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 103 of 187 · 3,739 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Tylenol PM Extra StrengthACETAMINOPHEN AND DIPHENHYDRAMINE HYDROCHLORIDEMorning Star OTC6cd07a01-7034-4994-bbd3-bedcdf7d5b832025-06-19WarningsExact identifier
unii: 362O9ITL9D
Tylenol Sinus SevereACETAMINOPHEN, GUAIFENESIN, AND PHENYLEPHRINE HYDROCHLORIDEMorning Star OTC37e939c6-064b-3548-e063-6294a90a337d2025-06-19WarningsExact identifier
unii: 362O9ITL9D
Anti-wrinkle eye creamEYE CREAMGuangzhou Yapeng Refinement Chemical Co., Ltd.37f84240-942f-9028-e063-6294a90a41ad2025-06-19WarningsExact identifier
unii: 3G6A5W338E
Mucinex Sinus Max Clear and CoolACETAMINOPHEN AND GUAIFENESINRB Health (US) LLC37de813a-54b7-672a-e063-6294a90a374e2025-06-18WarningsExact identifier
unii: 362O9ITL9D
NyQuil Cold and Flu w/VapoCOOL, 4ct, Travel BASIXACETAMINOPHEN, DOXYLAMINE SUCCINATE, DEXTROMETHORPHAN HYDROBROMIDE TABLET, COATEDLil' Drug Store Products, Inc.37c768f5-dabd-22d0-e063-6394a90af9e52025-06-17WarningsExact identifier
unii: 362O9ITL9D
BUTALBITAL AND ACETAMINOPHENBUTALBITAL AND ACETAMINOPHENAarkish Pharmaceuticals NJ Inc.82fa5151-d5ee-4ad8-ba7c-a2df8a09e1a62025-06-17Boxed warning, Warnings, Adverse reactionsExact identifier
unii: KHS0AZ4JVK
unii: 362O9ITL9D
ANTI-AGING EYE MASKANTI-AGING EYE MASKGuangzhou Yapeng Refinement Chemical Co., Ltd.37d02e3b-383f-0628-e063-6394a90a7aa22025-06-17WarningsExact identifier
unii: 3G6A5W338E
migraine formulaACETAMINOPHEN, ASPIRIN, CAFFEINEMeijer Distribution Inc8f1ee554-1021-4613-ba0e-aa02f8a751f82025-06-16WarningsExact identifier
unii: 3G6A5W338E
unii: 362O9ITL9D
DRX CHOICE Tension HeadacheACETAMINOPHEN, CAFFEINERaritan Pharmaceuticals Inc.8a5cb38b-669d-4177-b33b-d73c7ef48d182025-06-13WarningsExact identifier
unii: 3G6A5W338E
unii: 362O9ITL9D
good sense childrens pain and feverACETAMINOPHENNuCare Pharmaceuticals,Inc.3777f4fb-d279-199d-e063-6394a90acf362025-06-13WarningsExact identifier
unii: 362O9ITL9D
topcare 8 hr arthritis pain reliefACETAMINOPHENTopco Associates LLCa82f8818-1c22-46d0-b05f-698d2395ac482025-06-13WarningsExact identifier
unii: 362O9ITL9D
Aspirina CafeinaASPIRIN,CAFFEINEBayer HealthCare LLC.2e709acc-325a-baca-e063-6394a90a24be2025-06-12WarningsExact identifier
unii: 3G6A5W338E
foster and thrive migraine reliefACETAMINOPHEN, ASPIRIN, CAFFEINEStrategic Sourcing Services LLCfe9bf032-fc8b-4b2d-8c6b-acdbe1f320bf2025-06-11WarningsExact identifier
unii: 3G6A5W338E
unii: 362O9ITL9D
YVES ICED AMERICANO ENERGY MASKCAFFEINE 0.5% NIACINAMIDE 0.4% SOLUBLE COLLAGEN 0.009% PANTHENOL 1%Guangdong Joyan Biological Technology Co.,Ltd373292f4-f5f9-15e9-e063-6394a90a94f12025-06-10WarningsExact identifier
unii: 3G6A5W338E
YVES CONOPEPTIDE LUXURY TIGHTEN CREME EYE MASKCAFFEINE 0.5% MU-CONOTOXIN CNIIIC 0.0001% ELASTIN 0.009% UBIQUINONE 0.02%Guangdong Joyan Biological Technology Co.,Ltd3732c9f4-720e-4ea1-e063-6294a90ab3a12025-06-10WarningsExact identifier
unii: 3G6A5W338E
Cold Max NighttimeACETAMINOPHEN, CHLORPHENIRAMINE MALEATE, DEXTROMETHORPHAN HYDROBROMIDE, AND PHENYLEPHRINE HYDROCHLORIDERETAIL BUSINESS SERVICES , LLC.e65d2815-6932-123c-e053-2a95a90a2cf92025-06-10WarningsExact identifier
unii: 362O9ITL9D
Cold Head Congestion DaytimeACETAMINOPHEN, DEXTROMETHORPHAN HYDROBROMIDE, AND PHENYLEPHRINE HYDROCHLORIDEAmerican Sales Company0cc66c6c-db26-4bb2-a97d-c4106210d70c2025-06-10WarningsExact identifier
unii: 362O9ITL9D
AcetaminophenACETAMINOPHENCVS Pharmacy, Inc.6dea9e11-ff99-63c7-e053-2a91aa0a5b542025-06-10WarningsExact identifier
unii: 362O9ITL9D
Children Acetaminophen Oral SolutionACETAMINOPHENMAJOR PHARMACEUTICALScfca5147-f390-40bd-8f13-c5b3b8d1c5b02025-06-09WarningsExact identifier
unii: 362O9ITL9D
Nuvicare DayTime Cold and Flu SoftgelACETAMINOPHEN, DEXTROMETHORPHAN HYDROBROMIDE, PHENYLEPHRINE HYDROCHLORIDENUVICARE LLCbdc35570-c8df-4797-a13e-7f2479ec42b72025-06-09WarningsExact identifier
unii: 362O9ITL9D

Reported adverse events (FAERS/openFDA)#

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