Home NDC 11523-0101 Claritin
Product NDC 11523-0101
11-digit product format 115230101
Labeler code 11523
Product ID 11523-0101_4526da60-c33b-fb4a-e063-6294a90a8692
Type HUMAN OTC DRUG
Nonproprietary name loratadine
Dosage form SOLUTION
Route ORAL
Labeler Bayer HealthCare LLC.
Application NDA020641
Marketing category NDA
Marketing start 2024-05-22
Substance LORATADINE
Active strength 1 mg/mL
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 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CLARITIN HIVES RELIEF LORATADINE 1MG/ML **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** SYRUP / ORAL RLD 2003-11-19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 · 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 N020641-002 CLARITIN 1MG/ML SYRUP / ORAL RLD, RS 2002-11-27 caaa826d4ba7…2026-08-18 06:07:40 2026-07 N020641-003 CLARITIN HIVES RELIEF 1MG/ML **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** SYRUP / ORAL RLD 2003-11-19 caaa826d4ba7…2026-02-19 14:30 UTC 2026-02 N020641-002 CLARITIN 1MG/ML SYRUP / ORAL RLD, RS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2026-02 N020641-003 CLARITIN HIVES RELIEF 1MG/ML **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** SYRUP / ORAL RLD 2003-11-19 011fe1cb6892…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 N020641-002 CLARITIN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…
Additional Listing Data#
Finished product Yes
Brand name base Claritin
Brand name suffix Allergy
Listing expiration 2026-12-31 Active Ingredients# Ingredient, Strength table Ingredient Strength LORATADINE 1 mg/mL
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 11523-0101-1 ClaritinAllergy 30 mL in 1 BOTTLE SOLUTION 30 2 11523-0101-1 ClaritinAllergy 1 in 1 CARTON SOLUTION 1 2 11523-0101-2 ClaritinAllergy 1 in 1 CARTON SOLUTION 1 2 11523-0101-2 ClaritinAllergy 80 mL in 1 BOTTLE SOLUTION 80 2 11523-0101-3 ClaritinAllergy 240 mL in 1 BOTTLE SOLUTION 240 2 11523-0101-3 ClaritinAllergy 1 in 1 CARTON SOLUTION 1 2
DailyMed Dashboard NDC Coverage# NDC, Dashboard title, SPL version table NDC Dashboard title SPL version Validation Dashboard ZIP 11523-0101 CLARITIN ALLERGY (LORATADINE) SOLUTION [BAYER HEALTHCARE LLC.] 1 Current NDC, 6 package rows 20240612_19afd658-8c67-af44-e063-6394a90abada.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 Sample Exclude flag Status 11523-0101-1 11523010101 1 BOTTLE in 1 CARTON (11523-0101-1) / 30 mL in 1 BOTTLE 1 bottle 2024-06-28 No No Current 11523-0101-2 11523010102 1 BOTTLE in 1 CARTON (11523-0101-2) / 80 mL in 1 BOTTLE 1 bottle 2024-06-28 No No Current 11523-0101-3 11523010103 1 BOTTLE in 1 CARTON (11523-0101-3) / 240 mL in 1 BOTTLE 1 bottle 2024-06-28 No No Current