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 |
|---|---|---|---|---|---|---|
| Quantum Resonance | ALCOHOLUS, ALUMINA SILICATA, ANACARDIUM ORIENTALE, AQUA MARINA, BAPTISIA TINCTORIA, CANDIDA ALBICANS, COLLAGEN, DNA, LAVANDULA OFFICINALIS, MEDULLA OSSIS SUIS, NATRUM MURIATICUM, NATRUM PHOSPHORICUM, NUX MOSCHATA, PHOSPHORUS, QUARTZ, SILICEA, TELA ARANEA, VALERIANA OFFICINALIS, VISCUM ALBUM | Deseret Biologicals, Inc. | 1467111a-bef6-473d-b7f2-3309a9bb72ce | 2026-04-10 | Warnings | ETJ7Z6XBU4 |
| basic care nighttime cold and flu | ACETAMINOPHEN, DEXTROMETHORPHAN HYDROBROMIDE, DOXYLAMINE SUCCINATE | Amazon.com Services LLC | 88d27c25-a305-4398-9590-df10d2504b01 | 2026-04-09 | Warnings | 362O9ITL9D |
| Hydrocodone Bitartrate and Acetaminophen | HYDROCODONE BITARTRATE AND ACETAMINOPHEN | Bryant Ranch Prepack | 8e99994a-83b4-4b1f-9654-4ae373bf2c4d | 2026-04-09 | Boxed warning, Warnings, Adverse reactions | 362O9ITL9D |
| Leader Nighttime Cold and Flu | ACETAMINOPHEN, DEXTROMETHORPHAN HBR, DOXYLAMINE SUCCINATE | Cardinal Health 110, LLC. dba Leader | e7ad8d2d-01fd-40d9-a972-b2ca14cc97fb | 2026-04-09 | Warnings | 362O9ITL9D |
| Sinus and Headache Daytime | ACETAMINOPHEN, PHENYLEPHRINE HCL | L.N.K. International, Inc. | e20b1093-d77f-4c39-b105-adaa1b82ea76 | 2026-04-09 | Warnings | 362O9ITL9D |
| Oxycodone Hydrochloride and Acetaminophen | OXYCODONE HYDROCHLORIDE AND ACETAMINOPHEN | Elite Laboratories, Inc. | 27fa8190-d334-4bb9-b277-d1f44db433e3 | 2026-04-09 | Boxed warning, Warnings, Adverse reactions | 362O9ITL9D |
| Cold and Flu Nighttime | ACETAMINOPHEN, DEXTROMETHORPHAN HBR, DOXYLAMINE SUCCINATE | Lidl US LLC | b26ac105-f8e4-4ad0-8a26-9fdf30c01700 | 2026-04-09 | Warnings | 362O9ITL9D |
| Hydrocodone Bitartrate and Acetaminophen | HYDROCODONE BITARTRATE AND ACETAMINOPHEN | Bryant Ranch Prepack | 5a7fb0e7-eb06-4332-a786-d0051afd1dd9 | 2026-04-09 | Boxed warning, Warnings, Adverse reactions | 362O9ITL9D |
| Care One migraine relief | ACETAMINOPHEN, ASPIRIN, CAFFEINE | American Sales Company | be6c9dc5-853e-4342-ba6a-e5b7be5afe72 | 2026-04-09 | Warnings | 3G6A5W338E 362O9ITL9D |
| Hydrocodone Bitartrate and Acetaminophen | HYDROCODONE BITARTRATE AND ACETAMINOPHEN | Bryant Ranch Prepack | 679b4f87-59df-48d4-a9e6-e78aaeab23ea | 2026-04-09 | Boxed warning, Warnings, Adverse reactions | 362O9ITL9D |
| Hydrocodone Bitartrate and Acetaminophen | HYDROCODONE BITARTRATE AND ACETAMINOPHEN | Bryant Ranch Prepack | d3b7f2b3-28c4-4ba5-961f-48e838600be2 | 2026-04-09 | Boxed warning, Warnings, Adverse reactions | 362O9ITL9D |
| Sinus Pressure and Pain Maximum Strength | ACETAMINOPHEN, PHENYLEPHRINE HCL | Cardinal Health 110, LLC. DBA Leader | 80d25e23-b108-4eb1-88c7-73fe9da8f942 | 2026-04-09 | Warnings | 362O9ITL9D |
| Pain Reliever Childrens | ACETAMINOPHEN | H E B | 7e43de11-d20b-4920-a04d-3c1b5d35e005 | 2026-04-09 | Warnings | 362O9ITL9D |
| Tylenol Cold Plus Flu Plus Chest Congestion | ACETAMINOPHEN, GUAIFENESIN | Kenvue Brands LLC | 4e60e1ad-4ad4-c329-e063-6294a90ab318 | 2026-04-08 | Warnings | 362O9ITL9D |
| FreshKote Preservative Free Lubricant Eye Drops | POVIDONE, POLYVINYL ALCOHOL | Eyevance Pharmaceuticals | f51c50c3-43ae-4169-9d2b-22b239461dd1 | 2026-04-08 | Warnings | FZ989GH94E |
| Excedrin Extra Strength Pain Reliever | ACETAMINOPHEN, ASPIRIN (NSAID), AND CAFFEINE | Navajo Manufacturing Company Inc. | f7e572e9-82a7-2127-e053-6394a90ab01a | 2026-04-08 | Warnings | 3G6A5W338E 362O9ITL9D |
| Midol | ACETAMINOPHEN, CAFFEINE, AND PYRILAMINE MALEATE | Navajo Manufacturing Company Inc. | cabd10f2-a91e-4406-9249-915e306c867b | 2026-04-08 | Warnings | 3G6A5W338E 362O9ITL9D |
| Excedrin Migraine | ACETAMINOPHEN, ASPIRIN, AND CAFFEINE | Navajo Manufacturing Company Inc. | 4efbd21b-92fe-96a7-e063-6294a90ac4ad | 2026-04-08 | Warnings | 3G6A5W338E 362O9ITL9D |
| Menstrual Pain Relief Maximum Strength / Multi Symptom | ACETAMINOPHEN, PAMABROM, PYRILAMINE MALEATE | DOLGENCORP, LLC | d441088b-fb1d-4fdc-954f-032f3122212f | 2026-04-08 | Warnings | 362O9ITL9D |
| MIGRAINE FORMULA | ACETAMINOPHEN, ASPIRIN, CAFFEINE | Meijer, Inc. | 529b6ee6-043c-430a-b2e1-b63c81f10291 | 2026-04-08 | Warnings | 3G6A5W338E 362O9ITL9D |
Reported adverse events (FAERS/openFDA)#
Adverse event summaries are temporarily unavailable. Other product information remains available.