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 124 of 341 · 6,807 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
AcetaminophenACETAMINOPHENWALMART INC21b22e9f-b6d1-1819-e063-6294a90ae09c2025-12-19WarningsExact identifier
unii: 362O9ITL9D
Acetaminophen and Diphenhydramine HCLACETAMINOPHEN AND DIPHENHYDRAMINE HCLSAFEWAYf18c1aa2-5f8b-5458-e053-2995a90ab9472025-12-19WarningsExact identifier
unii: 362O9ITL9D
Cherry Cough DropsMENTHOLPublix66d8e5f7-9766-57f3-e053-2991aa0a7e172025-12-19WarningsExact identifier
application number: M012
Honey Lemon Cough DropsMENTHOLPublix66e89fa3-ee09-1d16-e053-2a91aa0ae17c2025-12-19WarningsExact identifier
application number: M012
Acetaminophen, Aspirin and CaffeineACETAMINOPHEN, ASPIRIN AND CAFFEINESafeway, Incf2a2cbb5-5a63-7514-e053-2995a90a572c2025-12-19WarningsExact identifier
unii: 362O9ITL9D
GuaifenesinGUAIFENESINSafeway, Incf32e5b0f-1fd9-9b33-e053-2995a90a81032025-12-19WarningsExact identifier
unii: 495W7451VQ
AcetaminophenACETAMINOPHENMEIJER DISTRIBUTION INCed23c587-7806-1f64-e053-2a95a90aea7f2025-12-19WarningsExact identifier
unii: 362O9ITL9D
AcetaminophenACETAMINOPHENMEIJER, INC.ed25620f-e39b-e30c-e053-2995a90af6212025-12-19WarningsExact identifier
unii: 362O9ITL9D
AcetaminophenACETAMINOPHENMeijer181b3148-fa33-c650-e063-6294a90a0de62025-12-19WarningsExact identifier
unii: 362O9ITL9D
Poly-Vent DMDEXTROMETHORPHAN HBR, GUAIFENESIN AND PSEUDOEPHEDRINE HCLPoly Pharmaceuticals, Inc.739329ae-0b62-4eab-a07d-867b5d3d61e02025-12-19WarningsExact identifier
application number: M012
unii: 9D2RTI9KYH
unii: 495W7451VQ
AcetaminophenACETAMINOPHENRETAIL BUSINESS SERVICES,LLC.a0fb0afe-9c25-d0f6-e053-2995a90adbba2025-12-19WarningsExact identifier
unii: 362O9ITL9D
AcetaminophenACETAMINOPHENTOPCO ASSOCIATES LLC1a00a49e-f9ff-b928-e063-6394a90a4cb52025-12-19WarningsExact identifier
unii: 362O9ITL9D
Acetaminophen and Ibuprofen (NSAID)ACETAMINOPHEN AND IBUPROFEN (NSAID)RETAIL BUSINESS SERVICES,LLCe7b7009a-89a4-720d-e053-2a95a90abff72025-12-19WarningsExact identifier
unii: 362O9ITL9D
AcetaminophenACETAMINOPHENRETAIL BUSINESS SERVICES,LLC.a56791ec-0037-51a3-e053-2995a90af7612025-12-19WarningsExact identifier
unii: 362O9ITL9D
Chest Congestion and Cough Relief DMDEXTROMETHORPHAN HBR, GUAIFENESINARMY AND AIR FORCE EXCHANGE SERVICE89494a7c-cdbf-48f1-aaa9-2e57d4388a682025-12-19WarningsExact identifier
application number: M012
unii: 9D2RTI9KYH
unii: 495W7451VQ
AcetaminophenACETAMINOPHENRAONBIO CORPf6f5251d-db89-4b69-e053-6394a90a10282025-12-19WarningsExact identifier
unii: 362O9ITL9D
AcetaminophenACETAMINOPHENWALGREENS8f8d43d1-8e73-483e-e053-2a95a90ac99b2025-12-19WarningsExact identifier
unii: 362O9ITL9D
DayTime Cold/Flu ReliefACETAMINOPHEN, DEXTROMETHORPHAN HBR, PHENYLEPHRINE HCLARMY AND AIR FORCE EXCHANGE SERVICE04f9134e-1311-4843-90db-9244b9e61e1d2025-12-19WarningsExact identifier
application number: M012
unii: 9D2RTI9KYH
unii: 04JA59TNSJ
unii: 362O9ITL9D
Nighttime Cold/Flu ReliefACETAMINOPHEN, DEXTROMETHORPHAN HBR, DOXYLAMINE SUCCINATEARMY AND AIR FORCE EXCHANGE SERVICE029e6215-b72d-4fd0-8918-db1abcc4490a2025-12-19WarningsExact identifier
application number: M012
unii: 9D2RTI9KYH
unii: 362O9ITL9D
AcetaminophenACETAMINOPHENPUBLIX SUPERMARKETS, INC08f57305-0c4b-96b1-e063-6394a90a77df2025-12-19WarningsExact identifier
unii: 362O9ITL9D

Reported adverse events (FAERS/openFDA)#

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