIA, HYDRASTIS CANADENSIS, LACHESIS MUTUS, LYMPHOGRANULOMA, MERCURIUS SOLUBILIS, OOPHORINUM, PHOSPHORUS, PNEUMOCOCCINUM, PYROGENIUM, SILICEA TERRA | Natural Creations, Inc | cad24325-e658-4427-a2e7-f821f0111170 | 2025-12-12 | Warnings | ETJ7Z6XBU4 |
| Cold and Flu | ACETAMINOPHEN, DEXTROMETHORPHAN HBR, GUAIFENESIN, PHENYLEPHRINE HCL | WALMART INC. | de55a9fd-53a2-4f3e-82b7-cabcbe287d46 | 2025-12-12 | Warnings | 362O9ITL9D |
| Nighttime Cold and Flu Relief | ACETAMINOPHEN, DEXTROMETHORPHAN HBR AND DOXYLAMINE SUCCINATE | SALADO SALES INC. | cc73b668-cc6a-41d6-800a-4988c59c0449 | 2025-12-12 | Warnings | 362O9ITL9D |
| HEADACHE HP | SILVER NITRATE, ATROPA BELLADONNA, BRYONIA ALBA ROOT, GELSEMIUM SEMPERVIRENS ROOT, NITROGLYCERIN, LACHESIS MUTA VENOM, LYCOPODIUM CLAVATUM SPORE, MELILOTUS OFFICINALIS TOP, SODIUM CHLORIDE, STRYCHNOS NUX-VOMICA SEED, SILICON DIOXIDE, SPIGELIA ANTHELMIA | Natural Creations, Inc. | c38b83f0-3918-4ef6-8dfd-48fe438e584a | 2025-12-12 | Warnings | ETJ7Z6XBU4 |
| Acetaminophen | ACETAMINOPHEN | PAI Holdings, LLC dba PAI Pharma | 33599f18-5f49-4f22-8a77-a072115763ef | 2025-12-11 | Warnings | 362O9ITL9D |
| Sinus Congestion and Pain Relief Non-Drowsy | ACETAMINOPHEN, PHENYLEPHRINE HCL | WinCo Foods, LLC | f7e925f4-7da6-4157-a97f-e6a3e399911f | 2025-12-11 | Warnings | 362O9ITL9D |
| Menstrual Complete | ACETAMINOPHEN, CAFFEINE, PYRILAMINE MALEATE | WinCo Foods, LLC | 860c4e94-1d1a-4f74-a14a-35f86f4523c4 | 2025-12-11 | Warnings | 3G6A5W338E 362O9ITL9D |
Reported adverse events (FAERS/openFDA)#
Adverse event summaries are temporarily unavailable. Other product information remains available.