Childrens Loratadine

Product NDC
37808-131
11-digit product format
378080131
Labeler code
37808
Product ID
37808-131_3c5477aa-2b46-b58a-e063-6294a90aeaf5
Type
HUMAN OTC DRUG
Nonproprietary name
Loratadine
Dosage form
SOLUTION
Route
ORAL
Labeler
H E B
Application
ANDA076805
Marketing category
ANDA
Marketing start
2017-03-17
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 Loratadine
Brand name suffix
Sugar Free
Listing expiration
2026-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
LORATADINE5 mg/5mL

Harmonized Identifiers#

Field, Values table
FieldValues
Unii7AJO3BO7QN
Rxcui692783

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
37808-131-082025-08-14C16284748780-13b156c62-3067-fb37-e063-e6dba90a4e07Children's Loratadine Oral Solution Sugar Free
37808-131-082025-07-29C16284748780-13b156c62-3067-fb37-e063-e6dba90a4e07Children's Loratadine Oral Solution Sugar Free

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
37808-131-08Childrens Loratadine Sugar Free1 in 1 CARTONSOLUTION12
37808-131-08Childrens Loratadine Sugar Free120 mL in 1 BOTTLESOLUTION1202

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
37808-131CHILDRENS LORATADINE SUGAR FREE (LORATADINE) SOLUTION [H E B]1Current NDC, Legacy NDC, 2 package rows20180511_d710b760-794e-490b-a413-c7b2ee5149b9.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
692783loratadine 5 MG in 5 mL Oral SolutionPSNd710b760-794e-490b-a413-c7b2ee5149b92
692783loratadine 1 MG/ML Oral SolutionSCDd710b760-794e-490b-a413-c7b2ee5149b92
692783loratadine 5 MG per 5 ML Oral SolutionSYd710b760-794e-490b-a413-c7b2ee5149b92

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
37808-131-08378080131081 BOTTLE in 1 CARTON (37808-131-08) / 120 mL in 1 BOTTLE1 bottle2018-04-160000-00-00NoNoCurrent