NDC 51316-004 - 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
51316-004
Package NDCs from labels
51316-004-45
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
51316-004-45Severe Congestion, Cough, Cold and Flu ReliefMaximum Strength, Nighttime177 mL in 1 BOTTLE, PLASTICSOLUTION177 mL400 mg in 20mL5

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
51316-004SEVERE 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 213 of 336 · 6,712 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Tyson 2.0 Mike Red Eye Drops For Dry High EyesGLYCERIN, NAPHAZOLINE HCLJbrands Pharma L.L.C.288e9c85-0562-89bf-e063-6394a90a110d2025-02-07WarningsExact identifier
unii: PDC6A3C0OX
Pain ReliefACETAMINOPHENBETTER LIVING BRANDS LLC.f3008928-c555-64ad-e053-2995a90a73072025-02-05WarningsExact identifier
unii: 362O9ITL9D
Hydrocodone Bitartrate and AcetaminophenHYDROCODONE BITARTRATE AND ACETAMINOPHENNuCare Pharmaceuticals,Inc.fed1eb12-3e39-1bf9-e053-6294a90afd772025-02-05Boxed warning, Warnings, Adverse reactionsExact identifier
unii: 362O9ITL9D
Halls Sugar Free Honey LemonMENTHOLMondelez Global LLC5d56ccd2-1c28-4750-9454-44809091ad2f2025-02-05WarningsExact identifier
application number: M012
Pain Reliever PMACETAMINOPHEN, DIPHENHYDRAMINE HCLStrategic Sourcing Services LLC5d174187-cf89-41ff-9a64-10e0276daf172025-02-05WarningsExact identifier
unii: 362O9ITL9D
good sense pain reliefACETAMINOPHENBryant Ranch Prepackc226205d-7c3c-49af-b3e2-fc7b09ad78572025-02-05WarningsExact identifier
unii: 362O9ITL9D
ACETAMINOPHEN AND CODEINE PHOSPHATEACETAMINOPHEN AND CODEINE PHOSPHATENuCare Pharmaceuticals,Inc.73e2086e-f513-537f-e053-2991aa0a13482025-02-04Boxed warning, Warnings, Adverse reactionsExact identifier
unii: 362O9ITL9D
SanaTos Mucus Relief Cold ToddlersDEXTROMETHORPHAN HBR, GUAIFENESINPharmadel LLC60672feb-1421-651e-e053-2a91aa0af41d2025-02-04WarningsExact identifier
application number: M012
unii: 9D2RTI9KYH
unii: 495W7451VQ
SofSkin Vaporizing Chest Rub and Cough SuppressantCAMPHOR, MENTHOL, EUCALYPTUS OILViny Health and Beauty Inc34626cf5-64fc-15c0-e063-6294a90aa3102025-02-04WarningsExact identifier
application number: M012
Pain Reliever PMACETAMINOPHEN, DIPHENHYDRAMINE HCLCVS PHARMACY, INC17922df7-7867-4300-bd99-55aee7b606062025-02-04WarningsExact identifier
application number: M012
unii: 362O9ITL9D
Dye Free Childrens AcetaminophenACETAMINOPHENPAI Holdings, LLC dba PAI Pharmaa69fca9d-c0a0-4321-bf03-5c8e99cc07cc2025-02-04WarningsExact identifier
unii: 362O9ITL9D
Dextromethorphan hydrobromide and quinidine sulfateDEXTROMETHORPHAN HYDROBROMIDE AND QUINIDINE SULFATECamber Pharmaceuticals, Inc.7028dcb7-f436-4cf6-9beb-23c1d215c7982025-02-03Warnings, Adverse reactionsExact identifier
unii: 9D2RTI9KYH
Promethazine Hydrochloride and Dextromethorphan Hydrobromide Oral SolutionPROMETHAZINE HYDROCHLORIDE AND DEXTROMETHORPHAN HYDROBROMIDE ORAL SOLUTIONNuCare Pharmaceuticals,Inc.0b7bfbab-decb-970c-e063-6394a90a50ef2025-02-03Boxed warning, Warnings, Adverse reactionsExact identifier
unii: 9D2RTI9KYH
No Drip Nasal MistOXYMETAZOLINE SPRAYCVS Healthf4b8ff54-47b5-4d18-bf4e-b101abb22a242025-02-03WarningsExact identifier
application number: M012
Diphenhydramine HydrochlorideDIPHENHYDRAMINE HYDROCHLORIDEBryant Ranch Prepackf40bfdfc-1cb4-4604-9790-fb8d1d5173c62025-01-31WarningsExact identifier
application number: M012
TENSION HEADACHE RELIEFACETAMINOPHEN-CAFFEINETARGET CORPORATION8ed1679d-d3a1-11b1-e053-2995a90a61ad2025-01-31WarningsExact identifier
unii: 362O9ITL9D
AN12 Secret Therapy Feminine CleanserGLYCERINBESTVALUE Co., Ltdd2117c4c-9f1a-3a6e-e053-2995a90a0cc82025-01-31WarningsExact identifier
unii: PDC6A3C0OX
AN12 Skin Therapy Vita-B Aloe Soothing GelGLYCERINBESTVALUE Co., Ltdd274c973-057d-1c9f-e053-2995a90a82b12025-01-31WarningsExact identifier
unii: PDC6A3C0OX
AN12 ANUS PREMIUM CLEANSERGLYCERIN, ALLANTOINBESTVALUE Co., Ltdd11b7443-2dfc-3e17-e053-2a95a90afb762025-01-31WarningsExact identifier
unii: PDC6A3C0OX
ValuMeds Extra Strength Headache ReliefACETAMINOPHEN, ASPIRIN, CAFFEINECabinet Health P.B.C.0f864e73-e4b8-4e23-8990-8439ac17bd582025-01-31WarningsExact identifier
unii: 362O9ITL9D

Reported adverse events (FAERS/openFDA)#

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