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 |
|---|---|---|---|---|---|---|
| Oxycodone/APAP | OXYCODONE/APAP | Direct_Rx | e84245ca-957f-e85b-e053-2a95a90a836b | 2026-03-05 | Boxed warning, Warnings, Adverse reactions | 362O9ITL9D |
| Osteoplex | EQUISETUM HYEMALE, MAGNESIA MURIATICA, ASCORBICUM ACIDUM, MANGANUM MURIATICUM, SYMPHYTUM OFFICINALE, MEDULLA OSSIS SUIS, CALCAREA FLUORICA, CALCAREA PHOSPHORICA, SILICEA, PARATHYROID GLAND (SUIS), LIGAMENT (SUIS) | BioActive Nutritional, Inc. | 8a7e1397-a387-4f2c-ab4f-7f1a7f1a849b | 2026-03-05 | Warnings | ETJ7Z6XBU4 |
| Respiforce A-HP | ARSENICUM ALBUM, BELLADONNA, IPECACUANHA, KALI CARBONICUM, LOBELIA INFLATA, NATRUM SULPHURICUM, SILICEA | BioActive Nutritional, Inc. | ebf5f0c7-e7a4-45fe-acfd-52c46a8d789c | 2026-03-05 | Warnings | ETJ7Z6XBU4 |
| Sinus Defense 2.0 | LAC VACCINUM, SILICEA, ASPERGILLUS NIGER, BABESIA MICROTI, BORRELIA BURGDORFERI, CANDIDA ALBICANS, CANDIDA PARAPSILOSIS, CHLAMYDIA TRACHOMATIS, COLIBACILLINUM CUM NATRUM MURIATICUM, CYTOMEGALOVIRUS NOSODE, EHRLICHIA NOSODE, HERPES SIMPLEX I AND II NOSODE, HUMAN PAPILLOMA NOSODE, KLEBSIELLA PNEUMONIAE, MUCOR RACEMOSUS, MYCOBACTERIUM PARATUBERCULOSIS, PNEUMOCCOCCINUM, STAPHYLOCOCCUS AUREUS, STREPTOCOCCUS VIRIDANS, EPSTEIN-BARR VIRUS NOSODE, HERPES ZOSTER NOSODE | Micro Balance Health Products LLC | 560f84f6-2544-4ba8-8236-a95906eb7d97 | 2026-03-04 | Warnings | ETJ7Z6XBU4 |
| Cold and Flu Nighttime | ACETAMINOPHEN, DEXTROMETHORPHAN HBR, DOXYLAMINE SUCCINATE | Best Choice (Valu Merchandisers Company) | d1131759-dd2e-4c06-bb73-92dd975f5511 | 2026-03-04 | Warnings | 362O9ITL9D |
| Snore Control | BROMIUM, CHAMOMILLA, CINCHONA, CUPRUM METALLICUM, HELLEBORUS NIGER, HISTAMINUM HYDROCHLORICUM, HYDRASTIS CANADENSIS, KALI BICHROMICUM, LAUROCERASUS, NUX VOMICA, PHOSPHORICUM ACIDUM, RHUS TOX, SILICEA, STRAMONIUM, SULPHUR AND ZINCUM METALLICUM. | King Bio Inc. | 704bb574-6c54-49d1-bdae-81ffe0e79d10 | 2026-03-04 | Warnings | ETJ7Z6XBU4 |
| Cold and Flu | ACETAMINOPHEN, DEXTROMETHORPHAN HBR, PHENYLEPHRINE HCL | Walgreen Company | c5cb09d4-c049-461c-8898-2c5bb6a8a138 | 2026-03-04 | Warnings | 362O9ITL9D |
| DayTime | ACETAMINOPHEN, DEXTROMETHORPHAN HBR, PHENYLEPHRINE HCL | H E B | e2994c0f-add8-4f75-a6d2-24cd2af271e4 | 2026-03-03 | Warnings | 362O9ITL9D |
| NIGHTTIME CHERRY COLD AND FLU | ACETAMINOPHEN, DEXTROMETHORPHAN HYDROBROMIDE, AND DOXYLAMINE SUCCINATE | BETTER LIVING BRANDS LLC. | 36924420-f514-4225-e063-6294a90a330c | 2026-03-03 | Warnings | 362O9ITL9D |
| Infants Pain and Fever | ACETAMINOPHEN | Kroger | 41e149df-4140-95cc-e063-6294a90a866b | 2026-03-03 | Warnings | 362O9ITL9D |
| Hydrocodone Bitartrate and Acetaminophen | HYDROCODONE BITARTRATE AND ACETAMINOPHEN | Redpharm Drug | 46c13d54-b181-4da2-e063-6294a90ab5c5 | 2026-03-03 | Boxed warning, Warnings, Adverse reactions | 362O9ITL9D |
| foster and thrive nighttime cold and flu relief | ACETAMINOPHEN, DEXTROMETHORPHAN HYDROBROMIDE, DOXYLAMINE SUCCINATE | Sportpharm LLC | 7bdfd2ef-bb99-41f5-97ae-3a02c994bddd | 2026-03-03 | Warnings | 362O9ITL9D |
| Medique at Home Decorel Forte | ACETAMINOPHEN, DEXTROMETHORPHAN HYDROBROMIDE, GUAIFENESIN, PHENYLEPHRINE HYDROCHLORIDE | Sportpharm LLC | d27b5976-8cc0-4d99-96f6-9069b786affd | 2026-03-03 | Warnings | 362O9ITL9D |
| Medique Pain Off | ACETAMINOPHEN, ASPIRIN, CAFFEINE | Sportpharm LLC | 2b35acdc-ff88-46e6-a108-5240aac1d53f | 2026-03-03 | Warnings | 3G6A5W338E 362O9ITL9D |
| Childrens Pain and Fever | ACETAMINOPHEN | Best Choice (Valu Merchandisers Company) | a8a0d9a5-1a36-4ed2-ae9c-7e1a3d674c07 | 2026-03-03 | Warnings | 362O9ITL9D |
| CVS PHARMACY Nighttime MS Flu Relief | ACETAMINOPHEN, CHLORPHENIRAMINE MALEATE AND DEXTROMETHOPHAN HBR | CVS PHARMACY | 23cafaa1-34fe-4cef-960b-5f664ea32cb4 | 2026-02-27 | Warnings | 362O9ITL9D |
| pain relief | ACETAMINOPHEN | HyVee Inc | 6820a515-4004-407b-969b-c4069dc0c3b5 | 2026-02-26 | Warnings | 362O9ITL9D |
| migraine relief | ACETAMINOPHEN, ASPIRIN, CAFFEINE | CVS Pharmacy | e130831a-ec50-467a-9e5c-ba6ebc7bef3c | 2026-02-26 | Warnings | 3G6A5W338E 362O9ITL9D |
| 911 Adrenal Burnout and Fatigue | ACETICUM AC, ADRENALINUM, ADRENOCORTICOTROPHIN (30X), AESCULUS HIPPOCASTANUM, FLOS, ALFALFA, ALPHA-LIPOIC AC, AMBRA, ARG NIT, AVENA SATIVA, BRYONIA, CARBONEUM OXYGENISATUM, CARPINUS BETULUS, FLOS, DNA, FUMARICUM ACIDUM, GELSEMIUM SEMPERVIRENS, HEPAR SULPHURIS CALCAREUM, HYPOTHALAMUS, KALI PHOSPHORICUM, LACTICUM ACIDUM, LECITHIN, NATRUM MURIATICUM, OXALICUM ACIDUM, PHOSPHORICUM ACIDUM, PITUITARUM POSTERIUM, SARCOLACTICUM ACIDUM, SELENIUM METALLICUM, SEPIA, SILICEA, SUCCINICUM ACIDUM AND THYROIDINUM. | King Bio Inc. | 21c6b6c1-e846-4f25-a1dc-02e79d1be756 | 2026-02-26 | Warnings | ETJ7Z6XBU4 |
| Acetaminophen, Diphenhydramine Hydrochloride | ACETAMINOPHEN, DIPHENHYDRAMINE HYDROCHLORIDE | LEADER/ Cardinal Health 110, Inc. | 7be4d67e-1af9-f059-e053-2991aa0a382e | 2026-02-26 | Warnings | 362O9ITL9D |
Reported adverse events (FAERS/openFDA)#
Adverse event summaries are temporarily unavailable. Other product information remains available.