Home NDC 11523-4328 Claritin
Product NDC 11523-4328
11-digit product format 115234328
Labeler code 11523
Product ID 11523-4328_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 Source provenance: Browse the complete Orange Book source catalog · source snapshot 42 .
Orange Book products# Current product rows page 1 of 1 · 2 matching rows.
Application-product, Trade name, Ingredient table Application-product Trade name Ingredient Strength Dosage form / route TE codes RLD / RS Approval date N021891-001 CHILDREN'S CLARITIN LORATADINE 5MG TABLET, CHEWABLE / ORAL RLD 2006-08-23 N021891-002 CLARITIN LORATADINE 10MG TABLET, CHEWABLE / ORAL RLD, RS 2018-11-21
Observed Orange Book product history# Observed FDA ZIP history: Each table is queried independently by exact application/product key from successfully parsed Orange Book snapshots. Capture times identify archived source observations; absence or a change between snapshots is not inferred. FDA publication files that were not recoverable as structured ZIP data are not represented as states.
Product history page 1 of 3 · 84 observed states.
Captured, Edition, Application-product table Captured Edition Application-product Trade name Strength Dosage form / route Product TE source text RLD / RS Approval date Source SHA-256 2026-08-18 06:07:40 2026-07 N021891-001 CHILDREN'S CLARITIN 5MG TABLET, CHEWABLE / ORAL RLD 2006-08-23 caaa826d4ba7…2026-08-18 06:07:40 2026-07 N021891-002 CLARITIN 10MG TABLET, CHEWABLE / ORAL RLD, RS 2018-11-21 caaa826d4ba7…2026-02-19 14:30 UTC 2026-02 N021891-001 CHILDREN'S CLARITIN 5MG TABLET, CHEWABLE / ORAL RLD 2006-08-23 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 N021891-002 CLARITIN 10MG TABLET, CHEWABLE / ORAL RLD, RS 2018-11-21 011fe1cb6892…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 N021891-001 CHILDREN'S CLARITIN 5MG TABLET, CHEWABLE / ORAL RLD 2006-08-23 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 N021891-002 CLARITIN 10MG TABLET, CHEWABLE / ORAL RLD, RS 2018-11-21 31067a03dcf5…2025-08-23 18:47 UTC 2025-08 N021891-001 CHILDREN'S CLARITIN 5MG TABLET, CHEWABLE / ORAL RLD 2006-08-23 6a471c1ec25d…2025-08-23 18:47 UTC 2025-08 N021891-002 CLARITIN 10MG TABLET, CHEWABLE / ORAL RLD, RS 2018-11-21 6a471c1ec25d…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 N021891-001 CHILDREN'S CLARITIN 5MG TABLET, CHEWABLE / ORAL RLD 2006-08-23 fd3edfee7708…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 N021891-002 CLARITIN 10MG TABLET, CHEWABLE / ORAL RLD, RS 2018-11-21 fd3edfee7708…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 N021891-001 CHILDREN'S CLARITIN 5MG TABLET, CHEWABLE / ORAL RLD 2006-08-23 b8a1b40f171c…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 N021891-002 CLARITIN 10MG TABLET, CHEWABLE / ORAL RLD, RS 2018-11-21 b8a1b40f171c…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 N021891-001 CHILDREN'S CLARITIN 5MG TABLET, CHEWABLE / ORAL RLD 2006-08-23 03ed91905a0d…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 N021891-002 CLARITIN 10MG TABLET, CHEWABLE / ORAL RLD, RS 2018-11-21 03ed91905a0d…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 N021891-001 CHILDREN'S CLARITIN 5MG TABLET, CHEWABLE / ORAL RLD 2006-08-23 2680178bc6a6…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 N021891-002 CLARITIN 10MG TABLET, CHEWABLE / ORAL RLD, RS 2018-11-21 2680178bc6a6…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 N021891-001 CHILDREN'S CLARITIN 5MG TABLET, CHEWABLE / ORAL RLD 2006-08-23 5bbf6a4d5a75…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 N021891-002 CLARITIN 10MG TABLET, CHEWABLE / ORAL RLD, RS 2018-11-21 5bbf6a4d5a75…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 N021891-001 CHILDREN'S CLARITIN 5MG TABLET, CHEWABLE / ORAL RLD 2006-08-23 d8e5a09893c0…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 N021891-002 CLARITIN 10MG TABLET, CHEWABLE / ORAL RLD, RS 2018-11-21 d8e5a09893c0…2024-10-29 15:01 UTC 2024-10 N021891-001 CHILDREN'S CLARITIN 5MG TABLET, CHEWABLE / ORAL RLD 2006-08-23 d06236e962d9…2024-10-29 15:01 UTC 2024-10 N021891-002 CLARITIN 10MG TABLET, CHEWABLE / ORAL RLD, RS 2018-11-21 d06236e962d9…2024-08-13 05:28 UTC · 3 captures of this ZIP 2024-08 N021891-001 CHILDREN'S CLARITIN 5MG TABLET, CHEWABLE / ORAL RLD 2006-08-23 79d66fd596c7…2024-08-13 05:28 UTC · 3 captures of this ZIP 2024-08 N021891-002 CLARITIN 10MG TABLET, CHEWABLE / ORAL RLD, RS 2018-11-21 79d66fd596c7…2024-07-13 05:37 UTC · 2 captures of this ZIP 2024-07 N021891-001 CHILDREN'S CLARITIN 5MG TABLET, CHEWABLE / ORAL RLD 2006-08-23 301d65b070ca…2024-07-13 05:37 UTC · 2 captures of this ZIP 2024-07 N021891-002 CLARITIN 10MG TABLET, CHEWABLE / ORAL RLD, RS 2018-11-21 301d65b070ca…2024-06-18 03:08 UTC · 5 captures of this ZIP 2024-06 N021891-001 CHILDREN'S CLARITIN 5MG TABLET, CHEWABLE / ORAL RLD 2006-08-23 1e350fbaab3a…2024-06-18 03:08 UTC · 5 captures of this ZIP 2024-06 N021891-002 CLARITIN 10MG TABLET, CHEWABLE / ORAL RLD, RS 2018-11-21 1e350fbaab3a…2024-05-31 18:47 UTC 2024-05 N021891-001 CHILDREN'S CLARITIN 5MG TABLET, CHEWABLE / ORAL RLD 2006-08-23 8072bd15b7f6…2024-05-31 18:47 UTC 2024-05 N021891-002 CLARITIN 10MG TABLET, CHEWABLE / ORAL RLD, RS 2018-11-21 8072bd15b7f6…2022-06-29 02:47 UTC · 2 captures of this ZIP 2022-06 N021891-001 CHILDREN'S CLARITIN 5MG TABLET, CHEWABLE / ORAL RLD 2006-08-23 5c6f7cd8ea54…2022-06-29 02:47 UTC · 2 captures of this ZIP 2022-06 N021891-002 CLARITIN 10MG TABLET, CHEWABLE / ORAL RLD, RS 2018-11-21 5c6f7cd8ea54…2022-04-08 23:34 UTC 2022-04 N021891-001 CHILDREN'S CLARITIN 5MG TABLET, CHEWABLE / ORAL RLD, RS 2006-08-23 5d02ea3f76ae…2022-04-08 23:34 UTC 2022-04 N021891-002 CLARITIN 10MG TABLET, CHEWABLE / ORAL RLD 2018-11-21 5d02ea3f76ae…2022-04-04 05:41 UTC 2022-04 N021891-001 CHILDREN'S CLARITIN 5MG TABLET, CHEWABLE / ORAL RLD, RS 2006-08-23 4b0b4de00fa7…2022-04-04 05:41 UTC 2022-04 N021891-002 CLARITIN 10MG TABLET, CHEWABLE / ORAL RLD 2018-11-21 4b0b4de00fa7…2019-12-13 00:20 UTC 2019-12 N021891-001 CHILDREN'S CLARITIN 5MG TABLET, CHEWABLE / ORAL RLD, RS 2006-08-23 74a2ff9319b5…2019-12-13 00:20 UTC 2019-12 N021891-002 CLARITIN 10MG TABLET, CHEWABLE / ORAL RLD 2018-11-21 74a2ff9319b5…2022-03-09 01:35 UTC 2022-03 N021891-001 CHILDREN'S CLARITIN 5MG TABLET, CHEWABLE / ORAL RLD, RS 2006-08-23 bb7c543d1eb4…2022-03-09 01:35 UTC 2022-03 N021891-002 CLARITIN 10MG TABLET, CHEWABLE / ORAL RLD 2018-11-21 bb7c543d1eb4…
Additional Listing Data#
Finished product Yes
Brand name base Claritin
Listing expiration 2026-12-31 Active Ingredients# Ingredient, Strength table Ingredient Strength LORATADINE 5 mg/1
Harmonized UNII identifiers# UNII identifiers page 1 of 1 · 1 matching rows.
Identifier, FDA.report destination table Identifier FDA.report destination 7AJO3BO7QN Internal UNII lookup
Harmonized RxCUI identifiers# RxCUI identifiers page 1 of 1 · 2 matching rows.
Identifier, FDA.report destination table Identifier FDA.report destination 665078 Internal RxNorm lookup 668469 Internal RxNorm lookup
Harmonized SPL set identifiers# SPL set identifiers page 1 of 1 · 1 matching rows.
DailyMed Product Concepts# DailyMed Package Descriptions# Package NDC, Product, Description table Package NDC Product Description Form Quantity Strength SPL version 11523-4328-1 Claritin 1 in 1 CARTON TABLET, CHEWABLE 1 14 11523-4328-1 Claritin 10 in 1 BLISTER PACK TABLET, CHEWABLE 10 14 11523-4328-2 Claritin 2 in 1 CARTON TABLET, CHEWABLE 2 14 11523-4328-2 Claritin 10 in 1 BLISTER PACK TABLET, CHEWABLE 10 14 11523-4328-3 Claritin 10 in 1 BLISTER PACK TABLET, CHEWABLE 10 14 11523-4328-3 Claritin 3 in 1 CARTON TABLET, CHEWABLE 3 14 11523-4328-4 Claritin 1 in 1 POUCH TABLET, CHEWABLE 1 14 11523-4328-4 Claritin 2 in 1 BLISTER PACK TABLET, CHEWABLE 2 14 11523-4328-5 Claritin 10 in 1 BLISTER PACK TABLET, CHEWABLE 10 14 11523-4328-5 Claritin 5 in 1 CARTON TABLET, CHEWABLE 5 14 11523-4328-6 Claritin 2 in 1 POUCH TABLET, CHEWABLE 2 14 11523-4328-6 Claritin 50 in 1 BOX TABLET, CHEWABLE 50 14 11523-4328-7 Claritin 10 in 1 BLISTER PACK TABLET, CHEWABLE 10 14 11523-4328-7 Claritin 2.5 in 1 PACKAGE, COMBINATION TABLET, CHEWABLE 2.5 14 11523-4328-9 Claritin 10 in 1 BLISTER PACK TABLET, CHEWABLE 10 14 11523-4328-9 Claritin 4 in 1 CARTON TABLET, CHEWABLE 4 14
DailyMed Socrata Ingredients# Ingredient, Type, UNII table Ingredient Type UNII DailyMed label SPL version Uploaded Loratadine ACTIVE INGREDIENT 7AJO3BO7QN CLARITIN (LORATADINE) TABLET, CHEWABLE [MSD CONSUMER CARE, INC.] 2 Loratadine ACTIVE MOIETY 7AJO3BO7QN CLARITIN (LORATADINE) TABLET, CHEWABLE [MSD CONSUMER CARE, INC.] 2 aluminum oxide INACTIVE INGREDIENT LMI26O6933 CLARITIN (LORATADINE) TABLET, CHEWABLE [MSD CONSUMER CARE, INC.] 2 anhydrous citric acid INACTIVE INGREDIENT XF417D3PSL CLARITIN (LORATADINE) TABLET, CHEWABLE [MSD CONSUMER CARE, INC.] 2 aspartame INACTIVE INGREDIENT Z0H242BBR1 CLARITIN (LORATADINE) TABLET, CHEWABLE [MSD CONSUMER CARE, INC.] 2 cellulose, microcrystalline INACTIVE INGREDIENT OP1R32D61U CLARITIN (LORATADINE) TABLET, CHEWABLE [MSD CONSUMER CARE, INC.] 2 D&C red No. 27 INACTIVE INGREDIENT 2LRS185U6K CLARITIN (LORATADINE) TABLET, CHEWABLE [MSD CONSUMER CARE, INC.] 2 FD&C blue No. 2 INACTIVE INGREDIENT L06K8R7DQK CLARITIN (LORATADINE) TABLET, CHEWABLE [MSD CONSUMER CARE, INC.] 2 magnesium stearate INACTIVE INGREDIENT 70097M6I30 CLARITIN (LORATADINE) TABLET, CHEWABLE [MSD CONSUMER CARE, INC.] 2 mannitol INACTIVE INGREDIENT 3OWL53L36A CLARITIN (LORATADINE) TABLET, CHEWABLE [MSD CONSUMER CARE, INC.] 2 silicon dioxide INACTIVE INGREDIENT ETJ7Z6XBU4 CLARITIN (LORATADINE) TABLET, CHEWABLE [MSD CONSUMER CARE, INC.] 2 sodium starch glycolate type A potato INACTIVE INGREDIENT 5856J3G2A2 CLARITIN (LORATADINE) TABLET, CHEWABLE [MSD CONSUMER CARE, INC.] 2 stearic acid INACTIVE INGREDIENT 4ELV7Z65AP CLARITIN (LORATADINE) TABLET, CHEWABLE [MSD CONSUMER CARE, INC.] 2
DailyMed Dashboard NDC Coverage# NDC, Dashboard title, SPL version table NDC Dashboard title SPL version Validation Dashboard ZIP 11523-4328 CLARITIN (LORATADINE) TABLET, CHEWABLE [BAYER HEALTHCARE LLC.] 13 Current NDC, Legacy NDC, 16 package rows 20230629_37732ca2-b454-4215-91a2-c62e0f7a56af.zip
openFDA label cross-check# OpenFDA label data provides additional search and identifier links. DailyMed’s Structured Product Label is the canonical label on FDA.report. Matching records are deduplicated before they are shown below.
Matched openFDA labels page 1 of 1 · 4 matching rows.
DailyMed RxNorm Mappings# Packages# Package NDC, 11-digit format, Description table Package NDC 11-digit format Description Units Marketing start Marketing end Sample Exclude flag Status 11523-4328-1 11523432801 1 BLISTER PACK in 1 CARTON (11523-4328-1) / 10 TABLET, CHEWABLE in 1 BLISTER PACK 1 blister pack 2006-08-23 0000-00-00 No No Current 11523-4328-2 11523432802 2 BLISTER PACK in 1 CARTON (11523-4328-2) / 10 TABLET, CHEWABLE in 1 BLISTER PACK 2 blister pack 2006-08-23 0000-00-00 No No Current 11523-4328-3 11523432803 3 BLISTER PACK in 1 CARTON (11523-4328-3) / 10 TABLET, CHEWABLE in 1 BLISTER PACK 3 blister pack 2006-08-23 0000-00-00 No No Current 11523-4328-4 11523432804 1 BLISTER PACK in 1 POUCH (11523-4328-4) / 2 TABLET, CHEWABLE in 1 BLISTER PACK 1 blister pack 2006-08-23 0000-00-00 No No Current 11523-4328-5 11523432805 5 BLISTER PACK in 1 CARTON (11523-4328-5) / 10 TABLET, CHEWABLE in 1 BLISTER PACK 5 blister pack 2006-08-23 0000-00-00 No No Current 11523-4328-6 11523432806 50 POUCH in 1 BOX (11523-4328-6) / 2 TABLET, CHEWABLE in 1 POUCH 50 pouch 2006-08-23 0000-00-00 No No Current 11523-4328-7 11523432807 2.5 BLISTER PACK in 1 PACKAGE, COMBINATION (11523-4328-7) / 10 TABLET, CHEWABLE in 1 BLISTER PACK 2.5 blister pack 2006-08-23 0000-00-00 No No Current 11523-4328-9 11523432809 4 BLISTER PACK in 1 CARTON (11523-4328-9) / 10 TABLET, CHEWABLE in 1 BLISTER PACK 4 blister pack 2006-08-23 0000-00-00 No No Current