FDA.reportPublic FDA data

NDC 51316-130 - Cold and Flu Daytime 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
51316-130
Package NDCs from labels
51316-130-02
Manufacturer
CVS WOONSOCKET PRESCRIPTION CENTER, INCORPORATED | LNK International, Inc.
Effective date
2026-04-24
Current FDA listing
Not matched in FDA.report NDC product tables

DailyMed Labels#

Label, Manufacturer, Effective date table
LabelManufacturerEffective dateType
CVS 44-012013CVS WOONSOCKET PRESCRIPTION CENTER, INCORPORATED | LNK International, Inc.2026-04-24HUMAN OTC DRUG LABEL

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
51316-130-02Cold and FluDaytime Nighttime355 mL in 1 BOTTLE, PLASTICSOLUTION355 mL650 mg in 30mL7

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
51316-130COLD AND FLU DAYTIME NIGHTTIME (ACETAMINOPHEN, DEXTROMETHORPHAN HBR, DOXYLAMINE SUCCINATE, PHENYLEPHRINE HCL) KIT [CVS WOONSOCKET PRESCRIPTION CENTER, INCORPORATED]3Unmatched20240627_dcb33d5f-87fa-4043-9b6d-36adec96796c.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 67 of 377 · 7,527 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Hydrocodone Bitartrate and AcetaminophenHYDROCODONE BITARTRATE AND ACETAMINOPHENBryant Ranch Prepack69ce724d-6440-4def-aea9-26ad284ac35c2026-04-22Boxed warning, Warnings, Adverse reactionsExact identifier
unii: 362O9ITL9D
Oxycodone and AcetaminophenOXYCODONE AND ACETAMINOPHENBryant Ranch Prepack639aba0b-1ef6-415f-9732-ebf52bcc1b862026-04-22Boxed warning, Warnings, Adverse reactionsExact identifier
unii: 362O9ITL9D
Guaifenesin and Dextromethorphan HBrGUAIFENESIN AND DEXTROMETHORPHAN HBROHM LABORATORIES INCf2eb5494-2672-444f-afa3-d1ef8ed1eaa12026-04-22WarningsExact identifier
unii: 9D2RTI9KYH
Vicks Sinex SEVERE MOISTURIZING ULTRA FINE MISTOXYMETAZOLINE HYDROCHLORIDEProcter & Gamble Manufacturing GmbHf4b01827-7444-3bfc-e053-2a95a90aebed2026-04-22WarningsExact identifier
application number: M012
Vicks Sinex SEVERE ORIGINAL ULTRA FINE MISTOXYMETAZOLINE HYDROCHLORIDEProcter & Gamble Manufacturing GmbH,cfd43b8f-8064-6b88-e053-2a95a90a329e2026-04-22WarningsExact identifier
application number: M012
Vicks Sinex Severe OriginalOXYMETAZOLINE HYDROCHLORIDEProcter & Gamble Manufacturing GmbHcfd048c9-2f33-101d-e053-2995a90ad8542026-04-22WarningsExact identifier
application number: M012
Vicks Sinex SEVERE VapoCOOL ULTRA FINE MISTOXYMETAZOLINE HYDROCHLORIDEProcter & Gamble Manufacturing GmbHd0768332-7c24-7c30-e053-2a95a90a26d42026-04-22WarningsExact identifier
application number: M012
HistanazPSEUDOEPHEDRINE HCL, PYRILAMINE MALEATECapital Pharmaceutical, LLC3e87d0f3-f16c-5972-e063-6294a90acc8a2026-04-22WarningsExact identifier
application number: M012
Good Sense Severe Daytime Cold and FluACETAMINOPHEN, DEXTROMETHORPHAN HBR, GUAIFENESIN, PHENYLEPHRINE HCLL. Perrigo Companyd5faf89f-3641-4be1-8d43-35504f12fe8d2026-04-22WarningsExact identifier
application number: M012
unii: 9D2RTI9KYH
unii: 04JA59TNSJ
unii: 362O9ITL9D
Multi-Symptom Cold childrensDEXTROMETHORPHAN HBR, GUAIFENESIN, PHENYLEPHRINE HCLWALMART INC.5ee5eb75-fc56-42a1-bf2c-b9c10ea8bfd42026-04-22WarningsExact identifier
application number: M012
unii: 9D2RTI9KYH
unii: 04JA59TNSJ
good sense nasalOXYMETAZOLINE HYDROCHLORIDEL. Perrigo Company95f23049-e523-4c59-904c-b8e9ae82602c2026-04-22WarningsExact identifier
application number: M012
Pure Eyes Sterile EyesNAPHAZOLINE HYDROCHLORIDE AND GLYCERINSAMSON PHARMACEUTICALc0234e82-211f-4731-ac48-12db13b16e8a2026-04-21WarningsExact identifier
unii: PDC6A3C0OX
Mucinex Childrens FreeFrom Multi-Symptom Cold and Stuffy NoseDEXTROMETHORPHAN HYDROBROMIDE, GUAIFENESIN, AND PHENYLEPHRINE HYDROCHLORIDEReckitt Benckiser LLCc07dad99-87b0-419b-9230-7c22a77ecf9e2026-04-21WarningsExact identifier
application number: M012
unii: 9D2RTI9KYH
unii: 04JA59TNSJ
Cough and Cold HBPCHLORPHENIRAMINE MALEATE, DEXTROMETHORPHAN HBRValu Merchandisers Company83db90da-9155-4f6a-8209-44c87d14b6962026-04-21WarningsExact identifier
application number: M012
unii: 9D2RTI9KYH
Pain, Headache and CoughACETAMINOPHEN, DEXTROMETHORPHAN HBRCVS WOONSOCKET PRESCRIPTION CENTER, INCORPORATED613a2516-fc61-4bb4-bd44-ca60045481932026-04-21WarningsExact identifier
application number: M012
unii: 9D2RTI9KYH
unii: 362O9ITL9D
AcetaminophenACETAMINOPHENBetter Living Brands, LLCde3d9840-4ada-5c9a-e053-2a95a90a57212026-04-21WarningsExact identifier
unii: 362O9ITL9D
Syncol MaxACETAMINOPHEN, CAFFEINE, PYRILAMINE MALEATELaboratorios Sanfer, S.A. de C.V.c844d5c4-3e4b-4169-904e-eb5c3334bc4e2026-04-20WarningsExact identifier
unii: 362O9ITL9D
Guaifenesin and Dextromethorphan HydrobromideGUAIFENESIN AND DEXTROMETHORPHAN HYDROBROMIDECVS PHARMACY, INCdd00dfc0-e523-4dec-8fc0-50363eadec572026-04-20WarningsExact identifier
unii: 9D2RTI9KYH
Guaifenesin and Dextromethorphan HBrGUAIFENESIN AND DEXTROMETHORPHAN HBROHM LABORATORIES INC07b9854d-1ec6-4c8a-983e-96ed1e2de1c22026-04-20WarningsExact identifier
unii: 9D2RTI9KYH
Dr. Simi Allergy ReliefDIPHENHYDRAMINE HCLFarmacias De Similares TX LLC4fe8bbe3-13c9-5458-e063-6294a90a90642026-04-20WarningsExact identifier
application number: M012

Reported adverse events (FAERS/openFDA)#

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