Home NDC 71335-1461 Allergy Relief
Product NDC 71335-1461
11-digit product format 713351461
Labeler code 71335
Product ID 71335-1461_0607e8b0-b231-47bb-8133-10d46e7c0ac7
Type HUMAN OTC DRUG
Nonproprietary name Loratadine
Dosage form TABLET
Route ORAL
Labeler Bryant Ranch Prepack
Application ANDA075209
Marketing category ANDA
Marketing start 2018-12-31
Marketing end 0000-00-00
Substance LORATADINE
Active strength 10 mg/1
NDC exclude flag No
Listing certified through 2023-12-31
Current FDA listing Historical FDA.report record
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 3 · 150 matching rows.
View current auxiliary records. · View the auxiliary file history.
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 A075209-001 LORATADINE LORATADINE 10MG TABLET / ORAL 2003-01-21
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 A075209-001 LORATADINE 10MG TABLET / ORAL 2003-01-21 84e616aacf4f…2026-08-18 06:07:40 2026-07 A075209-001 LORATADINE 10MG TABLET / ORAL 2003-01-21 caaa826d4ba7…2026-02-19 14:30 UTC 2026-02 A075209-001 LORATADINE 10MG TABLET / ORAL 2003-01-21 011fe1cb6892…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A075209-001 LORATADINE 10MG TABLET / ORAL 2003-01-21 31067a03dcf5…2025-08-23 18:47 UTC 2025-08 A075209-001 LORATADINE 10MG TABLET / ORAL 2003-01-21 6a471c1ec25d…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 A075209-001 LORATADINE 10MG TABLET / ORAL 2003-01-21 fd3edfee7708…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 A075209-001 LORATADINE 10MG TABLET / ORAL 2003-01-21 b8a1b40f171c…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 A075209-001 LORATADINE 10MG TABLET / ORAL 2003-01-21 03ed91905a0d…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 A075209-001 LORATADINE 10MG TABLET / ORAL 2003-01-21 2680178bc6a6…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 A075209-001 LORATADINE 10MG TABLET / ORAL 2003-01-21 5bbf6a4d5a75…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 A075209-001 LORATADINE 10MG TABLET / ORAL 2003-01-21 d8e5a09893c0…2024-10-29 15:01 UTC 2024-10 A075209-001 LORATADINE 10MG TABLET / ORAL 2003-01-21 d06236e962d9…2024-08-13 05:28 UTC · 3 captures of this ZIP 2024-08 A075209-001 LORATADINE 10MG TABLET / ORAL 2003-01-21 79d66fd596c7…2024-07-13 05:37 UTC · 2 captures of this ZIP 2024-07 A075209-001 LORATADINE 10MG TABLET / ORAL 2003-01-21 301d65b070ca…2024-06-18 03:08 UTC · 5 captures of this ZIP 2024-06 A075209-001 LORATADINE 10MG TABLET / ORAL 2003-01-21 1e350fbaab3a…2024-05-31 18:47 UTC 2024-05 A075209-001 LORATADINE 10MG TABLET / ORAL 2003-01-21 8072bd15b7f6…2022-06-29 02:47 UTC · 2 captures of this ZIP 2022-06 A075209-001 LORATADINE 10MG TABLET / ORAL 2003-01-21 5c6f7cd8ea54…2022-04-08 23:34 UTC 2022-04 A075209-001 LORATADINE 10MG TABLET / ORAL 2003-01-21 5d02ea3f76ae…2022-04-04 05:41 UTC 2022-04 A075209-001 LORATADINE 10MG TABLET / ORAL 2003-01-21 4b0b4de00fa7…2019-12-13 00:20 UTC 2019-12 A075209-001 LORATADINE 10MG TABLET / ORAL 2003-01-21 74a2ff9319b5…2022-03-09 01:35 UTC 2022-03 A075209-001 LORATADINE 10MG TABLET / ORAL 2003-01-21 bb7c543d1eb4…2021-12-28 21:50 UTC 2021-12 A075209-001 LORATADINE 10MG TABLET / ORAL 2003-01-21 782e0a99824c…2021-05-05 16:15 UTC · 3 captures of this ZIP 2021-05 A075209-001 LORATADINE 10MG TABLET / ORAL 2003-01-21 87673890dc5c…2021-03-12 10:30 UTC 2021-03 A075209-001 LORATADINE 10MG TABLET / ORAL 2003-01-21 5aa47cf7b7d7…2020-12-22 03:56 UTC 2020-12 A075209-001 LORATADINE 10MG TABLET / ORAL 2003-01-21 8869cabd3fbd…2020-11-12 02:37 UTC 2020-11 A075209-001 LORATADINE 10MG TABLET / ORAL 2003-01-21 c0c555d07b60…2019-12-14 00:12 UTC 2019-12 A075209-001 LORATADINE 10MG TABLET / ORAL 2003-01-21 3f01610625f2…2019-09-15 20:21 UTC 2019-09 A075209-001 LORATADINE 10MG TABLET / ORAL 2003-01-21 b00525d2431f…2019-07-19 19:46 UTC 2019-07 A075209-001 LORATADINE 10MG TABLET / ORAL 2003-01-21 ea99ee380514…2024-03-16 18:09 UTC · 4 captures of this ZIP 2024-03 A075209-001 LORATADINE 10MG TABLET / ORAL 2003-01-21 6a51e52b5d6a…2024-02-18 07:12 UTC 2024-02 A075209-001 LORATADINE 10MG TABLET / ORAL 2003-01-21 1c564ffb4f44…2023-12-20 04:57 UTC 2023-12 A075209-001 LORATADINE 10MG TABLET / ORAL 2003-01-21 ea1830bbd6c7…2023-11-28 05:40 UTC · 2 captures of this ZIP 2023-11 A075209-001 LORATADINE 10MG TABLET / ORAL 2003-01-21 a72a2bbeb626…2023-10-25 00:34 UTC · 2 captures of this ZIP 2023-10 A075209-001 LORATADINE 10MG TABLET / ORAL 2003-01-21 9b2671bbb829…2023-07-15 15:27 UTC · 2 captures of this ZIP 2023-07 A075209-001 LORATADINE 10MG TABLET / ORAL 2003-01-21 a67488948f0b…2023-06-13 01:57 UTC · 3 captures of this ZIP 2023-06 A075209-001 LORATADINE 10MG TABLET / ORAL 2003-01-21 3f0d92c62455…2023-05-13 08:27 UTC 2023-05 A075209-001 LORATADINE 10MG TABLET / ORAL 2003-01-21 053a50430f4f…2023-01-26 05:58 UTC 2023-01 A075209-001 LORATADINE 10MG TABLET / ORAL 2003-01-21 3bdfa0b2c4d7…2022-11-12 20:34 UTC · 5 captures of this ZIP 2022-11 A075209-001 LORATADINE 10MG TABLET / ORAL 2003-01-21 3a93d1ddd44b…2022-10-28 04:53 UTC 2022-10 A075209-001 LORATADINE 10MG TABLET / ORAL 2003-01-21 f41ea6bd6efb…
Reported adverse events (FAERS/openFDA)# Adverse event summaries are temporarily unavailable. Other product information remains available.
FDA-Initiated Inactive NDC Indexing# DailyMed Package Descriptions# Package NDC, Product, Description table Package NDC Product Description Form Quantity Strength SPL version 71335-1461-1 Allergy ReliefNon drowsy 20 in 1 BOTTLE TABLET 20 4 71335-1461-2 Allergy ReliefNon drowsy 30 in 1 BOTTLE TABLET 30 4 71335-1461-3 Allergy ReliefNon drowsy 60 in 1 BOTTLE TABLET 60 4 71335-1461-4 Allergy ReliefNon drowsy 14 in 1 BOTTLE TABLET 14 4 71335-1461-5 Allergy ReliefNon drowsy 10 in 1 BOTTLE TABLET 10 4 71335-1461-6 Allergy ReliefNon drowsy 90 in 1 BOTTLE TABLET 90 4 71335-1461-7 Allergy ReliefNon drowsy 28 in 1 BOTTLE TABLET 28 4 71335-1461-8 Allergy ReliefNon drowsy 15 in 1 BOTTLE TABLET 15 4 71335-1461-9 Allergy ReliefNon drowsy 100 in 1 BOTTLE TABLET 100 4
DailyMed Dashboard NDC Coverage# NDC, Dashboard title, SPL version table NDC Dashboard title SPL version Validation Dashboard ZIP 71335-1461 ALLERGY RELIEF NON DROWSY (LORATADINE) TABLET [BRYANT RANCH PREPACK] 4 Legacy NDC, 9 package rows 20220205_0607e8b0-b231-47bb-8133-10d46e7c0ac7.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 2 · 23 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 71335-1461-1 71335146101 20 TABLET in 1 BOTTLE (71335-1461-1) 20 tablet 2020-01-03 0000-00-00 No No Current 71335-1461-2 71335146102 30 TABLET in 1 BOTTLE (71335-1461-2) 30 tablet 2020-01-30 0000-00-00 No No Current 71335-1461-3 71335146103 60 TABLET in 1 BOTTLE (71335-1461-3) 60 tablet 2021-12-28 0000-00-00 No No Current 71335-1461-4 71335146104 14 TABLET in 1 BOTTLE (71335-1461-4) 14 tablet 2021-12-28 0000-00-00 No No Current 71335-1461-5 71335146105 10 TABLET in 1 BOTTLE (71335-1461-5) 10 tablet 2020-05-19 0000-00-00 No No Current 71335-1461-6 71335146106 90 TABLET in 1 BOTTLE (71335-1461-6) 90 tablet 2020-01-13 0000-00-00 No No Current 71335-1461-7 71335146107 28 TABLET in 1 BOTTLE (71335-1461-7) 28 tablet 2021-12-28 0000-00-00 No No Current 71335-1461-8 71335146108 15 TABLET in 1 BOTTLE (71335-1461-8) 15 tablet 2021-12-28 0000-00-00 No No Current 71335-1461-9 71335146109 100 TABLET in 1 BOTTLE (71335-1461-9) 100 tablet 2021-12-28 0000-00-00 No No Current