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 259 of 445 · 8,892 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Menstrual Complete Maximum StrengthACETAMINOPHEN, CAFFEINE AND PYRILAMINE MALEATERite Aid Corporation69bda7d7-8660-4e8d-b8ac-892a3b1f21242025-06-03WarningsExact identifier
unii: 362O9ITL9D
8HR Muscle Aches and Pain ReliefACETAMINOPHENLEADER/ Cardinal Health 110, Inc.331f4bd1-1303-cc48-e063-6394a90a74d32025-06-03WarningsExact identifier
unii: 362O9ITL9D
Children Allergy Relief Bubblegum flavorDIPHENHYDRAMINE HCLTARGET CORPORATION69d33f77-06e1-48fa-a516-892fdf11bb1c2025-06-03WarningsExact identifier
application number: M012
oxymetazoline hydrochlorideOXYMETAZOLINE HYDROCHLORIDENuCare Pharmaceuticals,Inc.fd058e2b-5445-e416-e053-6394a90a611b2025-06-03WarningsExact identifier
application number: M012
Major Nasal DecongestantOXYMETAZOLINE HYDROCHLORIDENuCare Pharmaceuticals, Inc.36b1a7e0-c8b9-0890-e063-6394a90ab13a2025-06-03WarningsExact identifier
application number: M012
Acetaminophen and Codeine PhosphateACETAMINOPHEN AND CODEINE PHOSPHATEAdvanced Rx of Tennessee, LLC36988ba2-cefd-99f8-e063-6294a90aa41a2025-06-02Boxed warning, Warnings, Adverse reactionsExact identifier
unii: 362O9ITL9D
Acetaminophen and Codeine PhosphateACETAMINOPHEN AND CODEINE PHOSPHATEAdvanced Rx of Tennessee, LLC3698e0ff-6a1c-e1ad-e063-6294a90a163a2025-06-02Boxed warning, Warnings, Adverse reactionsExact identifier
unii: 362O9ITL9D
ACETAMINOPHEN AND CODEINE PHOSPHATEACETAMINOPHEN AND CODEINE PHOSPHATEPreferred Pharmaceuticals Inc.7ab27392-9c6e-4ec3-85e7-06b43fcab3b12025-06-02Boxed warning, Warnings, Adverse reactionsExact identifier
unii: 362O9ITL9D
Acetaminophen and Codeine PhosphateACETAMINOPHEN AND CODEINE PHOSPHATEPreferred Pharmaceuticals Inc.caa96b80-d8a7-4920-9d5c-717435e798de2025-06-02Warnings, Adverse reactionsExact identifier
unii: 362O9ITL9D
BUTALBITAL, ACETAMINOPHEN AND CAFFEINEBUTALBITAL, ACETAMINOPHEN AND CAFFEINEBryant Ranch Prepack2eefa0ac-70f6-43ab-b59e-c4ecad853fe72025-06-02Boxed warning, Warnings, Adverse reactionsExact identifier
unii: 362O9ITL9D
Allergy MedicineDIPHENHYDRAMINE HCLBi-Mart297f7ffd-ca78-439e-8377-b495c3aed8ab2025-06-01WarningsExact identifier
application number: M012
SalineNASALBi-Mart1d122b09-5987-4bd7-b212-4c3c27ec0ac62025-06-01WarningsExact identifier
unii: 451W47IQ8X
Orajel Rescue Relief PenORAL PAIN RELIEVERChurch & Dwight Co., Inc.2d68eec5-ae8a-9cdf-e063-6294a90a97992025-06-01WarningsExact identifier
unii: L7T10EIP3A
Kids Pain and FeverACETAMINOPHENKinderFarms, LLCfb74e8f9-d72f-4681-90bd-df48364405b52025-06-01WarningsExact identifier
unii: 362O9ITL9D
COLD, FLU and SORE THROAT RELIEFACETAMINOPHEN 650 MG, DEXTROMETHORPHAN HBR 20 MG, GUAIFENESIN 400 MG, PHENYLEPHRINE HCL 10 MGBETTER LIVING BRANDS, LLC202d60a8-83da-5afc-e063-6394a90ad7792025-05-31WarningsExact identifier
application number: M012
unii: 9D2RTI9KYH
unii: 04JA59TNSJ
unii: 362O9ITL9D
PRISMASOL BGK2/0MAGNESIUM CHLORIDE, DEXTROSE ANHYDROUS, LACTIC ACID, SODIUM CHLORIDE, SODIUM BICARBONATE, AND POTASSIUM CHLORIDEVantive US Healthcare LLC7f675fee-8940-4ece-bb0c-75ac79d8708c2025-05-31Warnings, Adverse reactionsExact identifier
unii: 451W47IQ8X
Promethazine DMPROMETHAZINE HYDROCHLORIDE AND DEXTROMETHORPHAN HYDROBROMIDEPAI Holdings, LLC dba PAI Pharma1d47280d-28c9-4701-8c5f-a6e6b524083b2025-05-31Boxed warning, Warnings, Adverse reactionsExact identifier
unii: 9D2RTI9KYH
Allergy ReliefDIPHENHYDRAMINE HCLTARGET CORPORATIONf935341f-1e33-d78e-e053-6294a90a348e2025-05-30WarningsExact identifier
application number: M012
Diphenhydramine HClDIPHENHYDRAMINE HCLAARNA USA INC.365bb414-8425-a900-e063-6394a90aa8872025-05-30WarningsExact identifier
application number: M012
Childrens AllergyDIPHENHYDRAMINE HYDROCHLORIDEP & L Development, LLC8559be55-8b00-4353-8e26-b5dff2ada8062025-05-30WarningsExact identifier
application number: M012

Reported adverse events (FAERS/openFDA)#

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