Quality Choice day time severe cold and cough

Product NDC
64525-0549
11-digit product format
645250549
Labeler code
64525
Product ID
64525-0549_35b034c1-20c3-493f-9080-c65e1de5f365
Type
HUMAN OTC DRUG
Nonproprietary name
Acetaminophen, Dextromethorphan HBr, and Phenylephrine HCL.
Dosage form
GRANULE, FOR SOLUTION
Route
ORAL
Labeler
Quality Home Products
Application
part341
Marketing category
OTC MONOGRAPH FINAL
Marketing start
2009-10-31
Marketing end
0000-00-00
Substance
ACETAMINOPHEN; DEXTROMETHORPHAN HYDROBROMIDE; PHENYLEPHRINE HYDROCHLORIDE
Active strength
650 mg/1; mg/1; mg/1
NDC exclude flag
E
Listing certified through
2018-12-31
Current FDA listing
Historical FDA.report record

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
ed912195-5da0-0f2f-6f4b-3ef17710cbe3Product name120140508

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
64525-0549-62020-01-31C16284748780-19d75b9d0-7cb1-f424-e053-dadaa90a57ceDay time Severe Cold and Cough berry infused with menthol and green tea flavors

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
64525-0549-6Quality Choice day time severe cold and cough berry infused with menthol and green tea flavors6 in 1 BOXGRANULE, FOR SOLUTION63

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
AcetaminophenACTIVE INGREDIENT362O9ITL9DQUALITY CHOICE DAY TIME SEVERE COLD AND COUGH (ACETAMINOPHEN, DEXTROMETHORPHAN HBR, AND PHENYLEPHRINE HCL.) GRANULE, FOR SOLUTION [QUALITY HOME PRODUCTS]3
Dextromethorphan HydrobromideACTIVE INGREDIENT9D2RTI9KYHQUALITY CHOICE DAY TIME SEVERE COLD AND COUGH (ACETAMINOPHEN, DEXTROMETHORPHAN HBR, AND PHENYLEPHRINE HCL.) GRANULE, FOR SOLUTION [QUALITY HOME PRODUCTS]3
Phenylephrine HydrochlorideACTIVE INGREDIENT04JA59TNSJQUALITY CHOICE DAY TIME SEVERE COLD AND COUGH (ACETAMINOPHEN, DEXTROMETHORPHAN HBR, AND PHENYLEPHRINE HCL.) GRANULE, FOR SOLUTION [QUALITY HOME PRODUCTS]3
AcetaminophenACTIVE MOIETY362O9ITL9DQUALITY CHOICE DAY TIME SEVERE COLD AND COUGH (ACETAMINOPHEN, DEXTROMETHORPHAN HBR, AND PHENYLEPHRINE HCL.) GRANULE, FOR SOLUTION [QUALITY HOME PRODUCTS]3
DextroseACTIVE MOIETYIY9XDZ35W2QUALITY CHOICE DAY TIME SEVERE COLD AND COUGH (ACETAMINOPHEN, DEXTROMETHORPHAN HBR, AND PHENYLEPHRINE HCL.) GRANULE, FOR SOLUTION [QUALITY HOME PRODUCTS]3
PhenylephrineACTIVE MOIETY1WS297W6MVQUALITY CHOICE DAY TIME SEVERE COLD AND COUGH (ACETAMINOPHEN, DEXTROMETHORPHAN HBR, AND PHENYLEPHRINE HCL.) GRANULE, FOR SOLUTION [QUALITY HOME PRODUCTS]3
AcesulfameINACTIVE INGREDIENTMA3UYZ6K1HQUALITY CHOICE DAY TIME SEVERE COLD AND COUGH (ACETAMINOPHEN, DEXTROMETHORPHAN HBR, AND PHENYLEPHRINE HCL.) GRANULE, FOR SOLUTION [QUALITY HOME PRODUCTS]3
AspartameINACTIVE INGREDIENTZ0H242BBR1QUALITY CHOICE DAY TIME SEVERE COLD AND COUGH (ACETAMINOPHEN, DEXTROMETHORPHAN HBR, AND PHENYLEPHRINE HCL.) GRANULE, FOR SOLUTION [QUALITY HOME PRODUCTS]3
citric acid monohydrateINACTIVE INGREDIENT2968PHW8QPQUALITY CHOICE DAY TIME SEVERE COLD AND COUGH (ACETAMINOPHEN, DEXTROMETHORPHAN HBR, AND PHENYLEPHRINE HCL.) GRANULE, FOR SOLUTION [QUALITY HOME PRODUCTS]3
MaltodextrinINACTIVE INGREDIENT7CVR7L4A2DQUALITY CHOICE DAY TIME SEVERE COLD AND COUGH (ACETAMINOPHEN, DEXTROMETHORPHAN HBR, AND PHENYLEPHRINE HCL.) GRANULE, FOR SOLUTION [QUALITY HOME PRODUCTS]3
Sodium CitrateINACTIVE INGREDIENT1Q73Q2JULRQUALITY CHOICE DAY TIME SEVERE COLD AND COUGH (ACETAMINOPHEN, DEXTROMETHORPHAN HBR, AND PHENYLEPHRINE HCL.) GRANULE, FOR SOLUTION [QUALITY HOME PRODUCTS]3
SucroseINACTIVE INGREDIENTC151H8M554QUALITY CHOICE DAY TIME SEVERE COLD AND COUGH (ACETAMINOPHEN, DEXTROMETHORPHAN HBR, AND PHENYLEPHRINE HCL.) GRANULE, FOR SOLUTION [QUALITY HOME PRODUCTS]3

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
64525-0549QUALITY CHOICE DAY TIME SEVERE COLD AND COUGH (ACETAMINOPHEN, DEXTROMETHORPHAN HBR, AND PHENYLEPHRINE HCL.) GRANULE, FOR SOLUTION [QUALITY HOME PRODUCTS]3Legacy NDC, 1 package rows20091031_ec87b0a5-514d-44db-adcf-1f8a81244284.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
1659967acetaminophen 650 MG / dextromethorphan HBr 20 MG / phenylephrine HCl 10 MG Granules for Oral SolutionPSNec87b0a5-514d-44db-adcf-1f8a812442843
1659967acetaminophen 650 MG / dextromethorphan hydrobromide 20 MG / phenylephrine hydrochloride 10 MG Granules for Oral SolutionSCDec87b0a5-514d-44db-adcf-1f8a812442843
1659967acetaminophen 650 MG / dextromethorphan HBr 20 MG / phenylephrine HCl 10 MG Powder for Oral SolutionSYec87b0a5-514d-44db-adcf-1f8a812442843
1659967APAP 650 MG / Dextromethorphan Hydrobromide 20 MG / Phenylephrine Hydrochloride 10 MG Granules for Oral SolutionSYec87b0a5-514d-44db-adcf-1f8a812442843

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionStatus
64525-0549-6645250549066 in 1 BOXHistorical