Home NDC 85828-193 Allergy Relief
Product NDC 85828-193
11-digit product format 858280193
Labeler code 85828
Product ID 85828-193_5256c518-31ca-f73b-e063-6394a90a71da
Type HUMAN OTC DRUG
Nonproprietary name Loratadine
Dosage form TABLET
Route ORAL
Labeler Grocery Outlet, Inc
Application ANDA210722
Marketing category ANDA
Marketing start 2026-02-18
Substance LORATADINE
Active strength 10 mg/1
NDC exclude flag No
Listing certified through 2027-12-31
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 A210722-001 LORATADINE LORATADINE 10MG TABLET / ORAL 2019-12-23
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 A210722-001 LORATADINE 10MG TABLET / ORAL 2019-12-23 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 2 · 40 matching rows.
Additional Listing Data#
Finished product Yes
Brand name base Allergy Relief
Listing expiration 2027-12-31 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 85828-193-19 Allergy Relief 30 in 1 BOTTLE, PLASTIC TABLET 30 3 85828-193-19 Allergy Relief 1 in 1 CARTON TABLET 1 3
DailyMed RxNorm Mappings# Packages# Package NDC, 11-digit format, Description table Package NDC 11-digit format Description Marketing start Sample Exclude flag Status 85828-193-19 85828019319 1 BOTTLE, PLASTIC in 1 CARTON (85828-193-19) / 30 TABLET in 1 BOTTLE, PLASTIC 2026-02-18 No No Current