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 168 of 381 · 7,602 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
TOPCARE Multi Symptom Flu Relief Combo PackACETAMINOPHEN, DEXTROMETHORPHAN HBR, AND ACETAMINOPHEN, CHLORPHENIRAMINE MALEATE, DEXTROMETHORPHAN HBRTopco Associates, LLC01c517e5-d693-4926-9eb5-4b894a2f69172025-11-11WarningsExact identifier
application number: M012
Butalbital, Acetaminophen, and CaffeineBUTALBITAL, ACETAMINOPHEN, AND CAFFEINEAvKAREf5bbad36-6a0e-3518-3f12-138ae9f639802025-11-11Boxed warning, Warnings, Adverse reactionsExact identifier
unii: 362O9ITL9D
Tylenol PM Extra StrengthACETAMINOPHEN AND DIPHENHYDRAMINE HYDROCHLORIDENavajo Manufacturing Company Inc.435b1a31-353d-af20-e063-6294a90aa9072025-11-11WarningsExact identifier
unii: 362O9ITL9D
Tylenol Sinus SevereACETAMINOPHEN, GUAIFENESIN, AND PHENYLEPHRINE HYDROCHLORIDENavajo Manufacturing Company Inc.435b4a2a-d6bf-ec25-e063-6294a90a3f062025-11-11WarningsExact identifier
application number: M012
unii: 04JA59TNSJ
unii: 362O9ITL9D
unii: 495W7451VQ
TYLENOL Cold Plus Flu SevereACETAMINOPHEN, DEXTROMETHORPHAN HYDROBROMIDE, GUAIFENESIN, AND PHENYLEPHRINE HYDROCHLORIDENavajo Manufacturing Company Inc.435e6387-1ee0-c20f-e063-6294a90adac52025-11-11WarningsExact identifier
application number: M012
unii: 9D2RTI9KYH
unii: 04JA59TNSJ
unii: 362O9ITL9D
unii: 495W7451VQ
SODIUM CHLORIDESODIUM CHLORIDEHospira, Inc.af6aebad-ef03-4d19-9a40-18e5a278b8122025-11-11Warnings, Adverse reactionsExact identifier
unii: 451W47IQ8X
Mucus Relief DMGUAIFENESIN, DEXTROMETHORPHAN HBRDolgencorp, Inc. (DOLLAR GENERAL & REXALL)2426bf76-19bf-4bfd-8f9e-3b348e4b56412025-11-11WarningsExact identifier
unii: 9D2RTI9KYH
unii: 495W7451VQ
Good Neighbor Pharmacy Pain ReliefACETAMINOPHENAmerisource Bergen4b829607-f5fb-427f-83b5-5b6b9c44ebeb2025-11-11WarningsExact identifier
unii: 362O9ITL9D
BuscapinaACETAMINOPHEN, CAFFEINE, PYRILAMINE MALEATEOPMX LLC10b09674-d6bd-41cd-b92c-b5b6a0fd2f5b2025-11-10WarningsExact identifier
application number: M012
unii: 362O9ITL9D
Hydrocodone Bitartrate and AcetaminophenHYDROCODONE BITARTRATE AND ACETAMINOPHENAsclemed USA, Inc.d1de0f93-1439-4ee3-b692-56e1a14006822025-11-10Boxed warning, Warnings, Adverse reactionsExact identifier
unii: 362O9ITL9D
Pamprin Max Menstrual Pain ReliefACETAMINOPHEN AND ASPIRIN AND CAFFEINEFocus Consumer Healthcare, LLC5bd4b935-f003-7df8-e053-2a91aa0a5d792025-11-10WarningsExact identifier
unii: 362O9ITL9D
FARGELIN HEMORRHOIDALCALAMINE, PETROLATUM AND PHENYLEPHRINE HYDROCHLORIDEMADISON ONE ACME INC6844ad63-512d-496a-9458-011894185b0d2025-11-10WarningsExact identifier
unii: 04JA59TNSJ
GURUNANDA NASAL SALINENASAL WASHGURUNANDA LLC27dbf0bf-c273-2108-e063-6394a90a0a092025-11-10WarningsExact identifier
unii: 451W47IQ8X
Leader 8HR Arthritis Pain ReliefACETAMINOPHENCardinal Health 110, LLC. dba Leader2b28e5aa-da4b-4fee-ad49-e5fd6f1c65f62025-11-10WarningsExact identifier
unii: 362O9ITL9D
good sense migraine formulaACETAMINOPHEN, ASPIRIN, CAFFEINEL. Perrigo Company93e7ba56-5682-4184-9a93-3b4b972b0e722025-11-10WarningsExact identifier
unii: 362O9ITL9D
TOPCARE Childrens Allergy ChewsDIPHENHYDRAMINE HCLTopco Associates, LLCb5e15dd1-6e99-411c-9183-8a4265eae4042025-11-08WarningsExact identifier
application number: M012
Severe Sinus Congestion and PainACETAMINOPHEN, GUAIFENESIN, PHENYLEPHRINEShield Pharmaceuticals Corp103de130-ef12-4c58-bbcf-234b3f3b2cbf2025-11-08WarningsExact identifier
application number: M012
unii: 04JA59TNSJ
unii: 362O9ITL9D
unii: 495W7451VQ
Cough Drops Dollar General Strawberry 30ctMENTHOLDollar General Corporation2b3fbab9-92b5-42a7-b27b-ff46350ce0552025-11-07WarningsExact identifier
application number: M012
AZO Yeast PlusCANDIDA ALBICANS, WOOD CREOSOTE, SODIUM CHLORIDE, AND SULFURi-Health, Inc.22845cac-8011-4ea8-b35e-b72973eddb442025-11-07WarningsExact identifier
unii: 451W47IQ8X
Robitussin Day and Night Maximum Strength Cough DMDEXTROMETHORPHAN HYDROBROMIDE, GUAIFENESIN, DOXYLAMINE SUCCINATEHaleon US Holdings LLCb43d8fbd-1977-4465-aa64-79e7b7f54e092025-11-07WarningsExact identifier
application number: M012

Reported adverse events (FAERS/openFDA)#

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