Home NDC 41520-131 Childrens Loratadine
Product NDC 41520-131
11-digit product format 415200131
Labeler code 41520
Product ID 41520-131_28dbc446-66f2-7eb5-e063-6294a90a1d1a
Type HUMAN OTC DRUG
Nonproprietary name Loratadine
Dosage form SOLUTION
Route ORAL
Labeler American Sales Company
Application ANDA076805
Marketing category ANDA
Marketing start 2017-03-17
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 · 1 matching rows.
Application-product, Trade name, Ingredient table Application-product Trade name Ingredient Strength Dosage form / route TE codes RLD / RS Approval date A076805-001 LORATADINE LORATADINE 1MG/ML SYRUP / ORAL 2004-08-20
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 2 · 41 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 A076805-001 LORATADINE 1MG/ML SYRUP / ORAL 2004-08-20 011fe1cb6892…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A076805-001 LORATADINE 1MG/ML SYRUP / ORAL 2004-08-20 31067a03dcf5…2025-08-23 18:47 UTC 2025-08 A076805-001 LORATADINE 1MG/ML SYRUP / ORAL 2004-08-20 6a471c1ec25d…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 A076805-001 LORATADINE 1MG/ML SYRUP / ORAL 2004-08-20 fd3edfee7708…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 A076805-001 LORATADINE 1MG/ML SYRUP / ORAL 2004-08-20 b8a1b40f171c…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 A076805-001 LORATADINE 1MG/ML SYRUP / ORAL 2004-08-20 03ed91905a0d…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 A076805-001 LORATADINE 1MG/ML SYRUP / ORAL 2004-08-20 2680178bc6a6…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 A076805-001 LORATADINE 1MG/ML SYRUP / ORAL 2004-08-20 5bbf6a4d5a75…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 A076805-001 LORATADINE 1MG/ML SYRUP / ORAL 2004-08-20 d8e5a09893c0…2024-10-29 15:01 UTC 2024-10 A076805-001 LORATADINE 1MG/ML SYRUP / ORAL 2004-08-20 d06236e962d9…2024-08-13 05:28 UTC · 3 captures of this ZIP 2024-08 A076805-001 LORATADINE 1MG/ML SYRUP / ORAL 2004-08-20 79d66fd596c7…2024-07-13 05:37 UTC · 2 captures of this ZIP 2024-07 A076805-001 LORATADINE 1MG/ML SYRUP / ORAL 2004-08-20 301d65b070ca…2024-06-18 03:08 UTC · 5 captures of this ZIP 2024-06 A076805-001 LORATADINE 1MG/ML SYRUP / ORAL 2004-08-20 1e350fbaab3a…2024-05-31 18:47 UTC 2024-05 A076805-001 LORATADINE 1MG/ML SYRUP / ORAL 2004-08-20 8072bd15b7f6…2022-06-29 02:47 UTC · 2 captures of this ZIP 2022-06 A076805-001 LORATADINE 1MG/ML SYRUP / ORAL 2004-08-20 5c6f7cd8ea54…2022-04-08 23:34 UTC 2022-04 A076805-001 LORATADINE 1MG/ML SYRUP / ORAL 2004-08-20 5d02ea3f76ae…2022-04-04 05:41 UTC 2022-04 A076805-001 LORATADINE 1MG/ML SYRUP / ORAL 2004-08-20 4b0b4de00fa7…2019-12-13 00:20 UTC 2019-12 A076805-001 LORATADINE 1MG/ML SYRUP / ORAL 2004-08-20 74a2ff9319b5…2022-03-09 01:35 UTC 2022-03 A076805-001 LORATADINE 1MG/ML SYRUP / ORAL 2004-08-20 bb7c543d1eb4…2021-12-28 21:50 UTC 2021-12 A076805-001 LORATADINE 1MG/ML SYRUP / ORAL 2004-08-20 782e0a99824c…2021-05-05 16:15 UTC · 3 captures of this ZIP 2021-05 A076805-001 LORATADINE 1MG/ML SYRUP / ORAL 2004-08-20 87673890dc5c…2021-03-12 10:30 UTC 2021-03 A076805-001 LORATADINE 1MG/ML SYRUP / ORAL 2004-08-20 5aa47cf7b7d7…2020-12-22 03:56 UTC 2020-12 A076805-001 LORATADINE 1MG/ML SYRUP / ORAL 2004-08-20 8869cabd3fbd…2020-11-12 02:37 UTC 2020-11 A076805-001 LORATADINE 1MG/ML SYRUP / ORAL 2004-08-20 c0c555d07b60…2019-12-14 00:12 UTC 2019-12 A076805-001 LORATADINE 1MG/ML SYRUP / ORAL 2004-08-20 3f01610625f2…2019-09-15 20:21 UTC 2019-09 A076805-001 LORATADINE 1MG/ML SYRUP / ORAL 2004-08-20 b00525d2431f…2019-07-19 19:46 UTC 2019-07 A076805-001 LORATADINE 1MG/ML SYRUP / ORAL 2004-08-20 ea99ee380514…2024-03-16 18:09 UTC · 4 captures of this ZIP 2024-03 A076805-001 LORATADINE 1MG/ML SYRUP / ORAL 2004-08-20 6a51e52b5d6a…2024-02-18 07:12 UTC 2024-02 A076805-001 LORATADINE 1MG/ML SYRUP / ORAL 2004-08-20 1c564ffb4f44…2023-12-20 04:57 UTC 2023-12 A076805-001 LORATADINE 1MG/ML SYRUP / ORAL 2004-08-20 ea1830bbd6c7…2023-11-28 05:40 UTC · 2 captures of this ZIP 2023-11 A076805-001 LORATADINE 1MG/ML SYRUP / ORAL 2004-08-20 a72a2bbeb626…2023-10-25 00:34 UTC · 2 captures of this ZIP 2023-10 A076805-001 LORATADINE 1MG/ML SYRUP / ORAL 2004-08-20 9b2671bbb829…2023-07-15 15:27 UTC · 2 captures of this ZIP 2023-07 A076805-001 LORATADINE 1MG/ML SYRUP / ORAL 2004-08-20 a67488948f0b…2023-06-13 01:57 UTC · 3 captures of this ZIP 2023-06 A076805-001 LORATADINE 1MG/ML SYRUP / ORAL 2004-08-20 3f0d92c62455…2023-05-13 08:27 UTC 2023-05 A076805-001 LORATADINE 1MG/ML SYRUP / ORAL 2004-08-20 053a50430f4f…2023-01-26 05:58 UTC 2023-01 A076805-001 LORATADINE 1MG/ML SYRUP / ORAL 2004-08-20 3bdfa0b2c4d7…2022-11-12 20:34 UTC · 5 captures of this ZIP 2022-11 A076805-001 LORATADINE 1MG/ML SYRUP / ORAL 2004-08-20 3a93d1ddd44b…2022-10-28 04:53 UTC 2022-10 A076805-001 LORATADINE 1MG/ML SYRUP / ORAL 2004-08-20 f41ea6bd6efb…2022-09-29 23:25 UTC 2022-09 A076805-001 LORATADINE 1MG/ML SYRUP / ORAL 2004-08-20 e64feba35796…2022-07-09 03:26 UTC · 3 captures of this ZIP 2022-07 A076805-001 LORATADINE 1MG/ML SYRUP / ORAL 2004-08-20 cb3db0bc1861…
Additional Listing Data#
Finished product Yes
Brand name base Childrens Loratadine
Brand name suffix Sugar Free
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 · 1 matching rows.
Identifier, FDA.report destination table Identifier FDA.report destination 692783 Internal RxNorm lookup
Harmonized SPL set identifiers# SPL set identifiers page 1 of 1 · 1 matching rows.
DailyMed Package Descriptions# Package NDC, Product, Description table Package NDC Product Description Form Quantity Strength SPL version 41520-131-08 Childrens Loratadine Sugar Free 1 in 1 CARTON SOLUTION 1 3 41520-131-08 Childrens Loratadine Sugar Free 120 mL in 1 BOTTLE SOLUTION 120 3
DailyMed Dashboard NDC Coverage# NDC, Dashboard title, SPL version table NDC Dashboard title SPL version Validation Dashboard ZIP 41520-131 CHILDRENS LORATADINE SUGAR FREE (LORATADINE) SOLUTION [AMERICAN SALES COMPANY] 3 Current NDC, Legacy NDC, 2 package rows 20241211_6977d7e0-9d01-4f5e-8d55-98dabb719585.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 · 15 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 41520-131-08 41520013108 1 BOTTLE in 1 CARTON (41520-131-08) / 120 mL in 1 BOTTLE 1 bottle 2017-07-27 0000-00-00 No No Current