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 |
|---|---|---|---|---|---|---|
| SanaTos Severe Cold Relief Nighttime | ACETAMINOPHEN, DIPHENHYDRAMINE HYDROCHLORIDE, AND PHENYLEPHRINE HYDROCHLORIDE | Pharmadel LLC | 144aafcc-6ec2-a322-e063-6294a90afc27 | 2026-01-15 | Warnings | 362O9ITL9D |
| SanaTos Severe Cold and Cough Daytime | ACETAMINOPHEN, DEXTROMETHORPHAN HYDROBROMIDE, AND PHENYLEPHRINE HYDROCHLORIDE | Pharmadel LLC | 14484bf5-ff45-b859-e063-6394a90a9a0f | 2026-01-15 | Warnings | 362O9ITL9D |
| BUTALBITAL, ASPIRIN, CAFFEINE and CODEINE PHOSPHATE | BUTALBITAL, ASPIRIN, CAFFEINE AND CODEINE PHOSPHATE | Amneal Pharmaceuticals of New York, LLC | 828e30fa-7bb1-486b-80ee-806fce45e4e4 | 2026-01-15 | Boxed warning, Warnings, Adverse reactions | 3G6A5W338E KHS0AZ4JVK |
| ACETAMINOPHEN AND CODEINE PHOSPHATE | ACETAMINOPHEN AND CODEINE PHOSPHATE | Preferred Pharmaceuticals Inc. | 55d494b1-c828-4841-8f64-75b92cd54cb6 | 2026-01-14 | Boxed warning, Warnings, Adverse reactions | 362O9ITL9D |
| Leader Vapor Ice Cold and Flu | ACETAMINOPHEN, DEXTROMETHORPHAN HYDROBROMIDE | Cardinal Health 110, LLC. dba Leader | f27bf0b2-25cc-474c-ab6b-f227ed3525fa | 2026-01-14 | Warnings | 362O9ITL9D |
| Unisom PM Pain Nighttime Sleep Aid and Pain Reliever | ACETAMINOPHEN AND DIPHENHYDRAMINE HYDROCHLORIDE | Chattem, Inc. | 451daeeb-88a9-44b1-9a2d-1ff0b0ec41cb | 2026-01-14 | Warnings | 362O9ITL9D |
| ACETAMINOPHEN AND CODEINE PHOSPHATE | ACETAMINOPHEN AND CODEINE PHOSPHATE | Preferred Pharmaceuticals Inc. | 2453d635-989d-4569-96b3-4efaf61cca71 | 2026-01-14 | Boxed warning, Warnings, Adverse reactions | 362O9ITL9D |
| Nighttime Cold and Flu | ACETAMINOPHEN, DEXTROMETHORPHAN HBR, DOXYLAMINE SUCCINATE | BETTER LIVING BRANDS LLC. | 41f4bf6d-f83c-92e4-e063-6394a90aebab | 2026-01-13 | Warnings | 362O9ITL9D |
| Severe Cold and Flu | ACETAMINOPHEN, DEXTROMETHORPHAN HYDROBROMIDE, GUAIFENESIN, AND PHENYLEPHRINE HYDROCHLORIDE | HYVEE INC | 462cbf3d-51b1-dab9-e063-6394a90a70ba | 2026-01-13 | Warnings | 362O9ITL9D |
| Pain Terminator Extra Strength Pain Relief | CAFFEINE, ACETAMINOPHEN, ASPIRIN | Wildman Business Group | 8ffb02d9-92df-4d2f-a367-1c71490807fb | 2026-01-12 | Warnings | 3G6A5W338E 362O9ITL9D |
| Acetaminophen and Ibuprofen | ACETAMINOPHEN AND IBUPROFEN | BIONPHARMA INC. | 4834aa7f-cb0c-ec58-e063-6394a90ae2fc | 2026-01-12 | Warnings | 362O9ITL9D |
| Tramadol Hydrochloride and Acetaminophen | TRAMADOL HYDROCHLORIDE AND ACETAMINOPHEN | AvPAK | 244f6e5d-e1b4-ba8b-ca6f-af2d8a31d5f0 | 2026-01-12 | Warnings, Adverse reactions | 362O9ITL9D |
| Constipation Relief | ALUMINUM OXIDE, BRYONIA ALBA ROOT, SODIUM CHLORIDE, GRAPHITE, SILICON DIOXIDE | Homeocare Laboratories | 62374240-cd14-44e2-9405-5f8996faf047 | 2026-01-12 | Warnings | ETJ7Z6XBU4 |
| OXYCODONE AND ACETAMINOPHEN | OXYCODONE AND ACETAMINOPHEN | KVK-Tech, Inc. | 9986aa04-c976-4654-8ad7-b97d2eecea93 | 2026-01-12 | Boxed warning, Warnings, Adverse reactions | 362O9ITL9D |
| Menopause Relief | BARIUM CARBONATE, ATROPA BELLADONNA, BLACK COHOSH, NITROGLYCERIN, LACHESIS MUTA VENOM, SILICON DIOXIDE | Homeocare Laboratories | 99b182d5-4102-4b25-85d3-f4be077d753f | 2026-01-12 | Warnings | ETJ7Z6XBU4 |
| Amber Amethyst | AMBER AMETHYST | Uriel Pharmacy, Inc | 4837e805-a777-c1fa-e063-6294a90ae9c4 | 2026-01-12 | Warnings | ETJ7Z6XBU4 |
| Acetaminophen | ACETAMINOPHEN | PD-Rx Pharmaceuticals, Inc. | 64696f65-415e-4ce1-a5b3-70662fbcb002 | 2026-01-12 | Warnings | 362O9ITL9D |
| ECHINACEA | ECHINACEA ANGUSTIFOLIA, HAMAMMELIS VIRGINIANA, CALCAREA PHOSPHORICA, HYDRASTIS CANADANESIS, SENEGA OFFICINALIS, SILICEA, CONIUM, AURUM MURIATICUM NATRONATUM, CALCAREA CARBONICA, FUCUS VESICULOSUS, LACHESIS MUTUS | Marco Pharma International LLC. | 7efadb70-99e4-428b-a8ef-a2797327c6fa | 2026-01-12 | Warnings | ETJ7Z6XBU4 |
| Tension Headache | ACETAMINOPHEN, CAFFEINE | Cardinal Health 110, LLC. DBA Leader | 96684e3f-a13e-49c3-b437-d2627e528a2d | 2026-01-12 | Warnings | 3G6A5W338E 362O9ITL9D |
| Sinu-Phen Plus Sinus Pain and Pressure | ACETAMINOPHEN, PHENYLEPHRINE HYDROCHLORIDE | Wildman Business Group | c66e0b52-5531-4a84-ae90-8a26d27df1ec | 2026-01-12 | Warnings | 362O9ITL9D |
Reported adverse events (FAERS/openFDA)#
Adverse event summaries are temporarily unavailable. Other product information remains available.