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 98 of 188 · 3,751 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Dr Simi Pain Relief 100ACETAMINOPHENFarmacias De Similares TX LLC3c42e48d-cdb2-eb74-e063-6394a90a29402025-08-13WarningsExact identifier
unii: 362O9ITL9D
Dr Simi Pain ReliefACETAMINOPHENFarmacias De Similares TX LLC3c477d33-a8c2-d39f-e063-6294a90ac5f02025-08-13WarningsExact identifier
unii: 362O9ITL9D
Headache Relief Extra StrengthACETAMINOPHEN, ASPIRIN AND CAFFEINECHAIN DRUG MARKETING ASSOCIATION INC4005f8dd-3050-4590-8703-6997444e8df32025-08-13WarningsExact identifier
unii: 3G6A5W338E
unii: 362O9ITL9D
good sense headache reliefACETAMINOPHEN, ASPIRIN, CAFFEINEL. Perrigo Company4cae0580-7ee3-4f38-8d13-79c7d7615f8f2025-08-12WarningsExact identifier
unii: 3G6A5W338E
unii: 362O9ITL9D
TYLENOL Extra StrengthACETAMINOPHENKenvue Brands LLC3bb7dc60-97b2-1291-e063-6294a90a26d92025-08-12WarningsExact identifier
unii: 362O9ITL9D
Arthritis PainACETAMINOPHENSAM'S WEST INC3928090d-b45e-6948-e063-6394a90a47dd2025-08-11WarningsExact identifier
unii: 362O9ITL9D
Dr Simi Pain Reliever PMACETAMINOPHEN, DIPHENHYDRAMINE HYDROCHLORIDEFarmacias De Similares TX LLC3c19ad99-6e0f-3116-e063-6394a90a914c2025-08-11WarningsExact identifier
unii: 362O9ITL9D
good sense pain reliefACETAMINOPHENNuCare Pharmaceuticals,Inc.3c1f505d-0319-a179-e063-6294a90a0b172025-08-11WarningsExact identifier
unii: 362O9ITL9D
Cloveden Vegan Whitening ToothSILICA, HYDROGEN PEROXIDE, TOCOPHERYL ACETATEAcuseplanet Inc3c04778b-9535-856e-e063-6294a90aa8682025-08-10WarningsExact identifier
unii: ETJ7Z6XBU4
AcetaminophenACETAMINOPHENProstat First Aid3bdbea6a-3f11-9142-e063-6294a90a20ea2025-08-08WarningsExact identifier
unii: 362O9ITL9D
M-PAPACETAMINOPHENBryant Ranch Prepack3d6bf733-800c-420a-a9ab-ae4a261347992025-08-08WarningsExact identifier
unii: 362O9ITL9D
Headache Relief Extra StrengthACETAMINOPHEN, ASPIRIN, CAFFEINEP & L Development, LLCc54ad829-f2e8-4367-b439-af20b0ef8ad22025-08-06WarningsExact identifier
unii: 3G6A5W338E
unii: 362O9ITL9D
TYLENOL Regular StrengthACETAMINOPHENKenvue Brands LLC398d8996-b522-a3cd-e063-6394a90ac2c82025-08-06WarningsExact identifier
unii: 362O9ITL9D
Daytime SevereACETAMINOPHEN, DEXTROMETHORPHAN HYDROBROMIDE, GUAIFENESIN, PHENYLEPHRINE HYDROCHLORIDEH E Bb7434978-44a8-4c51-979d-0bc446461e432025-08-06WarningsExact identifier
unii: 362O9ITL9D
AcetaminophenACETAMINOPHENProstat First Aid3ba313db-bafe-1947-e063-6294a90a528c2025-08-05WarningsExact identifier
unii: 362O9ITL9D
MEDIQUE APAP acetaminophenMEDIQUE APAP ACETAMINOPHENHF Acquisition Co LLC, DBA HealthFirst3ba5c802-fe5a-e42a-e063-6394a90ae67e2025-08-05WarningsExact identifier
unii: 362O9ITL9D
OXYCODONE AND ACETAMINOPHENOXYCODONE AND ACETAMINOPHENCamber Pharmaceuticals, Inc.42777191-0454-4ccb-8fc3-8b18b0ee43f72025-08-05Boxed warning, Warnings, Adverse reactionsExact identifier
unii: 362O9ITL9D
meijer EXTRA STRENGTH Pain Relief PM CAPLETACETAMINOPHEN, DIPHENHYDRAMINE HYDROCHLORIDEMeijer, Inc.376fed3b-7625-6379-e063-6394a90a188d2025-08-05WarningsExact identifier
unii: 362O9ITL9D
Schuessler Tissue Salts Silica Cleanser and Conditioner 12SILICEAMartin & Pleasance Pty Ltdf70dcf90-bde9-404d-9ede-4113553ccbff2025-08-04WarningsExact identifier
unii: ETJ7Z6XBU4
CAREONE INFANTS ACETAMINOPHENACETAMINOPHENRetail Business Services, LLCb8024ec2-97c6-4aa1-b1dd-894164f488112025-08-04WarningsExact identifier
unii: 362O9ITL9D

Reported adverse events (FAERS/openFDA)#

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