Home NDC 82501-0612 goodnow allergy relief
Product NDC 82501-0612
11-digit product format 825010612
Labeler code 82501
Product ID 82501-0612_645238bd-7af1-4616-bc2b-c237f634d238
Type HUMAN OTC DRUG
Nonproprietary name Loratadine
Dosage form TABLET
Route ORAL
Labeler Gobrands, Inc
Application ANDA076301
Marketing category ANDA
Marketing start 2025-10-27
Substance LORATADINE
Active strength 10 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 43 .
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 A076301-001 LORATADINE LORATADINE 10MG TABLET / ORAL 2004-06-25
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 · 43 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 2026-09-14 22:38:34 2026-08 A076301-001 LORATADINE 10MG TABLET / ORAL 2004-06-25 84e616aacf4f…2026-08-18 06:07:40 2026-07 A076301-001 LORATADINE 10MG TABLET / ORAL 2004-06-25 caaa826d4ba7…2026-02-19 14:30 UTC 2026-02 A076301-001 LORATADINE 10MG TABLET / ORAL 2004-06-25 011fe1cb6892…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A076301-001 LORATADINE 10MG TABLET / ORAL 2004-06-25 31067a03dcf5…2025-08-23 18:47 UTC 2025-08 A076301-001 LORATADINE 10MG TABLET / ORAL 2004-06-25 6a471c1ec25d…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 A076301-001 LORATADINE 10MG TABLET / ORAL 2004-06-25 fd3edfee7708…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 A076301-001 LORATADINE 10MG TABLET / ORAL 2004-06-25 b8a1b40f171c…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 A076301-001 LORATADINE 10MG TABLET / ORAL 2004-06-25 03ed91905a0d…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 A076301-001 LORATADINE 10MG TABLET / ORAL 2004-06-25 2680178bc6a6…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 A076301-001 LORATADINE 10MG TABLET / ORAL 2004-06-25 5bbf6a4d5a75…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 A076301-001 LORATADINE 10MG TABLET / ORAL 2004-06-25 d8e5a09893c0…2024-10-29 15:01 UTC 2024-10 A076301-001 LORATADINE 10MG TABLET / ORAL 2004-06-25 d06236e962d9…2024-08-13 05:28 UTC · 3 captures of this ZIP 2024-08 A076301-001 LORATADINE 10MG TABLET / ORAL 2004-06-25 79d66fd596c7…2024-07-13 05:37 UTC · 2 captures of this ZIP 2024-07 A076301-001 LORATADINE 10MG TABLET / ORAL 2004-06-25 301d65b070ca…2024-06-18 03:08 UTC · 5 captures of this ZIP 2024-06 A076301-001 LORATADINE 10MG TABLET / ORAL 2004-06-25 1e350fbaab3a…2024-05-31 18:47 UTC 2024-05 A076301-001 LORATADINE 10MG TABLET / ORAL 2004-06-25 8072bd15b7f6…2022-06-29 02:47 UTC · 2 captures of this ZIP 2022-06 A076301-001 LORATADINE 10MG TABLET / ORAL 2004-06-25 5c6f7cd8ea54…2022-04-08 23:34 UTC 2022-04 A076301-001 LORATADINE 10MG TABLET / ORAL 2004-06-25 5d02ea3f76ae…2022-04-04 05:41 UTC 2022-04 A076301-001 LORATADINE 10MG TABLET / ORAL 2004-06-25 4b0b4de00fa7…2019-12-13 00:20 UTC 2019-12 A076301-001 LORATADINE 10MG TABLET / ORAL 2004-06-25 74a2ff9319b5…2022-03-09 01:35 UTC 2022-03 A076301-001 LORATADINE 10MG TABLET / ORAL 2004-06-25 bb7c543d1eb4…2021-12-28 21:50 UTC 2021-12 A076301-001 LORATADINE 10MG TABLET / ORAL 2004-06-25 782e0a99824c…2021-05-05 16:15 UTC · 3 captures of this ZIP 2021-05 A076301-001 LORATADINE 10MG TABLET / ORAL 2004-06-25 87673890dc5c…2021-03-12 10:30 UTC 2021-03 A076301-001 LORATADINE 10MG TABLET / ORAL 2004-06-25 5aa47cf7b7d7…2020-12-22 03:56 UTC 2020-12 A076301-001 LORATADINE 10MG TABLET / ORAL 2004-06-25 8869cabd3fbd…2020-11-12 02:37 UTC 2020-11 A076301-001 LORATADINE 10MG TABLET / ORAL 2004-06-25 c0c555d07b60…2019-12-14 00:12 UTC 2019-12 A076301-001 LORATADINE 10MG TABLET / ORAL 2004-06-25 3f01610625f2…2019-09-15 20:21 UTC 2019-09 A076301-001 LORATADINE 10MG TABLET / ORAL 2004-06-25 b00525d2431f…2019-07-19 19:46 UTC 2019-07 A076301-001 LORATADINE 10MG TABLET / ORAL 2004-06-25 ea99ee380514…2024-03-16 18:09 UTC · 4 captures of this ZIP 2024-03 A076301-001 LORATADINE 10MG TABLET / ORAL 2004-06-25 6a51e52b5d6a…2024-02-18 07:12 UTC 2024-02 A076301-001 LORATADINE 10MG TABLET / ORAL 2004-06-25 1c564ffb4f44…2023-12-20 04:57 UTC 2023-12 A076301-001 LORATADINE 10MG TABLET / ORAL 2004-06-25 ea1830bbd6c7…2023-11-28 05:40 UTC · 2 captures of this ZIP 2023-11 A076301-001 LORATADINE 10MG TABLET / ORAL 2004-06-25 a72a2bbeb626…2023-10-25 00:34 UTC · 2 captures of this ZIP 2023-10 A076301-001 LORATADINE 10MG TABLET / ORAL 2004-06-25 9b2671bbb829…2023-07-15 15:27 UTC · 2 captures of this ZIP 2023-07 A076301-001 LORATADINE 10MG TABLET / ORAL 2004-06-25 a67488948f0b…2023-06-13 01:57 UTC · 3 captures of this ZIP 2023-06 A076301-001 LORATADINE 10MG TABLET / ORAL 2004-06-25 3f0d92c62455…2023-05-13 08:27 UTC 2023-05 A076301-001 LORATADINE 10MG TABLET / ORAL 2004-06-25 053a50430f4f…2023-01-26 05:58 UTC 2023-01 A076301-001 LORATADINE 10MG TABLET / ORAL 2004-06-25 3bdfa0b2c4d7…2022-11-12 20:34 UTC · 5 captures of this ZIP 2022-11 A076301-001 LORATADINE 10MG TABLET / ORAL 2004-06-25 3a93d1ddd44b…2022-10-28 04:53 UTC 2022-10 A076301-001 LORATADINE 10MG TABLET / ORAL 2004-06-25 f41ea6bd6efb…
Reported adverse events (FAERS/openFDA)# Adverse event summaries are temporarily unavailable. Other product information remains available.
Additional Listing Data#
Finished product Yes
Brand name base goodnow allergy relief
Listing expiration 2026-12-31 Active Ingredients# Ingredient, Strength table Ingredient Strength LORATADINE 10 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 311372 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 82501-0612-0 goodnow allergy relief 30 in 1 BOTTLE TABLET 30 2 82501-0612-1 goodnow allergy relief 1 in 1 CARTON TABLET 1 2
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 3 · 41 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 82501-0612-0 82501061200 30 in 1 BOTTLE Historical 82501-0612-1 82501061201 1 BOTTLE in 1 CARTON (82501-0612-1) / 30 TABLET in 1 BOTTLE (82501-0612-0) 1 bottle 2025-10-27 No No Current