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 22 of 191 · 3,809 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
BM BIO28 ALCOHOLCALC SULPH, CALC FLUOR, CALC PHOS, FERR PHOS, KALI MUR, KALI PHOS, KALI SULPH, MAG PHOS, NAT PHOS, NAT SULPH, NAT MUR, SILICEABM Private Limited53d1c51a-77eb-bb3c-e063-6394a90aab3f2026-06-09WarningsExact identifier
unii: ETJ7Z6XBU4
BM BIO18CALC FLUOR, CALC SULF, SILICEA.Total Operations Management LLC DBA:Bestmade Natural Products Micro53d3c1d6-d0ba-5ea7-e063-6394a90a02942026-06-09WarningsExact identifier
unii: ETJ7Z6XBU4
AcetaminophenACETAMINOPHENPUBLIX SUPERMARKETS, INC3f17fa06-4932-b8ec-e063-6294a90a03812026-06-09WarningsExact identifier
unii: 362O9ITL9D
Oxycodone Hydrochloride and AcetaminophenOXYCODONE HYDROCHLORIDE AND ACETAMINOPHENSt. Mary's Medical Park Pharmacy53de17b1-6d5b-c7c0-e063-6394a90a70642026-06-09Boxed warning, Warnings, Adverse reactionsExact identifier
unii: 362O9ITL9D
Butalbital, Acetaminophen and CaffeineBUTALBITAL, ACETAMINOPHEN AND CAFFEINEPreferred Pharmaceuticals Inc.65fa9aca-ef3d-4bc6-a107-72e6eb5ce2242026-06-09Boxed warning, Warnings, Adverse reactionsExact identifier
rxcui: 238154
unii: 3G6A5W338E
unii: KHS0AZ4JVK
unii: 362O9ITL9D
Daytime Cold and FluACETAMINOPHEN, DEXTROMETHORPHAN HBR, GUAIFENESIN, PHENYLEPHRINE HCLMeijer Distribution Inc932b11b1-f4a0-417a-bfa1-05261a1721552026-06-08WarningsExact identifier
unii: 362O9ITL9D
Sleep Aid Plus Pain ReliefACETAMINOPHEN, DIPHENHYDRAMINE HCLWalgreen Companye3929179-dad2-4f7e-a971-dbf80f2b5e1b2026-06-08WarningsExact identifier
unii: 362O9ITL9D
Hydrocodone Bitartrate and AcetaminophenHYDROCODONE BITARTRATE AND ACETAMINOPHENBryant Ranch Prepack418ea599-55e0-4d57-a4b1-16568e30f6f72026-06-08Boxed warning, Warnings, Adverse reactionsExact identifier
unii: 362O9ITL9D
DAYTIME SEVERE COLD AND FLUACETAMINOPHEN, DEXTROMETHORPHAN HYDROBROMIDE, GUAIFENESIN, PHENYLEPHRINE HYDROCHLORIDECVS WOONSOCKET PRESCRIPTION CENTER, INCORPORATED493caecb-e687-49ea-b7a1-2a5b9376896d2026-06-08WarningsExact identifier
unii: 362O9ITL9D
Hydrocodone Bitartrate and AcetaminophenHYDROCODONE BITARTRATE AND ACETAMINOPHENBryant Ranch Prepack25d49886-9f9a-4015-bca2-9190b30d91202026-06-08Boxed warning, Warnings, Adverse reactionsExact identifier
unii: 362O9ITL9D
Stay AwakeCAFFEINEWal-Mart Stores Inc5f5b65a2-4db7-4c8e-a954-95611a0872172026-06-08WarningsExact identifier
unii: 3G6A5W338E
Severe Cold and Flu ReliefACETAMINOPHEN, DEXTROMETHORPHAN HBR, GUAIFENESIN, PHENYLEPHRINE HCLCVS PHARMACY4ad10fd7-c088-4356-9d34-a95cfe3a41332026-06-08WarningsExact identifier
unii: 362O9ITL9D
BM SiliceaSILICEATotal Operations Management LLC DBA:Bestmade Natural Products Micro53bb3927-6053-eb3d-e063-6394a90a5ddf2026-06-08WarningsExact identifier
unii: ETJ7Z6XBU4
Diurex UltimateCAFFEINEKobayashi Healthcare International, Inc.c6debbfe-6061-463f-8f17-fb240c6f1bab2026-06-08WarningsExact identifier
unii: 3G6A5W338E
Severe Cold and FluACETAMINOPHEN, DEXTROMETHORPHAN HBR, GUAIFENESIN, PHENYLEPHRINE HCLWalgreen Company54254b61-7861-4eeb-bd3c-54fd5266f4a72026-06-08WarningsExact identifier
unii: 362O9ITL9D
ScrofularoforceRUMEX CRISPUS, XANTHOXYLUM FRAXINEUM, LYMPH NODE (SUIS), SCROPHULARIA NODOSA, BARYTA CARBONICA, BARYTA MURIATICA, BELLADONNA, CALCAREA CARBONICA, CONIUM MACULATUM, HELLEBORUS NIGER, IODIUM, KALI PHOSPHORICUM, LACHESIS MUTUS, NATRUM PHOSPHORICUM, SILICEA, JUNIPERUS VIRGINIANABioActive Nutritional, Inc.737cd410-0405-41b0-b7f2-29bb200378492026-06-08WarningsExact identifier
unii: ETJ7Z6XBU4
Pain Reliever PMACETAMINOPHEN, DIPHENHYDRAMINE HCLWalgreen Company9655c38a-126b-459e-b31d-0aa33d9eb5222026-06-08WarningsExact identifier
unii: 362O9ITL9D
VAXBAPTISIA TINCTORIA, ECHINACEA (ANGUSTIFOLIA), TABEBUIA IMPETIGINOSA, TRIFOLIUM PRATENSE, ARNICA MONTANA, CALENDULA OFFICINALIS, CHELIDONIUM MAJUS, LEPTANDRA VIRGINICA, LIGUSTICUM PORTERI, LOMATIUM DISSECTUM, MYRRHA, NASTURTIUM AQUATICUM, PHYTOLACCA DECANDRA, TARAXACUM OFFICINALE, TRIGONELLA FOENUM-GRAECUM, URTICA DIOICA, HYDRASTIS CANADENSIS, ASTRAGALUS MEMBRANACEUS, PROPOLIS, GLANDULA SUPRARENALIS SUIS, THYMUS (SUIS), ARSENICUM ALBUM, BELLADONNA, CHAMOMILLA, LYCOPODIUM CLAVATUM, RHUS TOX, SILICEA,BioActive Nutritional, Inc.faa4a678-321a-4982-a5d4-01b713e6862d2026-06-08WarningsExact identifier
unii: ETJ7Z6XBU4
Acetaminophen Regular StrengthACETAMINOPHENAurohealth LLCdce938f5-eeba-4a76-9261-2b1324c39a312026-06-08WarningsExact identifier
unii: 362O9ITL9D
Childrens MapapACETAMINOPHENBryant Ranch Prepack69c90cc8-846a-42cf-933a-108671689e8f2026-06-05WarningsExact identifier
unii: 362O9ITL9D

Reported adverse events (FAERS/openFDA)#

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