FDA.reportPublic FDA data

Claritin

Product NDC
11523-6655
11-digit product format
115236655
Labeler code
11523
Product ID
11523-6655_4523713e-42b4-1ee9-e063-6394a90abb7d
Type
HUMAN OTC DRUG
Nonproprietary name
Loratadine
Dosage form
TABLET
Route
ORAL
Labeler
Bayer HealthCare LLC
Application
NDA019658
Marketing category
NDA
Marketing start
1993-04-12
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
Listing expiration
2026-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
LORATADINE10 mg/1

Harmonized Identifiers#

Field, Values table
FieldValues
Unii7AJO3BO7QN
Rxcui206805, 311372

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
11523-6655-1Claritin1 in 1 POUCHTABLET19
11523-6655-1Claritin1 in 1 BLISTER PACKTABLET19
11523-6655-2Claritin70 in 1 BOTTLETABLET709
11523-6655-2Claritin1 in 1 CARTONTABLET19
11523-6655-3Claritin2 in 1 BLISTER PACKTABLET29
11523-6655-3Claritin45 in 1 BOTTLETABLET459
11523-6655-4Claritin105 in 1 BOTTLETABLET1059
11523-6655-4Claritin1 in 1 BLISTER PACKTABLET19
11523-6655-5Claritin1 in 1 CARTONTABLET19
11523-6655-5Claritin60 in 1 BOTTLETABLET609
11523-6655-6Claritin105 in 1 BOTTLETABLET1059
11523-6655-6Claritin1 in 1 BLISTER PACKTABLET19
11523-6655-7Claritin25 in 1 BOXTABLET259
11523-6655-7Claritin1 in 1 POUCHTABLET19
11523-6655-8Claritin1 in 1 CARTONTABLET19
11523-6655-8Claritin30 in 1 BOTTLETABLET309
11523-6655-9Claritin1 in 1 CARTONTABLET19
11523-6655-9Claritin80 in 1 BOTTLETABLET809

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
11523-6655-1EA - Each11523-6655dde71ab6-6809-4ac7-a7d9-9d9c742a2b8f12024-04-05
11523-6655-2EA - Each11523-66555605a8ba-b61d-432a-ad81-9fb5116f9d4612015-03-03
11523-6655-6EA - Each11523-665591e9062d-e1f2-4e78-9761-7f65d491a10a12015-10-02
11523-6655-8EA - Each11523-6655ea2498f1-91fa-4f87-ab4c-62a689bc230812017-06-15

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
LoratadineACTIVE INGREDIENT7AJO3BO7QNCLARITIN (LORATADINE) TABLET [MSD CONSUMER CARE, INC.]5
LoratadineACTIVE MOIETY7AJO3BO7QNCLARITIN (LORATADINE) TABLET [MSD CONSUMER CARE, INC.]5
lactose monohydrateINACTIVE INGREDIENTEWQ57Q8I5XCLARITIN (LORATADINE) TABLET [MSD CONSUMER CARE, INC.]5
magnesium stearateINACTIVE INGREDIENT70097M6I30CLARITIN (LORATADINE) TABLET [MSD CONSUMER CARE, INC.]5
starch, cornINACTIVE INGREDIENTO8232NY3SJCLARITIN (LORATADINE) TABLET [MSD CONSUMER CARE, INC.]5

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
11523-6655CLARITIN (LORATADINE) TABLET [BAYER HEALTHCARE LLC]8Current NDC, Legacy NDC, 18 package rows20221014_ac32d6f9-f553-4d5c-ad36-575af5ea56de.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
206805Claritin 24HR Allergy 10 MG Oral TabletPSNac32d6f9-f553-4d5c-ad36-575af5ea56de9
311372loratadine 10 MG 24HR Oral TabletPSNac32d6f9-f553-4d5c-ad36-575af5ea56de9
206805loratadine 10 MG Oral Tablet [Claritin]SBDac32d6f9-f553-4d5c-ad36-575af5ea56de9
311372loratadine 10 MG Oral TabletSCDac32d6f9-f553-4d5c-ad36-575af5ea56de9
206805Claritin 10 MG 24 HR Oral TabletSYac32d6f9-f553-4d5c-ad36-575af5ea56de9
206805Claritin 10 MG Oral TabletSYac32d6f9-f553-4d5c-ad36-575af5ea56de9
311372loratadine 10 MG 24 HR Oral TabletSYac32d6f9-f553-4d5c-ad36-575af5ea56de9
206805Claritin 24HR Allergy 10 MG Oral TabletPSNa34e8cb7-4fdf-45be-b288-45d93eef62204
311372loratadine 10 MG 24HR Oral TabletPSNa34e8cb7-4fdf-45be-b288-45d93eef62204
206805loratadine 10 MG Oral Tablet [Claritin]SBDa34e8cb7-4fdf-45be-b288-45d93eef62204
311372loratadine 10 MG Oral TabletSCDa34e8cb7-4fdf-45be-b288-45d93eef62204
206805Claritin 10 MG 24 HR Oral TabletSYa34e8cb7-4fdf-45be-b288-45d93eef62204
206805Claritin 10 MG Oral TabletSYa34e8cb7-4fdf-45be-b288-45d93eef62204
311372loratadine 10 MG 24 HR Oral TabletSYa34e8cb7-4fdf-45be-b288-45d93eef62204

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
11523-6655-1115236655011 BLISTER PACK in 1 POUCH (11523-6655-1) / 1 TABLET in 1 BLISTER PACK1 blister pack1993-04-120000-00-00NoNoCurrent
11523-6655-2115236655021 BOTTLE in 1 CARTON (11523-6655-2) / 70 TABLET in 1 BOTTLE1 bottle1993-04-120000-00-00NoNoCurrent
11523-6655-3115236655032 BOTTLE in 1 BLISTER PACK (11523-6655-3) / 45 TABLET in 1 BOTTLE2 bottle1993-04-120000-00-00NoNoCurrent
11523-6655-4115236655041 BOTTLE in 1 BLISTER PACK (11523-6655-4) / 105 TABLET in 1 BOTTLE1 bottle1993-04-120000-00-00NoNoCurrent
11523-6655-5115236655051 BOTTLE in 1 CARTON (11523-6655-5) / 60 TABLET in 1 BOTTLE1 bottle1993-04-120000-00-00NoNoCurrent
11523-6655-6115236655061 BOTTLE in 1 BLISTER PACK (11523-6655-6) / 105 TABLET in 1 BOTTLE1 bottle1993-04-120000-00-00NoNoCurrent
11523-6655-71152366550725 POUCH in 1 BOX (11523-6655-7) / 1 TABLET in 1 POUCH25 pouch1993-04-120000-00-00NoNoCurrent
11523-6655-8115236655081 BOTTLE in 1 CARTON (11523-6655-8) / 30 TABLET in 1 BOTTLE1 bottle1993-04-120000-00-00NoNoCurrent
11523-6655-9115236655091 BOTTLE in 1 CARTON (11523-6655-9) / 80 TABLET in 1 BOTTLE1 bottle1993-04-120000-00-00NoNoCurrent