FDA.reportPublic FDA data

NDC 51316-646 - CVS PHARMACY COLD and COUGH And NIGHTTIME VALUE PACK

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
51316-646
Package NDCs from labels
51316-646-04
Manufacturer
CVS PHARMACY, INC.
Effective date
2026-08-19
Current FDA listing
Not matched in FDA.report NDC product tables

DailyMed Labels#

Label, Manufacturer, Effective date table
LabelManufacturerEffective dateType
CVS PHARMACY COLD and COUGH And NIGHTTIME VALUE PACK - CVS PHARMACY, INC.CVS PHARMACY, INC.2026-08-19HUMAN OTC DRUG LABEL

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
51316-646-04CVS PHARMACYCOLD and COUGH And NIGHTTIME VALUE PACK118 mL in 1 BOTTLE, PLASTICLIQUID118 mL12.5 mg in 10mL2

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
51316-646CVS PHARMACY COLD AND COUGH AND NIGHTTIME VALUE PACK (BROMPHENIRAMINE MALEATE,DEXTROMETHORPHAN HBR,DIPHENHYDRAMINE HCL) KIT [CVS PHARMACY, INC.]1Unmatched20250322_4d94968b-ada3-4344-8563-cba7fc491d74.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 90 of 252 · 5,039 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
MUCUS RELIEFGUAIFENESIN 400 MGPioneer Life Sciences, LLC1194c338-e115-4105-93d8-9ab833c431932025-12-26WarningsExact identifier
application number: M012
Sleep AidDIPHENHYDRAMINE HCLSafeway, Inc.837ddc3a-a8d4-454f-974c-979732cb0a222025-12-26WarningsExact identifier
unii: TC2D6JAD40
MUCUS RELIEFGUAIFENESIN 400 MGPioneer Life Sciences, LLC9c9e558d-d991-4a2e-aa13-37c0b08071e62025-12-26WarningsExact identifier
application number: M012
MUCUS RELIEFGUAIFENESIN 400 MGPioneer Life Sciences, LLC1695e7ea-2f83-4d3a-980e-c91be6c1f2a52025-12-25WarningsExact identifier
application number: M012
PharbedrylDIPHENHYDRAMINE HCLPharbest Pharmaceuticals, Inc.070e556b-e083-452f-8a7c-aca92470dd612025-12-24WarningsExact identifier
unii: TC2D6JAD40
GUAIFENESINGUAIFENESINPharbest Pharmaceuticals, Inc.0bf70fb4-d3c8-476d-b864-4eadc697a7d82025-12-24WarningsExact identifier
application number: M012
PHARBEDRYLDIPHENHYDRAMINE HCLPharbest Pharmaceuticals, Inc.a19f1edc-d2cf-45fc-8233-d882441b02472025-12-24WarningsExact identifier
unii: TC2D6JAD40
CETAFEN COUGH and COLDACETAMINOPHEN, DEXTROMETHORPHAN HBR, PHENYLEPHRINE HCL , GUAIFENESIN, ,HART Health44da0d8c-4a12-4122-99da-781e2809e1a82025-12-24WarningsExact identifier
unii: 9D2RTI9KYH
PHARBINEX-DMGUAIFENESIN 400MG AND DEXTROMETHORPHAN HBR 20MGPharbest Pharmaceuticals, Inc.8d71db43-da87-45ee-aa4a-7e870bc5016d2025-12-24WarningsExact identifier
application number: M012
unii: 9D2RTI9KYH
Daytime Nighttime Cold Flu ReliefACETAMINOPHEN, DEXTROMETHORPHAN HBR, DOXYLAMINE SUCCINATE, PHENYLEPHRINE HCLSafeway, Inc.764bcc58-bc5f-4ee6-82b7-cb0ed5baf3be2025-12-23WarningsExact identifier
application number: M012
TussinGUAIFENESINDiscount Drug Mart14de3d6d-4eb0-42cf-8941-cb42b3dd5c712025-12-23WarningsExact identifier
application number: M012
Allergy ReliefDIPHENHYDRAMINE HCL 25 MGPioneer Life Sciences, LLCc8dcba06-a461-4af5-a120-666a63f06ac42025-12-23WarningsExact identifier
application number: M012
unii: TC2D6JAD40
SAFETUSSIN MAX STRENGTH MS Cough, Cold and FluACETAMINOPHEN, DEXTROMETHORPHAN HYDROBROMIDE, AND GUAIFENESINKRAMER LABORATORIES920bde5f-4079-45de-aa59-24b00e50cb562025-12-23WarningsExact identifier
application number: M012
unii: 9D2RTI9KYH
Daytime Cold and FluACETAMINOPHEN AND DEXTROMETHORPHAN HYDROBROMIDEHumanwell PuraCap Pharmaceuticals (Wuhan) Co., Ltd46996bbf-948c-0aba-e063-6394a90a09e32025-12-23WarningsExact identifier
application number: M012
unii: 9D2RTI9KYH
Nighttime Cold and FluACETAMINOPHEN, DEXTROMETHORPHAN HYDROBROMIDE, AND DOXYLAMINE SUCCINATELil' Drug Store Products, Inc.1d2e2a5a-099b-41b3-82bd-5bf704377f782025-12-23WarningsExact identifier
application number: M012
unii: 9D2RTI9KYH
Daytime Cold and FluACETAMINOPHEN, DEXTROMETHORPHAN HYDROBROMIDE, AND PHENYLEPHRINE HYDROCHLORIDELil' Drug Store Products, Inc.5b493ed7-9044-4841-9935-236d0bdc71a92025-12-23WarningsExact identifier
application number: M012
unii: 9D2RTI9KYH
Daytime Cold and FluACETAMINOPHEN, DEXTROMETHORPHAN HYDROBROMIDE, AND PHENYLEPHRINE HYDROCHLORIDELil' Drug Store Products, Inc.77a7ff9a-a414-4053-8d8d-369907d4380d2025-12-23WarningsExact identifier
application number: M012
unii: 9D2RTI9KYH
Nighttime Cold and FluACETAMINOPHEN, DEXTROMETHORPHAN HYDROBROMIDE, AND DOXYLAMINE SUCCINATELil' Drug Store Products, Inc.8f320235-f243-4211-b99c-18526e6865482025-12-23WarningsExact identifier
application number: M012
unii: 9D2RTI9KYH
Circle K Daytime Cold and FluACETAMINOPHEN, DEXTROMETHORPHAN HYDROBROMIDE, AND PHENYLEPHRINE HYDROCHLORIDELil' Drug Store Products, Inc.b6a46498-d9a8-4da2-9283-57d135f305a52025-12-23WarningsExact identifier
application number: M012
unii: 9D2RTI9KYH
Circle K Nighttime Cold and FluACETAMINOPHEN, DEXTROMETHORPHAN HYDROBROMIDE, AND DOXYLAMINE SUCCINATELil' Drug Store Products, Inc.7c5faec2-28c6-4c15-a268-d8b578140b742025-12-23WarningsExact identifier
application number: M012
unii: 9D2RTI9KYH

Reported adverse events (FAERS/openFDA)#

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