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 274 of 362 · 7,232 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Mucus Relief XpectGUAIFENSIN, DEXTROMETHORPHANMidway Importing Inc.c2c8bd26-bbf1-c2e6-e053-2995a90a86a72024-10-17WarningsExact identifier
application number: M012
unii: 9D2RTI9KYH
Pain Relief Regular StrengthACETAMINOPHENSTRATEGIC SOURCING SERVICES LLC6a5d43c8-f4b7-4447-b2e1-53eb12208ef02024-10-17WarningsExact identifier
unii: 362O9ITL9D
Pain Relief Extra StrengthACETAMINOPHENSTRATEGIC SOURCING SERVICES LLC9f0aef5d-20b0-469d-a58d-1cbf83a0dd8e2024-10-17WarningsExact identifier
unii: 362O9ITL9D
Antiflu Des Cough and FluACETAMINOPHEN PHENYLEPHRINE HCL CHLORPHENIRAMINE MALEATEProductos Farmaceuticos, S.A. de C.V.dcf3897a-a793-6df7-e053-2995a90a25f82024-10-17WarningsExact identifier
application number: M012
unii: 04JA59TNSJ
unii: 362O9ITL9D
ChemtoxTRITICUM AESTIVUM, BERBERIS VULGARIS, GLYCYRRHIZA GLABRA, LAPPA MAJOR, RHAMNUS FRANGULA, RHAMNUS PURSHIANA, STILLINGIA SYLVATICA, TRIFOLIUM PRATENSE, XANTHOXYLUM FRAXINEUM, PHYTOLACCA DECANDRA, GLANDULA SUPRARENALIS SUIS, HEPAR SUIS, LYMPH NODE (SUIS), THYROIDINUM (SUIS), BELLADONNA, LYCOPODIUM CLAVATUM, NITRICUM ACIDUM, NUX VOMICA, PHOSPHORICUM ACIDUM, PHOSPHORUS, SALICYLICUM ACIDUM, CORTISONE ACETICUM, EUGENOL, STEARYL ALCOHOL, XYLITOL, FOLLICULINUM, BENZOICUM ACIDUM, CHLORINUM, POTASSIUM SORBATE,BioActive Nutritional, Inc.9aa060f1-f8f6-46e6-a7d0-bd46a73f26762024-10-17WarningsExact identifier
unii: 506T60A25R
hemorrhoidalCOCOA BUTTER, PHENYLEPHRINE HCLH E B1435432d-5ff2-468b-808d-fb0c99a0717b2024-10-17WarningsExact identifier
unii: 04JA59TNSJ
AcetaminophenACETAMINOPHENRising Pharma Holdings, Inc.319ede76-110e-4902-a931-39a6d3b8c7312024-10-17WarningsExact identifier
unii: 362O9ITL9D
hemorrhoidalMINERAL OIL, PETROLATUM, PHENYLEPHRINE HCLMeijer Distribution Inc14319ba4-3bce-497c-a380-65bd24defc5d2024-10-17WarningsExact identifier
unii: 04JA59TNSJ
equate hemorrhoidalCOCOA BUTTER, PHENYLEPHRINE HCLWal-Mart Stores Inc581dd76f-d052-4448-8139-9a2e31891b252024-10-17WarningsExact identifier
unii: 04JA59TNSJ
Acetaminophen Extra StrengthACETAMINOPHENFSA Store Inc.ec6add55-f4a3-7818-e053-2a95a90aee042024-10-16WarningsExact identifier
unii: 362O9ITL9D
Allergy ReliefDIPHENHYDRAMINE HYDROCHLORIDEFSA STORE INC.ec6aef90-ece1-4fe6-e053-2995a90a93102024-10-16WarningsExact identifier
application number: M012
Acetaminophen PMACETAMINOPHEN AND DIPHENHYDRAMINE HYDROCHLORIDEFSA STORE INC.f4322f34-ac19-371e-e053-2a95a90ac8642024-10-16WarningsExact identifier
unii: 362O9ITL9D
Tukol MAX ACTION Cold, Sore Throat and CoughACETAMINOPHEN, DEXTROMETHORPHAN HBR, GUAIFENESIN, PHENYLEPHRINE HCLGenomma Lab USA, Incc8eebe64-00bf-436d-a9fc-1623401bebfa2024-10-16WarningsExact identifier
application number: M012
unii: 9D2RTI9KYH
unii: 04JA59TNSJ
unii: 362O9ITL9D
Pain ReliefACETAMINOPHENDISCOUNT DRUG MART850b5ad8-8774-413c-ae38-022215a94f952024-10-16WarningsExact identifier
unii: 362O9ITL9D
AllergyDIPHENHYDRAMINE HYDROCHLORIDEDiscount Drug Mart4f42c8d2-0538-4bcd-aac0-e26103a304992024-10-16WarningsExact identifier
application number: M012
Tukol MAX ACTION Severe Congestion and CoughDEXTROMETHORPHAN HBR, GUAIFENESIN, PHENYLEPHRINE HCLGenomma Lab USA, Inc9ac3e24a-d18a-48fc-8005-55393085d57b2024-10-16WarningsExact identifier
application number: M012
unii: 9D2RTI9KYH
unii: 04JA59TNSJ
LACTATED RINGERSSODIUM CHLORIDE, SODIUM LACTATE, POTASSIUM CHLORIDE, CALCIUM CHLORIDEBecton Dickinson and Companybb2ad9cd-5d9a-4337-be61-0842d738c79e2024-10-16Warnings, Adverse reactionsExact identifier
unii: 451W47IQ8X
Nighttime CoughDEXTROMETHORPHAN HYDROBROMIDE, DOXYLAMINE SUCCINATECVS WOONSOCKET PRESCRIPTION CENTER, INCORPORATED45471fdd-c4cd-46ad-a932-aa37327e8a412024-10-16WarningsExact identifier
application number: M012
unii: 9D2RTI9KYH
unii: V9BI9B5YI2
Equate HemorrhoidalMINERAL OIL, PETROLATUM, PHENYLEPHRINE HCLWal-Mart Stores Inc81ecb091-38da-4b3e-a0a1-b4986b97ee092024-10-16WarningsExact identifier
unii: 04JA59TNSJ
Elliotts BSODIUM CATION, SODIUM BICARBONATE, ANHYDROUS DEXTROSE, MAGNESIUM SULFATE, POTASSIUM CHLORIDE, CALCIUM CHLORIDE, SODIUM PHOSPHATELukare Medical, LLC08036dbd-55b3-47b9-9890-000f253544f32024-10-16Warnings, Adverse reactionsExact identifier
unii: 451W47IQ8X

Reported adverse events (FAERS/openFDA)#

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