Best Choice Childrens Loratadine

Product NDC
63941-092
11-digit product format
639410092
Labeler code
63941
Product ID
63941-092_a5314bac-570f-40b2-a1e6-520820f72781
Type
HUMAN OTC DRUG
Nonproprietary name
Loratadine
Dosage form
SOLUTION
Route
ORAL
Labeler
Valu Merchandisers Company
Application
ANDA076805
Marketing category
ANDA
Marketing start
2010-02-27
Marketing end
0000-00-00
Substance
LORATADINE
Active strength
5 mg/5mL
NDC exclude flag
No
Listing certified through
2019-12-31
Current FDA listing
Historical FDA.report record

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
63941-092-082020-01-31C16284748780-19d75b9d0-cd7b-f424-e053-dadaa90a57ceBest Choice ® Children's Loratadine Sugar Free

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
63941-092-08Best Choice Childrens Loratadine Sugar Free120 mL in 1 BOTTLESOLUTION1203
63941-092-08Best Choice Childrens Loratadine Sugar Free1 in 1 CARTONSOLUTION13

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
LoratadineACTIVE INGREDIENT7AJO3BO7QNBEST CHOICE CHILDRENS LORATADINE SUGAR FREE (LORATADINE) SOLUTION [VALU MERCHANDISERS COMPANY]3
LoratadineACTIVE MOIETY7AJO3BO7QNBEST CHOICE CHILDRENS LORATADINE SUGAR FREE (LORATADINE) SOLUTION [VALU MERCHANDISERS COMPANY]3
glycerinINACTIVE INGREDIENTPDC6A3C0OXBEST CHOICE CHILDRENS LORATADINE SUGAR FREE (LORATADINE) SOLUTION [VALU MERCHANDISERS COMPANY]3
phosphoric acidINACTIVE INGREDIENTE4GA8884NNBEST CHOICE CHILDRENS LORATADINE SUGAR FREE (LORATADINE) SOLUTION [VALU MERCHANDISERS COMPANY]3
polyethylene glycolsINACTIVE INGREDIENT3WJQ0SDW1ABEST CHOICE CHILDRENS LORATADINE SUGAR FREE (LORATADINE) SOLUTION [VALU MERCHANDISERS COMPANY]3
propylene glycolINACTIVE INGREDIENT6DC9Q167V3BEST CHOICE CHILDRENS LORATADINE SUGAR FREE (LORATADINE) SOLUTION [VALU MERCHANDISERS COMPANY]3
sodium benzoateINACTIVE INGREDIENTOJ245FE5EUBEST CHOICE CHILDRENS LORATADINE SUGAR FREE (LORATADINE) SOLUTION [VALU MERCHANDISERS COMPANY]3
sodium metabisulfiteINACTIVE INGREDIENT4VON5FNS3CBEST CHOICE CHILDRENS LORATADINE SUGAR FREE (LORATADINE) SOLUTION [VALU MERCHANDISERS COMPANY]3
sodium phosphate, monobasic, dihydrateINACTIVE INGREDIENT5QWK665956BEST CHOICE CHILDRENS LORATADINE SUGAR FREE (LORATADINE) SOLUTION [VALU MERCHANDISERS COMPANY]3
sorbitolINACTIVE INGREDIENT506T60A25RBEST CHOICE CHILDRENS LORATADINE SUGAR FREE (LORATADINE) SOLUTION [VALU MERCHANDISERS COMPANY]3
waterINACTIVE INGREDIENT059QF0KO0RBEST CHOICE CHILDRENS LORATADINE SUGAR FREE (LORATADINE) SOLUTION [VALU MERCHANDISERS COMPANY]3

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
63941-092BEST CHOICE CHILDRENS LORATADINE SUGAR FREE (LORATADINE) SOLUTION [VALU MERCHANDISERS COMPANY]3Legacy NDC, 2 package rows20140306_f5ba0644-fa3d-4022-ad78-4f699af94f5f.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
692783loratadine 5 MG in 5 mL Oral SolutionPSNf5ba0644-fa3d-4022-ad78-4f699af94f5f3
692783loratadine 1 MG/ML Oral SolutionSCDf5ba0644-fa3d-4022-ad78-4f699af94f5f3
692783loratadine 5 MG per 5 ML Oral SolutionSYf5ba0644-fa3d-4022-ad78-4f699af94f5f3

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsStatus
63941-092-0863941009208120 mL in 1 BOTTLE120 mlHistorical