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 |
|---|---|---|---|---|---|---|
| Severe Sinus Congestion and Pain | ACETAMINOPHEN, GUAIFENESIN, PHENYLEPHRINE | Shield Pharmaceuticals Corp | 103de130-ef12-4c58-bbcf-234b3f3b2cbf | 2025-11-08 | Warnings | 362O9ITL9D |
| Ananassa Resina | ANANASSA RESINA | Uriel Pharmacy Inc. | 52a18d0a-2c97-4e81-81ff-c836582d0a4c | 2025-11-07 | Warnings | ETJ7Z6XBU4 |
| Pain Reliever | ACETAMINOPHEN | Shield Pharmaceuticals Corp | 61e50135-a7c2-4a86-8a1a-d47b41d3f9d1 | 2025-11-07 | Warnings | 362O9ITL9D |
| Allergy plus Sinus Headache | ACETAMINOPHEN 325 MG, DIPHENHYDRAMINE HCL 12.5 MG, PHENYLEPHRINE HCL 5 MG | Shield Pharmaceuticals Corp | 093649a4-f968-49bd-83af-bb7e0f448ecf | 2025-11-07 | Warnings | 362O9ITL9D |
| Cold and Flu Relief | ACETAMINOPHEN DEXTROMETHORPHAN HBR PHENYLEPHRINE HCL | QUALITY CHOICE (Chain Drug Marketing Association) | 1d512053-7a54-4691-a657-77da4c627cb8 | 2025-11-07 | Warnings | 362O9ITL9D |
| Allergy and Headache | ACETAMINOPHEN, DIPHENHYDRAMINE HCL | CVS WOONSOCKET PRESCRIPTION CENTER, INCORPORATED | dc249163-26dd-42ca-b423-2f16299f2d65 | 2025-11-07 | Warnings | 362O9ITL9D |
| Childrens Chewables | ACETAMINOPHEN | Strategic Sourcing Services LLC | af2cbbaf-9b73-440a-bc88-a790cafccc6b | 2025-11-07 | Warnings | 362O9ITL9D |
| Vicks DayQuil HIGH BLOOD PRESSURE COLD and FLU | ACETAMINOPHEN, DEXTROMETHORPHAN HBR | The Procter & Gamble Manufacturing Company | ff0bffee-9a36-8246-e053-6294a90a86c7 | 2025-11-06 | Warnings | 362O9ITL9D |
| Teething-Colic | CHAMOMILLA, VALERIANA OFFICINALIS, ACONITUM NAPELLUS, APIS MELLIFICA, BAPTISIA TINCTORIA, BELLADONNA, BORAX, BRYONIA, CALCAREA CARBONICA, CALCAREA PHOSPHORICA, CHAMOMILLA, CHELIDONIUM MAJUS, COFFEA CRUDA, COLLINSONIA CANADENSIS, COLOCYNTHIS, KREOSOTUM, MAGNESIA PHOSPHORICA, NUX VOMICA, PODOPHYLLUM PELTATUM, RHEUM, SCUTELLARIA LATERIFLORA, SILICEA, TEREBINTHINA, ZINGIBER OFFICINALE | Newton Laboratories, Inc. | 9db30229-3031-ff10-e053-2995a90aff75 | 2025-11-06 | Warnings | ETJ7Z6XBU4 |
| Teething-Colic | CHAMOMILLA, VALERIANA OFFICINALIS, ACONITUM NAPELLUS, APIS MELLIFICA, BAPTISIA TINCTORIA, BELLADONNA, BORAX, BRYONIA, CALCAREA CARBONICA, CALCAREA PHOSPHORICA, CHAMOMILLA, CHELIDONIUM MAJUS, COFFEA CRUDA, COLLINSONIA CANADENSIS, COLOCYNTHIS, KREOSOTUM, MAGNESIA PHOSPHORICA, NUX VOMICA, PODOPHYLLUM PELTATUM, RHEUM, SCUTELLARIA LATERIFLORA, SILICEA, TEREBINTHINA, ZINGIBER OFFICINALE | Newton Laboratories, Inc. | 9db4790e-28c2-2dce-e053-2a95a90ae792 | 2025-11-06 | Warnings | ETJ7Z6XBU4 |
| Severe Allergy Plus Sinus Headache | ACETAMINOPHEN, DIPHENHYDRAMINE HCL, PHENYLEPHRINE HCL | Wal-Mart Stores Inc | 1a1f41c4-5430-4cff-873e-6547dadc8779 | 2025-11-06 | Warnings | 362O9ITL9D |
| TYLENOL Extra Strength | ACETAMINOPHEN | Kenvue Brands LLC | 42321456-d7dd-3b51-e063-6394a90ac292 | 2025-11-05 | Warnings | 362O9ITL9D |
| Target Overnight Cold and Flu | ACETAMINOPHEN, DEXTROMETHORPHAN HBR, TRIPROLIDINE HCL | TARGET CORPORATION | 05e944d5-3473-4d8c-8df4-2ffc7474e9fa | 2025-11-05 | Warnings | 362O9ITL9D |
| Target Maximum Strength Cold Flu and Sore Throat | ACETAMINOPHEN, DEXTROMETHORPHAN HBR, GUAIFENESIN, PHENYLEPHRINE HCL | TARGET CORPORATION | 1d3ad31f-ef4d-45ba-a6e3-13d66b51d1d2 | 2025-11-05 | Warnings | 362O9ITL9D |
| Childrens Pain Relief | ACETAMINOPHEN | Family Dollar Services Inc | 76058eb3-2d3f-4414-87df-7167cd27d26b | 2025-11-05 | Warnings | 362O9ITL9D |
| Daytime Cold and Flu | ACETAMINOPHEN DEXTROMETHORPHAN HBR PHENYLEPHRINE HCL | QUALITY CHOICE (Chain Drug Marketing Association) | 4754363d-e163-42e0-a65d-1c4bac24f6c9 | 2025-11-05 | Warnings | 362O9ITL9D |
| Day Time Cold and Flu | ACETAMINOPHEN DEXTROMETHORPHAN HBR PHENYLEPHRINE HCL | Safeway, Inc. | 76d62892-615d-4744-95aa-3be1207a0e57 | 2025-11-05 | Warnings | 362O9ITL9D |
| Children Pain and Fever Reliver | ACETAMINOPHEN | Target Corporation | 1116f808-f61e-47ec-b0d0-d4be5aa905be | 2025-11-04 | Warnings | 362O9ITL9D |
| Pain Reliever Dye Free | ACETAMINOPHEN | TIME CAP LABORATORIES, INC. | 42c4f0b2-6483-0f3c-e063-6294a90a140f | 2025-11-04 | Warnings | 362O9ITL9D |
| Headache Relief | ACETAMINOPHEN, ASPIRIN, CAFFEINE | Walmart Inc. | 1557bd9b-3e7c-4769-e063-6394a90a9d91 | 2025-11-04 | Warnings | 3G6A5W338E 362O9ITL9D |
Reported adverse events (FAERS/openFDA)#
Adverse event summaries are temporarily unavailable. Other product information remains available.