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 |
|---|---|---|---|---|---|---|
| Excedrin Extra Strength Headache | ACETAMINOPHEN, ASPIRIN (NSAID), CAFFEINE | R J General Corporation | 907c89e7-2482-465f-9f85-2381ecab1b86 | 2025-11-17 | Warnings | 3G6A5W338E 362O9ITL9D |
| Theraflu Severe Cold Relief Daytime | ACETAMINOPHEN, DEXTROMETHORPHAN HBR | R J General Corporation | 8f0e4876-6bf0-4f6d-9cf0-f2aef2682ffc | 2025-11-17 | Warnings | 362O9ITL9D |
| EXTRA STRENGTH PAIN RELIEVER | ACETAMINOPHEN, ASPIRIN AND CAFFEINE | Geri-Care Pharmaceutical Corp | b670a898-2360-76e2-e053-2a95a90a3380 | 2025-11-17 | Warnings | 3G6A5W338E 362O9ITL9D |
| Formica Stibium comp. | FORMICA STIBIUM COMP. | Uriel Pharmacy Inc. | 439073f2-1dee-4b4e-a65e-74aee1c73c2b | 2025-11-17 | Warnings | ETJ7Z6XBU4 |
| Lavender Quartz Ear Oil | LAVENDER QUARTZ EAR OIL | Uriel Pharmacy Inc. | b1a8d75c-77a9-40a7-8dd8-9c32cac31d2c | 2025-11-17 | Warnings | ETJ7Z6XBU4 |
| Polygonatum Cepa | POLYGONATUM CEPA | Uriel Pharmacy Inc. | 6ba0ac36-16cc-49bd-b37f-90cf18acbd5a | 2025-11-17 | Warnings | ETJ7Z6XBU4 |
| Multi-Symptom Flu HBP | ACETAMINOPHEN, CHLORPHENIRAMINE MALEATE, DEXTROMETHORPHAN HBR | CVS WOONSOCKET PRESCRIPTION CENTER, INCORPORATED | 50f3157b-5788-4b63-835a-e60c8dc33df9 | 2025-11-17 | Warnings | 362O9ITL9D |
| Tramadol Hydrochloride and Acetaminophen | TRAMADOL HYDROCHLORIDE AND ACETAMINOPHEN | Aurobindo Pharma Limited | 6c2894df-eeeb-4b22-ab32-8ce1601bfdfa | 2025-11-17 | Boxed warning, Warnings, Adverse reactions | 362O9ITL9D |
| Pain Reliever PM | ACETAMINOPHEN, DIPHENHYDRAMINE HCL | L.N.K. International, Inc. | ec902e52-0f48-4a61-b67d-17e1c1461619 | 2025-11-15 | Warnings | 362O9ITL9D |
| Menstrual Complete | ACETAMINOPHEN, CAFFEINE, PYRILAMINE MALEATE | Chain Drug Marketing Association, Inc. | 5f8f9644-48c5-4556-a0a4-7bdc9a629daa | 2025-11-15 | Warnings | 3G6A5W338E 362O9ITL9D |
| Sinus Pressure, Pain and Cough | ACETAMINOPHEN, DEXTROMETHORPHAN HBR, GUAIFENESIN, PHENYLEPHRINE HCL | Meijer Distribution, Inc. | f701a6ae-200d-48dc-94e4-6bd3228f50d4 | 2025-11-15 | Warnings | 362O9ITL9D |
| Cold and Flu Severe | ACETAMINOPHEN, DEXTROMETHORPHAN HBR, GUAIFENESIN, PHENYLEPHRINE HCL | Rite Aid Corporation | 1affbef6-dd27-40c2-a5d3-b121aa62496a | 2025-11-15 | Warnings | 362O9ITL9D |
| Pain Reliever Extra Strength | ACETAMINOPHEN | L.N.K. International, Inc. | 72babe91-2586-4f05-ae90-6debfd23aa5d | 2025-11-15 | Warnings | 362O9ITL9D |
| Childrens Pain and Fever | ACETAMINOPHEN | Walgreen Company | a482e715-bec0-44a4-bb0e-ea5f5fda558e | 2025-11-15 | Warnings | 362O9ITL9D |
| Acetaminophen PM Extra Strength | ACETAMINOPHEN, DIPHENHYDRAMINE HCL | ARMY AND AIR FORCE EXCHANGE SERVICE | f1157dbc-d86c-4554-954c-60a74674ff6b | 2025-11-15 | Warnings | 362O9ITL9D |
| Bambusa Viscum Stannum | BAMBUSA VISCUM STANNUM | Uriel Pharmacy Inc. | 7b2a95d0-6f51-4a6b-b05f-fe7d13d83b89 | 2025-11-14 | Warnings | ETJ7Z6XBU4 |
| Earthmed Uplift Chewable Orange | CAFFEINE | Earthmed LLC | 43958b2a-c2cd-bbf9-e063-6294a90a66d9 | 2025-11-14 | Warnings | 3G6A5W338E |
| equate vapor ice cold and flu | ACETAMINOPHEN, DEXTROMETHORPHAN HYDROBROMIDE, DOXYLAMINE SUCCINATE, PHENYLEPHRINE HYDROCHLORIDE | Wal-Mart Stores Inc | b2c0692c-ed0b-4fcf-b88d-59a788b124c6 | 2025-11-14 | Warnings | 362O9ITL9D |
| Acetaminophen, Aspirin, Caffeine | ACETAMINOPHEN, ASPIRIN, CAFFEINE | NuCare Pharmaceuticals,Inc. | 437e4fd9-c7d9-77d6-e063-6294a90a22b7 | 2025-11-13 | Warnings | 3G6A5W338E 362O9ITL9D |
| Theraflu Severe Cold Relief Nighttime | ACETAMINOPHEN, DIPHENHYDRAMINE HCL | Haleon US Holdings LLC | c24b9489-208c-472b-8ae5-c6e86c12e04d | 2025-11-13 | Warnings | 362O9ITL9D |
Reported adverse events (FAERS/openFDA)#
Adverse event summaries are temporarily unavailable. Other product information remains available.