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 9 of 377 · 7,527 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
DG health mucus dmDEXTROMETHORPHAN HYDROBROMIDE, GUAIFENESINDolgencorp Inca95401cc-349e-435a-b953-4d8fd1f547442026-08-24WarningsExact identifier
unii: 9D2RTI9KYH
HyVee Extra Strength Headache Relief CAPLETACETAMINOPHEN, ASPIRIN, CAFFEINEHyVee Inc495c75bf-c09a-accd-e063-6294a90a75ec2026-08-24WarningsExact identifier
unii: 362O9ITL9D
Sterile WaterWATERREMEDYREPACK INC.5dd5d148-6e23-41de-bff5-551b2aea95982026-08-24Warnings, Adverse reactionsExact identifier
unii: 059QF0KO0R
Feverall ChildrensACETAMINOPHENSun Pharmaceutical Industries, Inc.861e2987-5473-45b0-b2a6-f980a9b0e8092026-08-24WarningsExact identifier
unii: 362O9ITL9D
AcetaminophenACETAMINOPHENWalgreens543f93d1-df14-0bd2-e063-6294a90a44132026-08-24WarningsExact identifier
unii: 362O9ITL9D
ACETAMINOPHENACETAMINOPHENAkron Pharma Inc.ab79fd60-8315-4c63-8045-1b0511ac268f2026-08-24WarningsExact identifier
unii: 362O9ITL9D
Doxylamine Succinate and Pyridoxine HydrochlorideDOXYLAMINE SUCCINATE AND PYRIDOXINE HYDROCHLORIDE, DELAYED RELEASE TABLETS 10 MG/10 MGPar Health USA, LLCde265fd1-bc22-4da1-aab5-b5fedd649c8b2026-08-24Warnings, Adverse reactionsExact identifier
unii: V9BI9B5YI2
Aging Eye FormulaCINERARIA MARITIMA, EYE (SUIS), CALCAREA FLUORICA, CAUSTICUM, PHOSPHORUS, SILICEA, ZINCUM METALLICUM, GERMANIUM METALLICUM, NATRUM MURIATICUMNutritional Specialties, Inc.d5b44f79-5299-4b31-ba45-0e511cdbe17c2026-08-24WarningsExact identifier
unii: 451W47IQ8X
Allergy ReliefDIPHENHYDRAMINE HCLWalgreen Company7d972559-6184-476b-9cbf-1bc5663ea00d2026-08-24WarningsExact identifier
application number: M012
migraine reliefACETAMINOPHEN, ASPIRIN, CAFFEINEWalgreen Company36503181-0fda-4127-b3f0-bdb1b56bb0ed2026-08-24WarningsExact identifier
unii: 362O9ITL9D
GOOD NEIGHBOR PHARMACY MUCUS DMDEXTROMETHORPHAN HYDROBROMIDE, GUAIFENESINAmerisource Bergenf0aea945-1c18-4c6f-a7d1-6d56624011bb2026-08-24WarningsExact identifier
unii: 9D2RTI9KYH
Cold, Flu and Sore ThroatACETAMINOPHEN, DEXTROMETHORPHAN HBR, GUAIFENESIN, PHENYLEPHRINE HCLMeijer Distribution, Inc.9be8437c-6053-4ed4-bdd2-97f556b5289e2026-08-24WarningsExact identifier
application number: M012
unii: 9D2RTI9KYH
unii: 04JA59TNSJ
unii: 362O9ITL9D
Genexa Infants Pain and FeverACETAMINOPHENGenexa Inc.4fd048c3-70bc-2ea7-e063-6394a90a55f22026-08-22WarningsExact identifier
unii: 362O9ITL9D
Genexa Kids Pain and FeverACETAMINOPHENGenexa Inc.59adabeb-97e8-2de4-e063-6394a90acc472026-08-22WarningsExact identifier
unii: 362O9ITL9D
Extra Strength Tylenol Cold Plus Flu Multi-Symptom Day NightACETAMINOPHEN, DEXTROMETHORPHAN HYDROBROMIDE, CHLORPHENIRAMINE MALEATEKenvue Brands LLC594f515c-b369-816d-e063-6294a90a59a12026-08-21WarningsExact identifier
application number: M012
DG HEALTH MULTI SYMPTOM SEVERE COLDACETAMINOPHEN, DEXTROMETHORPHAN HBR, PHENYLEPHRINE HCLDolgencorp, LLC47ddbb0d-0823-4817-9c56-e7fff77d601c2026-08-21WarningsExact identifier
application number: M012
unii: 9D2RTI9KYH
unii: 04JA59TNSJ
unii: 362O9ITL9D
Mucus Relief DM MaxDEXTROMETHORPHAN HBR, GUAIFENESINDOLGENCORP, LLC5be4e730-3cd6-414e-a23b-f6cad80887502026-08-21WarningsExact identifier
application number: M012
unii: 9D2RTI9KYH
Mucus Relief DM Cough Maximum StrengthDEXTROMETHORPHAN HBR AND GUAIFENESINCardinal Health 110, LLC. DBA Leader6304a581-9238-4539-b157-293fc05c173e2026-08-21WarningsExact identifier
application number: M012
unii: 9D2RTI9KYH
Headache ReliefACETAMINOPHEN, ASPIRIN, CAFFEINEPublix Super Markets Inca876daa7-ade3-497d-87bb-46d6e4dc185a2026-08-21WarningsExact identifier
unii: 362O9ITL9D
Rohto Optic GlowNAPHAZOLINE HYDROCHLORIDE, POVIDONE, PROPYLENE GLYCOLThe Mentholatum Companydf9c5f7c-96e6-4b2b-b8cb-21a6a3342dff2026-08-20WarningsExact identifier
unii: 6DC9Q167V3

Reported adverse events (FAERS/openFDA)#

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