FDA.reportPublic FDA data

NDC 70518-4309-01 - 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
70518-4309
Requested NDC
70518-4309-01
Package NDCs from labels
70518-4309-0, 70518-4309-1, 70518-4309-01
Manufacturer
REMEDYREPACK INC.
Effective date
2026-09-03
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 mgREMEDYREPACK INC.2026-09-03HUMAN PRESCRIPTION DRUG LABEL

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
70518-4309-0Butalbital, Acetaminophen, Caffeine100 in 1 BOTTLE, PLASTICTABLET1003
70518-4309-1Butalbital, Acetaminophen, Caffeine60 in 1 BOTTLE, PLASTICTABLET603

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
70518-4309BUTALBITAL, ACETAMINOPHEN, CAFFEINE (BUTALBITAL, ACETAMINOPHEN, AND CAFFEINE) TABLET [REMEDYREPACK INC.]1Current NDC, 2 package rows20250316_dc2bb7fc-1722-4865-a02c-be5e5c211505.zip

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 78 of 187 · 3,739 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Alka-Seltzer Plus Maximum Strength Severe Sinus, Allergy and CoughACETAMINOPHEN, DEXTROMETHORPHAN HYDROBROMIDE, DOXYLAMINE SUCCINATE, PHENYLEPHRINE HYDROCHLORIDEBayer HealthCare LLC.5213ca7f-5a78-6471-e054-00144ff88e882025-12-04WarningsExact identifier
unii: 362O9ITL9D
Alka-Seltzer Plus Maximum Strength Night Cold and Flu PowerMax GelsACETAMINOPHEN, DEXTROMETHORPHAN HYDROBROMIDE, DOXYLAMINE SUCCINATE, PHENYLEPHRINE HYDROCHLORIDEBayer HealthCare LLC.6f7ba256-ed14-5fe0-e053-2a91aa0aacc12025-12-04WarningsExact identifier
unii: 362O9ITL9D
Midol Long Lasting ReliefACETAMINOPHENBayer HealthCare LLC.4a3a711d-c882-3525-e054-00144ff8d46c2025-12-04WarningsExact identifier
unii: 362O9ITL9D
Midol Complete GelcapsMIDOL COMPLETEBayer HealthCare LLC0a4477ce-0a02-197d-e054-00144ff88e882025-12-04WarningsExact identifier
unii: 3G6A5W338E
unii: 362O9ITL9D
Coricidin HBP Maximum Strength Multi Symptom FluACETAMINOPHEN, CHLORPHENIRAMINE MALEATE, DEXTROMETHORPHAN HYDROBROMIDEBayer HealthCare LLC.ae7cf41e-b618-d6bb-e053-2a95a90a66922025-12-04WarningsExact identifier
unii: 362O9ITL9D
Coricidin HBP Maximum Strength Cold Flu And Chest CongestionACETAMINOPHEN, GUAIFENESINBayer HealthCare LLC.de95d2dd-e766-f7ec-e053-2995a90afc5f2025-12-04WarningsExact identifier
unii: 362O9ITL9D
DayTime Relief, Cold and Flu, 24-7 Life by 7-ElevenACETAMINOPHEN, DEXTROMETHORPHAN HBR, PHENYLEPHRINE HCL SOLUTIONLil' Drug Store Products, Inc.450e8974-8ff8-4b82-e063-6394a90a93662025-12-03WarningsExact identifier
unii: 362O9ITL9D
Nighttime Relief, Cold and Flu, 24-7 Life by 7-ElevenACETAMINOPHEN, DEXTROMETHORPHAN HBR, DOXYLAMINE SUCCINATE SOLUTIONLil' Drug Store Products, Inc.4510223f-1c88-2796-e063-6394a90a18ac2025-12-03WarningsExact identifier
unii: 362O9ITL9D
BM BIO28 ICING SUGARCALC SULPH, CALC FLUOR, CALC PHOS, FERR PHOS, KALI MUR, KALI PHOS, KALI SULPH, MAG PHOS, NAT PHOS, NAT SULPH, NAT MUR, SILICEABM Private Limited3e855f3b-c73d-a153-e063-6394a90ad63a2025-12-02WarningsExact identifier
unii: ETJ7Z6XBU4
Bestmade Natural Products Bio28CALC SULPH, CALC FLUOR, CALC PHOS, FERR PHOS, KALI MUR, KALI PHOS, KALI SULPH, MAG PHOS, NAT PHOS, NAT SULPH, NAT MUR, SILICEATotal Operations Management LLC DBA:Bestmade Natural Products Micro3e85a931-57f6-2a55-e063-6294a90ac1802025-12-02WarningsExact identifier
unii: ETJ7Z6XBU4
Bestmade Natural Products BIO28CALC SULPH, CALC FLUOR, CALC PHOS, FERR PHOS, KALI MUR, KALI PHOS, KALI SULPH, MAG PHOS, NAT PHOS, NAT SULPH, NAT MUR, SILICEATotal Operations Management LLC DBA: Bestmade Natural Products Micro3e46ee90-2c2c-0a70-e063-6294a90a576a2025-12-02WarningsExact identifier
unii: ETJ7Z6XBU4
DayTime Severe, Cold and Flu, 24-7 Life by 7-ElevenACETAMINOPHEN, DEXTROMETHORPHAN HBR, GUAIFENESIN, PHENYLEPHRINE HCL TABLET, FILM COATED TABLETLil' Drug Store Products, Inc.44fa0193-2a19-bdc1-e063-6394a90a60e82025-12-02WarningsExact identifier
unii: 362O9ITL9D
BM SiliceaSILICEABM Private Limited37b0535d-6bcf-2d40-e063-6294a90a2a8e2025-12-02WarningsExact identifier
unii: ETJ7Z6XBU4
BM Silicea Icing SugarSILICEA ICING SUGARBM Private Limited37c1f61d-dfe4-9dcf-e063-6394a90aceb12025-12-02WarningsExact identifier
unii: ETJ7Z6XBU4
Nighttime Severe, Cold and Flu, 24-7 Life by 7-ElevenACETAMINOPHEN, DEXTROMETHORPHAN HBR, DOXYLAMINE SUCCINATE, PHENYLEPHRINE HCL TABLET, FILM COATEDLil' Drug Store Products, Inc.44fb9958-d771-f4b3-e063-6294a90a91352025-12-02WarningsExact identifier
unii: 362O9ITL9D
Pain Reliever Extra StrengthACETAMINOPHEN, ASPIRIN AND CAFFEINERite Aid Corporationd9caee45-be43-45ec-927f-e7fec5c14f072025-12-02WarningsExact identifier
unii: 3G6A5W338E
unii: 362O9ITL9D
Pain Reliever PM Extra StrengthACETAMINOPHEN, DIPHENHYDRAMINE HCLWalgreen Companyb4d8860b-d72f-4789-945e-1c6420a8efab2025-12-02WarningsExact identifier
unii: 362O9ITL9D
Cold and Flu Relief DaytimeACETAMINOPHEN DEXTROMETHORPHAN HBR PHENYLEPHRINE HCLCARDINAL HEALTH 110, LLC. DBA LEADER 70000ac74be47-30f0-418b-bd07-502feaa9723f2025-12-01WarningsExact identifier
unii: 362O9ITL9D
Infants Pain and FeverACETAMINOPHENWALGREEN COMPANYf7b304d8-e37c-4ac6-b4a2-1797b92cb8322025-12-01WarningsExact identifier
unii: 362O9ITL9D
Dye FreeInfants Pain and FeverACETAMINOPHENWALGREEN COMPANY1a304570-88b6-4c16-a8b4-c064bfa5d95a2025-12-01WarningsExact identifier
unii: 362O9ITL9D

Reported adverse events (FAERS/openFDA)#

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