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 |
|---|---|---|---|---|---|---|
| good sense pain relief | ACETAMINOPHEN | NuCare Pharamceuticals, Inc. | 440c13d7-edf0-f611-e063-6394a90af995 | 2025-11-20 | Warnings | 362O9ITL9D |
| Pain Relief | ACETAMINOPHEN | HYVEE INC | 42394377-c874-a955-e063-6294a90ace0b | 2025-11-20 | Warnings | 362O9ITL9D |
| Pain Relief | ACETAMINOPHEN | HYVEE INC | 4227a2cc-69fa-869d-e063-6294a90a1d41 | 2025-11-20 | Warnings | 362O9ITL9D |
| Pain Relief | ACETAMINOPHEN | HYVEE INC | 422796ed-7558-f7e8-e063-6294a90ad1c7 | 2025-11-20 | Warnings | 362O9ITL9D |
| Arthritis Pain | ACETAMINOPHEN | HYVEE INC | 3e61b583-c1cb-23bd-e063-6294a90aa006 | 2025-11-20 | Warnings | 362O9ITL9D |
| Pain Relief | ACETAMINOPHEN | HYVEE INC | 3e61abe4-b4be-01af-e063-6394a90a8b24 | 2025-11-20 | Warnings | 362O9ITL9D |
| Pain Relief PM | ACETAMINOPHEN AND DIPHENHYDRAMINE HYDROCHLORIDE | HYVEE INC | 3e60703b-a5cf-333a-e063-6394a90a2087 | 2025-11-20 | Warnings | 362O9ITL9D |
| Cold | BAPTISIA TINCTORIA, ECHINACEA ANGUSTIFOLIA, EUPATORIUM PERFOLIATUM, LOMATIUM DISSECTUM, PUERARIA LOBATA, TRIFOLIUM PRATENSE, PHYTOLACCA DECANDRA, ALLIUM CEPA, ARSENICUM IODATUM, BARYTA CARBONICA, BROMIUM, CALCAREA CARBONICA, KALI MURIATICUM, LACHESIS MUTUS, MERCURIUS SOLUBILIS, SILICEA | Natural Creations, Inc | c45d1d8f-24be-4c13-8c4b-388962421415 | 2025-11-20 | Warnings | ETJ7Z6XBU4 |
| Endometrium Argentum | ENDOMETRIUM ARGENTUM | Uriel Pharmacy Inc. | 5590d577-3a98-49b8-bb12-ddd7f5cfd080 | 2025-11-19 | Warnings | ETJ7Z6XBU4 |
| Dizziness HP | CALCAREA CARBONICA, CHENOPODIUM ANTHELMINTICUM, COCCULUS INDICUS, CONIUM MACULATUM, NUX VOMICA, PHOSPHORUS, PULSATILLA (PRATENSIS), SILICEA, TABACUM, | Energique, Inc. | 0bf53ecc-c2ad-40b5-b921-7c10a1b00626 | 2025-11-19 | Warnings | ETJ7Z6XBU4 |
| Robitussin Maximum Strength Severe Multi-Symptom Cough Cold Flu | ACETAMINOPHEN, DEXTROMETHORPHAN HYDROBROMIDE, GUAIFENESIN | Haleon US Holdings LLC | a6f750c8-8738-4965-a3ad-612c24611056 | 2025-11-18 | Warnings | 362O9ITL9D |
| YINCHIAO | ACETAMINOPHEN AND CHLORPHENIRAMINE MALEATE | ANHUI DONGSHENGYOUBANG PHARMACEUTICAL CO., LTD. | 09ba45f6-03e1-46b9-83ab-a618b2626716 | 2025-11-18 | Warnings | 362O9ITL9D |
| GANMAOLING | ACETAMINOPHEN AND CHLORPHENIRAMINE MALEATE | ANHUI DONGSHENGYOUBANG PHARMACEUTICAL CO., LTD. | c757a03e-59ea-469c-970d-4bc62e73f36f | 2025-11-18 | Warnings | 362O9ITL9D |
| MIDOL COMPLETE | ACETAMINOPHEN, CAFFEINE, AND PYRILAMINE MALEATE | R J General Corporation | 0c09a178-1a07-4079-b4a6-d1657cb8e714 | 2025-11-17 | Warnings | 3G6A5W338E 362O9ITL9D |
| Alka-Seltzer Plus Severe Cold and Flu PowerFast Fizz | CHLORPHENIRAMINE MALEATE, ACETAMINOPHEN, PHENYLEPHRINE HYDROCHLORIDE, DEXTROMETHORPHAN HYDROBROMIDE | R J General Corporation | d786ae07-ce57-44c7-9ba5-f4c87df115de | 2025-11-17 | Warnings | 362O9ITL9D |
| TYLENOL COLD AND FLU | ACETAMINPHEN | R J General Corporation | b618877b-9dbc-4ba2-be2c-bf1922c646cc | 2025-11-17 | Warnings | 362O9ITL9D |
| TYLENOL SINUS SEVERE | ACETAMINOPHEN | R J General Corporation | 2cbf7954-b28f-4d7b-b142-6c6c5c58b25d | 2025-11-17 | Warnings | 362O9ITL9D |
| TYLENOL EXTRA STRENGTH | ACETAMINOPHEN | R J General Corporation | 99e45e83-37a3-44df-9a2a-98ba7457a5bb | 2025-11-17 | Warnings | 362O9ITL9D |
| TYLENOL PM EXTRA STRENGTH | ACETAMINOPHEN | R J General Corporation | a40ea0e3-d666-4605-b5e0-beeaf8f586f2 | 2025-11-17 | Warnings | 362O9ITL9D |
| Acetaminophen 250 mg and Ibuprofen 125 mg | ACETAMINOPHEN 250 MG AND IBUPROFEN 125 MG | R J General Corporation | 68d3be55-9340-4cc9-a05a-12b9338ddc56 | 2025-11-17 | Warnings | 362O9ITL9D |
Reported adverse events (FAERS/openFDA)#
Adverse event summaries are temporarily unavailable. Other product information remains available.