Home NDC 11523-4360-2 Children Claritin
Product NDC 11523-4360
Requested package NDC 11523-4360-2
11-digit product format 115234360
Labeler code 11523
Product ID 11523-4360_352ebcfd-07bb-a60e-e063-6394a90a5d70
Type HUMAN OTC DRUG
Nonproprietary name loratadine
Dosage form SOLUTION
Route ORAL
Labeler Bayer HealthCare LLC.
Application NDA020641
Marketing category NDA
Marketing start 2015-05-26
Substance LORATADINE
Active strength 5 mg/5mL
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 1 .
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 N020641-002 CLARITIN LORATADINE 1MG/ML SYRUP / ORAL RLD, RS 2002-11-27 N020641-003 CLARITIN HIVES RELIEF LORATADINE 1MG/ML **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** SYRUP / ORAL RLD 2003-11-19
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 · 82 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 2026-02-19 14:30 UTC 2026-02 N020641-002 CLARITIN 1MG/ML SYRUP / ORAL RLD, RS 2002-11-27 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 N020641-003 CLARITIN HIVES RELIEF 1MG/ML **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** SYRUP / ORAL RLD 2003-11-19 011fe1cb6892…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 N020641-002 CLARITIN 1MG/ML SYRUP / ORAL RLD, RS 2002-11-27 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 N020641-003 CLARITIN HIVES RELIEF 1MG/ML **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** SYRUP / ORAL RLD 2003-11-19 31067a03dcf5…2025-08-23 18:47 UTC 2025-08 N020641-002 CLARITIN 1MG/ML SYRUP / ORAL RLD, RS 2002-11-27 6a471c1ec25d…2025-08-23 18:47 UTC 2025-08 N020641-003 CLARITIN HIVES RELIEF 1MG/ML **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** SYRUP / ORAL RLD 2003-11-19 6a471c1ec25d…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 N020641-002 CLARITIN 1MG/ML SYRUP / ORAL RLD, RS 2002-11-27 fd3edfee7708…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 N020641-003 CLARITIN HIVES RELIEF 1MG/ML **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** SYRUP / ORAL RLD 2003-11-19 fd3edfee7708…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 N020641-002 CLARITIN 1MG/ML SYRUP / ORAL RLD, RS 2002-11-27 b8a1b40f171c…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 N020641-003 CLARITIN HIVES RELIEF 1MG/ML **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** SYRUP / ORAL RLD 2003-11-19 b8a1b40f171c…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 N020641-002 CLARITIN 1MG/ML SYRUP / ORAL RLD, RS 2002-11-27 03ed91905a0d…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 N020641-003 CLARITIN HIVES RELIEF 1MG/ML **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** SYRUP / ORAL RLD 2003-11-19 03ed91905a0d…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 N020641-002 CLARITIN 1MG/ML SYRUP / ORAL RLD, RS 2002-11-27 2680178bc6a6…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 N020641-003 CLARITIN HIVES RELIEF 1MG/ML **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** SYRUP / ORAL RLD 2003-11-19 2680178bc6a6…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 N020641-002 CLARITIN 1MG/ML SYRUP / ORAL RLD, RS 2002-11-27 5bbf6a4d5a75…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 N020641-003 CLARITIN HIVES RELIEF 1MG/ML **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** SYRUP / ORAL RLD 2003-11-19 5bbf6a4d5a75…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 N020641-002 CLARITIN 1MG/ML SYRUP / ORAL RLD, RS 2002-11-27 d8e5a09893c0…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 N020641-003 CLARITIN HIVES RELIEF 1MG/ML **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** SYRUP / ORAL RLD 2003-11-19 d8e5a09893c0…2024-10-29 15:01 UTC 2024-10 N020641-002 CLARITIN 1MG/ML SYRUP / ORAL RLD, RS 2002-11-27 d06236e962d9…2024-10-29 15:01 UTC 2024-10 N020641-003 CLARITIN HIVES RELIEF 1MG/ML **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** SYRUP / ORAL RLD 2003-11-19 d06236e962d9…2024-08-13 05:28 UTC · 3 captures of this ZIP 2024-08 N020641-002 CLARITIN 1MG/ML SYRUP / ORAL RLD, RS 2002-11-27 79d66fd596c7…2024-08-13 05:28 UTC · 3 captures of this ZIP 2024-08 N020641-003 CLARITIN HIVES RELIEF 1MG/ML **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** SYRUP / ORAL RLD 2003-11-19 79d66fd596c7…2024-07-13 05:37 UTC · 2 captures of this ZIP 2024-07 N020641-002 CLARITIN 1MG/ML SYRUP / ORAL RLD, RS 2002-11-27 301d65b070ca…2024-07-13 05:37 UTC · 2 captures of this ZIP 2024-07 N020641-003 CLARITIN HIVES RELIEF 1MG/ML **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** SYRUP / ORAL RLD 2003-11-19 301d65b070ca…2024-06-18 03:08 UTC · 5 captures of this ZIP 2024-06 N020641-002 CLARITIN 1MG/ML SYRUP / ORAL RLD, RS 2002-11-27 1e350fbaab3a…2024-06-18 03:08 UTC · 5 captures of this ZIP 2024-06 N020641-003 CLARITIN HIVES RELIEF 1MG/ML **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** SYRUP / ORAL RLD 2003-11-19 1e350fbaab3a…2024-05-31 18:47 UTC 2024-05 N020641-002 CLARITIN 1MG/ML SYRUP / ORAL RLD, RS 2002-11-27 8072bd15b7f6…2024-05-31 18:47 UTC 2024-05 N020641-003 CLARITIN HIVES RELIEF 1MG/ML **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** SYRUP / ORAL RLD 2003-11-19 8072bd15b7f6…2022-06-29 02:47 UTC · 2 captures of this ZIP 2022-06 N020641-002 CLARITIN 1MG/ML SYRUP / ORAL RLD, RS 2002-11-27 5c6f7cd8ea54…2022-06-29 02:47 UTC · 2 captures of this ZIP 2022-06 N020641-003 CLARITIN HIVES RELIEF 1MG/ML **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** SYRUP / ORAL RLD 2003-11-19 5c6f7cd8ea54…2022-04-08 23:34 UTC 2022-04 N020641-002 CLARITIN 1MG/ML SYRUP / ORAL RLD, RS 2002-11-27 5d02ea3f76ae…2022-04-08 23:34 UTC 2022-04 N020641-003 CLARITIN HIVES RELIEF 1MG/ML **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** SYRUP / ORAL RLD 2003-11-19 5d02ea3f76ae…2022-04-04 05:41 UTC 2022-04 N020641-002 CLARITIN 1MG/ML SYRUP / ORAL RLD, RS 2002-11-27 4b0b4de00fa7…2022-04-04 05:41 UTC 2022-04 N020641-003 CLARITIN HIVES RELIEF 1MG/ML **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** SYRUP / ORAL RLD 2003-11-19 4b0b4de00fa7…2019-12-13 00:20 UTC 2019-12 N020641-002 CLARITIN 1MG/ML SYRUP / ORAL RLD, RS 2002-11-27 74a2ff9319b5…2019-12-13 00:20 UTC 2019-12 N020641-003 CLARITIN HIVES RELIEF 1MG/ML **Federal Register determination that product was not discontinued or withdrawn for safety or efficacy reasons** SYRUP / ORAL RLD 2003-11-19 74a2ff9319b5…2022-03-09 01:35 UTC 2022-03 N020641-002 CLARITIN 1MG/ML SYRUP / ORAL RLD, RS 2002-11-27 bb7c543d1eb4…2022-03-09 01:35 UTC 2022-03 N020641-003 CLARITIN HIVES RELIEF 1MG/ML **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** SYRUP / ORAL RLD 2003-11-19 bb7c543d1eb4…2021-12-28 21:50 UTC 2021-12 N020641-002 CLARITIN 1MG/ML SYRUP / ORAL RLD, RS 2002-11-27 782e0a99824c…2021-12-28 21:50 UTC 2021-12 N020641-003 CLARITIN HIVES RELIEF 1MG/ML **Federal Register determination that product was not discontinued or withdrawn for safety or efficacy reasons** SYRUP / ORAL RLD 2003-11-19 782e0a99824c…
Additional Listing Data#
Finished product Yes
Brand name base Children Claritin
Brand name suffix Allergy
Listing expiration 2026-12-31 Active Ingredients# Ingredient, Strength table Ingredient Strength LORATADINE 5 mg/5mL
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 692783 Internal RxNorm lookup 755476 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 11523-4360-1 Children ClaritinAllergy 1 in 1 CARTON SOLUTION 1 18 11523-4360-1 Children ClaritinAllergy 60 mL in 1 BOTTLE SOLUTION 60 18 11523-4360-2 Children ClaritinAllergy 120 mL in 1 BOTTLE SOLUTION 120 18 11523-4360-2 Children ClaritinAllergy 1 in 1 CARTON SOLUTION 1 18 11523-4360-3 Children ClaritinAllergy 1 in 1 CARTON SOLUTION 1 18 11523-4360-3 Children ClaritinAllergy 150 mL in 1 BOTTLE SOLUTION 150 18 11523-4360-4 Children ClaritinAllergy 1 in 1 CARTON SOLUTION 1 18 11523-4360-4 Children ClaritinAllergy 30 mL in 1 BOTTLE SOLUTION 30 18 11523-4360-5 Children ClaritinAllergy 1 in 1 CARTON SOLUTION 1 18 11523-4360-5 Children ClaritinAllergy 240 mL in 1 BOTTLE SOLUTION 240 18 11523-4360-6 Children ClaritinAllergy 1 in 1 CARTON SOLUTION 1 18 11523-4360-6 Children ClaritinAllergy 180 mL in 1 BOTTLE SOLUTION 180 18 11523-4360-7 Children ClaritinAllergy 2 in 1 CARTON SOLUTION 2 18 11523-4360-7 Children ClaritinAllergy 180 mL in 1 BOTTLE SOLUTION 180 18
DailyMed Socrata Ingredients# Ingredient, Type, UNII table Ingredient Type UNII DailyMed label SPL version Uploaded LORATADINE ACTIVE INGREDIENT 7AJO3BO7QN CHILDREN CLARITIN ALLERGY (LORATADINE) SOLUTION [MSD CONSUMER CARE, INC.] 7 LORATADINE ACTIVE MOIETY 7AJO3BO7QN CHILDREN CLARITIN ALLERGY (LORATADINE) SOLUTION [MSD CONSUMER CARE, INC.] 7 EDETATE DISODIUM INACTIVE INGREDIENT 7FLD91C86K CHILDREN CLARITIN ALLERGY (LORATADINE) SOLUTION [MSD CONSUMER CARE, INC.] 7 GLYCERIN INACTIVE INGREDIENT PDC6A3C0OX CHILDREN CLARITIN ALLERGY (LORATADINE) SOLUTION [MSD CONSUMER CARE, INC.] 7 MALTITOL INACTIVE INGREDIENT D65DG142WK CHILDREN CLARITIN ALLERGY (LORATADINE) SOLUTION [MSD CONSUMER CARE, INC.] 7 PHOSPHORIC ACID INACTIVE INGREDIENT E4GA8884NN CHILDREN CLARITIN ALLERGY (LORATADINE) SOLUTION [MSD CONSUMER CARE, INC.] 7 PROPYLENE GLYCOL INACTIVE INGREDIENT 6DC9Q167V3 CHILDREN CLARITIN ALLERGY (LORATADINE) SOLUTION [MSD CONSUMER CARE, INC.] 7 SODIUM BENZOATE INACTIVE INGREDIENT OJ245FE5EU CHILDREN CLARITIN ALLERGY (LORATADINE) SOLUTION [MSD CONSUMER CARE, INC.] 7 SODIUM PHOSPHATE, MONOBASIC INACTIVE INGREDIENT 3980JIH2SW CHILDREN CLARITIN ALLERGY (LORATADINE) SOLUTION [MSD CONSUMER CARE, INC.] 7 SORBITOL INACTIVE INGREDIENT 506T60A25R CHILDREN CLARITIN ALLERGY (LORATADINE) SOLUTION [MSD CONSUMER CARE, INC.] 7 SUCRALOSE INACTIVE INGREDIENT 96K6UQ3ZD4 CHILDREN CLARITIN ALLERGY (LORATADINE) SOLUTION [MSD CONSUMER CARE, INC.] 7 WATER INACTIVE INGREDIENT 059QF0KO0R CHILDREN CLARITIN ALLERGY (LORATADINE) SOLUTION [MSD CONSUMER CARE, INC.] 7 LORATADINE ACTIVE INGREDIENT 7AJO3BO7QN CHILDREN CLARITIN ALLERGY (LORATADINE) SOLUTION [BAYER HEALTHCARE CONSUMER CARE] 1 LORATADINE ACTIVE MOIETY 7AJO3BO7QN CHILDREN CLARITIN ALLERGY (LORATADINE) SOLUTION [BAYER HEALTHCARE CONSUMER CARE] 1 EDETATE DISODIUM INACTIVE INGREDIENT 7FLD91C86K CHILDREN CLARITIN ALLERGY (LORATADINE) SOLUTION [BAYER HEALTHCARE CONSUMER CARE] 1 GLYCERIN INACTIVE INGREDIENT PDC6A3C0OX CHILDREN CLARITIN ALLERGY (LORATADINE) SOLUTION [BAYER HEALTHCARE CONSUMER CARE] 1 MALTITOL INACTIVE INGREDIENT D65DG142WK CHILDREN CLARITIN ALLERGY (LORATADINE) SOLUTION [BAYER HEALTHCARE CONSUMER CARE] 1 PHOSPHORIC ACID INACTIVE INGREDIENT E4GA8884NN CHILDREN CLARITIN ALLERGY (LORATADINE) SOLUTION [BAYER HEALTHCARE CONSUMER CARE] 1 SODIUM BENZOATE INACTIVE INGREDIENT OJ245FE5EU CHILDREN CLARITIN ALLERGY (LORATADINE) SOLUTION [BAYER HEALTHCARE CONSUMER CARE] 1 SODIUM PHOSPHATE, MONOBASIC INACTIVE INGREDIENT 3980JIH2SW CHILDREN CLARITIN ALLERGY (LORATADINE) SOLUTION [BAYER HEALTHCARE CONSUMER CARE] 1 SORBITOL INACTIVE INGREDIENT 506T60A25R CHILDREN CLARITIN ALLERGY (LORATADINE) SOLUTION [BAYER HEALTHCARE CONSUMER CARE] 1 SUCRALOSE INACTIVE INGREDIENT 96K6UQ3ZD4 CHILDREN CLARITIN ALLERGY (LORATADINE) SOLUTION [BAYER HEALTHCARE CONSUMER CARE] 1 WATER INACTIVE INGREDIENT 059QF0KO0R CHILDREN CLARITIN ALLERGY (LORATADINE) SOLUTION [BAYER HEALTHCARE CONSUMER CARE] 1
DailyMed Dashboard NDC Coverage# NDC, Dashboard title, SPL version table NDC Dashboard title SPL version Validation Dashboard ZIP 11523-4360 CHILDREN CLARITIN ALLERGY (LORATADINE) SOLUTION [BAYER HEALTHCARE LLC.] 18 Current NDC, Legacy NDC, 14 package rows 20250519_170061e9-e529-4ff0-e054-00144ff8d46c.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 · 2 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 11523-4360-2 11523436002 1 BOTTLE in 1 CARTON (11523-4360-2) / 120 mL in 1 BOTTLE 1 bottle 2015-09-25 0000-00-00 No No Current