Home NDC 54473-166 CounterAct
Product NDC 54473-166
11-digit product format 544730166
Labeler code 54473
Product ID 54473-166_308f1711-b64c-1708-e063-6294a90ad99b
Type HUMAN OTC DRUG
Nonproprietary name Loratadine
Dosage form TABLET
Route ORAL
Labeler Melaleuca, Inc.
Application ANDA075209
Marketing category ANDA
Marketing start 2023-08-19
Substance LORATADINE
Active strength 10 mg/1
NDC exclude flag No
Listing certified through 2026-12-31
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 · 10 matching rows.
View current auxiliary records. · View the auxiliary file history.
Captured / source date, Dataset, Scope table Captured / source date Dataset Scope Package NDC Code Status Snapshot Source SHA-256 2025-03-22 03:12 UTC · source 2025-03-21 excluded product product I Inactivated by FDA cfe11265f3b6…090c488252e2…2025-03-22 03:12 UTC · source 2025-03-21 excluded package package 54473-166-31 I Inactivated by FDA cfe11265f3b6…090c488252e2…2025-03-10 12:48 UTC · source 2025-03-10 excluded product product I Inactivated by FDA cdf11ea48f46…ba0047e9e063…2025-03-10 12:48 UTC · source 2025-03-10 excluded package package 54473-166-31 I Inactivated by FDA cdf11ea48f46…ba0047e9e063…2025-02-02 03:52 UTC · source 2025-01-31 excluded product product U Excluded because listing certification expired 302b2466d912…e7b80fea0513…2025-02-02 03:52 UTC · source 2025-01-31 excluded package package 54473-166-31 U Excluded because listing certification expired 302b2466d912…e7b80fea0513…2025-01-20 13:05 UTC · source 2025-01-20 excluded product product U Excluded because listing certification expired ed331223b511…672a5bd82f5f…2025-01-20 13:05 UTC · source 2025-01-20 excluded package package 54473-166-31 U Excluded because listing certification expired ed331223b511…672a5bd82f5f…2025-01-11 03:41 UTC · source 2025-01-10 excluded product product U Excluded because listing certification expired 0efc9e666f02…f202fb6c5f17…2025-01-11 03:41 UTC · source 2025-01-10 excluded package package 54473-166-31 U Excluded because listing certification expired 0efc9e666f02…f202fb6c5f17…
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 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 · 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 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…2022-09-29 23:25 UTC 2022-09 A075209-001 LORATADINE 10MG TABLET / ORAL 2003-01-21 e64feba35796…2022-07-09 03:26 UTC · 3 captures of this ZIP 2022-07 A075209-001 LORATADINE 10MG TABLET / ORAL 2003-01-21 cb3db0bc1861…
Additional Listing Data#
Finished product Yes
Brand name base CounterAct
Brand name suffix Allergy
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.
FDA-Initiated Inactive NDC Indexing# DailyMed Package Descriptions# Package NDC, Product, Description table Package NDC Product Description Form Quantity Strength SPL version 54473-166-32 CounterActAllergy 30 in 1 BOTTLE TABLET 30 4 54473-166-32 CounterActAllergy 1 in 1 BOX TABLET 1 4
DailyMed Socrata Ingredients# DailyMed Dashboard NDC Coverage# NDC, Dashboard title, SPL version table NDC Dashboard title SPL version Validation Dashboard ZIP 54473-166 COUNTERACT ALLERGY (LORATADINE) TABLET [MELALEUCA, INC.] 4 Current NDC, Legacy NDC, 2 package rows 20250321_6b5d43ad-a709-4e0b-b91c-36ea0afe7221.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 · 24 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 54473-166-30 54473016630 3 BLISTER PACK in 1 CARTON (54473-166-30) > 10 TABLET in 1 BLISTER PACK 3 blister pack 2018-01-01 0000-00-00 No No Current 54473-166-32 54473016632 1 BOTTLE in 1 BOX (54473-166-32) / 30 TABLET in 1 BOTTLE 1 bottle 2025-02-28 No No Current