Home NDC 50594-010 Sound Body Allergy Relief
Product NDC 50594-010
11-digit product format 505940010
Labeler code 50594
Product ID 50594-010_d2bfbaa2-b7f1-4a07-8143-15c611c4dd83
Type HUMAN OTC DRUG
Nonproprietary name Loratadine
Dosage form TABLET
Route ORAL
Labeler Big Lots Stores, Inc.
Application ANDA076301
Marketing category ANDA
Marketing start 2015-06-12
Marketing end 0000-00-00
Substance LORATADINE
Active strength 10 mg/1
NDC exclude flag No
Listing certified through 2021-12-31
Current FDA listing Historical FDA.report record 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 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.
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 2026-08-01 22:54:32 2026-06 A076301-001 LORATADINE 10MG TABLET / ORAL 2004-06-25 a50c72e98297…
openFDA label cross-check# Cross-check layer: openFDA label JSON enriches search and identifies hydration gaps. The DailyMed Structured Product Label remains the canonical label presentation on FDA.report. Every label matching the complete exact-identifier union is deduplicated and paginated below.
Matched openFDA labels page 1 of 3 · 43 matching rows.
DailyMed Socrata Ingredients# DailyMed Dashboard NDC Coverage# NDC, Dashboard title, SPL version table NDC Dashboard title SPL version Validation Dashboard ZIP 50594-010 SOUND BODY ALLERGY RELIEF (LORATADINE) TABLET [BIG LOTS STORES, INC.] 7 Legacy NDC 20250309_d98e0ede-6f93-4069-b7a7-77977ae273bb.zip
Packages# Package NDC, 11-digit format, Description table Package NDC 11-digit format Description Units Marketing start Marketing end Sample Exclude flag Status 50594-010-39 50594001039 30 BLISTER PACK in 1 CARTON (50594-010-39) > 1 TABLET in 1 BLISTER PACK 30 blister pack 2016-03-29 0000-00-00 No No Current 50594-010-46 50594001046 10 BLISTER PACK in 1 CARTON (50594-010-46) > 1 TABLET in 1 BLISTER PACK 10 blister pack 2015-06-12 0000-00-00 No No Current 50594-010-75 50594001075 1 BOTTLE in 1 CARTON (50594-010-75) > 90 TABLET in 1 BOTTLE 1 bottle 2019-03-18 0000-00-00 No No Current 50594-010-87 50594001087 1 BOTTLE in 1 CARTON (50594-010-87) > 300 TABLET in 1 BOTTLE 1 bottle 2020-01-09 0000-00-00 No No Current