Childrens Allergy

Product NDC
49035-538
11-digit product format
490350538
Labeler code
49035
Product ID
49035-538_6ee5b7e9-711d-4d18-9cea-09a4d19d4332
Type
HUMAN OTC DRUG
Nonproprietary name
Loratadine
Dosage form
SOLUTION
Route
ORAL
Labeler
Wal-Mart Stores Inc
Application
ANDA201865
Marketing category
ANDA
Marketing start
2016-12-08
Substance
LORATADINE
Active strength
5 mg/5mL
NDC exclude flag
No
Listing certified through
2026-12-31
Current FDA listing
Yes

Additional Listing Data#

Finished product
Yes
Brand name base
Childrens Allergy
Listing expiration
2026-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
LORATADINE5 mg/5mL

Harmonized Identifiers#

Field, Values table
FieldValues
Unii7AJO3BO7QN
Rxcui692783

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
49035-538-08Childrens Allergy1 in 1 CARTONSOLUTION13
49035-538-08Childrens Allergy120 mL in 1 BOTTLESOLUTION1203
49035-538-09Childrens Allergy1 in 1 CARTONSOLUTION13
49035-538-09Childrens Allergy120 mL in 1 BOTTLESOLUTION1203

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
49035-538CHILDRENS ALLERGY (LORATADINE) SOLUTION [WAL-MART STORES INC]3Current NDC, Legacy NDC, 4 package rows20210417_9fb3a3a8-8812-4238-b596-291b79085db9.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
692783loratadine 5 MG in 5 mL Oral SolutionPSN9fb3a3a8-8812-4238-b596-291b79085db93
692783loratadine 1 MG/ML Oral SolutionSCD9fb3a3a8-8812-4238-b596-291b79085db93
692783loratadine 5 MG per 5 ML Oral SolutionSY9fb3a3a8-8812-4238-b596-291b79085db93

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
49035-538-08490350538081 BOTTLE in 1 CARTON (49035-538-08) / 120 mL in 1 BOTTLE1 bottle2019-06-210000-00-00NoNoCurrent
49035-538-09490350538091 BOTTLE in 1 CARTON (49035-538-09) / 120 mL in 1 BOTTLE1 bottle2021-03-070000-00-00NoNoCurrent