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 143 of 251 · 5,004 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Dr Simi Pain Reliever PMACETAMINOPHEN, DIPHENHYDRAMINE HYDROCHLORIDEFarmacias De Similares TX LLC3c19ad99-6e0f-3116-e063-6394a90a914c2025-08-11WarningsExact identifier
unii: TC2D6JAD40
Maximum Strength Mucus DM Extended ReleaseGUAIFENESIN AND DEXTROMETHORPHAN HBRCVS Pharmacy, Inc.5ea560d1-6443-4271-842c-7801fc6a60432025-08-11WarningsExact identifier
unii: 9D2RTI9KYH
Mucus DM Extended ReleaseGUAIFENESIN AND DEXTROMETHORPHAN HBRCVS Pharmacy, Inc.2aa1889f-bb76-4e70-81b5-c25c4ebab1132025-08-11WarningsExact identifier
unii: 9D2RTI9KYH
Norms HemorrhoidGLYCERIN, LIDOCAINE, PETROLATUM, PHENYLEPHRINE HCLTotally Normal Company3bdf8c74-3db6-1805-e063-6394a90aaba02025-08-08WarningsExact identifier
unii: PDC6A3C0OX
Systane COMPLETEPROPYLENE GLYCOLAlcon Laboratories, Inc.2df0de02-a3e2-471a-9e10-040c3fba75fe2025-08-08WarningsExact identifier
unii: 6DC9Q167V3
Promethazine Hydrochloride and Dextromethorphan HydrobromidePROMETHAZINE HYDROCHLORIDE AND DEXTROMETHORPHAN HYDROBROMIDEANI Pharmaceuticals, Inc.a52e210f-b99d-493e-b679-ec565c6ff72d2025-08-08Boxed warning, Warnings, Adverse reactionsExact identifier
unii: 9D2RTI9KYH
Diabetic Tussin DM Maximum StrengthDEXTROMETHORPHAN HYDROBROMIDE AND GUAIFENESINMEDTECH PRODUCTS INCa10a3b33-7503-4334-8ed7-2bb881df43272025-08-08WarningsExact identifier
application number: M012
unii: 9D2RTI9KYH
Allergy ReliefDIPHENHYDRAMINE HYDROCHLORIDECabinet Health, Inc26a55d74-f772-5d17-e063-6394a90a55832025-08-07WarningsExact identifier
application number: M012
unii: TC2D6JAD40
Durma DynaGelDURMA DYNAGELDynarex Corporation3bcbe314-98ca-78f1-e063-6394a90a13ad2025-08-07WarningsExact identifier
unii: PDC6A3C0OX
Medics Choice Fresh and SootheCARBOXYMETHYLCELLULOSE SODIUM, GLYCERINUnimed3bcd8394-f486-d306-e063-6294a90a4e9a2025-08-07WarningsExact identifier
unii: PDC6A3C0OX
Systane BalancePROPYLENE GLYCOLAlcon Laboratories, Inc.c7b1a03a-a5f2-409e-a34a-d6f166671de52025-08-07WarningsExact identifier
unii: 6DC9Q167V3
Nighttime Sleep AidNIGHTTIME SLEEP AIDAllegiant Health407ff0ee-41a3-4dea-95c8-556f664e115e2025-08-06WarningsExact identifier
unii: TC2D6JAD40
Daytime SevereACETAMINOPHEN, DEXTROMETHORPHAN HYDROBROMIDE, GUAIFENESIN, PHENYLEPHRINE HYDROCHLORIDEH E Bb7434978-44a8-4c51-979d-0bc446461e432025-08-06WarningsExact identifier
application number: M012
unii: 9D2RTI9KYH
Tussin DMDEXTROMETHORPHAN HBR, DOXYLAMINE SUCCINATECVS Pharmacyfc1e224c-5c57-43fc-ae6e-36aa0a4ae4392025-08-06WarningsExact identifier
application number: M012
unii: 9D2RTI9KYH
childrens cold cough dmBROMPHENIRAMINE MALEATE, DEXTROMETHORPHAN HYDROBROMIDEPublix Super Markets Inc6efe7097-2a99-4654-9d94-b47f2e64d19d2025-08-05WarningsExact identifier
application number: M012
rxcui: 2683421
unii: 9D2RTI9KYH
unii: IXA7C9ZN03
meijer EXTRA STRENGTH Pain Relief PM CAPLETACETAMINOPHEN, DIPHENHYDRAMINE HYDROCHLORIDEMeijer, Inc.376fed3b-7625-6379-e063-6394a90a188d2025-08-05WarningsExact identifier
unii: TC2D6JAD40
Sleep Aid Maximum StrengthDIPHENHYDRAMINE HCLH E B1069961c-ed3b-471f-a632-81024c37dbd92025-08-04WarningsExact identifier
unii: TC2D6JAD40
mucus dm extended releaseGUAIFENESIN, DEXTROMETHORPHAN HYDROBROMIDECVS Pharmacy6c9540ae-aea1-4717-8dca-60850ebdb1b42025-08-04WarningsExact identifier
unii: 9D2RTI9KYH
Quality Choice Throat Soothing Drops Creamy StrawberryPECTINChain Drug Marketing Association, Inc.3b7548ee-7cd3-62c3-e063-6294a90a06122025-08-03WarningsExact identifier
application number: M012
TopCare health NIGHTTIME MAXIMUM STRENGTH Sleep AidDIPHENHYDRAMINE HYDROCHLORIDETopco Associates LLC2ea0b2cf-f055-11f6-e063-6394a90a53642025-08-01WarningsExact identifier
unii: TC2D6JAD40

Reported adverse events (FAERS/openFDA)#

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