FDA.reportPublic FDA data

Claritin Chewable

Product NDC
11523-4364
11-digit product format
115234364
Labeler code
11523
Product ID
11523-4364_453711b1-0b16-f203-e063-6394a90a34e1
Type
HUMAN OTC DRUG
Nonproprietary name
loratadine
Dosage form
TABLET, CHEWABLE
Route
ORAL
Labeler
Bayer HealthCare LLC.
Application
NDA021891
Marketing category
NDA
Marketing start
2019-12-09
Substance
LORATADINE
Active strength
10 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 Chewable
Brand name suffix
Cool Mint Flavor
Listing expiration
2026-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
LORATADINE10 mg/1

Harmonized Identifiers#

Field, Values table
FieldValues
Unii7AJO3BO7QN
Rxcui2265266, 2265267

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
11523-4364-1Claritin ChewableCool Mint Flavor3 in 1 CARTONTABLET, CHEWABLE35
11523-4364-1Claritin ChewableCool Mint Flavor8 in 1 BLISTER PACKTABLET, CHEWABLE85
11523-4364-2Claritin ChewableCool Mint Flavor2 in 1 BLISTER PACKTABLET, CHEWABLE25
11523-4364-2Claritin ChewableCool Mint Flavor1 in 1 CARTONTABLET, CHEWABLE15
11523-4364-3Claritin ChewableCool Mint Flavor4 in 1 BLISTER PACKTABLET, CHEWABLE45
11523-4364-3Claritin ChewableCool Mint Flavor1 in 1 CARTONTABLET, CHEWABLE15
11523-4364-4Claritin ChewableCool Mint Flavor7 in 1 CARTONTABLET, CHEWABLE75
11523-4364-4Claritin ChewableCool Mint Flavor8 in 1 BLISTER PACKTABLET, CHEWABLE85
11523-4364-5Claritin ChewableCool Mint Flavor8 in 1 CARTONTABLET, CHEWABLE85
11523-4364-5Claritin ChewableCool Mint Flavor8 in 1 BLISTER PACKTABLET, CHEWABLE85
11523-4364-6Claritin ChewableCool Mint Flavor1 in 1 CARTONTABLET, CHEWABLE15
11523-4364-6Claritin ChewableCool Mint Flavor8 in 1 BLISTER PACKTABLET, CHEWABLE85
11523-4364-7Claritin ChewableCool Mint Flavor2 in 1 BLISTER PACKTABLET, CHEWABLE25
11523-4364-7Claritin ChewableCool Mint Flavor1 in 1 POUCHTABLET, CHEWABLE15

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
11523-4364-1EA - Each11523-4364a888024d-d3f7-43cb-9107-b6e9040b6de012025-05-14

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
11523-4364CLARITIN CHEWABLE COOL MINT FLAVOR (LORATADINE) TABLET, CHEWABLE [BAYER HEALTHCARE LLC.]4Current NDC, Legacy NDC, 14 package rows20231214_98b99bb9-d499-9ab4-e053-2a95a90a6ae6.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
2265267Claritin 10 MG Chewable TabletPSN98b99bb9-d499-9ab4-e053-2a95a90a6ae65
2265266loratadine 10 MG Chewable TabletPSN98b99bb9-d499-9ab4-e053-2a95a90a6ae65
2265267loratadine 10 MG Chewable Tablet [Claritin]SBD98b99bb9-d499-9ab4-e053-2a95a90a6ae65
2265266loratadine 10 MG Chewable TabletSCD98b99bb9-d499-9ab4-e053-2a95a90a6ae65
2265267Claritin 10 MG Chewable TabletSY98b99bb9-d499-9ab4-e053-2a95a90a6ae65

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
11523-4364-1115234364013 BLISTER PACK in 1 CARTON (11523-4364-1) / 8 TABLET, CHEWABLE in 1 BLISTER PACK3 blister pack2019-12-090000-00-00NoNoCurrent
11523-4364-2115234364021 BLISTER PACK in 1 CARTON (11523-4364-2) / 2 TABLET, CHEWABLE in 1 BLISTER PACK1 blister pack2019-12-090000-00-00NoNoCurrent
11523-4364-3115234364031 BLISTER PACK in 1 CARTON (11523-4364-3) / 4 TABLET, CHEWABLE in 1 BLISTER PACK1 blister pack2019-12-090000-00-00YesNoCurrent
11523-4364-4115234364047 BLISTER PACK in 1 CARTON (11523-4364-4) / 8 TABLET, CHEWABLE in 1 BLISTER PACK7 blister pack2019-12-090000-00-00NoNoCurrent
11523-4364-5115234364058 BLISTER PACK in 1 CARTON (11523-4364-5) / 8 TABLET, CHEWABLE in 1 BLISTER PACK8 blister pack2019-12-090000-00-00NoNoCurrent
11523-4364-6115234364061 BLISTER PACK in 1 CARTON (11523-4364-6) / 8 TABLET, CHEWABLE in 1 BLISTER PACK1 blister pack2019-12-090000-00-00NoNoCurrent
11523-4364-7115234364071 BLISTER PACK in 1 POUCH (11523-4364-7) / 2 TABLET, CHEWABLE in 1 BLISTER PACK1 blister pack2019-12-090000-00-00NoNoCurrent