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 302 of 370 · 7,399 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Extra Strength Pain RelieverACETAMINOPHEN 500 MGLil' Drug Store Products, Inc.ee8e0e79-4da4-101f-e053-2a95a90a30a42024-06-19WarningsExact identifier
unii: 362O9ITL9D
Extra Strength Headache ReliefACETAMINOPHEN, ASPIRIN, AND CAFFEINELil' Drug Store Products, Inc.b3a06e4b-0b31-4e2a-8dd1-9de85760477b2024-06-19WarningsExact identifier
unii: 362O9ITL9D
Theraflu Severe Cold Relief Soft ChewsACETAMINOPHEN, DEXTROMETHORPHAN HBRHaleon US Holdings LLC91dbb541-6a86-4803-a1fe-1bf61b457c342024-06-19WarningsExact identifier
application number: M012
unii: 9D2RTI9KYH
unii: 362O9ITL9D
Hydrocodone Bitartrate and AcetaminophenHYDROCODONE BITARTRATE AND ACETAMINOPHENNuCare Pharmaceuticals,Inc.8c2a7a68-5a84-c909-e053-2995a90ad5b62024-06-18Boxed warning, Warnings, Adverse reactionsExact identifier
unii: 362O9ITL9D
Acetaminophen and Codeine PhosphateACETAMINOPHEN AND CODEINE PHOSPHATENuCare Pharmaceuticals,Inc.8f12016d-904f-00b4-e053-2a95a90ad02a2024-06-18Boxed warning, Warnings, Adverse reactionsExact identifier
unii: 362O9ITL9D
pain reliefACETAMINOPHENMeijer Distribution Inc43c3fe72-a4ef-48a6-bc22-a644919c0c5c2024-06-17WarningsExact identifier
unii: 362O9ITL9D
Mucus ReliefGUAIFENESINHARRIS TEETER114a858c-a021-8915-e063-6394a90afdcf2024-06-14WarningsExact identifier
unii: 495W7451VQ
Mucus Relief Maximum StrengthGUAIFENESINHARRIS TEETER114a8c26-25be-5a0b-e063-6294a90a3e182024-06-14WarningsExact identifier
unii: 495W7451VQ
ACETAMINOPHEN PMACETAMINOPHEN AND DIPHENHYDRAMINE HYDROCHLORIDERETAIL BUSINESS SERVICES , LLC.093199be-e92a-6f60-e063-6294a90a85332024-06-14WarningsExact identifier
unii: 362O9ITL9D
AcetaminophenACETAMINOPHENRETAIL BUSINESS SERVICES , LLC.09315a3d-bb2d-4f06-e063-6294a90a3bd32024-06-14WarningsExact identifier
unii: 362O9ITL9D
Acetaminophen and Codeine PhosphateACETAMINOPHEN AND CODEINE PHOSPHATENuCare Pharmaceuticals,Inc.80c9a58d-98ae-5497-e053-2991aa0a61fb2024-06-14Boxed warning, Warnings, Adverse reactionsExact identifier
unii: 362O9ITL9D
Hydrocodone Bitartrate and AcetaminophenHYDROCODONE BITARTRATE AND ACETAMINOPHENNuCare Pharmaceuticals,Inc.8592e901-9353-6fb6-e053-2a91aa0ad33b2024-06-14Boxed warning, Warnings, Adverse reactionsExact identifier
unii: 362O9ITL9D
Eyesaline Emergency EyewashPURIFIED WATERHoneywell Safety Products USA, Inc.ad42a7e3-84ea-390d-e053-2a95a90a3a322024-06-14WarningsExact identifier
unii: 059QF0KO0R
Hydrocodone Bitartrate and AcetaminophenHYDROCODONE BITARTRATE AND ACETAMINOPHENNuCare Pharmaceuticals,Inc.86be8920-2f35-fbc3-e053-2991aa0a00152024-06-14Boxed warning, Warnings, Adverse reactionsExact identifier
unii: 362O9ITL9D
AcetaminophenACETAMINOPHENNuCare Pharmaceuticals,Inc.872365ca-0c6b-550a-e053-2a91aa0ab25a2024-06-14WarningsExact identifier
unii: 362O9ITL9D
Tukol Max Action Cold, Flu and Sore ThroatACETAMINOPHEN, DEXTROMETHORPHAN HYDROBROMIDE, GUAIFENESIN, AND PHENYLEPHRINE HYDROCHLORIDEGenomma Lab USAaedce1f9-4902-4c51-92e0-6056196394c22024-06-14WarningsExact identifier
application number: M012
unii: 9D2RTI9KYH
unii: 04JA59TNSJ
unii: 362O9ITL9D
unii: 495W7451VQ
Pain Relief Regular StrengthACETAMINOPHENCHAIN DRUG MARKETING ASSOCIATION INC613bc633-0426-41a7-aea9-9ff56311b6072024-06-13WarningsExact identifier
unii: 362O9ITL9D
Pain Relief Extra StrengthACETAMINOPHENChain Drug Marketing Associationcfaf9495-e654-4dfc-ba23-d2358c3720c42024-06-13WarningsExact identifier
unii: 362O9ITL9D
Migraine ReliefACETAMINOPHEN, ASPIRIN AND CAFFEINECHAIN DRUG MARKETING ASSOCIATION, INC.a6a07615-3108-436f-bbce-be7cb89ce4562024-06-13WarningsExact identifier
unii: 362O9ITL9D
8 Hour Pain ReliefACETAMINOPHENCHAIN DRUG MARKETING ASSOCIATION, INC.3ec966f5-bdcb-4bd8-b265-c776ba778f252024-06-13WarningsExact identifier
unii: 362O9ITL9D

Reported adverse events (FAERS/openFDA)#

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