FDA.reportPublic FDA data

Children Claritin

Product NDC
11523-4360
11-digit product format
115234360
Labeler code
11523
Product ID
11523-4360_352ebcfd-07bb-a60e-e063-6394a90a5d70
Type
HUMAN OTC DRUG
Nonproprietary name
loratadine
Dosage form
SOLUTION
Route
ORAL
Labeler
Bayer HealthCare LLC.
Application
NDA020641
Marketing category
NDA
Marketing start
2015-05-26
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
Children Claritin
Brand name suffix
Allergy
Listing expiration
2026-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
LORATADINE5 mg/5mL

Harmonized Identifiers#

Field, Values table
FieldValues
Unii7AJO3BO7QN
Rxcui692783, 755476

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
c6f86816-7da6-43ea-8c25-ac9758311cc5Product name120220118
252e11b6-1a9a-4283-a242-df2c129c496dProduct name320170717
6084a4f4-5437-c9a5-caec-5361ee075a59Product name120140508
90c5639a-61b0-88d6-ddcf-21888e94869aProduct name120140508
9514609b-a2a9-f8ec-6ba6-3f8e5ee89877Product name120140508

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
11523-4360-1Children ClaritinAllergy1 in 1 CARTONSOLUTION118
11523-4360-1Children ClaritinAllergy60 mL in 1 BOTTLESOLUTION6018
11523-4360-2Children ClaritinAllergy120 mL in 1 BOTTLESOLUTION12018
11523-4360-2Children ClaritinAllergy1 in 1 CARTONSOLUTION118
11523-4360-3Children ClaritinAllergy1 in 1 CARTONSOLUTION118
11523-4360-3Children ClaritinAllergy150 mL in 1 BOTTLESOLUTION15018
11523-4360-4Children ClaritinAllergy1 in 1 CARTONSOLUTION118
11523-4360-4Children ClaritinAllergy30 mL in 1 BOTTLESOLUTION3018
11523-4360-5Children ClaritinAllergy1 in 1 CARTONSOLUTION118
11523-4360-5Children ClaritinAllergy240 mL in 1 BOTTLESOLUTION24018
11523-4360-6Children ClaritinAllergy1 in 1 CARTONSOLUTION118
11523-4360-6Children ClaritinAllergy180 mL in 1 BOTTLESOLUTION18018
11523-4360-7Children ClaritinAllergy2 in 1 CARTONSOLUTION218
11523-4360-7Children ClaritinAllergy180 mL in 1 BOTTLESOLUTION18018

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
11523-4360-5ML - Milliliter11523-4360a5947025-273d-428e-9bc1-8472d5c4fae912019-01-24

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
LORATADINEACTIVE INGREDIENT7AJO3BO7QNCHILDREN CLARITIN ALLERGY (LORATADINE) SOLUTION [MSD CONSUMER CARE, INC.]7
LORATADINEACTIVE MOIETY7AJO3BO7QNCHILDREN CLARITIN ALLERGY (LORATADINE) SOLUTION [MSD CONSUMER CARE, INC.]7
EDETATE DISODIUMINACTIVE INGREDIENT7FLD91C86KCHILDREN CLARITIN ALLERGY (LORATADINE) SOLUTION [MSD CONSUMER CARE, INC.]7
GLYCERININACTIVE INGREDIENTPDC6A3C0OXCHILDREN CLARITIN ALLERGY (LORATADINE) SOLUTION [MSD CONSUMER CARE, INC.]7
MALTITOLINACTIVE INGREDIENTD65DG142WKCHILDREN CLARITIN ALLERGY (LORATADINE) SOLUTION [MSD CONSUMER CARE, INC.]7
PHOSPHORIC ACIDINACTIVE INGREDIENTE4GA8884NNCHILDREN CLARITIN ALLERGY (LORATADINE) SOLUTION [MSD CONSUMER CARE, INC.]7
PROPYLENE GLYCOLINACTIVE INGREDIENT6DC9Q167V3CHILDREN CLARITIN ALLERGY (LORATADINE) SOLUTION [MSD CONSUMER CARE, INC.]7
SODIUM BENZOATEINACTIVE INGREDIENTOJ245FE5EUCHILDREN CLARITIN ALLERGY (LORATADINE) SOLUTION [MSD CONSUMER CARE, INC.]7
SODIUM PHOSPHATE, MONOBASICINACTIVE INGREDIENT3980JIH2SWCHILDREN CLARITIN ALLERGY (LORATADINE) SOLUTION [MSD CONSUMER CARE, INC.]7
SORBITOLINACTIVE INGREDIENT506T60A25RCHILDREN CLARITIN ALLERGY (LORATADINE) SOLUTION [MSD CONSUMER CARE, INC.]7
SUCRALOSEINACTIVE INGREDIENT96K6UQ3ZD4CHILDREN CLARITIN ALLERGY (LORATADINE) SOLUTION [MSD CONSUMER CARE, INC.]7
WATERINACTIVE INGREDIENT059QF0KO0RCHILDREN CLARITIN ALLERGY (LORATADINE) SOLUTION [MSD CONSUMER CARE, INC.]7

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
11523-4360CHILDREN CLARITIN ALLERGY (LORATADINE) SOLUTION [BAYER HEALTHCARE LLC.]18Current NDC, Legacy NDC, 14 package rows20250519_170061e9-e529-4ff0-e054-00144ff8d46c.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
755476Claritin Children's 5 MG in 5 mL Oral SolutionPSN170061e9-e529-4ff0-e054-00144ff8d46c18
692783loratadine 5 MG in 5 mL Oral SolutionPSN170061e9-e529-4ff0-e054-00144ff8d46c18
755476loratadine 1 MG/ML Oral Solution [Claritin]SBD170061e9-e529-4ff0-e054-00144ff8d46c18
692783loratadine 1 MG/ML Oral SolutionSCD170061e9-e529-4ff0-e054-00144ff8d46c18
755476Claritin 1 MG/ML Oral SolutionSY170061e9-e529-4ff0-e054-00144ff8d46c18
755476Claritin 5 MG per 5 ML Oral SolutionSY170061e9-e529-4ff0-e054-00144ff8d46c18
755476Claritin Children's 5 MG per 5 ML Oral SolutionSY170061e9-e529-4ff0-e054-00144ff8d46c18
692783loratadine 5 MG per 5 ML Oral SolutionSY170061e9-e529-4ff0-e054-00144ff8d46c18

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
11523-4360-1115234360011 BOTTLE in 1 CARTON (11523-4360-1) / 60 mL in 1 BOTTLE1 bottle2015-05-260000-00-00NoNoCurrent
11523-4360-2115234360021 BOTTLE in 1 CARTON (11523-4360-2) / 120 mL in 1 BOTTLE1 bottle2015-09-250000-00-00NoNoCurrent
11523-4360-3115234360031 BOTTLE in 1 CARTON (11523-4360-3) / 150 mL in 1 BOTTLE1 bottle2016-01-010000-00-00NoNoCurrent
11523-4360-4115234360041 BOTTLE in 1 CARTON (11523-4360-4) / 30 mL in 1 BOTTLE1 bottle2015-11-010000-00-00NoNoCurrent
11523-4360-5115234360051 BOTTLE in 1 CARTON (11523-4360-5) / 240 mL in 1 BOTTLE1 bottle2015-05-260000-00-00NoNoCurrent
11523-4360-6115234360061 BOTTLE in 1 CARTON (11523-4360-6) / 180 mL in 1 BOTTLE1 bottle2015-10-050000-00-00NoNoCurrent
11523-4360-7115234360072 BOTTLE in 1 CARTON (11523-4360-7) / 180 mL in 1 BOTTLE2 bottle2016-03-010000-00-00NoNoCurrent