Home NDC 55681-303-03 ALLERGY RELIEF
Product NDC 55681-303
Requested package NDC 55681-303-03
11-digit product format 556810303
Labeler code 55681
Product ID 55681-303_4e68e4e1-8a60-a8f1-e063-6394a90ac63b
Type HUMAN OTC DRUG
Nonproprietary name LORATADINE
Dosage form TABLET
Route ORAL
Labeler TWIN MED LLC
Application ANDA210722
Marketing category ANDA
Marketing start 2022-03-02
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
Brand name suffix 10 mg
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 55681-303-03 ALLERGY RELIEF10 mg 300 in 1 BOTTLE TABLET 300 4
DailyMed Dashboard NDC Coverage# NDC, Dashboard title, SPL version table NDC Dashboard title SPL version Validation Dashboard ZIP 55681-303 ALLERGY RELIEF 10 MG (LORATADINE) TABLET [TWIN MED LLC] 3 Current NDC, Legacy NDC, 1 package rows 20240104_d943f548-aa0d-4476-e053-2a95a90a7bd4.zip
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 55681-303-03 55681030303 300 TABLET in 1 BOTTLE (55681-303-03) 300 tablet 2022-03-02 0000-00-00 No No Current