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 |
|---|---|---|---|---|---|---|
| Pain Reliever | ACETAMINOPHEN | Walgreen Company | 0b1bef50-7957-4ea1-9ae3-91f59ea2dbb4 | 2026-06-03 | Warnings | 362O9ITL9D |
| Pain Reliever PM | ACETAMINOPHEN, DIPHENHYDRAMINE HCL | WALMART INC. | 42310898-cf3a-4ffb-88bb-b8b84449156e | 2026-06-02 | Warnings | 362O9ITL9D |
| ALKA SELTZER COLD Cold and Flu plus Congestion Severe Fast Hot Liquid Night | ACETAMINOPHEN, DEXTROMETHORPHAN HYDROBROMIDE, DOXYLAMINE SUCCINATE, AND PHENYLEPHRINE HYDROCHLORIDE | Bayer HealthCare LLC. | 5349dbde-730c-610f-e063-6394a90a952a | 2026-06-02 | Warnings | 362O9ITL9D |
| GOOD NEIGHBOR PHARMACY MENSTRUAL PAIN RELIEF | ACETAMINOPHEN | Amerisource Bergen | ae07a064-fdbd-4bb4-8252-9c122bf3dd81 | 2026-06-02 | Warnings | 362O9ITL9D |
| PAIN RELIEF | ACETAMINOPHEN | Meijer, Inc. | 1319bab8-8f17-44fb-9d91-099b0ba38a8d | 2026-06-01 | Warnings | 362O9ITL9D |
| Pain Reliever PM | ACETAMINOPHEN, DIPHENHYDRAMINE HCL | Family Dollar (FAMILY WELLNESS) | 7a98d4d9-54e2-45c1-a76a-7f1907566e95 | 2026-06-01 | Warnings | 362O9ITL9D |
| BM Tooth Remineralization | CALC PHOS, CALC FLUOR, SILICEA | BM Private Limited | 5331dc40-2ac8-5fce-e063-6394a90a5875 | 2026-06-01 | Warnings | ETJ7Z6XBU4 |
| Period Pills by Biikay | ACETAMINOPHEN, IBUPROFEN | Kai Squared | 40d2ae73-82cf-3fa1-e063-6394a90a9ea2 | 2026-06-01 | Warnings | 362O9ITL9D |
| ALKA SELTZER COLD Cold Flu And Congestion Severe Fast Hot Liquid Day | ACETAMINOPHEN, DEXTROMETHORPHAN HYDROBROMIDE, GUAIFENESIN, AND PHENYLEPHRINE HYDROCHLORIDE | Bayer HealthCare LLC. | 53371691-2510-5039-e063-6394a90a6ea9 | 2026-06-01 | Warnings | 362O9ITL9D |
| ACETAMINOPHEN AND CODEINE PHOSPHATE | ACETAMINOPHEN AND CODEINE PHOSPHATE | St. Mary's Medical Park Pharmacy | eac5f350-93e5-4dc2-e053-2a95a90aed60 | 2026-06-01 | Boxed warning, Warnings, Adverse reactions | 362O9ITL9D |
| Extra Strength Acetaminophen | ACETAMINOPHEN | TIME CAP LABORATORIES, INC. | 58840cf4-aceb-c7cf-e063-6294a90a5ff4 | 2026-06-01 | Warnings | 362O9ITL9D |
| Cough and Runny Nose Childrens Plus | ACETAMINOPHEN, CHLORPHENIRAMINE MALEATE, DEXTROMETHORPHAN HYDROBROMIDE | TOP CARE (Topco Associates LLC) | 6f04bd51-093c-4624-aef3-0145ac387386 | 2026-06-01 | Warnings | 362O9ITL9D |
| night time | ACETAMINOPHEN, DEXTROMETHORPHAN HBR, DOXYLAMINE SUCCINATE | H E B | cf31538c-9eee-4c81-80cb-66eecabf0aff | 2026-06-01 | Warnings | 362O9ITL9D |
| Good Sense Pain Relief | ACETAMINOPHEN | L. Perrigo Company | cb5f6008-6884-402a-8a19-c8d585576d63 | 2026-06-01 | Warnings | 362O9ITL9D |
| Hydrocodone Bitartrate and Acetaminophen | HYDROCODONE BITARTRATE AND ACETAMINOPHEN | Bryant Ranch Prepack | 380ff458-d5d7-422e-ac96-e9a56ade16b6 | 2026-06-01 | Boxed warning, Warnings, Adverse reactions | 362O9ITL9D |
| Childrens Pain and Fever | ACETAMINOPHEN | CVS Pharmacy | 832acd72-1dda-4490-978f-5f31748942df | 2026-06-01 | Warnings | 362O9ITL9D |
| Acetaminophen PM | ACETAMINOPHEN, DIPHENHYDRAMINE HYDROCHLORIDE | Major Pharmaceuticals | 786dbcd5-f5c2-4491-e053-2991aa0a3437 | 2026-05-29 | Warnings | 362O9ITL9D |
| Cold and Flu Day | ACETAMINOPHEN, DEXTROMETHORPHAN HBR, PHENYLEPHRINE HCL | Walgreen Company | ebf8c82d-a653-4c02-893b-61704901acbb | 2026-05-29 | Warnings | 362O9ITL9D |
| Hydrocodone Bitartrate and Acetaminophen | HYDROCODONE BITARTRATE AND ACETAMINOPHEN | Rhodes Pharmaceuticals LLC | 1f9c1adc-f84f-43de-af5c-d93703aba7f8 | 2026-05-29 | Boxed warning, Warnings, Adverse reactions | 362O9ITL9D |
| Back and Body Extra Strength | ASPIRIN, CAFFEINE | Meijer Distribution Inc | e513f2d9-d591-4790-a117-6176ce2279dc | 2026-05-29 | Warnings | 3G6A5W338E |
Reported adverse events (FAERS/openFDA)#
Adverse event summaries are temporarily unavailable. Other product information remains available.