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 86 of 398 · 7,941 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Cold and Flu NighttimeACETAMINOPHEN, DEXTROMETHORPHAN HBR, DOXYLAMINE SUCCINATEBest Choice (Valu Merchandisers Company)d1131759-dd2e-4c06-bb73-92dd975f55112026-03-04WarningsExact identifier
application number: M012
unii: 9D2RTI9KYH
unii: 362O9ITL9D
AMAZON Maximim Strength Adult Nighttime Cough DMDEXTROMETHORPHAN HBR, DOXYLAMINE SUCCINATEAMAZON.COM SERVICES LLC6bbe8cc9-7a60-4476-b5cf-b13c5bebff262026-03-04WarningsExact identifier
application number: M012
unii: 9D2RTI9KYH
Severe Cold and Flu Daytime, NighttimeACETAMINOPHEN, CHLORPHENIRAMINE MALEATE, DEXTROMETHORPHAN HBR, GUAIFENESIN, PHENYLEPHRINE HCLCVS WOONSOCKET PRESCRIPTION CENTER, INCORPORATED5a1dfaf3-370d-4ac7-a72d-a48863a357412026-03-04WarningsExact identifier
application number: M012
Cold and FluACETAMINOPHEN, DEXTROMETHORPHAN HBR, PHENYLEPHRINE HCLWalgreen Companyc5cb09d4-c049-461c-8898-2c5bb6a8a1382026-03-04WarningsExact identifier
application number: M012
unii: 9D2RTI9KYH
unii: 362O9ITL9D
Tussin CFDEXTROMETHORPHAN HBR GUAIFENESIN PHENYLEPHRINE HCLWinCo Foods, LLC3d96d6d0-8c04-43bb-aed0-4cd00cdf34562026-03-04WarningsExact identifier
application number: M012
unii: 9D2RTI9KYH
DayTimeACETAMINOPHEN, DEXTROMETHORPHAN HBR, PHENYLEPHRINE HCLH E Be2994c0f-add8-4f75-a6d2-24cd2af271e42026-03-03WarningsExact identifier
application number: M012
unii: 9D2RTI9KYH
unii: 362O9ITL9D
NIGHTTIME CHERRY COLD AND FLUACETAMINOPHEN, DEXTROMETHORPHAN HYDROBROMIDE, AND DOXYLAMINE SUCCINATEBETTER LIVING BRANDS LLC.36924420-f514-4225-e063-6294a90a330c2026-03-03WarningsExact identifier
application number: M012
unii: 9D2RTI9KYH
unii: 362O9ITL9D
Infants Pain and FeverACETAMINOPHENKroger41e149df-4140-95cc-e063-6294a90a866b2026-03-03WarningsExact identifier
unii: 362O9ITL9D
Daytime Nighttime Ultra ConcentratedDAYTIME - ACETAMINOPHEN, DEXTROMETHORPHAN HBR, PHENYLEPHRINE HCL AND NIGHTTIME - ACETAMINOPHEN, DEXTROMETHORPHAN HBR, DOXYLAMINE SUCCINATECVS HEALTH CORP4584d701-5a4e-e54e-e063-6394a90a38d62026-03-03WarningsExact identifier
application number: M012
Hydrocodone Bitartrate and AcetaminophenHYDROCODONE BITARTRATE AND ACETAMINOPHENRedpharm Drug46c13d54-b181-4da2-e063-6294a90ab5c52026-03-03Boxed warning, Warnings, Adverse reactionsExact identifier
unii: 362O9ITL9D
foster and thrive nighttime cold and flu reliefACETAMINOPHEN, DEXTROMETHORPHAN HYDROBROMIDE, DOXYLAMINE SUCCINATESportpharm LLC7bdfd2ef-bb99-41f5-97ae-3a02c994bddd2026-03-03WarningsExact identifier
application number: M012
unii: 9D2RTI9KYH
unii: 362O9ITL9D
Medique at Home Decorel ForteACETAMINOPHEN, DEXTROMETHORPHAN HYDROBROMIDE, GUAIFENESIN, PHENYLEPHRINE HYDROCHLORIDESportpharm LLCd27b5976-8cc0-4d99-96f6-9069b786affd2026-03-03WarningsExact identifier
application number: M012
unii: 9D2RTI9KYH
unii: 362O9ITL9D
Medique Pain OffACETAMINOPHEN, ASPIRIN, CAFFEINESportpharm LLC2b35acdc-ff88-46e6-a108-5240aac1d53f2026-03-03WarningsExact identifier
unii: 362O9ITL9D
Childrens Pain and FeverACETAMINOPHENBest Choice (Valu Merchandisers Company)a8a0d9a5-1a36-4ed2-ae9c-7e1a3d674c072026-03-03WarningsExact identifier
unii: 362O9ITL9D
Tusnel EXGUAIFENESINA-S Medication Solutions7f703c9c-2256-4524-9d31-c51919399d262026-03-03WarningsExact identifier
application number: M012
Cough ReliefDEXTROMETHORPHAN HBRBest Choice (Valu Merchandisers Company)f49f1e9a-07ac-443e-9df8-3281d5f35e782026-03-03WarningsExact identifier
application number: M012
unii: 9D2RTI9KYH
berkley and jensen nasalOXYMETAZOLINE HYDROCHLORIDEBJWC77cbe75d-4ed9-4a8b-91dc-1cc28af255082026-03-02WarningsExact identifier
application number: M012
MUCUS DMDEXTROMETHORPHAN HYDROBROMIDE, GUAIFENESINHyVee Inc4ffa61d9-d24d-4982-a318-1660b56704e62026-03-02WarningsExact identifier
unii: 9D2RTI9KYH
childrens cold and cough relief dmBROMPHENIRAMINE MALEATE, DEXTROMETHORPHAN HYDROBROMIDEWalgreen Company6c7c950d-ed48-4428-9e9e-73684cabc6992026-02-28WarningsExact identifier
application number: M012
unii: 9D2RTI9KYH
Mineral OilMINERAL OILChain Drug Marketing Association3bfdad9c-ac58-4e92-b952-555e8a8351cd2026-02-27Warnings, Adverse reactionsExact identifier
unii: T5L8T28FGP

Reported adverse events (FAERS/openFDA)#

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