FDA.reportPublic FDA data

Childrens Non-Drowsy

Product NDC
21130-092
11-digit product format
211300092
Labeler code
21130
Product ID
21130-092_4e144acb-8dbe-4872-8e23-cf277d07a3e1
Type
HUMAN OTC DRUG
Nonproprietary name
Loratadine
Dosage form
SOLUTION
Route
ORAL
Labeler
Safeway Inc.
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
21130-092-082020-01-31C16284748780-19d75b9cf-fc68-f424-e053-dadaa90a57ceChildren's Non-Drowsy 24-Hour Allergy Relief

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
21130-092-08Childrens Non-Drowsy 24-Hour Allergy Relief1 in 1 CARTONSOLUTION12
21130-092-08Childrens Non-Drowsy 24-Hour Allergy Relief120 mL in 1 BOTTLESOLUTION1202

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
LoratadineACTIVE INGREDIENT7AJO3BO7QNCHILDRENS NON-DROWSY 24-HOUR ALLERGY RELIEF (LORATADINE) SOLUTION [SAFEWAY INC.]1
LoratadineACTIVE MOIETY7AJO3BO7QNCHILDRENS NON-DROWSY 24-HOUR ALLERGY RELIEF (LORATADINE) SOLUTION [SAFEWAY INC.]1
glycerinINACTIVE INGREDIENTPDC6A3C0OXCHILDRENS NON-DROWSY 24-HOUR ALLERGY RELIEF (LORATADINE) SOLUTION [SAFEWAY INC.]1
phosphoric acidINACTIVE INGREDIENTE4GA8884NNCHILDRENS NON-DROWSY 24-HOUR ALLERGY RELIEF (LORATADINE) SOLUTION [SAFEWAY INC.]1
polyethylene glycolsINACTIVE INGREDIENT3WJQ0SDW1ACHILDRENS NON-DROWSY 24-HOUR ALLERGY RELIEF (LORATADINE) SOLUTION [SAFEWAY INC.]1
propylene glycolINACTIVE INGREDIENT6DC9Q167V3CHILDRENS NON-DROWSY 24-HOUR ALLERGY RELIEF (LORATADINE) SOLUTION [SAFEWAY INC.]1
sodium benzoateINACTIVE INGREDIENTOJ245FE5EUCHILDRENS NON-DROWSY 24-HOUR ALLERGY RELIEF (LORATADINE) SOLUTION [SAFEWAY INC.]1
sodium metabisulfiteINACTIVE INGREDIENT4VON5FNS3CCHILDRENS NON-DROWSY 24-HOUR ALLERGY RELIEF (LORATADINE) SOLUTION [SAFEWAY INC.]1
sodium phosphate, monobasic, dihydrateINACTIVE INGREDIENT5QWK665956CHILDRENS NON-DROWSY 24-HOUR ALLERGY RELIEF (LORATADINE) SOLUTION [SAFEWAY INC.]1
sorbitolINACTIVE INGREDIENT506T60A25RCHILDRENS NON-DROWSY 24-HOUR ALLERGY RELIEF (LORATADINE) SOLUTION [SAFEWAY INC.]1
waterINACTIVE INGREDIENT059QF0KO0RCHILDRENS NON-DROWSY 24-HOUR ALLERGY RELIEF (LORATADINE) SOLUTION [SAFEWAY INC.]1

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
21130-092CHILDRENS NON-DROWSY 24-HOUR ALLERGY RELIEF (LORATADINE) SOLUTION [SAFEWAY INC.]2Legacy NDC, 2 package rows20160119_a527808b-5edc-4dc4-8629-346be73ed18e.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
692783loratadine 5 MG in 5 mL Oral SolutionPSNa527808b-5edc-4dc4-8629-346be73ed18e2
692783loratadine 1 MG/ML Oral SolutionSCDa527808b-5edc-4dc4-8629-346be73ed18e2
692783loratadine 5 MG per 5 ML Oral SolutionSYa527808b-5edc-4dc4-8629-346be73ed18e2

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionStatus
21130-092-08211300092081 in 1 CARTONHistorical