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 238 of 392 · 7,835 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Acetaminophen and IbuprofenACETAMINOPHEN AND IBUPROFENAMERISOURCE BERGEN353136b4-884d-baa2-e063-6394a90a89e92025-05-15WarningsExact identifier
unii: 362O9ITL9D
Mucinex Nightshift Sinus Maximum StrengthACETAMINOPHEN, DEXTROMETHORPHAN HYDROBROMIDE, AND TRIPROLIDINE HYDROCHLORIDERB Health (US) LLC35322238-d498-1a52-e063-6394a90ac9c42025-05-15WarningsExact identifier
application number: M012
unii: 9D2RTI9KYH
unii: 362O9ITL9D
Theraflu Flu Relief Max Strength DaytimeACETAMINOPHEN, DEXTROMETHORPHAN HBRHaleon US Holdings LLCa1405038-80f2-45e5-bd8c-8c6b0ee348be2025-05-15WarningsExact identifier
application number: M012
unii: 9D2RTI9KYH
unii: 362O9ITL9D
Cold ReliefACETAMINOPHEN, DEXTROMETHORPHAN HBR, PHENYLEPHRINE HCLUnited Natural Foods, Inc. dba UNFIb919f0fe-fae0-4bd8-9ccd-d7569b2a70702025-05-13WarningsExact identifier
application number: M012
unii: 9D2RTI9KYH
unii: 362O9ITL9D
Childrens Robitussin Honey Nighttime Cough DMDEXTROMETHORPHAN HBR, DOXYLAMINE SUCCINATEHaleon US Holdings LLC6afaf85b-bf0c-4c99-acf3-a34f06be20f12025-05-13WarningsExact identifier
application number: M012
unii: 9D2RTI9KYH
Robitussin Honey Severe Cough, Flu Plus Sore ThroatACETAMINOPHEN, DEXTROMETHORPHAN HBRHaleon US Holdings LLC77be57fb-0ae5-4fad-97f3-b6a4b57383a92025-05-13WarningsExact identifier
application number: M012
unii: 9D2RTI9KYH
unii: 362O9ITL9D
good neighbor pharmacy childrens pain and feverACETAMINOPHENAmerisource Bergen268a789b-8f31-4739-9777-523249cac3262025-05-13WarningsExact identifier
unii: 362O9ITL9D
Topcare 8 Hour Pain ReliefACETAMINOPHENTopco Associates LLC38abe710-3d8a-41b0-b057-38c5dfd533222025-05-13WarningsExact identifier
unii: 362O9ITL9D
cough dmDEXTROMETHORPHAN POLISTIREXATLANTIC BIOLOGICALS CORP.73aede9d-37dd-4aa5-a906-0e0c94cecff12025-05-12WarningsExact identifier
unii: 9D2RTI9KYH
Bright Guard Sport SPFZINC SPFRENU LABORATORIES, LLCc9b48a9e-d69f-65a7-e053-2995a90a0baf2025-05-12WarningsExact identifier
unii: 15FIX9V2JP
AllergyCHLORPHENIRAMINE MALEATEBryant Ranch Prepackc948e612-a491-4ad0-adb9-cf31ef76e4d82025-05-12WarningsExact identifier
application number: M012
unii: V1Q0O9OJ9Z
Arthritis Pain ReliefACETAMINOPHENKROGER COMPANY0fec22a3-aad0-8c28-e063-6394a90adc182025-05-10WarningsExact identifier
unii: 362O9ITL9D
Maximum Strength Nighttime Severe Cold and FluACETAMINOPHEN, DEXTROMETHORPHAN HYDROBROMIDE, DOXYLAMINE SUCCINATE, PHENYLEPHRINE HYDROCHLORIDEProdose, Inc.c3d0b70f-d213-4e38-88ab-1c89d93a391d2025-05-10WarningsExact identifier
application number: M012
unii: 9D2RTI9KYH
unii: 362O9ITL9D
basic care acetaminophenACETAMINOPHENAmazon.com Services LLCe88731b1-a6a9-407a-b7f8-b58d88aa92642025-05-10WarningsExact identifier
unii: 362O9ITL9D
arthritis pain reliefACETAMINOPHENPublix Super Markets Incaf407852-5476-421d-a80a-d726c24b63912025-05-09WarningsExact identifier
unii: 362O9ITL9D
arthritis pain relieverACETAMINOPHENWalgreen Company5028c116-d0e3-4e30-8fa8-caaf08d99ec72025-05-09WarningsExact identifier
unii: 362O9ITL9D
Mineral Lip SunscreenTITANIUM DIOXIDE, ZINC OXIDEThe Maui Medical Group, Inc34b6aa46-657b-2676-e063-6294a90abadd2025-05-09Exact identifier
unii: 15FIX9V2JP
Childrens AllergyDIPHENHYDRAMINE HYDROCHLORIDESafeway, Inc.c639a36d-c683-4a4d-90b7-eadec7464aa22025-05-08WarningsExact identifier
application number: M012
BUTAL/APAP/CAFFEINEBUTAL/APAP/CAFFEINEDirect_Rx2abb9915-edb2-6218-e063-6394a90ad4622025-05-08Boxed warning, Warnings, Adverse reactionsExact identifier
unii: 362O9ITL9D
Tinted Lip SunscreenTITANIUM DIOXIDE, ZINC OXIDEScottsdale Skin Boutique and Dermatology Pllc34a5a99f-9e22-52ab-e063-6294a90a93232025-05-08Exact identifier
unii: 15FIX9V2JP

Reported adverse events (FAERS/openFDA)#

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