Home NDC 63981-612 kirkland signature allerclear
Product NDC 63981-612
11-digit product format 639810612
Labeler code 63981
Product ID 63981-612_39dbaef4-0637-4ba0-9af1-ccb87eb17daf
Type HUMAN OTC DRUG
Nonproprietary name Loratadine
Dosage form TABLET
Route ORAL
Labeler Costco Wholesale Company
Application ANDA076301
Marketing category ANDA
Marketing start 2010-10-15
Substance LORATADINE
Active strength 10 mg/1
NDC exclude flag No
Listing certified through 2026-12-31
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 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.
Additional Listing Data#
Finished product Yes
Brand name base kirkland signature allerclear
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.
DailyMed Package Descriptions# Package NDC, Product, Description table Package NDC Product Description Form Quantity Strength SPL version 63981-612-88 kirkland signature allerclear 365 in 1 BOTTLE TABLET 365 9 63981-612-88 kirkland signature allerclear 1 in 1 PACKAGE TABLET 1 9
DailyMed Socrata Ingredients# DailyMed Dashboard NDC Coverage# NDC, Dashboard title, SPL version table NDC Dashboard title SPL version Validation Dashboard ZIP 63981-612 KIRKLAND SIGNATURE ALLERCLEAR (LORATADINE) TABLET [COSTCO WHOLESALE COMPANY] 9 Current NDC, Legacy NDC, 2 package rows 20240118_2074d52e-8c0a-4e69-bfb1-864ffc07e25f.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 63981-612-88 63981061288 1 BOTTLE in 1 PACKAGE (63981-612-88) / 365 TABLET in 1 BOTTLE 1 bottle 2010-10-15 0000-00-00 No No Current