FDA.reportPublic FDA data

Claritin

Product NDC
11523-0101
11-digit product format
115230101
Labeler code
11523
Product ID
11523-0101_4526da60-c33b-fb4a-e063-6294a90a8692
Type
HUMAN OTC DRUG
Nonproprietary name
loratadine
Dosage form
SOLUTION
Route
ORAL
Labeler
Bayer HealthCare LLC.
Application
NDA020641
Marketing category
NDA
Marketing start
2024-05-22
Substance
LORATADINE
Active strength
1 mg/mL
NDC exclude flag
No
Listing certified through
2026-12-31
Current FDA listing
Yes

Additional Listing Data#

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

Active Ingredients#

Ingredient, Strength table
IngredientStrength
LORATADINE1 mg/mL

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
11523-0101-1ClaritinAllergy30 mL in 1 BOTTLESOLUTION302
11523-0101-1ClaritinAllergy1 in 1 CARTONSOLUTION12
11523-0101-2ClaritinAllergy1 in 1 CARTONSOLUTION12
11523-0101-2ClaritinAllergy80 mL in 1 BOTTLESOLUTION802
11523-0101-3ClaritinAllergy240 mL in 1 BOTTLESOLUTION2402
11523-0101-3ClaritinAllergy1 in 1 CARTONSOLUTION12

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
11523-0101CLARITIN ALLERGY (LORATADINE) SOLUTION [BAYER HEALTHCARE LLC.]1Current NDC, 6 package rows20240612_19afd658-8c67-af44-e063-6394a90abada.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
755476Claritin Children's 5 MG in 5 mL Oral SolutionPSN19afd658-8c67-af44-e063-6394a90abada2
692783loratadine 5 MG in 5 mL Oral SolutionPSN19afd658-8c67-af44-e063-6394a90abada2
755476loratadine 1 MG/ML Oral Solution [Claritin]SBD19afd658-8c67-af44-e063-6394a90abada2
692783loratadine 1 MG/ML Oral SolutionSCD19afd658-8c67-af44-e063-6394a90abada2
755476Claritin 1 MG/ML Oral SolutionSY19afd658-8c67-af44-e063-6394a90abada2
755476Claritin 5 MG per 5 ML Oral SolutionSY19afd658-8c67-af44-e063-6394a90abada2
755476Claritin Children's 5 MG per 5 ML Oral SolutionSY19afd658-8c67-af44-e063-6394a90abada2
692783loratadine 5 MG per 5 ML Oral SolutionSY19afd658-8c67-af44-e063-6394a90abada2

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startSampleExclude flagStatus
11523-0101-1115230101011 BOTTLE in 1 CARTON (11523-0101-1) / 30 mL in 1 BOTTLE1 bottle2024-06-28NoNoCurrent
11523-0101-2115230101021 BOTTLE in 1 CARTON (11523-0101-2) / 80 mL in 1 BOTTLE1 bottle2024-06-28NoNoCurrent
11523-0101-3115230101031 BOTTLE in 1 CARTON (11523-0101-3) / 240 mL in 1 BOTTLE1 bottle2024-06-28NoNoCurrent