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 46 of 191 · 3,809 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Stay Awake Maximum StrengthCAFFEINEBetter Living Brands, LLC976780f9-228c-44cb-b1f4-8027280fc7cb2026-03-11WarningsExact identifier
unii: 3G6A5W338E
severe cold and fluACETAMINOPHEN, DEXTROMETHORPHAN HYDROBROMIDE, GUAIFENESIN, PHENYLEPHRINE HYDROCHLORIDECVS WOONSOCKET PRESCRIPTION CENTER, INCORPORATEDc17a10a3-6b8f-4734-8f00-1f4c5c7297252026-03-11WarningsExact identifier
unii: 362O9ITL9D
Lower GI and Probiotic RestorationAETHUSA CYNAPIUM, ALLIUM SATIVUM, BAPTISIA TINCTORIA, CAPSICUM ANNUUM, CARBO VEGETABILIS, CHAMOMILLA, CINCHONA OFFICINALIS, COLLINSONIA CANADENSIS, COLOCYNTHIS, CONDURANGO, GAMBOGIA, GRATIOLA OFFICINALIS, LAC VACCINUM, LACTICUM ACIDUM, NATRUM CARBONICUM, NUX VOMICA, PODOPHYLLUM PELTATUM, SEPIA AND SILICEA.King Bio Inc.2e1f3ca1-9036-4f14-bd3c-d0eed9a9ff932026-03-10WarningsExact identifier
unii: ETJ7Z6XBU4
Hydrocodone Bitartrate and AcetaminophenHYDROCODONE BITARTRATE AND ACETAMINOPHENAsclemed USA, Inc.66e184cd-fa32-431f-b843-9c4bea12593b2026-03-10Boxed warning, Warnings, Adverse reactionsExact identifier
unii: 362O9ITL9D
Sudafed PE Sinus Pressure Plus PainACETAMINOPHEN AND PHENYLEPHRINE HYDROCHLORIDESportpharm LLC67428f4b-28be-4682-a9a9-781bf85089ff2026-03-10WarningsExact identifier
unii: 362O9ITL9D
Acetaminophen 250 mg and Ibuprofen 125 mgACETAMINOPHEN 250 MG AND IBUPROFEN 125 MG TABLETSSun Pharmaceutical Industries, Inc.2a31a975-72f9-2a16-e063-6394a90a81492026-03-10WarningsExact identifier
unii: 362O9ITL9D
AcetaminophenACETAMINOPHENCVS WOONSOCKET PRESCRIPTION CENTER, INCORPORATEDd79828d8-9279-4ae9-8872-aeca641be5d92026-03-10WarningsExact identifier
unii: 362O9ITL9D
Constitutional EnhancerACONITUM NAPELLUS, ARSENICUM ALBUM, BARYTA CARBONICA, BRYONIA, CALCAREA CARBONICA, CANTHARIS, GELSEMIUM SEMPERVIRENS, GRAPHITES, HYDRASTIS CANADENSIS, KALI IODATUM, LACHESIS MUTUS, LYCOPODIUM CLAVATUM, MERCURIUS VIVUS, NATRUM MURIATICUM, NUX VOMICA, PHOSPHORUS, PHYTOLACCA DECANDRA, PULSATILLA, RHUS TOX, SEPIA, SILICEA AND SULPHUR.King Bio Inc.448becd7-58aa-40ae-9b4b-39f48a8f13dd2026-03-10WarningsExact identifier
unii: ETJ7Z6XBU4
Hydrocodone Bitartrate and AcetaminophenHYDROCODONE BITARTRATE AND ACETAMINOPHENBryant Ranch Prepack806a981f-85ff-4e58-8ff0-7ab02ed2e5c12026-03-10Boxed warning, Warnings, Adverse reactionsExact identifier
unii: 362O9ITL9D
VermiclearGRANATUM, RHAMNUS PURSHIANA, JUGLANS REGIA, FILIX MAS, ABSINTHIUM, AESCULUS HIPPOCASTANUM, ARSENICUM ALBUM, BAPTISIA TINCTORIA, CINA, CINCHONA OFFICINALIS, CUPRUM METALLICUM, IPECACUANHA, LYCOPODIUM CLAVATUM, MERCURIUS VIVUS, NUX VOMICA, PODOPHYLLUM PELTATUM, PULSATILLA (VULGARIS), RATANHIA, RHUS TOX, SABADILLA, SILICEA, SPIGELIA ANTHELMIA, TEREBINTHINA, TEUCRIUM MARUMEnergique, Inc.f7cf3edd-2451-4a4f-b1f2-1b3db2bb4dca2026-03-09WarningsExact identifier
unii: ETJ7Z6XBU4
sinus pressure and pain and coughACETAMINOPHEN, DEXTROMETHORPHAN HBR, GUAIFENESIN, PHENYLEPHRINE HCLTarget Corporation488588f3-62d3-4248-937a-1c200792b5f12026-03-09WarningsExact identifier
unii: 362O9ITL9D
foster and thrive childrens pain and feverACETAMINOPHENStrategic Sourcing Services LLCe495a27e-eb64-4c42-8942-43bab99181722026-03-07WarningsExact identifier
unii: 362O9ITL9D
Butalbital, Acetaminophen, and CaffeineBUTALBITAL, ACETAMINOPHEN, AND CAFFEINEMajor Pharmaceuticals0ca49c3c-f2cb-40e3-a7d5-5f48eca590162026-03-06Boxed warning, Warnings, Adverse reactionsExact identifier
rxcui: 238154
unii: 3G6A5W338E
unii: KHS0AZ4JVK
unii: 362O9ITL9D
Acetaminophen PM Extra StrengthACETAMINOPHEN, DIPHENHYDRAMINE HCLCVS PHARMACY67a190c3-7de0-4f57-be94-d6b8285e12202026-03-06WarningsExact identifier
unii: 362O9ITL9D
5% Minoxidil Hair Growth Serum5% MINOXIDIL HAIR GROWTH SERUMGuangzhou Ariel Biotech Co., Ltd.22c42a75-23cc-c596-e063-6394a90a04082026-03-06WarningsExact identifier
unii: 3G6A5W338E
foster and thrive daytime severe cold and flu reliefACETAMINOPHEN, DEXTROMETHORPHAN HYDROBROMIDE, GUAIFENESIN, PHENYLEPHRINE HYDROCHLORIDESportpharm LLC51e34704-5e6b-4e80-836c-ddbc24a451b22026-03-06WarningsExact identifier
unii: 362O9ITL9D
good sense migraine formulaACETAMINOPHEN, ASPIRIN, CAFFEINESportpharm LLC2a27da49-23d6-4035-8088-806ee22b98b02026-03-06WarningsExact identifier
unii: 3G6A5W338E
unii: 362O9ITL9D
hydrocodone bitartrate and acetaminophenHYDROCODONE BITARTRATE AND ACETAMINOPHENEywa Pharma Inc8a201e19-3e47-7e58-e053-2995a90ab1d52026-03-06Boxed warning, Warnings, Adverse reactionsExact identifier
unii: 362O9ITL9D
Back and Body Pain ReliefASPIRIN, CAFFEINEWinCo Foods, LLCcf5c15e9-c45d-4bd6-a887-fd74de5f81b92026-03-06WarningsExact identifier
unii: 3G6A5W338E
Childrens Pain and FeverACETAMINOPHENTopco Associates, LLC87af092c-99e6-475d-81af-b9fd8fc337d72026-03-06WarningsExact identifier
unii: 362O9ITL9D

Reported adverse events (FAERS/openFDA)#

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