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 plus Sleep Aid NightTime | ACETAMINOPHEN, DIPHENHYDRAMINE HCL | Kroger Company | 286ca3b3-2ecc-4f90-adb5-d7bc0ba0b4d0 | 2026-04-02 | Warnings | 362O9ITL9D |
| Sinus Defense | 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 | 9c2f51c5-aa41-414e-a966-32e02e9e79a2 | 2026-04-02 | Warnings | ETJ7Z6XBU4 |
| Chewable Acetaminophen Childrens | ACETAMINOPHEN | Cardinal Health 110, LLC. DBA Leader | 8a18565c-b84e-43f8-8e96-e1dbcc39f08b | 2026-04-02 | Warnings | 362O9ITL9D |
| Childrens Pain Reliever | ACETAMINOPHEN | H E B | c713556c-cb9e-4ed2-bc2f-49b3d6256c0f | 2026-04-02 | Warnings | 362O9ITL9D |
| Cold and Flu | ACETAMINOPHEN, DEXTROMETHORPHAN HBR, PHENYLEPHRINE HCL | Lidl US LLC | 7227b330-590b-4731-8a58-e05a0233dd8a | 2026-04-01 | Warnings | 362O9ITL9D |
| menstrual pain relief maximum strength | ACETAMINOPHEN, PAMABROM, PYRILAMINE MALEATE | Rite Aid Corporation | 4a4ce4cd-1554-4772-a6f4-8f7830544949 | 2026-04-01 | Warnings | 362O9ITL9D |
| Sanatos Daytime Relief | ACETAMINOPHEN, DEXTROMETHORPHAN HBR, PHENYLEPHRINE HCL | Pharmadel LLC | 4c26be18-733a-e4a8-e063-6294a90a8b02 | 2026-04-01 | Warnings | 362O9ITL9D |
| Sanatos Nighttime Relief | ACETAMINOPHEN, DEXTROMETHORPHAN HBR, DOXYLAMINE SUCCINATE | Pharmadel LLC | 4c26c8bf-0143-ddca-e063-6294a90a3552 | 2026-04-01 | Warnings | 362O9ITL9D |
| 5% Minoxidil Hair Growth Serum | 5% MINOXIDIL HAIR GROWTH SERUM | Guangzhou Ariel Biotech Co., Ltd. | 4e71babd-d113-3b7f-e063-6294a90af805 | 2026-04-01 | Warnings | 3G6A5W338E |
| Head and Cold | ACETAMINOPHEN, GUAIFENESIN, DEXTROMETHORPHAN HBR, PHENYLEPHRINE HCL | Hi-Tech Nutraceuticals, LLC | a39c772b-3cce-14cb-e053-2a95a90a733b | 2026-03-31 | Warnings | 362O9ITL9D |
| Tension Headache Relief | ACETAMINOPHEN, CAFFEINE | Hi-Tech Nutraceuticals, LLC | b119ba37-0ee3-851a-e053-2995a90a85b1 | 2026-03-31 | Warnings | 3G6A5W338E 362O9ITL9D |
| Acne HP | CARBO ANIMALIS, CARBO VEGETABILIS, KALI BICHROMICUM, NATRUM MURIATICUM, PULSATILLA (VULGARIS), SEPIA, SILICEA, SULPHUR, ZINCUM METALLICUM | BioActive Nutritional, Inc. | 2ab4ff53-4274-40c7-b05c-44d918d809be | 2026-03-31 | Warnings | ETJ7Z6XBU4 |
| Flu HBP Maximum Strength | ACETAMINOPHEN, CHLORPHENIRAMINE MALEATE, DEXTROMETHORPHAN HBR | Cardinal Health 110, LLC. DBA Leader | ba174fcc-da1e-420c-bf9c-179ad65c2848 | 2026-03-31 | Warnings | 362O9ITL9D |
| Lymphoplex | MYRRHA, TRIGONELLA FOENUM-GRAECUM, PINUS SYLVESTRIS, LYMPH (SUIS), SPLEEN (SUIS), CONIUM MACULATUM, ECHINACEA (ANGUSTIFOLIA), HEPAR SULPHURIS CALCAREUM, HYDRANGEA ARBORESCENS, PHYTOLACCA DECANDRA, SILICEA | BioActive Nutritional, Inc. | 624f35db-291e-4e7f-a2c9-ae319717157a | 2026-03-30 | Warnings | ETJ7Z6XBU4 |
| Equisetum Silicea | EQUISETUM SILICEA | Uriel Pharmacy Inc. | e88b820b-4a07-42e2-8fe2-b30729e91a8c | 2026-03-30 | Warnings | ETJ7Z6XBU4 |
| Dr. Simi Daytime Cold and Flu | ACETAMINOPHEN 325 MG, DEXTROMETHORPHAN HBR 10 MG, PHENYLEPHRINE HCL 5 MG | Farmacias De Similares TX LLC | 4e448fd0-cb6b-b69b-e063-6394a90afde8 | 2026-03-30 | Warnings | 362O9ITL9D |
| Dr. Simi Nighttime Cold and Flu | ACETAMINOPHEN 325 MG, DEXTROMETHORPHAN HBR 15 MG, DOXYLAMINE SUCCINATE 6.25 MG | Farmacias De Similares TX LLC | 4e5772ee-586c-6191-e063-6294a90a132d | 2026-03-30 | Warnings | 362O9ITL9D |
| B Force HP | APIS MELLIFICA, ARSENICUM ALBUM, BELLADONNA, CHAMOMILLA, LACHESIS MUTUS, MERCURIUS SOLUBILIS, PULSATILLA (PRATENSIS), RHUS TOX, SILICEA | BioActive Nutritional, Inc. | 811c6f32-fcad-464c-bcf6-ae6a59195b1c | 2026-03-30 | Warnings | ETJ7Z6XBU4 |
| Good Sense Pain and Fever | ACETAMINOPHEN | Preferred Pharmaceuticals Inc. | 7dbd0a2d-8597-4010-bfe2-94a8d145ca57 | 2026-03-27 | Warnings | 362O9ITL9D |
| Lymphdrainex | GERANIUM ROBERTIANUM, NASTURTIUM AQUATICUM, TEUCRIUM SCORODONIA, EQUISETUM HYEMALE, FUMARIA OFFICINALIS, NATRUM SULPHURICUM, PHYTOLACCA DECANDRA, PINUS SYLVESTRIS, VERONICA OFFICINALIS, BAPTISIA TINCTORIA, GALIUM APARINE, GENTIANA LUTEA, APIS MELLIFICA, SARSAPARILLA (SMILAX REGELII), BARYTA CARBONICA, HEPAR SULPHURIS CALCAREUM, MERCURIUS CYANATUS, SCROPHULARIA NODOSA, ALOE, FERRUM IODATUM, MYOSOTIS ARVENSIS, ARANEA DIADEMA, CALCAREA PHOSPHORICA, JUGLANS REGIA, PARATHYROID GLAND (BOVINE), SILICEA, | Energique, Inc. | c512f211-f4f8-46f6-87ed-dd50287359df | 2026-03-27 | Warnings | ETJ7Z6XBU4 |
Reported adverse events (FAERS/openFDA)#
Adverse event summaries are temporarily unavailable. Other product information remains available.