NDC 70518-4601-01 - BUTALBITAL, ACETAMINOPHEN AND 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
70518-4601
Requested NDC
70518-4601-01
Package NDCs from labels
70518-4601-0, 70518-4601-1, 70518-4601-2, 70518-4601-01
Manufacturer
REMEDYREPACK INC.
Effective date
2026-09-18
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 50 mg/325 mg/40 mg CIII RX OnlyREMEDYREPACK INC.2026-09-18HUMAN PRESCRIPTION DRUG LABEL

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
70518-4601-0BUTALBITAL, ACETAMINOPHEN AND CAFFEINE90 in 1 BOTTLE, PLASTICTABLET904
70518-4601-1BUTALBITAL, ACETAMINOPHEN AND CAFFEINE150 in 1 BOTTLE, PLASTICTABLET1504
70518-4601-2BUTALBITAL, ACETAMINOPHEN AND CAFFEINE120 in 1 BOTTLE, PLASTICTABLET1204

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 68 of 189 · 3,780 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Acetaminophen Diphenhydramine HClACETAMINOPHEN DIPHENHYDRAMINE HCLGranules USA, Inc.8c9f68e3-fedc-6457-e053-2995a90a045a2025-12-22WarningsExact identifier
unii: 362O9ITL9D
Nighttime Cold and Flu ReliefACETAMINOPHEN, DEXTROMETHORPHAN HBR, DOXYLAMINE SUCCINATEHarris Teeter, LLC89fd57d2-fe49-41cb-b02e-9643e526cf472025-12-22WarningsExact identifier
unii: 362O9ITL9D
Cold and Flu severeACETAMINOPHEN,DEXTROMETHORPHAN HBR,GUAIFENESIN,PHENYLEPHRINE HCLWal-Mart Stores Inc9fca25dc-f63e-487a-8b7c-84d65ea51cb52025-12-19WarningsExact identifier
unii: 362O9ITL9D
Cold and Flu SevereACETAMINOPHEN, DEXTROMETHORPHAN HBR, GUAIFENESIN, PHENYLEPHRINE HCLGeiss, Destin & Dunn Inc.a7d2eaee-484e-43aa-8ae3-0e050219383f2025-12-19WarningsExact identifier
unii: 362O9ITL9D
Tension Headache ReliefACETAMINOPHEN, CAFFEINENUVICARE LLCea4e50e9-2c4d-4e58-b2cb-ab23e91fd50e2025-12-19WarningsExact identifier
unii: 3G6A5W338E
unii: 362O9ITL9D
AcetaminophenACETAMINOPHENWAL-MART STORES INC940936ac-e59f-7489-e053-2a95a90a63642025-12-19WarningsExact identifier
unii: 362O9ITL9D
AcetaminophenACETAMINOPHENWAL-MART STORES INCe34d07b5-ccbb-cd14-e053-2a95a90a394b2025-12-19WarningsExact identifier
unii: 362O9ITL9D
Acetaminophen and IbuprofenACETAMINOPHEN AND IBUPROFENWAL-MART STORES INC.0aaddde9-4317-a828-e063-6294a90a26d52025-12-19WarningsExact identifier
unii: 362O9ITL9D
AcetaminophenACETAMINOPHENWalmart175495fd-c561-f813-e063-6294a90aac802025-12-19WarningsExact identifier
unii: 362O9ITL9D
AcetaminophenACETAMINOPHENWALMART INC21b22e9f-b6d1-1819-e063-6294a90ae09c2025-12-19WarningsExact identifier
unii: 362O9ITL9D
Acetaminophen and Diphenhydramine HCLACETAMINOPHEN AND DIPHENHYDRAMINE HCLSAFEWAYf18c1aa2-5f8b-5458-e053-2995a90ab9472025-12-19WarningsExact identifier
unii: 362O9ITL9D
Acetaminophen, Aspirin and CaffeineACETAMINOPHEN, ASPIRIN AND CAFFEINESafeway, Incf2a2cbb5-5a63-7514-e053-2995a90a572c2025-12-19WarningsExact identifier
unii: 3G6A5W338E
unii: 362O9ITL9D
AcetaminophenACETAMINOPHENMEIJER DISTRIBUTION INCed23c587-7806-1f64-e053-2a95a90aea7f2025-12-19WarningsExact identifier
unii: 362O9ITL9D
AcetaminophenACETAMINOPHENMEIJER, INC.ed25620f-e39b-e30c-e053-2995a90af6212025-12-19WarningsExact identifier
unii: 362O9ITL9D
AcetaminophenACETAMINOPHENMeijer181b3148-fa33-c650-e063-6294a90a0de62025-12-19WarningsExact identifier
unii: 362O9ITL9D
AcetaminophenACETAMINOPHENRETAIL BUSINESS SERVICES,LLC.a0fb0afe-9c25-d0f6-e053-2995a90adbba2025-12-19WarningsExact identifier
unii: 362O9ITL9D
AcetaminophenACETAMINOPHENTOPCO ASSOCIATES LLC1a00a49e-f9ff-b928-e063-6394a90a4cb52025-12-19WarningsExact identifier
unii: 362O9ITL9D
Acetaminophen and Ibuprofen (NSAID)ACETAMINOPHEN AND IBUPROFEN (NSAID)RETAIL BUSINESS SERVICES,LLCe7b7009a-89a4-720d-e053-2a95a90abff72025-12-19WarningsExact identifier
unii: 362O9ITL9D
AcetaminophenACETAMINOPHENRETAIL BUSINESS SERVICES,LLC.a56791ec-0037-51a3-e053-2995a90af7612025-12-19WarningsExact identifier
unii: 362O9ITL9D
AcetaminophenACETAMINOPHENRAONBIO CORPf6f5251d-db89-4b69-e053-6394a90a10282025-12-19WarningsExact identifier
unii: 362O9ITL9D

Reported adverse events (FAERS/openFDA)#

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