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 |
|---|---|---|---|---|---|---|
| Safetussin High Blood Pressure and diabetes Cough, Cold and Flu | ACETAMINOPHEN, DEXTROMETHORPHAN HYDROBROMIDE, AND GUAIFENESIN | KRAMER LABORATORIES | 279e309c-040d-4001-808d-b7d986a9a1d8 | 2025-12-23 | Warnings | 362O9ITL9D |
| Sinus PE Head Congestion and Flu Severe | ACETAMINOPHEN, DEXTROMETHORPHAN HBR, GUAIFENESIN, PHENYLEPHRINE HCL | CVS WOONSOCKET PRESCRIPTION CENTER, INCORPORATED | 76fd1f8e-2670-421c-a9e6-c8adefb7962e | 2025-12-23 | Warnings | 362O9ITL9D |
| StellaLife VEGA Oral Care Peppermint Pain and Swelling Relief | ARNICA, CALENDULA, CHAMOMILLA, ECHINACEA ANGUSTIFOLIA, ECHINACEA PURPUREA, HEPAR SULPH CALC, HYPERICUM, LGNATIA, LEDUM PALUSTRE, RUTA, SILICEA, STAPHYSAGRIA | StellaLife, Inc. | 10d42c12-713a-f461-e063-6294a90a223b | 2025-12-22 | Warnings | ETJ7Z6XBU4 |
| StellaLife VEGA Oral Care Pain and Swelling Relief | ARNICA, CALENDULA, CHAMOMILLA, ECHINACEA ANGUSTIFOLIA, ECHINACEA PURPUREA, HEPAR SULPH CALC, HYPERICUM, LGNATIA, RUTA, STAPHYSAGRIA | StellaLife, Inc. | 10f8dee1-d5d3-0602-e063-6294a90a6dbf | 2025-12-22 | Warnings | ETJ7Z6XBU4 |
| Acetaminophen | ACETAMINOPHEN | Granules USA, Inc | a1255f60-b9c6-9a95-e053-2995a90a9e80 | 2025-12-22 | Warnings | 362O9ITL9D |
| Acetaminophen | ACETAMINOPHEN | Granules USA, Inc | a51395ea-e038-dc9c-e053-2a95a90a287d | 2025-12-22 | Warnings | 362O9ITL9D |
| CareALL Acetaminophen | ACETAMINOPHEN | New World Imports, Inc | 1148b4d9-fa6a-49e6-9663-17b2c8373846 | 2025-12-22 | Warnings | 362O9ITL9D |
| Vitapirena | ACETAMINOPHEN | Pharmadel LLC | 0547bc1f-d000-f5a6-e063-6294a90ac73d | 2025-12-22 | Warnings | 362O9ITL9D |
| CareALL Acetaminophen Extra Strength | ACETAMINOPHEN | New World Imports, Inc | f818417e-0b31-4fe7-8313-4160a00b248a | 2025-12-22 | Warnings | 362O9ITL9D |
| CareALL Acetaminophen | ACETAMINOPHEN | New World Imports, Inc | c4f82ed8-b82c-47bb-9ab9-108a13d29cf7 | 2025-12-22 | Warnings | 362O9ITL9D |
| CareALL Acetaminophen Extra Strength | ACETAMINOPHEN | New World Imports, Inc | 5103450a-3095-49cc-9823-4fb4c1d258ff | 2025-12-22 | Warnings | 362O9ITL9D |
| CAREALL Non-Aspirin PM Extra Strength | ACETAMINOPHEN, DIPHENHYDRAMINE HCL | New World Imports, Inc | 499b2bf8-72fb-4500-b16e-517cab09a8ae | 2025-12-22 | Warnings | 362O9ITL9D |
| CAREALL Pain Relief PM Extra Strength | ACETAMINOPHEN, DIPHENHYDRAMINE HCL | New World Imports, Inc | 933154b9-c9d6-4260-8775-1c83631c74e4 | 2025-12-22 | Warnings | 362O9ITL9D |
| CAREALL Pain Relief PM Extra Strength | ACETAMINOPHEN, DIPHENHYDRAMINE HCL | New World Imports, Inc | c93aa5e4-3994-439f-8f14-4e81773ed4e2 | 2025-12-22 | Warnings | 362O9ITL9D |
| Acetaminophen | ACETAMINOPHEN | Granules USA, Inc. | 96131c7b-bdff-0642-e053-2a95a90a4f32 | 2025-12-22 | Warnings | 362O9ITL9D |
| Acetaminophen Diphenhydramine HCl | ACETAMINOPHEN DIPHENHYDRAMINE HCL | Granules USA, Inc. | 8c9f68e3-fedc-6457-e053-2995a90a045a | 2025-12-22 | Warnings | 362O9ITL9D |
| Nighttime Cold and Flu Relief | ACETAMINOPHEN, DEXTROMETHORPHAN HBR, DOXYLAMINE SUCCINATE | Harris Teeter, LLC | 89fd57d2-fe49-41cb-b02e-9643e526cf47 | 2025-12-22 | Warnings | 362O9ITL9D |
| Cold and Flu severe | ACETAMINOPHEN,DEXTROMETHORPHAN HBR,GUAIFENESIN,PHENYLEPHRINE HCL | Wal-Mart Stores Inc | 9fca25dc-f63e-487a-8b7c-84d65ea51cb5 | 2025-12-19 | Warnings | 362O9ITL9D |
| Cold and Flu Severe | ACETAMINOPHEN, DEXTROMETHORPHAN HBR, GUAIFENESIN, PHENYLEPHRINE HCL | Geiss, Destin & Dunn Inc. | a7d2eaee-484e-43aa-8ae3-0e050219383f | 2025-12-19 | Warnings | 362O9ITL9D |
| Tension Headache Relief | ACETAMINOPHEN, CAFFEINE | NUVICARE LLC | ea4e50e9-2c4d-4e58-b2cb-ab23e91fd50e | 2025-12-19 | Warnings | 3G6A5W338E 362O9ITL9D |
Reported adverse events (FAERS/openFDA)#
Adverse event summaries are temporarily unavailable. Other product information remains available.