Home NDC 37808-506 Childrens Allergy Relief
Product NDC 37808-506
11-digit product format 378080506
Labeler code 37808
Product ID 37808-506_17e2e605-d5de-4d95-b5c8-710e56b61334
Type HUMAN OTC DRUG
Nonproprietary name loratadine
Dosage form TABLET, CHEWABLE
Route ORAL
Labeler H E B
Application ANDA210033
Marketing category ANDA
Marketing start 2021-08-19
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 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 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 · 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 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…2022-07-09 03:26 UTC · 3 captures of this ZIP 2022-07 A210033-001 LORATADINE 5MG TABLET, CHEWABLE / ORAL 2019-06-12 cb3db0bc1861…
Additional Listing Data#
Finished product Yes
Brand name base Childrens Allergy Relief
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 · 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 37808-506-39 Childrens Allergy Relief 30 in 1 CARTON TABLET, CHEWABLE 30 2 37808-506-39 Childrens Allergy Relief 1 in 1 BLISTER PACK TABLET, CHEWABLE 1 2 37808-506-52 Childrens Allergy Relief 1 in 1 BLISTER PACK TABLET, CHEWABLE 1 2 37808-506-52 Childrens Allergy Relief 10 in 1 CARTON TABLET, CHEWABLE 10 2
DailyMed Dashboard NDC Coverage# NDC, Dashboard title, SPL version table NDC Dashboard title SPL version Validation Dashboard ZIP 37808-506 CHILDRENS ALLERGY RELIEF (LORATADINE) TABLET, CHEWABLE [H E B] 2 Current NDC, Legacy NDC, 4 package rows 20210829_704ee04d-6bdd-4d0a-ba24-2a9fd79a90fb.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 37808-506-39 37808050639 30 BLISTER PACK in 1 CARTON (37808-506-39) / 1 TABLET, CHEWABLE in 1 BLISTER PACK 30 blister pack 2021-08-19 0000-00-00 No No Current 37808-506-52 37808050652 10 BLISTER PACK in 1 CARTON (37808-506-52) / 1 TABLET, CHEWABLE in 1 BLISTER PACK 10 blister pack 2021-08-19 0000-00-00 No No Current