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 59 of 189 · 3,771 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Large Ring Combination 9302LARGE RING COMBINATIONProfessional Complementary Health Formulascced8a69-7bc0-42ad-b80a-58fc603bf7652026-01-08WarningsExact identifier
unii: ETJ7Z6XBU4
Domestic Animals Nosode Combination 9407DOMESTIC ANIMALS NOSODE COMBINATIONProfessional Complementary Health Formulas222c28aa-e07b-4706-9fb5-585b190f1c5b2026-01-08WarningsExact identifier
unii: ETJ7Z6XBU4
NorgesicORPHENADRINE CITRATE, ASPIRIN AND CAFFEINEGalt Pharmaceuticals, LLCbe2761bc-e537-4039-846a-2ffa3d8b2afc2026-01-08Warnings, Adverse reactionsExact identifier
unii: 3G6A5W338E
Thompson Cough and Cold Multi-Symptom ReliefACETAMINOPHEN, DEXTROMETHORPHAN HBR, PHENYLEPHRINE, GUAIFENESIN, ,Thompsone77725b1-15da-35bd-e053-2a95a90ad6ba2026-01-08WarningsExact identifier
unii: 362O9ITL9D
Thompson Cramp ReliefACETAMINOPHEN, PAMABROM, PYRILAMINE MALEATEThompson Safetye82f607d-05b1-2c50-e053-2995a90a607e2026-01-08WarningsExact identifier
unii: 362O9ITL9D
Mucosan Max with AcetaminophenACETAMINOPHEN, DEXTROMETHORPHAN HYDROBROMIDE, GUAIFENESIN AND PHENYLEPHRINE HYDROCHLORIDEMenper Distributors, Inc.26a4861b-5d8e-9ec6-e063-6394a90af5772026-01-08WarningsExact identifier
unii: 362O9ITL9D
Alka-Seltzer Plus Maximum Strength Sinus, Congestion and Pain Power Max GelsACETAMINOPHEN, DEXTROMETHORPHAN HYDROBROMIDE , PHENYLEPHRINE HYDROCHLORIDEBayer HealthCare LLC.e07931fc-f753-1aeb-e053-2a95a90ada3f2026-01-08WarningsExact identifier
unii: 362O9ITL9D
Alka Seltzer Plus Maximum Strength Sinus, Allergy And Cough Power Max GelsACETAMINOPHEN, DEXTROMETHORPHAN HYDROBROMIDE , DOXYLAMINE SUCCINATE, PHENYLEPHRINE HYDROCHLORIDEBayer HealthCare LLC.e17eb929-209d-a2d1-e053-2a95a90a4cf32026-01-08WarningsExact identifier
unii: 362O9ITL9D
Alka-Seltzer Plus Night Severe Cold and FluACETAMINOPHEN, DEXTROMETHORPHAN HYDROBROMIDE, DOXYLAMINE SUCCINATE, AND PHENYLEPHRINE HYDROCHLORIDEBayer HealthCare LLC.f4c60ca1-ba59-4a92-84a5-6ba65faa56ab2026-01-08WarningsExact identifier
unii: 362O9ITL9D
Alka-Seltzer Plus Day Severe Cold Plus FluACETAMINOPHEN, DEXTROMETHORPHAN HYDROBROMIDE, GUAIFENESIN, AND PHENYLEPHRINE HYDROCHLORIDEBayer HealthCare LLC.cec51eab-cce3-4965-a14e-a46d953050c42026-01-08WarningsExact identifier
unii: 362O9ITL9D
Hydrocodone Bitartrate and AcetaminophenHYDROCODONE BITARTRATE AND ACETAMINOPHENAvPAK678f3d54-3b62-c9e8-2ff3-a2a6bd9ecfc32026-01-08Boxed warning, Warnings, Adverse reactionsExact identifier
unii: 362O9ITL9D
Butalbital, Acetaminophen, CaffeineBUTALBITAL, ACETAMINOPHEN, AND CAFFEINEAdvanced Rx of Tennessee, LLC4871c36f-229b-4c12-e063-6394a90a028e2026-01-08Boxed warning, Warnings, Adverse reactionsExact identifier
application number: ANDA209587
rxcui: 238154
unii: 3G6A5W338E
unii: KHS0AZ4JVK
unii: 362O9ITL9D
Caffeine 1508CAFFEINEProfessional Complementary Health Formulas970ce7be-a373-45db-b35f-f150a49d1fba2026-01-08WarningsExact identifier
unii: 3G6A5W338E
Xpect Cold ReliefACETAMINOPHEN GUAIFENESEIN PHENYLEPHRINE HCLCintas Corporation02391d55-32b2-4083-9315-98e9b3650c552026-01-08WarningsExact identifier
unii: 362O9ITL9D
hydrocodone bitartrate and acetaminophenHYDROCODONE BITARTRATE AND ACETAMINOPHENCranbury Pharmaceuticals, LLC93b6dfdf-ba6e-4ea6-ab85-5ac121e331012026-01-08Boxed warning, Warnings, Adverse reactionsExact identifier
unii: 362O9ITL9D
Cataract Drops 2085CATARACT DROPSProfessional Complementary Health Formulas6040a096-ccdb-4e1e-a242-be29c3127f272026-01-08WarningsExact identifier
unii: ETJ7Z6XBU4
RET Thyroid/Adrenal 7011RET THYROID/ADRENALProfessional Complementary Health Formulaseb313eb9-4dfc-402e-92b3-14f09f4ba8692026-01-08WarningsExact identifier
unii: ETJ7Z6XBU4
Lymph Stim Liquescence 3016LYMPH STIM LIQUESCENCEProfessional Complementary Health Formulasd91939ea-e3dc-49b1-949a-6618a4c4ae0d2026-01-08WarningsExact identifier
unii: ETJ7Z6XBU4
Nitrogen Combination 9310NITROGEN COMBINATIONProfessional Complementary Health Formulas72a7c0f3-0a57-4aa8-8fe8-a3267b9acd532026-01-08WarningsExact identifier
unii: ETJ7Z6XBU4
Psorinum Miasm Drops 2054PSORINUM MIASM DROPSProfessional Complementary Health Formulasa34aadab-b634-461f-a0ff-58f42f6e08332026-01-08WarningsExact identifier
unii: ETJ7Z6XBU4

Reported adverse events (FAERS/openFDA)#

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