FDA.reportPublic FDA data

NDC 67296-1772-01 - Acetaminophen and Codeine

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
67296-1772
Requested NDC
67296-1772-01
Package NDCs from labels
67296-1772-6, 67296-1772-1, 67296-1772-5, 67296-1772-01
Manufacturer
RedPharm Drug, Inc.
Effective date
2025-04-09
Current FDA listing
Not matched in FDA.report NDC product tables

DailyMed Labels#

Label, Manufacturer, Effective date table
LabelManufacturerEffective dateType
Acetaminophen and Codeine 300/30mg tabsRedPharm Drug, Inc.2025-04-09HUMAN PRESCRIPTION DRUG LABEL

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
67296-1772-62024-07-25C16284748780-11030e365-4867-111a-e063-dadaa90a10e2Acetaminophen and Codeine 300/30mg tabs
67296-1772-62024-01-30C16284748780-11030e365-4867-111a-e063-dadaa90a10e2Acetaminophen and Codeine 300/30mg tabs

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
67296-1772-1Acetaminophen and Codeine10 in 1 BOTTLETABLET105
67296-1772-5Acetaminophen and Codeine15 in 1 BOTTLE, PLASTICTABLET155
67296-1772-6Acetaminophen and Codeine6 in 1 BOTTLETABLET65

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
67296-1772ACETAMINOPHEN AND CODEINE TABLET [REDPHARM DRUG, INC.]5Current NDC, Legacy NDC, 3 package rows20250410_a35b4ba3-43c0-73c8-e053-2a95a90af5b5.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 50 of 155 · 3,094 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
acetaminophenACETAMINOPHENHF Acquisition Co LLC, DBA HealthFirst4870ff00-f727-814d-e063-6394a90a6c8e2026-01-15WarningsExact identifier
unii: 362O9ITL9D
SanaTos Severe Cold Relief NighttimeACETAMINOPHEN, DIPHENHYDRAMINE HYDROCHLORIDE, AND PHENYLEPHRINE HYDROCHLORIDEPharmadel LLC144aafcc-6ec2-a322-e063-6294a90afc272026-01-15WarningsExact identifier
unii: 362O9ITL9D
SanaTos Severe Cold and Cough DaytimeACETAMINOPHEN, DEXTROMETHORPHAN HYDROBROMIDE, AND PHENYLEPHRINE HYDROCHLORIDEPharmadel LLC14484bf5-ff45-b859-e063-6394a90a9a0f2026-01-15WarningsExact identifier
unii: 362O9ITL9D
BUTALBITAL, ASPIRIN, CAFFEINE and CODEINE PHOSPHATEBUTALBITAL, ASPIRIN, CAFFEINE AND CODEINE PHOSPHATEAmneal Pharmaceuticals of New York, LLC828e30fa-7bb1-486b-80ee-806fce45e4e42026-01-15Boxed warning, Warnings, Adverse reactionsExact identifier
unii: GSL05Y1MN6
ACETAMINOPHEN AND CODEINE PHOSPHATEACETAMINOPHEN AND CODEINE PHOSPHATEPreferred Pharmaceuticals Inc.55d494b1-c828-4841-8f64-75b92cd54cb62026-01-14Boxed warning, Warnings, Adverse reactionsExact identifier
unii: GSL05Y1MN6
unii: 362O9ITL9D
Leader Vapor Ice Cold and FluACETAMINOPHEN, DEXTROMETHORPHAN HYDROBROMIDECardinal Health 110, LLC. dba Leaderf27bf0b2-25cc-474c-ab6b-f227ed3525fa2026-01-14WarningsExact identifier
unii: 362O9ITL9D
Unisom PM Pain Nighttime Sleep Aid and Pain RelieverACETAMINOPHEN AND DIPHENHYDRAMINE HYDROCHLORIDEChattem, Inc.451daeeb-88a9-44b1-9a2d-1ff0b0ec41cb2026-01-14WarningsExact identifier
unii: 362O9ITL9D
ACETAMINOPHEN AND CODEINE PHOSPHATEACETAMINOPHEN AND CODEINE PHOSPHATEPreferred Pharmaceuticals Inc.2453d635-989d-4569-96b3-4efaf61cca712026-01-14Boxed warning, Warnings, Adverse reactionsExact identifier
rxcui: 993781
unii: GSL05Y1MN6
unii: 362O9ITL9D
Nighttime Cold and FluACETAMINOPHEN, DEXTROMETHORPHAN HBR, DOXYLAMINE SUCCINATEBETTER LIVING BRANDS LLC.41f4bf6d-f83c-92e4-e063-6394a90aebab2026-01-13WarningsExact identifier
unii: 362O9ITL9D
Severe Cold and FluACETAMINOPHEN, DEXTROMETHORPHAN HYDROBROMIDE, GUAIFENESIN, AND PHENYLEPHRINE HYDROCHLORIDEHYVEE INC462cbf3d-51b1-dab9-e063-6394a90a70ba2026-01-13WarningsExact identifier
unii: 362O9ITL9D
Pain Terminator Extra Strength Pain ReliefCAFFEINE, ACETAMINOPHEN, ASPIRINWildman Business Group8ffb02d9-92df-4d2f-a367-1c71490807fb2026-01-12WarningsExact identifier
unii: 362O9ITL9D
Acetaminophen and IbuprofenACETAMINOPHEN AND IBUPROFENBIONPHARMA INC.4834aa7f-cb0c-ec58-e063-6394a90ae2fc2026-01-12WarningsExact identifier
unii: 362O9ITL9D
Tramadol Hydrochloride and AcetaminophenTRAMADOL HYDROCHLORIDE AND ACETAMINOPHENAvPAK244f6e5d-e1b4-ba8b-ca6f-af2d8a31d5f02026-01-12Warnings, Adverse reactionsExact identifier
unii: 362O9ITL9D
OXYCODONE AND ACETAMINOPHENOXYCODONE AND ACETAMINOPHENKVK-Tech, Inc.9986aa04-c976-4654-8ad7-b97d2eecea932026-01-12Boxed warning, Warnings, Adverse reactionsExact identifier
unii: 362O9ITL9D
AcetaminophenACETAMINOPHENPD-Rx Pharmaceuticals, Inc.64696f65-415e-4ce1-a5b3-70662fbcb0022026-01-12WarningsExact identifier
unii: 362O9ITL9D
Tension HeadacheACETAMINOPHEN, CAFFEINECardinal Health 110, LLC. DBA Leader96684e3f-a13e-49c3-b437-d2627e528a2d2026-01-12WarningsExact identifier
unii: 362O9ITL9D
Sinu-Phen Plus Sinus Pain and PressureACETAMINOPHEN, PHENYLEPHRINE HYDROCHLORIDEWildman Business Groupc66e0b52-5531-4a84-ae90-8a26d27df1ec2026-01-12WarningsExact identifier
unii: 362O9ITL9D
Daytime Cold and FluDAYTIME COLD AND FLUAllegiant Health69ed2da0-16b2-49eb-91b4-cc5cf328c8172026-01-09WarningsExact identifier
unii: 362O9ITL9D
Butalbital, Acetaminophen, Caffeine, and Codeine PhosphateBUTALBITAL, ACETAMINOPHEN, CAFFEINE, AND CODEINE PHOSPHATEActavis Pharma, Inc.a58819b8-a52c-44a7-9ab0-c74480d985062026-01-09Boxed warning, Warnings, Adverse reactionsExact identifier
unii: GSL05Y1MN6
unii: 362O9ITL9D
Xpect AcetaminophenACETAMINOPHENCintas Corporationf4aed854-730e-493d-b523-122156e08dde2026-01-09WarningsExact identifier
unii: 362O9ITL9D

Reported adverse events (FAERS/openFDA)#

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