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 |
|---|---|---|---|---|---|---|
| Topcare Pain Relief | ACETAMINOPHEN | Sixarp, LLC | 2e20be17-2b6c-1a07-e063-6394a90acdd3 | 2025-08-25 | Warnings | 362O9ITL9D |
| Pain Reliever PM Extra Strength | ACETAMINOPHEN, DIPHENHYDRAMINE HCL | Strategic Sourcing Services LLC | 997eb228-09cb-47ad-acbb-363b05c67635 | 2025-08-25 | Warnings | 362O9ITL9D |
| SanaTos Multi Symptom | ACETAMINOPHEN, DEXTROMETHORPHAN HBR, GUAIFENESIN, PHENYLEPHRINE HCI | Pharmadel LLC | df260190-89e7-b338-e053-2995a90a32cb | 2025-08-22 | Warnings | 362O9ITL9D |
| Hydrocodone Bitartrate and Acetaminophen | HYDROCODONE BITARTRATE AND ACETAMINOPHEN | Camber Pharmaceuticals, Inc. | ed6af366-753c-4f3b-a6a2-c9a183c50035 | 2025-08-21 | Boxed warning, Warnings, Adverse reactions | 362O9ITL9D |
| Severe Cold Daytime | ACETAMINOPHEN, DEXTROMETHORPHAN HBR, GUAIFENESIN, PHENYLEPHRINE HCL | CVS Pharmacy | 258d27a9-fea6-4076-8dfa-77c7e982d250 | 2025-08-20 | Warnings | 362O9ITL9D |
| Aurum Hypericum | AURUM HYPERICUM | Uriel Pharmacy Inc. | 0c3ed6fe-8dce-0496-e063-6394a90add56 | 2025-08-19 | Warnings | ETJ7Z6XBU4 |
| Fungus Fighter | CANDIDA ALBICANS, SANICULA, TELLURIUM METALLICUM, TORULA CEREVISIAE, ANTIMON. CRUD., ARSENICUM ALB., BARYTA CARB., BRYONIA, CALC. CARB., CARBO VEG., CUPRUM MET., DULCAMARA, GRAPHITES, KALI CARB., LACHESIS, LYCOPODIUM, MEZEREUM, NITRICUM AC., PHOSPHORUS, PHYTOLACCA, SEPIA, SILICEA, SULPHUR, SULPHURICUM AC., ZINC. MET., APIS MEL., THUJA OCC. | Newton Laboratories, Inc. | 93e05175-001b-c639-e053-2a95a90a289c | 2025-08-19 | Warnings | ETJ7Z6XBU4 |
| Fungus Fighter | CANDIDA ALBICANS, SANICULA, TELLURIUM METALLICUM, TORULA CEREVISIAE, ANTIMON. CRUD., ARSENICUM ALB., BARYTA CARB., BRYONIA, CALC. CARB., CARBO VEG., CUPRUM MET., DULCAMARA, GRAPHITES, KALI CARB., LACHESIS, LYCOPODIUM, MEZEREUM, NITRICUM AC., PHOSPHORUS, PHYTOLACCA, SEPIA, SILICEA, SULPHUR, SULPHURICUM AC., ZINC. MET., APIS MEL., THUJA OCC. | Newton Laboratories, Inc. | 9b4276af-b738-3293-e053-2a95a90ad022 | 2025-08-19 | Warnings | ETJ7Z6XBU4 |
| Daytime Cold and Flu Non Drowsy | ACETAMINOPHEN, DEXTROMETHORPHAN HBR, PHENYLEPHRINE HCL | Rite Aid Corporation | 09bd88ec-ff84-4640-b561-243fda727043 | 2025-08-19 | Warnings | 362O9ITL9D |
| pain relief | ACETAMINOPHEN | Publix Super Markets Inc | 6b691dc1-09e4-46d3-b199-8917e42848a6 | 2025-08-19 | Warnings | 362O9ITL9D |
| Night Time Cold and Flu Relief Multi Symptom | ACETAMINOPHEN, DEXTROMETHORPHAN HBR, DOXYLAMINE SUCCINATE | Rite Aid Corporation | 28785677-2e80-4d6e-8997-bf5ac2ffb5a2 | 2025-08-18 | Warnings | 362O9ITL9D |
| Pain Relief Extra Strength | ACETAMINOPHEN | P & L Development, LLC | 59eb14a5-40b0-4331-beb5-7166e6cdf411 | 2025-08-18 | Warnings | 362O9ITL9D |
| ACTIDOGESIC | DEXBROMPHENIRAMINE MALEATE, ACETAMINOPHEN | ACTIPHARMA, LLC | 697da3f9-9888-4d41-ba83-87ca9bf1e54b | 2025-08-18 | Warnings | 362O9ITL9D |
| Acetaminophen | ACETAMINOPHEN | PAI Holdings, LLC dba PAI Pharma | caf5daea-409e-5dd2-e053-2995a90acb12 | 2025-08-18 | Warnings | 362O9ITL9D |
| Night Time Cold and Flu Relief Multi Symptom | ACETAMINOPHEN, DEXTROMETHORPHAN HBR, DOXYLAMINE SUCCINATE | Rite Aid Corporation | 5f9c9c48-4e8f-4ace-a6fb-1c1bccaf02a0 | 2025-08-18 | Warnings | 362O9ITL9D |
| Acetaminophen | ACETAMINOPHEN | Hikma Pharmaceuticals USA Inc. | 88c29438-3648-4b09-bd43-70ad7a35bcb5 | 2025-08-18 | Boxed warning, Warnings, Adverse reactions | 362O9ITL9D |
| ACETAMINOPHEN AND CODEINE PHOSPHATE | ACETAMINOPHEN AND CODEINE PHOSPHATE | Asclemed USA, Inc. | 682ef287-647a-4d89-9bbf-75907ebd10f2 | 2025-08-17 | Boxed warning, Warnings, Adverse reactions | 362O9ITL9D |
| Nighttime Cold and Flu | ACETAMINOPHEN, DEXTROMETHORPHAN HYDROBROMIDE, DOXYLAMINE SUCCINATE | Rite Aid Corporation | 25bf4390-23f7-4bb6-b86e-c40eaf8d92da | 2025-08-15 | Warnings | 362O9ITL9D |
| Schuessler Tissue Salts Comb D Skin Disorders | KALI MURIATICUM,KALI SULPHURICUM,CALCAREA SULPHURICA,SILICEA | Martin & Pleasance Pty Ltd | 617303f8-4463-4a1e-a502-44abc181d91f | 2025-08-13 | Warnings | ETJ7Z6XBU4 |
| Schuessler Tissue Salts Comb D Skin Disorders | KALI MURIATICUM,KALI SULPHURICUM,CALCAREA SULPHURICA,SILICEA | Martin & Pleasance Pty Ltd | 03153d92-dc68-4b84-a8c9-634b1ffd7da1 | 2025-08-13 | Warnings | ETJ7Z6XBU4 |
Reported adverse events (FAERS/openFDA)#
Adverse event summaries are temporarily unavailable. Other product information remains available.