FDA.reportPublic FDA data

NDC 51316-412 - CVS DayTime and NightTime Value Pack Cold and Flu

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
51316-412
Package NDCs from labels
51316-412-12
Manufacturer
CVS PHARMACY
Effective date
2026-08-19
Current FDA listing
Not matched in FDA.report NDC product tables

DailyMed Labels#

Label, Manufacturer, Effective date table
LabelManufacturerEffective dateType
CVS DayTime and NightTime Value Pack Cold and Flu - CVS PHARMACYCVS PHARMACY2026-08-19HUMAN OTC DRUG LABEL

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
51316-412-12CVS DayTime and NightTime Value PackCold and Flu354 mL in 1 BOTTLELIQUID354 mL10 mg in 30mL5

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
51316-412CVS DAYTIME AND NIGHTTIME VALUE PACK COLD AND FLU (ACETAMINOPHEN, PHENYLEPHRINE HYDROCHLORIDE, AND DOXYLAMINE SUCCINATE) KIT [CVS PHARMACY]4Unmatched20240821_4c813cd5-2c97-4fc3-926c-1a0396551a31.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 221 of 377 · 7,537 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
EXTRANEALICODEXTRIN, SODIUM CHLORIDE, SODIUM LACTATE, CALCIUM CHLORIDE, MAGNESIUM CHLORIDEVantive US Healthcare LLC5bf31b49-24c8-4021-98da-33a151f2fcbe2025-05-08Exact identifier
unii: 451W47IQ8X
DIANEAL LOW CALCIUM WITH DEXTROSESODIUM CHLORIDE, SODIUM LACTATE, CALCIUM CHLORIDE, MAGNESIUM CHLORIDE AND DEXTROSEVantive US Healthcare LLC50fc30a0-0eca-452e-825e-08c2647ccfc12025-05-08Exact identifier
unii: 451W47IQ8X
SUKKHI Polyamino Sugar Condensate Massage CreamSUKKHI POLYAMINO SUGAR CONDENSATE MASSAGE CREAMGUANGZHOU YUSONG FINE CHEMICLS Co., Ltd34aaf4ef-26dc-f87e-e063-6394a90a9a592025-05-08WarningsExact identifier
unii: PDC6A3C0OX
GuaifenesinGUAIFENESINAurohealth LLC4ec1477e-6e33-4c40-a476-cf7f4f00192b2025-05-08WarningsExact identifier
unii: 495W7451VQ
GuaifenesinGUAIFENESINAurohealth LLC30c27274-a051-4884-b41e-12943d92b1992025-05-08WarningsExact identifier
unii: 495W7451VQ
Severe ColdACETAMINOPHEN, DEXTROMETHORPHAN HBR, GUAIFENESIN, PHENYLEPHRINE HCLUnited Natural Foods, Inc. dba UNFIcf2dd1fb-1d5b-428e-8c9a-a46dbd7cb6452025-05-07WarningsExact identifier
application number: M012
unii: 9D2RTI9KYH
unii: 04JA59TNSJ
unii: 362O9ITL9D
unii: 495W7451VQ
ShameADRENALINUM, AGNUS CASTUS, ALOE, AMBRA GRISEA, AURUM MURIATICUM NATRONATUM, BARYTA CARBONICA, CALCAREA IODATA, CANDIDA ALBICANS, CEREBRUM SUIS, CINCHONA OFFICINALIS, DIGITALIS PURPUREA, HYPOTHALAMUS SUIS, IGNATIA AMARA, LAC DEFLORATUM, LYCOPODIUM CLAVATUM, NATRUM MURIATICUM, RHUS GLABRA, SACCHARUM OFFICINALE, SEROTONIN (HYDROCHLORIDE), STAPHYSAGRIA, THUJA OCCIDENTALISDeseret Biologicals, Inc.090e4a23-3e1b-4b0c-a0cc-0172b05f7b642025-05-07WarningsExact identifier
unii: 451W47IQ8X
EXTRANEALICODEXTRIN, SODIUM CHLORIDE, SODIUM LACTATE, CALCIUM CHLORIDE, MAGNESIUM CHLORIDEVantive US Healthcare LLCe18bacfe-af60-49dc-bd30-cb3c29fa16db2025-05-07Exact identifier
unii: 451W47IQ8X
EXTRANEALICODEXTRIN, SODIUM CHLORIDE, SODIUM LACTATE, CALCIUM CHLORIDE, MAGNESIUM CHLORIDEVantive US Healthcare LLC2b327b13-a0e9-4b2c-9875-4470998e2e302025-05-07Exact identifier
unii: 451W47IQ8X
Promethazine Hydrochloride and Dextromethorphan HydrobromidePROMETHAZINE HYDROCHLORIDE AND DEXTROMETHORPHAN HYDROBROMIDEAsclemed USA, Inc.702eb7c0-db4c-4729-b69e-99f64c63c7bd2025-05-07Boxed warning, Warnings, Adverse reactionsExact identifier
unii: 9D2RTI9KYH
Cough DMDEXTROMETHORPHAN POLISTIREXMeijer Distribution Inc3febf0e0-b587-495a-9608-3a2dfbc327912025-05-07WarningsExact identifier
unii: 9D2RTI9KYH
VirimmuneACONITUM NAPELLUS, ALLIUM CEPA, ALLIUM SATIVUM, ARSENICUM ALBUM, BAPTISIA TINCTORIA, CHELIDONIUM MAJUS, ECHINACEA (ANGUSTIFOLIA), GELSEMIUM SEMPERVIRENS, GINKGO BILOBA, HAMAMELIS VIRGINIANA, INFLUENZINUM (2024-2025), MERCURIUS VIVUS, MORBILLINUM, NATRUM MURIATICUM, NUX VOMICA, SELENIUM METALLICUM, VISCUM ALBUMDeseret Biologicals, Inc.ac036ad8-6f48-4c15-b021-dc9bbb7e642e2025-05-06WarningsExact identifier
unii: 451W47IQ8X
Good Neighbor Pharmacy Infants Pain and FeverACETAMINOPHENAmerisource Bergen2cfbb8ad-3ecb-432b-9eb4-16c51bf23bb22025-05-06WarningsExact identifier
unii: 362O9ITL9D
Gout Relief 3310-SCELERY SEED MEDICAGO SATIVA WHOLEBispit Canada Ltd.346f68ea-73aa-99c6-e063-6394a90af5d52025-05-05WarningsExact identifier
unii: 451W47IQ8X
Theraflu Severe Cold Relief DaytimeACETAMINOPHEN, DEXTROMETHORPHAN HBRHaleon US Holdings LLC2b962d87-6ff5-4c0f-8504-e5b61c9406122025-05-05WarningsExact identifier
application number: M012
unii: 9D2RTI9KYH
unii: 362O9ITL9D
8hr arthritis pain reliefACETAMINOPHENMajor Pharmaceuticals31b3aaa2-8af2-670a-e063-6394a90a80032025-05-03WarningsExact identifier
unii: 362O9ITL9D
Cough and Sore ThroatACETAMINOPHEN, DEXTROMETHORPHAN HYDROBROMIDE LIQUIDCVS2d13564a-e8d1-c357-e063-6394a90ad90e2025-05-02WarningsExact identifier
application number: M012
unii: 9D2RTI9KYH
unii: 362O9ITL9D
SUDAFED OM Sinus Severe No Drip Nasal Mist with Cooling MentholOXYMETAZOLINE HYDROCHLORIDEKenvue Brands LLC33fe0e49-3de5-8afd-e063-6294a90a0ad52025-05-02WarningsExact identifier
application number: M012
Daytime and Nighttime High Blood Pressure Cold and Flu LiquidACETAMINOPHEN, DEXTROMETHORPHAN HBR AND ACETAMINOPHEN, DEXTROMETHORPHAN HBR, DOXYLAMINE SUCCINATECVS Pharmacy, Inc.2d13964a-8cc4-f3dc-e063-6394a90aa1052025-05-02WarningsExact identifier
application number: M012
ACETAMINOPHENACETAMINOPHENAARNA USA INC.34157f6a-3031-4388-e063-6394a90a670f2025-05-01WarningsExact identifier
unii: 362O9ITL9D

Reported adverse events (FAERS/openFDA)#

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