Home NDC 0113-1019 good sense childrens allergy relief
Product NDC 0113-1019
11-digit product format 001131019
Labeler code 0113
Product ID 0113-1019_296442d1-2f06-446d-9265-a8ae2830453a
Type HUMAN OTC DRUG
Nonproprietary name loratadine
Dosage form TABLET, CHEWABLE
Route ORAL
Labeler L. Perrigo Company
Application ANDA210033
Marketing category ANDA
Marketing start 2019-07-31
Substance LORATADINE
Active strength 5 mg/1
NDC exclude flag No
Listing certified through 2027-12-31
Current FDA listing Yes Observed NDC auxiliary status history# This history shows the information present in each captured FDA auxiliary file. It is not a continuous regulatory timeline, and a missing record does not establish a status.
Historic NDC status page 1 of 1 · 1 matching rows.
View current auxiliary records. · View the auxiliary file history.
Captured / source date, Dataset, Scope table Captured / source date Dataset Scope Product NDC Package NDC Code Status Reporting period Archive Snapshot Source SHA-256 2025-12-14 17:58 UTC · source 2025-12-05 excluded package package 0113-1019 0113-1019-39 D Discontinued by firm excluded / ndc_excluded.zip d630ba8d3edf…732f749b63fb…
Source provenance: Browse the complete Orange Book source catalog · source snapshot 42 .
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 A210033-001 LORATADINE LORATADINE 5MG TABLET, CHEWABLE / ORAL 2019-06-12
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 · 42 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 A210033-001 LORATADINE 5MG TABLET, CHEWABLE / ORAL 2019-06-12 caaa826d4ba7…2026-02-19 14:30 UTC 2026-02 A210033-001 LORATADINE 5MG TABLET, CHEWABLE / ORAL 2019-06-12 011fe1cb6892…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A210033-001 LORATADINE 5MG TABLET, CHEWABLE / ORAL 2019-06-12 31067a03dcf5…2025-08-23 18:47 UTC 2025-08 A210033-001 LORATADINE 5MG TABLET, CHEWABLE / ORAL 2019-06-12 6a471c1ec25d…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 A210033-001 LORATADINE 5MG TABLET, CHEWABLE / ORAL 2019-06-12 fd3edfee7708…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 A210033-001 LORATADINE 5MG TABLET, CHEWABLE / ORAL 2019-06-12 b8a1b40f171c…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 A210033-001 LORATADINE 5MG TABLET, CHEWABLE / ORAL 2019-06-12 03ed91905a0d…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 A210033-001 LORATADINE 5MG TABLET, CHEWABLE / ORAL 2019-06-12 2680178bc6a6…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 A210033-001 LORATADINE 5MG TABLET, CHEWABLE / ORAL 2019-06-12 5bbf6a4d5a75…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 A210033-001 LORATADINE 5MG TABLET, CHEWABLE / ORAL 2019-06-12 d8e5a09893c0…2024-10-29 15:01 UTC 2024-10 A210033-001 LORATADINE 5MG TABLET, CHEWABLE / ORAL 2019-06-12 d06236e962d9…2024-08-13 05:28 UTC · 3 captures of this ZIP 2024-08 A210033-001 LORATADINE 5MG TABLET, CHEWABLE / ORAL 2019-06-12 79d66fd596c7…2024-07-13 05:37 UTC · 2 captures of this ZIP 2024-07 A210033-001 LORATADINE 5MG TABLET, CHEWABLE / ORAL 2019-06-12 301d65b070ca…2024-06-18 03:08 UTC · 5 captures of this ZIP 2024-06 A210033-001 LORATADINE 5MG TABLET, CHEWABLE / ORAL 2019-06-12 1e350fbaab3a…2024-05-31 18:47 UTC 2024-05 A210033-001 LORATADINE 5MG TABLET, CHEWABLE / ORAL 2019-06-12 8072bd15b7f6…2022-06-29 02:47 UTC · 2 captures of this ZIP 2022-06 A210033-001 LORATADINE 5MG TABLET, CHEWABLE / ORAL 2019-06-12 5c6f7cd8ea54…2022-04-08 23:34 UTC 2022-04 A210033-001 LORATADINE 5MG TABLET, CHEWABLE / ORAL 2019-06-12 5d02ea3f76ae…2022-04-04 05:41 UTC 2022-04 A210033-001 LORATADINE 5MG TABLET, CHEWABLE / ORAL 2019-06-12 4b0b4de00fa7…2019-12-13 00:20 UTC 2019-12 A210033-001 LORATADINE 5MG TABLET, CHEWABLE / ORAL 2019-06-12 74a2ff9319b5…2022-03-09 01:35 UTC 2022-03 A210033-001 LORATADINE 5MG TABLET, CHEWABLE / ORAL 2019-06-12 bb7c543d1eb4…2021-12-28 21:50 UTC 2021-12 A210033-001 LORATADINE 5MG TABLET, CHEWABLE / ORAL 2019-06-12 782e0a99824c…2021-05-05 16:15 UTC · 3 captures of this ZIP 2021-05 A210033-001 LORATADINE 5MG TABLET, CHEWABLE / ORAL 2019-06-12 87673890dc5c…2021-03-12 10:30 UTC 2021-03 A210033-001 LORATADINE 5MG TABLET, CHEWABLE / ORAL 2019-06-12 5aa47cf7b7d7…2020-12-22 03:56 UTC 2020-12 A210033-001 LORATADINE 5MG TABLET, CHEWABLE / ORAL 2019-06-12 8869cabd3fbd…2020-11-12 02:37 UTC 2020-11 A210033-001 LORATADINE 5MG TABLET, CHEWABLE / ORAL 2019-06-12 c0c555d07b60…2019-12-14 00:12 UTC 2019-12 A210033-001 LORATADINE 5MG TABLET, CHEWABLE / ORAL 2019-06-12 3f01610625f2…2019-09-15 20:21 UTC 2019-09 A210033-001 LORATADINE 5MG TABLET, CHEWABLE / ORAL 2019-06-12 b00525d2431f…2019-07-19 19:46 UTC 2019-07 A210033-001 LORATADINE 5MG TABLET, CHEWABLE / ORAL 2019-06-12 ea99ee380514…2024-03-16 18:09 UTC · 4 captures of this ZIP 2024-03 A210033-001 LORATADINE 5MG TABLET, CHEWABLE / ORAL 2019-06-12 6a51e52b5d6a…2024-02-18 07:12 UTC 2024-02 A210033-001 LORATADINE 5MG TABLET, CHEWABLE / ORAL 2019-06-12 1c564ffb4f44…2023-12-20 04:57 UTC 2023-12 A210033-001 LORATADINE 5MG TABLET, CHEWABLE / ORAL 2019-06-12 ea1830bbd6c7…2023-11-28 05:40 UTC · 2 captures of this ZIP 2023-11 A210033-001 LORATADINE 5MG TABLET, CHEWABLE / ORAL 2019-06-12 a72a2bbeb626…2023-10-25 00:34 UTC · 2 captures of this ZIP 2023-10 A210033-001 LORATADINE 5MG TABLET, CHEWABLE / ORAL 2019-06-12 9b2671bbb829…2023-07-15 15:27 UTC · 2 captures of this ZIP 2023-07 A210033-001 LORATADINE 5MG TABLET, CHEWABLE / ORAL 2019-06-12 a67488948f0b…2023-06-13 01:57 UTC · 3 captures of this ZIP 2023-06 A210033-001 LORATADINE 5MG TABLET, CHEWABLE / ORAL 2019-06-12 3f0d92c62455…2023-05-13 08:27 UTC 2023-05 A210033-001 LORATADINE 5MG TABLET, CHEWABLE / ORAL 2019-06-12 053a50430f4f…2023-01-26 05:58 UTC 2023-01 A210033-001 LORATADINE 5MG TABLET, CHEWABLE / ORAL 2019-06-12 3bdfa0b2c4d7…2022-11-12 20:34 UTC · 5 captures of this ZIP 2022-11 A210033-001 LORATADINE 5MG TABLET, CHEWABLE / ORAL 2019-06-12 3a93d1ddd44b…2022-10-28 04:53 UTC 2022-10 A210033-001 LORATADINE 5MG TABLET, CHEWABLE / ORAL 2019-06-12 f41ea6bd6efb…2022-09-29 23:25 UTC 2022-09 A210033-001 LORATADINE 5MG TABLET, CHEWABLE / ORAL 2019-06-12 e64feba35796…
Additional Listing Data#
Finished product Yes
Brand name base good sense childrens allergy relief
Listing expiration 2027-12-31 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 · 1 matching rows.
Identifier, FDA.report destination table Identifier FDA.report destination 665078 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 0113-1019-00 good sense childrens allergy relief 1 in 1 BLISTER PACK TABLET, CHEWABLE 1 4 0113-1019-00 good sense childrens allergy relief 20 in 1 CARTON TABLET, CHEWABLE 20 4 0113-1019-39 good sense childrens allergy relief 30 in 1 CARTON TABLET, CHEWABLE 30 4 0113-1019-39 good sense childrens allergy relief 1 in 1 BLISTER PACK TABLET, CHEWABLE 1 4 0113-1019-49 good sense childrens allergy relief 1 in 1 BLISTER PACK TABLET, CHEWABLE 1 4 0113-1019-49 good sense childrens allergy relief 40 in 1 CARTON TABLET, CHEWABLE 40 4
DailyMed Dashboard NDC Coverage# NDC, Dashboard title, SPL version table NDC Dashboard title SPL version Validation Dashboard ZIP 0113-1019 GOOD SENSE CHILDRENS ALLERGY RELIEF (LORATADINE) TABLET, CHEWABLE [L. PERRIGO COMPANY] 2 Current NDC, Legacy NDC, 6 package rows 20200627_643dfe16-9cd1-47bb-8bce-303e6885c644.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 · 13 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 0113-1019-00 00113101900 20 BLISTER PACK in 1 CARTON (0113-1019-00) / 1 TABLET, CHEWABLE in 1 BLISTER PACK 20 blister pack 2026-02-12 No No Current 0113-1019-39 00113101939 30 BLISTER PACK in 1 CARTON (0113-1019-39) > 1 TABLET, CHEWABLE in 1 BLISTER PACK 30 blister pack 2019-07-31 0000-00-00 No No Current 0113-1019-49 00113101949 40 BLISTER PACK in 1 CARTON (0113-1019-49) / 1 TABLET, CHEWABLE in 1 BLISTER PACK 40 blister pack 2025-08-14 No No Current