FDA.reportPublic FDA data

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 table
LabelManufacturerEffective dateType
BUTALBITAL, ACETAMINOPHEN AND CAFFEINE TABLETS, USP 50 mg/325 mg/40 mgHAWAII REPACK, INC.2026-07-17HUMAN 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.

Matched openFDA labels page 99 of 188 · 3,751 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Exaprin PlusASPIRIN, ACETAMINOPHEN, CAFFEINEHART Health8a9ca680-e6cf-4ee4-8a5f-bd6d7470b8482025-08-04WarningsExact identifier
unii: 3G6A5W338E
unii: 362O9ITL9D
Antigrip Cough and ColdACETAMINOPHEN, CHLORPHENIRAMINE MALEATE, DEXTROMETHORPHAN HBRPharmadel LLC3b53e5fc-f258-c2b9-e063-6394a90ab5002025-08-01WarningsExact identifier
unii: 362O9ITL9D
Good Sense Pain ReliefACETAMINOPHENProficient Rx LPb4cb4a62-9ef7-4185-8770-e9a806c2fb3f2025-08-01WarningsExact identifier
unii: 362O9ITL9D
meijer Nighttime Cold and Flu SOFTGELACETAMINOPHEN, DEXTROMETHORPHAN HYDROBROMIDE, DOXYLAMINE SUCCINATEMeijer, Inc.377248b6-d64d-8dff-e063-6394a90a43f62025-07-31WarningsExact identifier
unii: 362O9ITL9D
Acetaminophen, IbuprofenACETAMINOPHEN, IBUPROFENGLENMARK THERAPEUTICS INC., USA57a8dc2b-a3bc-49fa-b605-2330155bdbff2025-07-31WarningsExact identifier
unii: 362O9ITL9D
meijer Daytime Cold and Flu SOFTGELACETAMINOPHEN, DEXTROMETHORPHAN HYDROBROMIDE, PHENYLEPHRINE HYDROCHLORIDEMeijer, Inc.3771f778-7ac9-7108-e063-6394a90a11052025-07-31WarningsExact identifier
unii: 362O9ITL9D
Pain ReliefACETAMINOPHENAAA Pharmaceutical, Inc.36ad21a3-6229-e91b-e063-6394a90a79332025-07-29WarningsExact identifier
unii: 362O9ITL9D
Hydrocodone Bitartrate and AcetaminophenHYDROCODONE BITARTRATE AND ACETAMINOPHENBryant Ranch Prepackfa88d7b2-6c8e-4893-bd81-ecd4f2aca4932025-07-29Boxed warning, Warnings, Adverse reactionsExact identifier
unii: 362O9ITL9D
Childrens AcetaminophenACETAMINOPHENBryant Ranch Prepack190bb2dc-92b4-4b59-a47f-a0251df8261c2025-07-29WarningsExact identifier
unii: 362O9ITL9D
Extra Strength NiteTime Pain ReliefACETAMINOPHEN 500 MG,DIPHENHYDRAMINE HYDROCHLORIDE 25 MG TABLETWALGREENSc25c75c7-157f-1c0d-e053-2995a90a2e3c2025-07-25WarningsExact identifier
unii: 362O9ITL9D
Pain Reliever PMACETAMINOPHEN, DIPHENHYDRAMINE HYDROCHLORIDEWalmart Inc.21ab3d58-bb0e-3e51-e063-6294a90ad4152025-07-25WarningsExact identifier
unii: 362O9ITL9D
Cell SaltsCALC. FLUOR., CALC. PHOS., CALC.SULPH., FERRUM PHOSPHORICUM, KALI MUR., KALI PHOS., KALI SULPH., MAG. PHOS., NAT. MUR., NAT. PHOS., NAT.SULPHURICUM, SILICEANewton Laboratories, Inc.985a3341-0fe0-1dd6-e053-2a95a90ad2c52025-07-25WarningsExact identifier
unii: ETJ7Z6XBU4
SILICA MARINASILICON DIOXIDEBoiron3aada26e-6a8e-f545-e063-6394a90a9f802025-07-24Exact identifier
unii: ETJ7Z6XBU4
Cell SaltsCALC. FLUOR., CALC. PHOS., CALC.SULPH., FERRUM PHOSPHORICUM, KALI MUR., KALI PHOS., KALI SULPH., MAG. PHOS., NAT. MUR., NAT. PHOS., NAT.SULPHURICUM, SILICEANewton Laboratories, Inc.7a1b4e96-c96f-6424-e053-2991aa0aef302025-07-24WarningsExact identifier
unii: ETJ7Z6XBU4
Cell SaltsCALC. FLUOR., CALC. PHOS., CALC.SULPH., FERRUM PHOSPHORICUM, KALI MUR., KALI PHOS., KALI SULPH., MAG. PHOS., NAT. MUR., NAT. PHOS., NAT.SULPHURICUM, SILICEANewton Laboratories, Inc.7a1a9ef9-9a54-5f94-e053-2a91aa0ab4772025-07-24WarningsExact identifier
unii: ETJ7Z6XBU4
Childrens TYLENOLACETAMINOPHENKenvue Brands LLC3a935584-6045-0a58-e063-6394a90a40c42025-07-23WarningsExact identifier
unii: 362O9ITL9D
DR. SANA PAIN AND FEVER FOR ChildrenACETAMINOPHENGADAL Laboratories, Inc8a22a5ba-8623-4cca-8723-52b4954034612025-07-23WarningsExact identifier
unii: 362O9ITL9D
OXYCODONE AND ACETAMINOPHENOXYCODONE AND ACETAMINOPHENDirect_Rx90a11364-fc42-e94e-e053-2a95a90a97822025-07-22Boxed warning, Warnings, Adverse reactionsExact identifier
unii: 362O9ITL9D
Defensol DACETAMINOPHEN, CHLORPHERINAMINE MALEATE, PHENYLEPHRINE HCIMenper Distributors, Inc.f466c660-69eb-4581-81ff-1499fa421d8b2025-07-22WarningsExact identifier
unii: 362O9ITL9D
Defensol D Blister PackACETAMINOPHEN, DIPHENHYDRAMINE HCL, PHENYLEPHRINE HCIMenper Distributors, Inc.0dfcc977-6101-4536-e063-6294a90a7a482025-07-22WarningsExact identifier
unii: 362O9ITL9D

Reported adverse events (FAERS/openFDA)#

Adverse event summaries are temporarily unavailable. Other product information remains available.