FDA.reportPublic FDA data

Claritin

Product NDC
11523-4331
11-digit product format
115234331
Labeler code
11523
Product ID
11523-4331_453703bf-d4b7-d090-e063-6394a90a7ebf
Type
HUMAN OTC DRUG
Nonproprietary name
Loratadine
Dosage form
TABLET, CHEWABLE
Route
ORAL
Labeler
Bayer HealthCare LLC.
Application
NDA021891
Marketing category
NDA
Marketing start
2006-08-23
Substance
LORATADINE
Active strength
5 mg/1
NDC exclude flag
No
Listing certified through
2026-12-31
Current FDA listing
Yes

Additional Listing Data#

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

Active Ingredients#

Ingredient, Strength table
IngredientStrength
LORATADINE5 mg/1

Harmonized Identifiers#

Field, Values table
FieldValues
Unii7AJO3BO7QN
Rxcui665078, 668469

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
e2db08c6-133f-4f4f-afb4-e90a2418d6f6Product name120230320
ce6d5c06-3ae0-18a6-d5b3-8cd3cc0f8906Product name720210625
a62a50ac-1535-4461-9768-8ae703e2e9fbProduct name120210525
f52be47f-7aa7-46c0-b1fa-50c18dd50206Product name120201029
11ed6f83-cdd2-4637-8379-b1a1d3ae3cdeProduct name120181101
86c45a79-b9f0-4476-a27c-6e10db098497Product name120180125
d5e51f11-ad28-caa4-4b49-4143974782adProduct name120150831
9514609b-a2a9-f8ec-6ba6-3f8e5ee89877Product name120140508
bc07ef78-e82d-0c19-31f4-31f263780582Product name120140508

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
11523-4331-1Claritin10 in 1 BLISTER PACKTABLET, CHEWABLE1014
11523-4331-1Claritin4 in 1 CARTONTABLET, CHEWABLE414
11523-4331-2Claritin10 in 1 BLISTER PACKTABLET, CHEWABLE1014
11523-4331-2Claritin6 in 1 CARTONTABLET, CHEWABLE614
11523-4331-6Claritin8 in 1 CARTONTABLET, CHEWABLE814
11523-4331-6Claritin10 in 1 BLISTER PACKTABLET, CHEWABLE1014

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
LoratadineACTIVE INGREDIENT7AJO3BO7QNCLARITIN (LORATADINE) TABLET, CHEWABLE [MSD CONSUMER CARE, INC.]2
LoratadineACTIVE MOIETY7AJO3BO7QNCLARITIN (LORATADINE) TABLET, CHEWABLE [MSD CONSUMER CARE, INC.]2
aluminum oxideINACTIVE INGREDIENTLMI26O6933CLARITIN (LORATADINE) TABLET, CHEWABLE [MSD CONSUMER CARE, INC.]2
anhydrous citric acidINACTIVE INGREDIENTXF417D3PSLCLARITIN (LORATADINE) TABLET, CHEWABLE [MSD CONSUMER CARE, INC.]2
aspartameINACTIVE INGREDIENTZ0H242BBR1CLARITIN (LORATADINE) TABLET, CHEWABLE [MSD CONSUMER CARE, INC.]2
cellulose, microcrystallineINACTIVE INGREDIENTOP1R32D61UCLARITIN (LORATADINE) TABLET, CHEWABLE [MSD CONSUMER CARE, INC.]2
D&C red No. 27INACTIVE INGREDIENT2LRS185U6KCLARITIN (LORATADINE) TABLET, CHEWABLE [MSD CONSUMER CARE, INC.]2
FD&C blue No. 2INACTIVE INGREDIENTL06K8R7DQKCLARITIN (LORATADINE) TABLET, CHEWABLE [MSD CONSUMER CARE, INC.]2
magnesium stearateINACTIVE INGREDIENT70097M6I30CLARITIN (LORATADINE) TABLET, CHEWABLE [MSD CONSUMER CARE, INC.]2
mannitolINACTIVE INGREDIENT3OWL53L36ACLARITIN (LORATADINE) TABLET, CHEWABLE [MSD CONSUMER CARE, INC.]2
silicon dioxideINACTIVE INGREDIENTETJ7Z6XBU4CLARITIN (LORATADINE) TABLET, CHEWABLE [MSD CONSUMER CARE, INC.]2
sodium starch glycolate type A potatoINACTIVE INGREDIENT5856J3G2A2CLARITIN (LORATADINE) TABLET, CHEWABLE [MSD CONSUMER CARE, INC.]2
stearic acidINACTIVE INGREDIENT4ELV7Z65APCLARITIN (LORATADINE) TABLET, CHEWABLE [MSD CONSUMER CARE, INC.]2

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
11523-4331CLARITIN (LORATADINE) TABLET, CHEWABLE [BAYER HEALTHCARE LLC.]13Current NDC, Legacy NDC, 6 package rows20230629_37732ca2-b454-4215-91a2-c62e0f7a56af.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
668469Claritin Children's 5 MG 24HR Chewable TabletPSN37732ca2-b454-4215-91a2-c62e0f7a56af14
665078loratadine 5 MG 24HR Chewable TabletPSN37732ca2-b454-4215-91a2-c62e0f7a56af14
668469loratadine 5 MG Chewable Tablet [Claritin]SBD37732ca2-b454-4215-91a2-c62e0f7a56af14
665078loratadine 5 MG Chewable TabletSCD37732ca2-b454-4215-91a2-c62e0f7a56af14
668469Claritin 5 MG Chewable TabletSY37732ca2-b454-4215-91a2-c62e0f7a56af14
668469Claritin Children's 5 MG 24HR Chewable TabletPSN0371368b-dca6-af2f-e063-6394a90a0ac02
665078loratadine 5 MG 24HR Chewable TabletPSN0371368b-dca6-af2f-e063-6394a90a0ac02
668469loratadine 5 MG Chewable Tablet [Claritin]SBD0371368b-dca6-af2f-e063-6394a90a0ac02
665078loratadine 5 MG Chewable TabletSCD0371368b-dca6-af2f-e063-6394a90a0ac02
668469Claritin 5 MG Chewable TabletSY0371368b-dca6-af2f-e063-6394a90a0ac02

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
11523-4331-1115234331014 BLISTER PACK in 1 CARTON (11523-4331-1) / 10 TABLET, CHEWABLE in 1 BLISTER PACK4 blister pack2006-08-230000-00-00NoNoCurrent
11523-4331-2115234331026 BLISTER PACK in 1 CARTON (11523-4331-2) / 10 TABLET, CHEWABLE in 1 BLISTER PACK6 blister pack2019-09-060000-00-00NoNoCurrent
11523-4331-6115234331068 BLISTER PACK in 1 CARTON (11523-4331-6) / 10 TABLET, CHEWABLE in 1 BLISTER PACK8 blister pack2006-08-23NoNoCurrent