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 322 of 370 · 7,399 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
GI DrainageCINNAMOMUM, GENTIANA LUTEA, SYZYGIUM JAMBOLANUM, ARGENTUM NITRICUM, COLCHICUM AUTUMNALE, COLOSTRUM (BOVINE), COPPER GLUCONATE, LAPPA MAJOR, LYCOPODIUM CLAVATUM, MAGNESIUM GLUCONICUM, MANGANESE GLUCONATE, PANCREAS SUIS, POTASSIUM GLUCONATE, RUMEX CRISPUS, STOMACH (SUIS), AURUM METALLICUM, CALCAREA CARBONICA, CARBO VEGETABILIS, INTESTINE (SUIS), MALUS PUMILA, FLOS, NITRICUM ACIDUM, PRUNUS CERASIFERA, FLOS, ROCK WATER, SCHROPHULARIA NODOSA, FAGUS SYLVATICA, FLOSDeseret Biologicals, Inc.ff81e3ca-2f88-4daf-a734-083107269d3a2024-02-21WarningsExact identifier
unii: 059QF0KO0R
Good Sense Mucus ERGUAIFENESINL. Perrigo Company49de9c3b-9840-4fc2-988f-4361de6aa3c12024-02-21WarningsExact identifier
unii: 495W7451VQ
Butalbital, Acetaminophen, and CaffeineBUTALBITAL, ACETAMINOPHEN, AND CAFFEINELGM PHARMA SOLUTIONS, LLCf6548126-faa1-4f53-8e0b-bc1b743de04d2024-02-21Boxed warning, Warnings, Adverse reactionsExact identifier
unii: 362O9ITL9D
Nasal Spray, 24-7 for LifeOXYMETAZOLINE HYDROCHLORIDE 0.05%Lil' Drug Store Products, Inc.11d27c75-fd95-f9da-e063-6394a90ac6b02024-02-20WarningsExact identifier
application number: M012
Basic Care Dual ActionACETAMINOPHEN, IBUPROFENAmazon.com Services LLC7e27f5cb-8728-400f-82c5-0984276aa5dd2024-02-20WarningsExact identifier
unii: 362O9ITL9D
Nighttime Cold and Cough childrensDIPHENHYDRAMINE HCL, PHENYLEPHRINE HCLBest Choice (Valu Merchandisers Company)11652e8a-2242-4449-8a41-a8e75509025e2024-02-20WarningsExact identifier
application number: M012
unii: 04JA59TNSJ
M-PAPACETAMINOPHENBryant Ranch Prepack31a41976-7f65-42d7-acf5-de9c2c5ca58e2024-02-20WarningsExact identifier
unii: 362O9ITL9D
Butalbital, Acetaminophen and CaffeineBUTALBITAL, ACETAMINOPHEN AND CAFFEINEKVK-Tech, Inc.7f9c4668-4f4a-453b-b2fa-a6fed903ddfa2024-02-16Boxed warning, Warnings, Adverse reactionsExact identifier
unii: 362O9ITL9D
Butalbital, Acetaminophen, CaffeineBUTALBITAL, ACETAMINOPHEN, AND CAFFEINEA-S Medication Solutionsf822c103-b678-4e76-8174-33b94421dd1e2024-02-15Boxed warning, Warnings, Adverse reactionsExact identifier
unii: 362O9ITL9D
Hydrocodone Bitartrate and AcetaminophenHYDROCODONE BITARTRATE AND ACETAMINOPHENLupin Pharmaceuticals,Inc.48cc1378-ffab-4645-95bb-a05d780665752024-02-15Boxed warning, Warnings, Adverse reactionsExact identifier
unii: 362O9ITL9D
Severe Sinus Relief MistOXYMETAZOLINE SPRAYWalgreens Company847f47d9-62b1-49a3-8bb3-9bf275685bd22024-02-14WarningsExact identifier
application number: M012
Extra Strength Pain RelieverACETAMINOPHENINGLES MARKETS, INC.115d0b4f-6f0f-79a9-e063-6394a90ab18a2024-02-14WarningsExact identifier
unii: 362O9ITL9D
Allergy Sinus, Lil Drug StoreACETAMINOPHEN, PHENYLEPHRINE HYDROCHLORIDE, CHLORPHENIRAMINE MALEATELil' Drug Store Products, Inc.1145440e-b37a-6e5e-e063-6294a90ab4a02024-02-13WarningsExact identifier
application number: M012
unii: 04JA59TNSJ
unii: 362O9ITL9D
Guaifenesin and Codeine PhosphateGUAIFENESIN AND CODEINE PHOSPHATEA-S Medication Solutions36140639-e7a8-43bc-83e2-469430af9d1a2024-02-13WarningsExact identifier
application number: M012
unii: 495W7451VQ
Promethazine Hydrochloride and Dextromethorphan HydrobromidePROMETHAZINE HYDROCHLORIDE AND DEXTROMETHORPHAN HYDROBROMIDEA-S Medication Solutionse451cb8d-f856-479f-bee9-4cccab210b1e2024-02-12Boxed warning, Warnings, Adverse reactionsExact identifier
unii: 9D2RTI9KYH
Theraflu ExpressMax Daytime Severe Cold and CoughACETAMINOPHEN, DEXTROMETHORPHAN HBR, PHENYLEPHRINE HCLHaleon US Holdings LLCff48b55a-0d32-47d6-941d-d99c7cf52f942024-02-12WarningsExact identifier
application number: M012
unii: 9D2RTI9KYH
unii: 04JA59TNSJ
unii: 362O9ITL9D
OXYCODONE AND ACETAMINOPHENOXYCODONE AND ACETAMINOPHENXLCare Pharmaceuticals, Inc.7f3c6dd7-6bc8-450e-aded-997f9cf63a8f2024-02-12Boxed warning, Warnings, Adverse reactionsExact identifier
unii: 362O9ITL9D
Childrens Robitussin Cough and Chest Congestion DMDEXTROMETHORPHAN HYDROBROMIDE AND GUAIFENESINHaleon US Holdings LLC15950273-14c9-4a0b-bbb4-683048add7222024-02-08WarningsExact identifier
application number: M012
unii: 9D2RTI9KYH
unii: 495W7451VQ
Bladder ReliefCAUSTICUM, NATRUM MURIATICUM, NUX VOMICA, PULSATILLA (VULGARIS), SEPIA, STAPHYSAGRIA, THUJA OCCIDENTALISThe Magni Companyb09bf037-703f-4c22-8535-b33d586ebefa2024-02-08WarningsExact identifier
unii: 451W47IQ8X
Guaifenesin Extended Release 600 mgGUAIFENESINTIME CAP LABORATORIES, INC.10c42869-7df0-3046-e063-6394a90aa6792024-02-07WarningsExact identifier
unii: 495W7451VQ

Reported adverse events (FAERS/openFDA)#

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