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 |
|---|---|---|---|---|---|---|
| Resilience | CEREBRUM SUIS, HYPOTHALAMUS SUIS, HYPOPHYSIS SUIS, SEROTONIN (HYDROCHLORIDE), NPY (NEUROPEPTIDE Y), CALCAREA CARBONICA, SILICEA, VERATRUM ALBUM, BLATTA AMERICANA, CACAO, DIOSPYROS KAKI, FORMICA RUFA, PALOONDO, SULPHUR, TAXUS BACCATA, TELA ARANEAE, SALIX VITELLINA, FLOS | Deseret Biologicals, Inc. | 3aa6c1e7-2bd9-4c2d-bfd4-63ffb7c62e9c | 2026-02-26 | Warnings | ETJ7Z6XBU4 |
| Acetaminophen | ACETAMINOPHEN | NCS HealthCare of KY, LLC dba Vangard Labs | f32fc2e9-c0e3-4a25-8399-9cdba6ae8a16 | 2026-02-26 | Warnings | 362O9ITL9D |
| Acetaminophen | ACETAMINOPHEN | NCS HealthCare of KY, LLC dba Vangard Labs | 1f4ac0e6-e986-4c22-8248-0691d64e1a30 | 2026-02-26 | Warnings | 362O9ITL9D |
| ACETAMINOPHEN | ACETAMINOPHEN | NCS HealthCare of KY, LLC dba Vangard Labs | a3217b48-7482-4cc7-8811-ae75fd9d7805 | 2026-02-26 | Warnings | 362O9ITL9D |
| Childrens Chewable Acetaminophen | ACETAMINOPHEN | Discount Drug Mart | f413a617-1166-4940-b6ec-fae32238a780 | 2026-02-26 | Warnings | 362O9ITL9D |
| Acetaminophen | ACETAMINOPHEN | NCS HealthCare of KY, LLC dba Vangard Labs | 19735691-33f3-4e19-85ad-e5f270251ec5 | 2026-02-26 | Warnings | 362O9ITL9D |
| Quantum Harmony | BLATTA AMERICANA, CEREBRUM SUIS, CACAO, COLUMBUS PALUMBA, HEART (SUIS), DIOSPYROS KAKI, FORMICA RUFA, HYPOTHALAMUS SUIS, HYPOPHYSIS SUIS, PALOONDO, NPY (NEUROPEPTIDE Y), SEROTONIN (HYDROCHLORIDE), SILICEA, SULPHUR, VERATRUM ALBUM, SALIX VITELLINA, FLOS | Deseret Biologicals, Inc. | 1742ac50-ec6e-4261-a0b8-791b893742ef | 2026-02-25 | Warnings | ETJ7Z6XBU4 |
| Multi-Symptom Cold and Fever Childrens | ACETAMINOPHEN, DEXTROMETHORPHAN HBR, GUAIFENESIN, PHENYLEPHRINE HCL | CVS PHARMACY | 2a569e47-3f17-4fc7-83d6-a3dddfd4987e | 2026-02-25 | Warnings | 362O9ITL9D |
| Acetaminophen and Codeine Phosphate | ACETAMINOPHEN AND CODEINE PHOSPHATE | Genus Lifesciences Inc. | 95a5d638-3072-4c37-a4cd-f8550328e2c6 | 2026-02-25 | Boxed warning, Warnings, Adverse reactions | 362O9ITL9D |
| leader tussin cf | ACETAMINOPHEN, DEXTROMETHORPHAN HYDROBROMIDE, GUAIFENESIN, PHENYLEPHRINE HYDROCHLORIDE | Cardinal Health 110, LLC. dba Leader | b3e3699b-b36c-453c-8f3b-0001388c8e82 | 2026-02-25 | Warnings | 362O9ITL9D |
| Childrens Pain and Fever | ACETAMINOPHEN | CVS WOONSOCKET PRESCRIPTION CENTER, INCORPORATED | 12fd643d-7c60-453f-a81f-407ed20e8725 | 2026-02-25 | Warnings | 362O9ITL9D |
| Childrens Pain and Fever | ACETAMINOPHEN | CVS WOONSOCKET PRESCRIPTION CENTER, INCORPORATED | d96a1531-772b-4a5c-89e4-66fff1fa3d78 | 2026-02-25 | Warnings | 362O9ITL9D |
| Sinus Pressure, Pain and Cough | ACETAMINOPHEN, DEXTROMETHORPHAN HBR, GUAIFENESIN, PHENYLEPHRINE HCL | Walgreen Company | 97554f40-f9aa-4dbf-a6f2-de6197236ab4 | 2026-02-25 | Warnings | 362O9ITL9D |
| Caffeine | CAFFEINE | CVS Pharmacy, Inc. | 6d9b3926-7198-5e00-e053-2a91aa0a9580 | 2026-02-24 | Warnings | 3G6A5W338E |
| Cold and Flu Nighttime | ACETAMINOPHEN, DEXTROMETHORPHAN HBR, DOXYLAMINE SUCCINATE | Best Choice (Valu Merchandisers Company) | 64a93715-e7b1-4de1-8099-8ad6c585d517 | 2026-02-24 | Warnings | 362O9ITL9D |
| Outdoor Allergies | ACONITUM NAPELLUS, ADRENALINUM, ALLIUM CEPA, RAGWEED POLLEN, ARSENICUM IODATUM, MUGWORT POLLEN, MUSTARD POLLEN, LAMBS QUARTERS POLLEN, EUPHRASIA OFFICINALIS, HISTAMINUM HYDROCHLORICUM, PERENNIAL RYE GRASS POLLEN, ALFALFA POLLEN, TIMOTHY GRASS POLLEN, YELLOW DOCK POLLEN, SABADILLA, SILICEA, DANDELION POLLEN, RED CLOVER POLLEN, COCKLEBUR POLLEN | NaturalCare | b0a76faa-a081-4cee-ae40-e5605458bec3 | 2026-02-23 | Warnings | ETJ7Z6XBU4 |
| BM BIO28 (General Tonic) | CALC SULPH, CALC FLUOR, CALC PHOS, FERR PHOS, KALI MUR, KALI PHOS, KALI SULPH, MAG PHOS, NAT PHOS, NAT SULPH, NAT MUR, SILICEA | BM Private Limited | 38d2cff0-3550-b119-e063-6394a90a31cb | 2026-02-23 | Warnings | ETJ7Z6XBU4 |
| Equate Childrens Pain and Fever | ACETAMINOPHEN | Wal-Mart Stores Inc | 40eedfe9-54e1-40a2-b4a2-55ff708b89cd | 2026-02-23 | Warnings | 362O9ITL9D |
| hydrocodone bitartrate and acetaminophen | HYDROCODONE BITARTRATE AND ACETAMINOPHEN | Strides Pharma Science Limited | cc7f0a16-ff27-44d0-b69a-3f6aea1b993b | 2026-02-23 | Boxed warning, Warnings, Adverse reactions | 362O9ITL9D |
| Excedrin Rapid Relief | ACETAMINOPHEN | Haleon US Holdings LLC | 3a36b7ca-396e-cfd8-e063-6294a90a76ab | 2026-02-22 | Warnings | 362O9ITL9D |
Reported adverse events (FAERS/openFDA)#
Adverse event summaries are temporarily unavailable. Other product information remains available.