FDA.reportPublic FDA data

Claritin-D

Product NDC
11523-7162
11-digit product format
115237162
Labeler code
11523
Product ID
11523-7162_45371982-daab-f344-e063-6394a90a2f41
Type
HUMAN OTC DRUG
Nonproprietary name
Loratadine and pseudoephedrine sulfate
Dosage form
TABLET, EXTENDED RELEASE
Route
ORAL
Labeler
Bayer HealthCare LLC.
Application
NDA019670
Marketing category
NDA
Marketing start
2009-12-01
Substance
LORATADINE; PSEUDOEPHEDRINE SULFATE
Active strength
5; 120 mg/1; mg/1
Pharmacologic classes
Adrenergic alpha-Agonists [MoA], alpha-Adrenergic Agonist [EPC]
NDC exclude flag
No
Listing certified through
2026-12-31
Current FDA listing
Yes

Additional Listing Data#

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

Active Ingredients#

Ingredient, Strength table
IngredientStrength
LORATADINE5 mg/1
PSEUDOEPHEDRINE SULFATE120 mg/1

Harmonized Identifiers#

Field, Values table
FieldValues
Unii7AJO3BO7QN, Y9DL7QPE6B
Rxcui1242399, 1242406

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
ba088a92-ab5e-b2d4-e908-f5ea691b7587Product name720210201
0fdb98e2-b951-a1ce-5715-2b187ba500efProduct name420170718
e974e22d-8688-7d92-1e87-40c1079e170cProduct name320151125
e8718272-64cb-4436-969b-176c3067c8f4Product name120150609
30c51294-7ae9-8007-7de6-58222684a0beProduct name120140508
4f26f669-fc6c-40ef-9e26-1c7b2390ee66Product name120140508
70a83adc-6047-bbea-5a08-dfd304aa47d2Product name120140508
858ce051-9941-aafc-8c7c-44a8e0227463Product name120140508
b893258d-0942-3d8a-3411-056ea0788ff5Product name120140508

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
11523-7162-1Claritin-D12 Hour10 in 1 BLISTER PACKTABLET, EXTENDED RELEASE1010
11523-7162-1Claritin-D12 Hour1 in 1 CARTONTABLET, EXTENDED RELEASE110
11523-7162-2Claritin-D12 Hour2 in 1 CARTONTABLET, EXTENDED RELEASE210
11523-7162-2Claritin-D12 Hour10 in 1 BLISTER PACKTABLET, EXTENDED RELEASE1010
11523-7162-3Claritin-D12 Hour3 in 1 CARTONTABLET, EXTENDED RELEASE310
11523-7162-3Claritin-D12 Hour10 in 1 BLISTER PACKTABLET, EXTENDED RELEASE1010

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
11523-7162-1EA - Each11523-716285cce7f3-cec5-4281-aaa0-08796678607d12012-07-24
11523-7162-2EA - Each11523-7162c215d904-7907-4d87-a34a-651e85e00f1212012-07-24
11523-7162-3EA - Each11523-7162a7d669e2-7d96-4d35-9050-88685311133312012-07-24

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
LoratadineACTIVE INGREDIENT7AJO3BO7QNCLARITIN-D 12 HOUR (LORATADINE AND PSEUDOEPHEDRINE SULFATE) TABLET, EXTENDED RELEASE [MSD CONSUMER CARE, INC.]2
pseudoephedrine sulfateACTIVE INGREDIENTY9DL7QPE6BCLARITIN-D 12 HOUR (LORATADINE AND PSEUDOEPHEDRINE SULFATE) TABLET, EXTENDED RELEASE [MSD CONSUMER CARE, INC.]2
LoratadineACTIVE MOIETY7AJO3BO7QNCLARITIN-D 12 HOUR (LORATADINE AND PSEUDOEPHEDRINE SULFATE) TABLET, EXTENDED RELEASE [MSD CONSUMER CARE, INC.]2
pseudoephedrineACTIVE MOIETY7CUC9DDI9FCLARITIN-D 12 HOUR (LORATADINE AND PSEUDOEPHEDRINE SULFATE) TABLET, EXTENDED RELEASE [MSD CONSUMER CARE, INC.]2
calcium phosphate, dibasic, anhydrousINACTIVE INGREDIENTL11K75P92JCLARITIN-D 12 HOUR (LORATADINE AND PSEUDOEPHEDRINE SULFATE) TABLET, EXTENDED RELEASE [MSD CONSUMER CARE, INC.]2
croscarmellose sodiumINACTIVE INGREDIENTM28OL1HH48CLARITIN-D 12 HOUR (LORATADINE AND PSEUDOEPHEDRINE SULFATE) TABLET, EXTENDED RELEASE [MSD CONSUMER CARE, INC.]2
hypromellosesINACTIVE INGREDIENT3NXW29V3WOCLARITIN-D 12 HOUR (LORATADINE AND PSEUDOEPHEDRINE SULFATE) TABLET, EXTENDED RELEASE [MSD CONSUMER CARE, INC.]2
lactose monohydrateINACTIVE INGREDIENTEWQ57Q8I5XCLARITIN-D 12 HOUR (LORATADINE AND PSEUDOEPHEDRINE SULFATE) TABLET, EXTENDED RELEASE [MSD CONSUMER CARE, INC.]2
magnesium stearateINACTIVE INGREDIENT70097M6I30CLARITIN-D 12 HOUR (LORATADINE AND PSEUDOEPHEDRINE SULFATE) TABLET, EXTENDED RELEASE [MSD CONSUMER CARE, INC.]2
povidonesINACTIVE INGREDIENTFZ989GH94ECLARITIN-D 12 HOUR (LORATADINE AND PSEUDOEPHEDRINE SULFATE) TABLET, EXTENDED RELEASE [MSD CONSUMER CARE, INC.]2
titanium dioxideINACTIVE INGREDIENT15FIX9V2JPCLARITIN-D 12 HOUR (LORATADINE AND PSEUDOEPHEDRINE SULFATE) TABLET, EXTENDED RELEASE [MSD CONSUMER CARE, INC.]2

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
11523-7162CLARITIN-D 12 HOUR (LORATADINE AND PSEUDOEPHEDRINE SULFATE) TABLET, EXTENDED RELEASE [BAYER HEALTHCARE LLC.]9Current NDC, Legacy NDC, 6 package rows20241208_a7125705-01ff-4418-8c53-9209c2bbb484.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
1242406Claritin-D 5 MG / 120 MG 12HR Extended Release Oral TabletPSNa7125705-01ff-4418-8c53-9209c2bbb48410
1242399pseudoephedrine sulfate 120 MG / loratadine 5 MG 12HR Extended Release Oral TabletPSNa7125705-01ff-4418-8c53-9209c2bbb48410
124240612 HR loratadine 5 MG / pseudoephedrine sulfate 120 MG Extended Release Oral Tablet [Claritin-D]SBDa7125705-01ff-4418-8c53-9209c2bbb48410
124239912 HR loratadine 5 MG / pseudoephedrine sulfate 120 MG Extended Release Oral TabletSCDa7125705-01ff-4418-8c53-9209c2bbb48410
1242406Claritin-D (loratadine 5 MG / pseudoephedrine sulfate 120 MG) 12 HR Extended Release Oral TabletSYa7125705-01ff-4418-8c53-9209c2bbb48410
1242399loratadine 5 MG / pseudoephedrine sulfate 120 MG 12 HR Extended Release Oral TabletSYa7125705-01ff-4418-8c53-9209c2bbb48410

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
11523-7162-1115237162011 BLISTER PACK in 1 CARTON (11523-7162-1) / 10 TABLET, EXTENDED RELEASE in 1 BLISTER PACK1 blister pack2009-12-010000-00-00NoNoCurrent
11523-7162-2115237162022 BLISTER PACK in 1 CARTON (11523-7162-2) / 10 TABLET, EXTENDED RELEASE in 1 BLISTER PACK2 blister pack2009-12-010000-00-00NoNoCurrent
11523-7162-3115237162033 BLISTER PACK in 1 CARTON (11523-7162-3) / 10 TABLET, EXTENDED RELEASE in 1 BLISTER PACK3 blister pack2009-12-010000-00-00NoNoCurrent