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 75 of 377 · 7,527 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Pain Reliever plus Sleep Aid NightTimeACETAMINOPHEN, DIPHENHYDRAMINE HCLKroger Company286ca3b3-2ecc-4f90-adb5-d7bc0ba0b4d02026-04-02WarningsExact identifier
unii: 362O9ITL9D
Chewable Acetaminophen ChildrensACETAMINOPHENCardinal Health 110, LLC. DBA Leader8a18565c-b84e-43f8-8e96-e1dbcc39f08b2026-04-02WarningsExact identifier
unii: 362O9ITL9D
Childrens Pain RelieverACETAMINOPHENH E Bc713556c-cb9e-4ed2-bc2f-49b3d6256c0f2026-04-02WarningsExact identifier
unii: 362O9ITL9D
Nasal FourPHENYLEPHRINE HYDROCHLORIDEHyVee Inc19879fc8-4962-4c6e-87ed-b874d1d564af2026-04-01WarningsExact identifier
application number: M012
unii: 04JA59TNSJ
Cold and FluACETAMINOPHEN, DEXTROMETHORPHAN HBR, PHENYLEPHRINE HCLLidl US LLC7227b330-590b-4731-8a58-e05a0233dd8a2026-04-01WarningsExact identifier
application number: M012
rxcui: 1113705
unii: 9D2RTI9KYH
unii: 04JA59TNSJ
unii: 362O9ITL9D
rugby cough syrupDEXTROMETHORPHAN HYDROBROMIDE, GUAIFENESINPreferred Pharmaceuticals Incc0f389ec-a683-4555-8892-896b3165952a2026-04-01WarningsExact identifier
unii: 9D2RTI9KYH
SudoGestCHLORPHENIRAMINE MALEATE, PSEUDOEPHEDRINE HCLMajor Pharmaceuticals7cd8f7f3-c262-4f7c-bcaf-068be2c952f92026-04-01WarningsExact identifier
application number: M012
menstrual pain relief maximum strengthACETAMINOPHEN, PAMABROM, PYRILAMINE MALEATERite Aid Corporation4a4ce4cd-1554-4772-a6f4-8f78305449492026-04-01WarningsExact identifier
unii: 362O9ITL9D
Sanatos Daytime ReliefACETAMINOPHEN, DEXTROMETHORPHAN HBR, PHENYLEPHRINE HCLPharmadel LLC4c26be18-733a-e4a8-e063-6294a90a8b022026-04-01WarningsExact identifier
application number: M012
unii: 9D2RTI9KYH
unii: 04JA59TNSJ
unii: 362O9ITL9D
Sanatos Nighttime ReliefACETAMINOPHEN, DEXTROMETHORPHAN HBR, DOXYLAMINE SUCCINATEPharmadel LLC4c26c8bf-0143-ddca-e063-6294a90a35522026-04-01WarningsExact identifier
application number: M012
unii: 9D2RTI9KYH
unii: V9BI9B5YI2
unii: 362O9ITL9D
Codeine-GuaifenesinCODEINE PHOSPHATE AND GUAIFENESINMethod Pharmaceuticals, LLCfe126254-6ee6-48c3-965c-96e4276a53142026-04-01WarningsExact identifier
application number: M012
Walgreens Pain Relief with LidocaineLIDOCAINE, PHENYLEPHRINE HCLWalgreens Co3ce78f2f-0264-f406-e063-6294a90a7e032026-04-01WarningsExact identifier
unii: 04JA59TNSJ
Migraine and HeadacheIRIS VERSICOLOR ROOT AND SODIUM CHLORIDEForces of Nature0dd2f2e2-78e2-435e-b7b2-ca590953ff942026-04-01WarningsExact identifier
unii: 451W47IQ8X
Good Neighbor Pharmacy Mucus ReliefGUAIFENESINAmerisourceBergen Drug Corp200dddd9-e3ff-4cec-a164-d1c9a698f1212026-03-31WarningsExact identifier
application number: M012
Cold Sore FormulaDULCAMARA, GLYCYRRHIZA GLABRA, RANUNCULUS BULBOSUS, RHUS TOX, NATRUM MURIATICUM, FAGOPYRUM ESCULENTUM, NATRUM MURIATICUM, ACONITUM NAPELLUS, CYTOMEGALOVIRUS NOSODE, HERPES SIMPLEX I AND II NOSODE, SEPIA, EPSTEIN BARR VIRUS NOSODE, HERPES ZOSTER NOSODE, ADENOVIREN NOSODENutritional Specialties, Inc.f4e7e469-baaf-4c61-af44-80b0832eadf02026-03-31WarningsExact identifier
unii: 451W47IQ8X
Sodium Chloride Normal SaltSODIUM CHLORIDETWIN MED LLC10230c8a-e5e5-44f1-b41d-80930899d6b92026-03-31WarningsExact identifier
unii: 451W47IQ8X
Head and ColdACETAMINOPHEN, GUAIFENESIN, DEXTROMETHORPHAN HBR, PHENYLEPHRINE HCLHi-Tech Nutraceuticals, LLCa39c772b-3cce-14cb-e053-2a95a90a733b2026-03-31WarningsExact identifier
application number: M012
unii: 9D2RTI9KYH
unii: 04JA59TNSJ
unii: 362O9ITL9D
Tension Headache ReliefACETAMINOPHEN, CAFFEINEHi-Tech Nutraceuticals, LLCb119ba37-0ee3-851a-e053-2995a90a85b12026-03-31WarningsExact identifier
unii: 362O9ITL9D
diphenhydramine hydrochlorideDIPHENHYDRAMINE HYDROCHLORIDEHF Acquisition Co LLC, DBA HealthFirst44217a8c-7656-a0f6-e063-6294a90af2ad2026-03-31WarningsExact identifier
application number: M012
H-Allergy FormulaALLIUM CEPA, AMBROSIA ARTEMISIAEFOLIA, ARUM TRIPHYLLUM, ARUNDO MAURITANICA, EUPHRASIA OFFICINALIS, GALPHIMIA GLAUCA, HISTAMINUM HYDROCHLORICUM, KALI BICHROMICUM, NATRUM MURIATICUM, SOLIDAGO VIRGAUREA, STICTA PULMONARIA, SULPHUR, TRIFOLIUM PRATENSE, WYETHIA HELENIOIDESHealing Natural Oils LLC4e586360-b3c4-1ce0-e063-6394a90ab6b82026-03-31WarningsExact identifier
unii: 451W47IQ8X

Reported adverse events (FAERS/openFDA)#

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