FDA.reportPublic FDA data

NDC 51316-604 - Acetaminophen, Dextromethorphan HBr, Chlorpheniramine Maleate

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
51316-604
Package NDCs from labels
51316-604-05
Manufacturer
CVS Pharmacy, Inc
Effective date
2025-10-21
Current FDA listing
Not matched in FDA.report NDC product tables

DailyMed Labels#

Label, Manufacturer, Effective date table
LabelManufacturerEffective dateType
Acetaminophen, Dextromethorphan HBr - CVS Pharmacy, IncCVS Pharmacy, Inc2025-10-21HUMAN OTC DRUG LABEL

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
51316-604-05Acetaminophen, Dextromethorphan HBr, Chlorpheniramine Maleate6 in 1 PACKETPOWDER6 in 1230 mg2

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
51316-604ACETAMINOPHEN, DEXTROMETHORPHAN HBR, CHLORPHENIRAMINE MALEATE KIT [CVS PHARMACY, INC]1Unmatched20240410_1532ee21-e114-ded7-e063-6294a90ab025.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 63 of 339 · 6,768 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Mucinex Childrens FreeFrom Multi-Symptom Cold and Stuffy NoseDEXTROMETHORPHAN HYDROBROMIDE, GUAIFENESIN, AND PHENYLEPHRINE HYDROCHLORIDEReckitt Benckiser LLCc07dad99-87b0-419b-9230-7c22a77ecf9e2026-04-21WarningsExact identifier
application number: M012
unii: 9D2RTI9KYH
Cough and Cold HBPCHLORPHENIRAMINE MALEATE, DEXTROMETHORPHAN HBRValu Merchandisers Company83db90da-9155-4f6a-8209-44c87d14b6962026-04-21WarningsExact identifier
application number: M012
unii: 9D2RTI9KYH
unii: V1Q0O9OJ9Z
Pain, Headache and CoughACETAMINOPHEN, DEXTROMETHORPHAN HBRCVS WOONSOCKET PRESCRIPTION CENTER, INCORPORATED613a2516-fc61-4bb4-bd44-ca60045481932026-04-21WarningsExact identifier
application number: M012
unii: 9D2RTI9KYH
unii: 362O9ITL9D
AcetaminophenACETAMINOPHENBetter Living Brands, LLCde3d9840-4ada-5c9a-e053-2a95a90a57212026-04-21WarningsExact identifier
unii: 362O9ITL9D
Syncol MaxACETAMINOPHEN, CAFFEINE, PYRILAMINE MALEATELaboratorios Sanfer, S.A. de C.V.c844d5c4-3e4b-4169-904e-eb5c3334bc4e2026-04-20WarningsExact identifier
unii: 362O9ITL9D
Guaifenesin and Dextromethorphan HydrobromideGUAIFENESIN AND DEXTROMETHORPHAN HYDROBROMIDECVS PHARMACY, INCdd00dfc0-e523-4dec-8fc0-50363eadec572026-04-20WarningsExact identifier
unii: 9D2RTI9KYH
Guaifenesin and Dextromethorphan HBrGUAIFENESIN AND DEXTROMETHORPHAN HBROHM LABORATORIES INC07b9854d-1ec6-4c8a-983e-96ed1e2de1c22026-04-20WarningsExact identifier
unii: 9D2RTI9KYH
Dr. Simi Allergy ReliefDIPHENHYDRAMINE HCLFarmacias De Similares TX LLC4fe8bbe3-13c9-5458-e063-6294a90a90642026-04-20WarningsExact identifier
application number: M012
Pamprin Multi-Symptom Maximum StrengthACETAMINOPHEN, PAMABROM, PYRILAMINE MALEATEFocus Consumer Healthcare, LLC60b3286d-5698-df50-e053-2991aa0afbe22026-04-20WarningsExact identifier
unii: 362O9ITL9D
Cold and Flu Day and Night, SevereACETAMINOPHEN, CHLORPHENIRAMINE MALEATE, DEXTROMETHORPHAN HBR, GUAIFENESIN, PHENYLEPHRINE HCLARMY AND AIR FORCE EXCHANGE SERVICE58d722ef-db67-44ac-a295-dd10e1f5ca1d2026-04-20WarningsExact identifier
application number: M012
Acetaminophen Extra StrengthACETAMINOPHENCVS PHARMACYaf6fe4a9-2d18-4fed-b952-0a7866f652512026-04-20WarningsExact identifier
unii: 362O9ITL9D
HYDROCODONE BITARTRATE AND ACETAMINOPHENHYDROCODONE BITARTRATE AND ACETAMINOPHENSpecGx LLC73c1059b-0c7d-42ef-9827-f018858fc4472026-04-20Boxed warning, Warnings, Adverse reactionsExact identifier
unii: 362O9ITL9D
Loratadine 10mgLORATADINEBETTER LIVING BRANDS, LLC46d615dd-45d5-2dfc-e063-6394a90a5d422026-04-18WarningsExact identifier
application number: M012
Multi-Symptom Cold DaytimeACETAMINOPHEN, DEXTROMETHORPHAN HBR, PHENYLEPHRINE HCLValu Merchandisers Companyd0f896a6-5637-45ef-bf60-b343cbcdcf7e2026-04-17WarningsExact identifier
application number: M012
unii: 9D2RTI9KYH
unii: 362O9ITL9D
Parry-500mg AcetaminophenACETAMINOPHENMDC PHARMACEUTICALS LIMITEDfb07ba10-3210-41bc-9310-c952118fdcf32026-04-17WarningsExact identifier
unii: 362O9ITL9D
Joint Tonic R IIHARPAGOPHYTUM PROCUMBENS, SALIX ALBA, COLCHICUM AUTUMNALE, PINUS SYLVESTRIS, SYMPHYTUM OFFICINALE, ACONITUM NAPELLUS, ARNICA MONTANA, GELSEMIUM SEMPERVIRENS, IRIS VERSICOLOR, LEDUM PALUSTRE, LESPEDEZA CAPITATA, RHUS TOX, SECALE CORNUTUM, SPIGELIA ANTHELMIA, SPIRAEA ULMARIA, TARTARICUM ACIDUMBioActive Nutritional, Inc.77afccf5-4e9c-45a1-8a6a-e686bcf22f162026-04-17WarningsExact identifier
unii: W4888I119H
MUCUS RELIEFGUAIFENESINBryant Ranch Prepack9ed5611f-4e1d-4f71-b430-a2a949bf7fe52026-04-17WarningsExact identifier
application number: M012
Multi-Symptom ColdACETAMINOPHEN, CHLORPHENIRAMINE MALEATE, DEXTROMETHORPHAN HBR, PHENYLEPHRINE HCLValu Merchandisers Companybf3158af-89ab-4b7c-9f39-0f316fbe90562026-04-17WarningsExact identifier
application number: M012
unii: 9D2RTI9KYH
unii: V1Q0O9OJ9Z
unii: 362O9ITL9D
MUCUS RELIEFGUAIFENESINBryant Ranch Prepack761825bc-f835-4947-bfa0-2940f1dff5fb2026-04-17WarningsExact identifier
application number: M012
Menstrual CompleteACETAMINOPHEN, CAFFEINE, PYRILAMINE MALEATEFamily Dollar Services Incd9050ed0-455d-4903-8f30-3e9ec9a128862026-04-17WarningsExact identifier
unii: 362O9ITL9D

Reported adverse events (FAERS/openFDA)#

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