NDC 51316-063 - Severe Congestion, Cough, Cold and Flu Relief Maximum Strength, Nighttime

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
51316-063
Package NDCs from labels
51316-063-45
Manufacturer
CVS WOONSOCKET PRESCRIPTION CENTER, INCORPORATED | LNK International, Inc.
Effective date
2025-10-17
Current FDA listing
Not matched in FDA.report NDC product tables

DailyMed Labels#

Label, Manufacturer, Effective date table
LabelManufacturerEffective dateType
CVS 44-004063CVS WOONSOCKET PRESCRIPTION CENTER, INCORPORATED | LNK International, Inc.2025-10-17HUMAN OTC DRUG LABEL

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
51316-063-45Severe Congestion, Cough, Cold and Flu ReliefMaximum Strength, Nighttime177 mL in 1 BOTTLE, PLASTICSOLUTION177 mL650 mg in 20mL5

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
51316-063SEVERE CONGESTION, COUGH, COLD AND FLU RELIEF MAXIMUM STRENGTH, NIGHTTIME (ACETAMINOPHEN, DEXTROMETHORPHAN HBR, GUAIFENESIN, PHENYLEPHRINE HCL, TRIPROLIDINE HCL) KIT [CVS WOONSOCKET PRESCRIPTION CENTER, INCORPORATED]4Unmatched20241017_92c570ff-139f-49ff-a7bd-8a540ecc07c7.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 27 of 341 · 6,807 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Mucus Relief DM CoughDEXTROMETHORPHAN HBR, GUAIFENESINAmerisource Bergen639a59b7-ccff-485e-a232-38b6808272292026-07-16WarningsExact identifier
application number: M012
unii: 9D2RTI9KYH
unii: 495W7451VQ
Acetaminophen Extra StrengthACETAMINOPHENDr. Reddy's Laboratories Inc.9d34abc2-3a9a-b68f-80d4-4ede1eb1e45f2026-07-15WarningsExact identifier
unii: 362O9ITL9D
Equate Nighttime Vapor Ice Cold and FluACETAMINOPHEN, DEXTROMETHORPHAN HYDROBROMIDE, DOXYLAMINE SUCCINATEWALMART INC.30470a01-4d42-44c6-a017-d68bb74cdef72026-07-15WarningsExact identifier
application number: M012
unii: 9D2RTI9KYH
unii: 362O9ITL9D
AcetaminophenACETAMINOPHENFamily Dollar, Inc.3f182571-3212-eb29-e063-6294a90a9fa02026-07-15WarningsExact identifier
unii: 362O9ITL9D
Quality Choice Effervescent Cold Relief - PlusASPIRIN, CHLORPHENIRAMINE MALEATE, PHENYLEPHRINE BITARTRATEChain Drug Marketing Association1f93fe6d-ee21-e323-e063-6394a90a61bf2026-07-15WarningsExact identifier
application number: M012
Pentrexcilina DaytimeACETAMINOPHEN, CHLORPHENIRAMINE MALEATE, PHENYLEPHRINE HCLOPMX LLCb7b3c15a-bb28-5c25-e053-2a95a90ad3b12026-07-15WarningsExact identifier
application number: M012
unii: 04JA59TNSJ
unii: 362O9ITL9D
Quality Choice Effervescent Cold Relief - OrangeASPIRIN, CHLORPHENIRAMINE MALEATE, PHENYLEPHRINE BITARTRATEChain Drug Marketing Association1f93c815-63c7-bfe0-e063-6394a90ab4a52026-07-15WarningsExact identifier
application number: M012
Mucus ReliefGUAIFENESINRugby Laboratoriesee413595-2687-4c38-84ce-18aac933d8e32026-07-15WarningsExact identifier
unii: 495W7451VQ
Nighttime Severe Cold and Flu Maximum Strength mini softgelsACETAMINOPHEN, DEXTROMETHORPHAN HBR, DOXYLAMINE SUCCINATE, PHENYLEPHRINE HCLShield Pharmaceuticals Corp5fa848ef-35ee-4e05-8ff2-781d034cf6ac2026-07-14WarningsExact identifier
application number: M012
unii: 9D2RTI9KYH
unii: 04JA59TNSJ
unii: 362O9ITL9D
Butalbital, Acetaminophen and CaffeineBUTALBITAL, ACETAMINOPHEN, AND CAFFEINESun Pharmaceutical Industries, Inc.a68de112-f5af-49ba-a8a8-3adbaa7df36e2026-07-14Boxed warning, Warnings, Adverse reactionsExact identifier
unii: 362O9ITL9D
Oxycodone Hydrochloride and AcetaminophenOXYCODONE HYDROCHLORIDE AND ACETAMINOPHENSt. Mary's Medical Park Pharmacy40a882d6-a4db-1ad9-e063-6394a90a72682026-07-14Boxed warning, Warnings, Adverse reactionsExact identifier
unii: 362O9ITL9D
Mucus Relief DM Extended Release CapletsGUAIFENESIN, DEXTROMETHORPHAN HBREQUATE (Wal-Mart Stores, Inc.) (see also WAL-MART INC)3850544d-0d25-429e-98a9-5c4ad6cfd2222026-07-14WarningsExact identifier
unii: 9D2RTI9KYH
unii: 495W7451VQ
Cough and Cold HBPCHLORPHENIRAMINE MALEATE, DEXTROMETHORPHAN HBRCardinal Health 110, LLC. DBA Leader0fad61d8-4393-47ec-9ff6-7df5be761f5b2026-07-14WarningsExact identifier
application number: M012
unii: 9D2RTI9KYH
Sinus and Allergy Relief PECHLORPHENIRAMINE MALEATE AND PHENYLEPHRINE HCLRite Aid Corporation211c4273-3b2c-4169-b9c6-7a87903e77cd2026-07-13WarningsExact identifier
application number: M012
unii: 04JA59TNSJ
Flu HBP Maximum StrengthACETAMINOPHEN, CHLORPHENIRAMINE MALEATE, DEXTROMETHORPHAN HBRRite Aid Corporationf1a4ee57-33a3-4791-a769-b208b38acb722026-07-13WarningsExact identifier
application number: M012
unii: 9D2RTI9KYH
unii: 362O9ITL9D
GOOD NEIGHBOR PHARMACY Childrens Allergy ReliefDIPHENHYDRAMINE HCLAMERISOURCE BERGENc499574c-f32b-4608-bf8b-51ad44e357252026-07-13WarningsExact identifier
application number: M012
BUTALBITAL, ACETAMINOPHEN AND CAFFEINEBUTALBITAL, ACETAMINOPHEN AND CAFFEINEBryant Ranch Prepackf6bd2076-869e-40de-94ce-6be43d50f6802026-07-13Boxed warning, Warnings, Adverse reactionsExact identifier
unii: 362O9ITL9D
Good NeighborChildrens Allergy Relief Bubblegum flavorDIPHENHYDRAMINE HCLAMERISOURCE BERGENf442c61b-7d2c-401c-b862-acbe2282927b2026-07-13WarningsExact identifier
application number: M012
SanatosMENTHOLPharmadel LLC5683b099-f029-2d08-e063-6394a90ad4822026-07-13WarningsExact identifier
application number: M012
Cold and Flu Relief NighttimeACETAMINOPHEN, DEXTROMETHORPHAN HBR, DOXYLAMINE SUCCINATEDolgencorp, Inc. (DOLLAR GENERAL & REXALL)f673cdeb-4f8b-46b4-be92-c725d74abc552026-07-13WarningsExact identifier
application number: M012
unii: 9D2RTI9KYH
unii: 362O9ITL9D

Reported adverse events (FAERS/openFDA)#

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