FDA.reportPublic FDA data

NDC 51316-451 - Acetaminophen, Chlorpheniramine Maleate, Dextromethorphan HBr

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
51316-451
Package NDCs from labels
51316-451-01
Manufacturer
CVS Pharmacy, Inc
Effective date
2025-09-04
Current FDA listing
Not matched in FDA.report NDC product tables

DailyMed Labels#

Label, Manufacturer, Effective date table
LabelManufacturerEffective dateType
DEXTROMETHORPHAN HYDROBROMIDE - CVS Pharmacy, IncCVS Pharmacy, Inc2025-09-04HUMAN OTC DRUG LABEL

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
51316-451-01Acetaminophen, Chlorpheniramine Maleate, Dextromethorphan HBr10 in 1 BLISTER PACKTABLET, FILM COATED20 in 40500 mg2

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
51316-451ACETAMINOPHEN, CHLORPHENIRAMINE MALEATE, DEXTROMETHORPHAN HBR KIT [CVS PHARMACY, INC]1Unmatched20250403_31aa77e0-cfdb-57a8-e063-6394a90af98c.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 324 of 386 · 7,718 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Artificial TearsPOLYVINYL ALCOHOL, POVIDONENuCare Pharmaceuticals,Inc.9c1c4911-908e-3c3c-e053-2995a90abcfc2024-06-14WarningsExact identifier
unii: FZ989GH94E
Tukol Max Action Cold, Flu and Sore ThroatACETAMINOPHEN, DEXTROMETHORPHAN HYDROBROMIDE, GUAIFENESIN, AND PHENYLEPHRINE HYDROCHLORIDEGenomma Lab USAaedce1f9-4902-4c51-92e0-6056196394c22024-06-14WarningsExact identifier
application number: M012
unii: 9D2RTI9KYH
unii: 362O9ITL9D
Pain Relief Regular StrengthACETAMINOPHENCHAIN DRUG MARKETING ASSOCIATION INC613bc633-0426-41a7-aea9-9ff56311b6072024-06-13WarningsExact identifier
unii: 362O9ITL9D
Pain Relief Extra StrengthACETAMINOPHENChain Drug Marketing Associationcfaf9495-e654-4dfc-ba23-d2358c3720c42024-06-13WarningsExact identifier
unii: 362O9ITL9D
Migraine ReliefACETAMINOPHEN, ASPIRIN AND CAFFEINECHAIN DRUG MARKETING ASSOCIATION, INC.a6a07615-3108-436f-bbce-be7cb89ce4562024-06-13WarningsExact identifier
unii: 362O9ITL9D
8 Hour Pain ReliefACETAMINOPHENCHAIN DRUG MARKETING ASSOCIATION, INC.3ec966f5-bdcb-4bd8-b265-c776ba778f252024-06-13WarningsExact identifier
unii: 362O9ITL9D
Pain Relief Extra StrengthACETAMINOPHENCHAIN DRUG MARKETING ASSOCIATION, INC.9fdbaf5e-f88b-4d18-97df-0b2e8dddf3772024-06-13WarningsExact identifier
unii: 362O9ITL9D
8 Hour Arthritis PainACETAMINOPHENCHAIN DRUG MARKETING ASSOCIATION, INC.b098ebf6-a76d-4550-b5c4-fdc3b4ceb9a82024-06-13WarningsExact identifier
unii: 362O9ITL9D
Pain Relief Extra StrengthACETAMINOPHENCHAIN DRUG MARKETING ASSOCIATION, INC.1ac7ed71-5afe-d09c-e063-6294a90a3b882024-06-13WarningsExact identifier
unii: 362O9ITL9D
Pain Relief PM Extra StrengthACETAMINOPHEN AND DIPHENHYDRAMINE HYDROCHLORIDECHAIN DRUG MARKETING ASSOCIATION, INC.3ce5bbf2-d449-464e-abeb-5c26866d1ab52024-06-13WarningsExact identifier
unii: 362O9ITL9D
8HR Muscle Aches and PainACETAMINOPHENAAA Pharmaceutical, Inc.15abb899-e301-40e6-e063-6294a90a4bac2024-06-13WarningsExact identifier
unii: 362O9ITL9D
Migraine ReliefACETAMINOPHEN, ASPIRIN AND CAFFEINEDISCOUNT DRUG MART0ac12ced-70b3-7bbe-e063-6394a90aad522024-06-13WarningsExact identifier
unii: 362O9ITL9D
8HR Muscle Aches and PainACETAMINOPHENFSA STORE INC.13268603-0080-22cf-e063-6394a90a7db42024-06-13WarningsExact identifier
unii: 362O9ITL9D
Protectif UntintedZINC OXIDE AND TITANIUM DIOXIDEDerma Research Group Inc.1acd3f09-87f2-75e4-e063-6394a90a0cd92024-06-13WarningsExact identifier
unii: 15FIX9V2JP
topcare infants pain and feverACETAMINOPHENTopco Associates LLCf1e940ef-3cf0-4a5c-8158-156d0e5a680d2024-06-13WarningsExact identifier
unii: 362O9ITL9D
AcetaminophenACETAMINOPHENTrifecta Pharmaceuticals USA LLC026bf664-d598-73de-e063-6394a90a92062024-06-12WarningsExact identifier
unii: 362O9ITL9D
Regular Strength Pain ReliefACETAMINOPHENNuCare Pharmaceuticals,Inc.7c73fc75-af9b-177c-e053-2a91aa0ada562024-06-12WarningsExact identifier
unii: 362O9ITL9D
Acetaminophen and Codeine PhosphateACETAMINOPHEN AND CODEINE PHOSPHATENuCare Pharmaceuticals,Inc.7d69403e-90d0-7a80-e053-2a91aa0a55522024-06-12Boxed warning, Warnings, Adverse reactionsExact identifier
unii: 362O9ITL9D
Daytime Nighttime Cold Flu ReliefACETAMINOPHEN, DEXTROMETHORPHAN HBR, DOXYLAMINE SUCCINATE, PHENYLEPHRINE HCLUnited Natural Foods, Inc. dba UNFIdbc71f58-0704-4d2b-aed1-0dc01f9800062024-06-11WarningsExact identifier
application number: M012
ACETAMINOPHEN AND CODEINE PHOSPHATEACETAMINOPHEN AND CODEINE PHOSPHATENuCare Pharmaceuticals,Inc.6f2ce909-6356-1c2c-e053-2a91aa0a01352024-06-10Boxed warning, Warnings, Adverse reactionsExact identifier
unii: 362O9ITL9D

Reported adverse events (FAERS/openFDA)#

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