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 |
|---|---|---|---|---|---|---|
| Lymph-Tone II | AESCULUS HIPP, AZADIRACHTA, BARYTA CARB, BERBER VULG, BOLDO, BUFO, CALC CARB, CALC PHOS, COENZYME A, COLLINSONIA, ECHINACEA, FERRUM PHOS, GLANDULA SUPRARENALIS SUIS, HYPOTHALAMUS, KREOSOTUM, NADIDUM, NAT MUR, PHOS, PHYTOLACCA, PINUS SYL, PITUITARUM POSTERIUM, PIX LIQUIDA, PULSATILLA, SILICEA, STILLINGIA, THUJA OCC. | Energetix Corporation | c46aa8d3-4aa5-4e07-be3d-d71abc5e2407 | 2026-08-11 | Warnings | ETJ7Z6XBU4 |
| Lymph-Tone III | ADENOSINUM CYCLOPHOSPHORICUM, ARNICA, BOLDO, CALC IOD, CALENDULA, CARTILAGO SUIS, CEANOTHUS, COENZYME A, ECHINACEA, HAMAMELIS, HEPAR SULPH CALC, HYPOTHALAMUS, NADIDUM, NAJA, NAT SULPHURICUM, PHASEOLUS, PHOS, PHYTOLACCA, PINUS SYL, PITUITARUM POSTERIUM, PYROGENIUM, SILICEA, SULPHUR, THUJA OCC, THYROIDINUM, VISCUM | Energetix Corporation | 4c9ae54c-ce7d-4276-add7-2922a8f0e310 | 2026-08-11 | Warnings | ETJ7Z6XBU4 |
| Metabopath | ADENOSINUM CYCLOPHOSPHORICUM, ADENOSINUM TRIPHOSPHORICUM DINATRUM, ALPHA-KETOGLUTARICUM ACIDUM, BERBERIS VULGARIS, CITRICUM ACIDUM, COENZYME A, DNA, FUMARICUM ACIDUM, GLYCYRRHIZA GLABRA, HEPAR SULPHURIS CALCAREUM, LAPPA MAJOR, MAGNESIA PHOSPHORICA, MANGANUM ACETICUM, NADIDUM, NATRUM MURIATICUM, NATRUM OXALACETICUM, NATRUM PYRUVICUM, NICOTINAMIDUM, PULSATILLA, PYRIDOXINUM HYDROCHLORICUM, RHAMNUS PURSHIANA, RIBOFLAVINUM, RNA, SILICEA, SUCCINICUM ACIDUM, SULPHUR, THIAMINUM HYDROCHLORICUM, | Energetix Corporation | 58bfe670-d308-45a2-8046-7897b6221452 | 2026-08-11 | Warnings | ETJ7Z6XBU4 |
| Vac-Chord | ALUMINA, ARSENICUM ALBUM, BAPTISIA TINCTORIA, BELLADONNA, BOLDO, CALCAREA CARBONICA, CARDUUS MARIANUS, CHAMOMILLA, CHELIDONIUM MAJUS, ECHINACEA, HYDRASTIS CANADENSIS, LECITHIN, LEDUM PALUSTRE, LYCOPODIUM CLAVATUM, MERCURIUS SOLUBILIS, MORBILLINUM, PERTUSSINUM, PHYTOLACCA DECANDRA, PYROGENIUM, RHUS TOX, SILICEA, SULPHUR, TARAXACUM OFFICINALE, THUJA OCCIDENTALIS, THYROIDINUM. | Energetix Corporation | 880ea1e6-8d4d-486e-9a8f-9d3158a99667 | 2026-08-11 | Warnings | ETJ7Z6XBU4 |
| Tox-Chord | ALFALFA, ALUMINA, BENZOICUM AC, CARBONEUM, CETRARIA, FOLLICULINUM, FUCUS, FUMARICUM AC, HEPAR SUIS, KALI CARB, KREOSOTUM, NAT MUR, PARAFFINUM, PETROLEUM, PHOSPHORICUM AC, PHOS, PIX LIQUIDA, PLANTAGO, PLUMB MET, PULSATILLA, RADIUM BROM, RESORCINUM, SALOL, SILICEA, SYMPHYTUM, TABACUM, TEREBINTHINA, THYROIDINUM, TRITICUM, ZINC OXYD. | Energetix Corporation | b06b4794-e5bb-4ccd-87fd-37afca7b0f98 | 2026-08-11 | Warnings | ETJ7Z6XBU4 |
| Thyro-Chord | HOMEOPATHIC LIQUID | Energetix Corporation | 6655b504-dfa8-46df-9d3a-b7fa4078207e | 2026-08-11 | Warnings | ETJ7Z6XBU4 |
| Para-Chord | HOMEOPATHIC LIQUID | Energetix Corporation | 9f8f646e-634a-47ff-b208-b2249d685e55 | 2026-08-11 | Warnings | ETJ7Z6XBU4 |
| MycoCan-Chord | ALUMINA, AVENA SATIVA, BORAX, CANDIDA ALBICANS, CARBOLICUM ACIDUM, CEANOTHUS AMERICANUS, ECHINACEA, GAULTHERIA PROCUMBENS, GLANDULA SUPRARENALIS SUIS, HYDRASTIS CANADENSIS, LINUM USITATISSIMUM, LITHIUM CARBONICUM, MEDULLA OSSIS SUIS, NATRUM MURIATICUM, PHOSPHORICUM ACIDUM, PHYTOLACCA DECANDRA, SARCOLACTICUM ACIDUM, SEPIA, SILICEA, SOLIDAGO VIRGAUREA, TELLURIUM METALLICUM, TEUCRIUM MARUM, ZINCUM METALLICUM | Energetix Corporation | 227199f8-a45e-44ff-892d-ade4fefea354 | 2026-08-11 | Warnings | ETJ7Z6XBU4 |
| Daytime Cold and Flu mini Softgels | ACETAMINOPHEN, DEXTROMETHORPHAN HBR, PHENYLEPHRINE HCL | Shield Pharmaceuticals Corp | eff114fe-fb15-48dd-b673-4d4d66406e69 | 2026-08-10 | Warnings | 362O9ITL9D |
| GenCare Headache Relief | ACETAMINOPHEN, ASPIRIN, CAFFEINE | Pioneer Life Sciences, LLC | ac8c4bdf-30c9-2b09-e053-2a95a90a9b67 | 2026-08-09 | Warnings | 3G6A5W338E 362O9ITL9D |
| WINCO Maximum StrengthCold Flu and Sore Throat | ACETAMINOPHEN, DEXTROMETHORPHAN HBR, GUAIFENESIN, PHENYLEPHRINE HCL | WINCO FOODS, LLC | f34bfb71-2c81-44d0-a2a0-4d320c43c217 | 2026-08-07 | Warnings | 362O9ITL9D |
| Severe Cold and Cough Daytime | ACETAMINOPHEN, DEXTROMETHORPHAN, PHENYLEPHRINE | WinCo Foods, LLC | 790d534a-0f40-495b-a815-67851ac3d20d | 2026-08-07 | Warnings | 362O9ITL9D |
| berkley and jensen acetaminophen | ACETAMINOPHEN | BJWC | dee57d73-73ac-48bb-b1da-9971f1ff21c4 | 2026-08-07 | Warnings | 362O9ITL9D |
| Sinus PE Pressure plus Pain MAXIMUM STRENGTH | ACETAMINOPHEN, PHENYLEPHRINE HCL | CVS Pharmacy | a3b073b4-494c-4531-b08e-475c86ba321d | 2026-08-07 | Warnings | 362O9ITL9D |
| Severe Cold and Cough Nighttime | ACETAMINOPHEN, DIPHENHYDRAMINE, PHENYLEPHRINE | WinCo Foods, LLC | dc56197c-c108-4b35-b791-dde5c3384ddd | 2026-08-07 | Warnings | 362O9ITL9D |
| Sinus Severe Non Drowsy, Daytime | ACETAMINOPHEN, GUAIFENESIN, PHENYLEPHRINE HCL | Meijer Distribution, Inc. | 84c30ec9-a7b5-4d2f-95b2-d6fb895945de | 2026-08-07 | Warnings | 362O9ITL9D |
| Pain Reliever PM Extra Strength | ACETAMINOPHEN, DIPHENHYDRAMINE HCL | Salado Sales, Inc. | aef30709-f33d-48ff-b2d4-0639ffbd1ffd | 2026-08-07 | Warnings | 362O9ITL9D |
| Allergy Multi-Symptom | ACETAMINOPHEN, CHLORPHENIRAMINE MALEATE AND PHENYLEPHRINE HCL | ARMY AND AIR FORCE EXCHANGE SERVICE | f311b56f-b959-4070-9b23-82c642dd98b8 | 2026-08-06 | Warnings | 362O9ITL9D |
| Nalocet | OXYCODONE AND ACETAMINOPHEN | Forte Bio-Pharma LLC | f5f7dfca-a5c7-4445-8a5e-9ec62f33f5be | 2026-08-06 | Boxed warning, Warnings, Adverse reactions | 362O9ITL9D |
| butalbital and acetaminophen | BUTALBITAL AND ACETAMINOPHEN | Par Health | e619b656-4123-4878-b601-b0edad3c428b | 2026-08-06 | Boxed warning, Warnings, Adverse reactions | KHS0AZ4JVK 362O9ITL9D |
Reported adverse events (FAERS/openFDA)#
Adverse event summaries are temporarily unavailable. Other product information remains available.