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 67 of 155 · 3,084 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Walgreens High Blood Pressure Cold and FluACETAMINOPHEN, DEXTROMETHORPHANWALGREENS CO.bc83b55e-c3d8-460f-8ef9-ff7b2e4f72722025-12-01WarningsExact identifier
unii: 362O9ITL9D
Walgreen High Blood Pressure Nighttime Cold and FluACETAMINOPHEN, DEXTROMETHORPHAN HYDROBROMIDE, AND DOXYLAMINE SUCCINATEWALGREENS CO.f1b7b58f-bbc3-441f-926f-d66e6a9b4e3a2025-12-01WarningsExact identifier
unii: 362O9ITL9D
Walgreen Severe Multi-Symptom Cough Cold FluACETAMINOPHEN, DEXTROMETHORPHAN HYDROBROMIDE, GUAIFENESIN, PHENYLEPHRINE HYDROCHLORIDEWALGREENSb48d93fe-bb60-493f-8d1a-b2dc864203c42025-12-01WarningsExact identifier
unii: 362O9ITL9D
WALGREENS Cold Cough and Flu ReliefACETAMINOPHEN, DEXTROMETHORPHAN HYDROBROMIDEWALGREENS CO.1e903034-942e-4c6e-9f96-eb097c2665802025-12-01WarningsExact identifier
unii: 362O9ITL9D
Advil Dual Action with Acetaminophen, Travel BASIXIBUPROFEN, ACETAMINOPHEN TABLET, FILM COATEDLil' Drug Store Products, Inc.030d9bca-a934-6ef9-e063-6394a90a82772025-12-01WarningsExact identifier
unii: 362O9ITL9D
CareALL Non Aspirin Extra StrengthACETAMINOPHENNew World Imports, Incda05a1a1-35b4-4787-8c56-12e369f18ff02025-12-01WarningsExact identifier
unii: 362O9ITL9D
CareALL Acetaminophen Extra StrengthACETAMINOPHENNew World Imports, Inc80a699b9-bf5c-4765-9e20-ccbc7e3ace7a2025-12-01WarningsExact identifier
unii: 362O9ITL9D
CareALL Acetaminophen Extra StrengthACETAMINOPHENNew World Imports, Inc66244cdb-2680-4fa8-890d-32aefd4900382025-12-01WarningsExact identifier
unii: 362O9ITL9D
Oxycodone and AcetaminophenOXYCODONE AND ACETAMINOPHENEpic Pharma, LLC700a229f-dc2d-7086-e053-2991aa0aec912025-12-01Boxed warning, Warnings, Adverse reactionsExact identifier
unii: 362O9ITL9D
Acetaminophen and CodeineACETAMINOPHEN AND CODEINEAmneal Pharmaceuticals LLC8bc4108b-314e-4a52-a37c-631c6b869b042025-12-01Boxed warning, WarningsExact identifier
application number: ANDA040779
ndc (product): 65162-033
rxcui: 993781
spl id: 75a6d334-42b8-44d0-a4a1-fd3eeb95008f
spl set id: 8bc4108b-314e-4a52-a37c-631c6b869b04
unii: GSL05Y1MN6
unii: 362O9ITL9D
ENDOCETOXYCODONE AND ACETAMINOPHENPar Health USA, LLC944d3e60-7eee-11de-a413-0002a5d5c51b2025-12-01Boxed warning, Warnings, Adverse reactionsExact identifier
unii: 362O9ITL9D
Acetaminophen and Codeine PhosphateACETAMINOPHEN AND CODEINE PHOSPHATEElite Laboratories, Inc.6286e128-1288-4dc0-b14b-f04a0e2a22f92025-12-01Boxed warning, Warnings, Adverse reactionsExact identifier
rxcui: 993781
unii: GSL05Y1MN6
unii: 362O9ITL9D
Daytime Cold and FluACETAMINOPHEN, DEXTROMETHORPHAN HBR, PHENYLEPHRINE HCLCVS PHARMACY, INCbbb1b395-48d9-4859-ad52-6650961089d92025-12-01WarningsExact identifier
unii: 362O9ITL9D
Family Wellness Childrens Pain Reliever 574ACETAMINOPHENFamily Dollar Services, Inc.902c1136-04d2-41f0-81c6-412663cdf3782025-12-01WarningsExact identifier
unii: 362O9ITL9D
Oxycodone and AcetaminophenOXYCODONE AND ACETAMINOPHENAlvogen, Inc.900ec197-720e-5428-b526-055b7756aa4a2025-11-30Boxed warning, Warnings, Adverse reactionsExact identifier
unii: 362O9ITL9D
Severe Sinus Pain and CongestionACETAMINOPHEN, GUAIFENESIN, PHENYLEPHRINE HCLCVS WOONSOCKET PRESCRIPTION CENTER, INCORPORATEDfbc541ac-9465-4296-bb1e-811b9d811f402025-11-26WarningsExact identifier
unii: 362O9ITL9D
Daytime Cold and Flu ReliefACETAMINOHPEN, DEXTROMETHORPHAN HBR, GUAIFENESIN PHENYLEPHRINE HCLWALGREENS CO.bfc58cd5-9815-43af-895d-ec6cbd10937e2025-11-26WarningsExact identifier
unii: 362O9ITL9D
WalgreenChildrens Pain FeverACETAMINOPHENWALGREENS CO.2f757cde-2604-4ca4-b54e-e444f3757cdd2025-11-26WarningsExact identifier
unii: 362O9ITL9D
Walgreen Childrens Pain plus FeverACETAMINOPHENWALGREENS CO.29ca2855-3c07-435d-a8e1-2997fcedd0882025-11-26WarningsExact identifier
unii: 362O9ITL9D
Walgreens Childrens Cold plus Cough plus Runny NoseACETAMINOPHEN, CHLORPHENIRAMINE MALEATE, AND DEXTROMETHORPHAN HYDROBROMIDEWALGREENS CO.8714d4e6-3a3b-48c8-8ac1-51b933a2ceac2025-11-26WarningsExact identifier
unii: 362O9ITL9D

Reported adverse events (FAERS/openFDA)#

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