FDA.reportPublic FDA data

NDC 51316-620 - CVS DT and NT Combo 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
51316-620
Package NDCs from labels
51316-620-12
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 DT and NT Combo Pack Cold and Flu - CVS PHARMACYCVS PHARMACY2026-08-19HUMAN OTC DRUG LABEL

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
51316-620-12CVS DT and NT Combo PackCold and Flu354 mL in 1 BOTTLELIQUID354 mL5 mg in 15mL6

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
51316-620CVS DT AND NT COMBO PACK COLD AND FLU (ACETAMINOPHEN, PHENYLEPHRINE HYDROCHLORIDE, AND DOXYLAMINE SUCCINATE) KIT [CVS PHARMACY]5Unmatched20240821_360c8c62-0945-4031-b291-d40c4270b940.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 218 of 453 · 9,057 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Coralite Cold and HotMENTHOLUnited Exchange Corp.064a6149-a0e2-8a73-e063-6394a90a79532025-10-22WarningsExact identifier
unii: L7T10EIP3A
Topical AnalgesicMENTHOLYoungevity International Inc.b4693947-f5b3-6fd3-e053-2995a90ab5812025-10-22WarningsExact identifier
unii: L7T10EIP3A
Hydrocodone Bitartrate and AcetaminophenHYDROCODONE BITARTRATE AND ACETAMINOPHENBryant Ranch Prepack39b8382a-e96d-462d-895f-27cbb9a305ec2025-10-22Boxed warning, Warnings, Adverse reactionsExact identifier
unii: 362O9ITL9D
Acetaminophen and Codeine PhosphateACETAMINOPHEN AND CODEINE PHOSPHATEBryant Ranch Prepack3e41e55f-7e41-4653-aadb-32a9e47962d92025-10-22Boxed warning, Warnings, Adverse reactionsExact identifier
unii: 362O9ITL9D
Hydrocodone Bitartrate and AcetaminophenHYDROCODONE BITARTRATE AND ACETAMINOPHENAmneal Pharmaceuticals of New York LLC62be4147-6a72-49e5-9338-10887c65a93a2025-10-22Boxed warning, Warnings, Adverse reactionsExact identifier
unii: 362O9ITL9D
Oxycodone and AcetaminophenOXYCODONE AND ACETAMINOPHENAmneal Pharmaceuticals of New York LLC683d563f-0686-4964-8183-cf08758cae712025-10-22Boxed warning, Warnings, Adverse reactionsExact identifier
unii: 362O9ITL9D
AcetaminophenACETAMINOPHENRugby Laboratoriesb16ed4ef-689c-4df2-ab6c-207aa8b9925d2025-10-22WarningsExact identifier
unii: 362O9ITL9D
Sterile WaterWATERBecton Dickinson and Companycab03cda-4660-4020-a3be-bf86242ff6642025-10-22Warnings, Adverse reactionsExact identifier
unii: 059QF0KO0R
Refresh Relieva Preservative FreeCARBOXYMETHYLCELLULOSE SODIUM AND GLYCERINAllergan, Inc.3481f9b3-5a90-40d3-80f8-81f51cc864be2025-10-22WarningsExact identifier
unii: PDC6A3C0OX
Hydrocodone Bitartrate and AcetaminophenHYDROCODONE BITARTRATE AND ACETAMINOPHENBryant Ranch Prepackac88fa99-625b-4854-a406-9e21a6b9c1c82025-10-21Boxed warning, Warnings, Adverse reactionsExact identifier
unii: 362O9ITL9D
Tension Headache ReliefACETAMINOPHEN, CAFFEINETIME CAP LABS INC05364eb4-07a1-a4d9-e063-6294a90a47e52025-10-21WarningsExact identifier
unii: 362O9ITL9D
KINKANAMMONIA, CAMPHOR (NATURAL), MENTHOLKINKANDO CO., LTD .f2c0f3e1-792b-4798-bf6d-acd1bbefa2612025-10-21WarningsExact identifier
unii: L7T10EIP3A
Acetaminophen, Aspirin, CaffeineACETAMINOPHEN, ASPIRIN, CAFFEINECVS Pharmacy, Inc.6deb854f-863e-24ad-e053-2991aa0afb172025-10-21WarningsExact identifier
unii: 362O9ITL9D
BackAidACETAMINOPHEN, CAFFEINEKobayashi Healthcare International, Inc.25db6bb5-96b6-4be1-e063-6294a90a23002025-10-21WarningsExact identifier
unii: 362O9ITL9D
RycontussCHLORPHENIRAMINE MALEATE, DEXTROMETHORPHAN HYDROBROMIDE, PHENYLEPHRINE HYDROCHLORIDEDextrum Laboratories, Inc41afb883-1158-9764-e063-6294a90a17122025-10-21WarningsExact identifier
application number: M012
unii: 9D2RTI9KYH
unii: 04JA59TNSJ
Hydrocodone Bitartrate and AcetaminophenHYDROCODONE BITARTRATE AND ACETAMINOPHENAvPAK5174bd9a-b777-a6e3-f72f-c16082ee67d32025-10-21Boxed warning, Warnings, Adverse reactionsExact identifier
unii: 362O9ITL9D
Acetaminophen, Dextromethorphan HBr, Chlorpheniramine MaleateACETAMINOPHEN, DEXTROMETHORPHAN HBR, CHLORPHENIRAMINE MALEATECVS Pharmacy, Inc1532ee21-e114-ded7-e063-6294a90ab0252025-10-21WarningsExact identifier
application number: M012
Coralite Extra Strength Pain Relief Sleeve WristMENTHOLUnited Exchange Corp.ae314478-b8ab-4e90-bd0a-7a882d5c1b2e2025-10-21WarningsExact identifier
unii: L7T10EIP3A
Coralite Cold and HotMENTHOLUnited Exchange Corp.85bd7658-e951-7daf-e053-2a91aa0a9f542025-10-21WarningsExact identifier
unii: L7T10EIP3A
Family Care Maximum Strength Medicated Anti ItchMENTHOLUnited Exchange Corp.430b5753-3087-4cb1-bf54-0eedc3f4b1d52025-10-21WarningsExact identifier
unii: L7T10EIP3A

Reported adverse events (FAERS/openFDA)#

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