NDC 80425-0352-01 - Loratadine

This NDC is not currently matched to an FDA NDC product listing in FDA.report, but it is a valid NDC-form code. FDA.report is showing the available DailyMed label context for the product root.

Product NDC: 80425-0352
Requested NDC: 80425-0352-01
Package NDCs from labels: 80425-0352-1, 80425-0352-01
Manufacturer: Advanced Rx Pharmacy of Tennessee, LLC
Effective date: 2024-12-31
Current FDA listing: Not matched in FDA.report NDC product tables

DailyMed Labels#

Label, Manufacturer, Effective date table
Label	Manufacturer	Effective date	Type
Loratadine - Advanced Rx Pharmacy of Tennessee, LLC	Advanced Rx Pharmacy of Tennessee, LLC	2024-12-31	HUMAN OTC DRUG LABEL

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDC	Product	Description	Form	Quantity	Strength	SPL version
80425-0352-1	Loratadine	30 in 1 BOTTLE	TABLET	30		2

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
80425-0352	LORATADINE TABLET [ADVANCED RX PHARMACY OF TENNESSEE, LLC]	2	Current NDC, 1 package rows	20250102_01cb43cf-57a9-f189-e063-6294a90afd88.zip

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDC	Billing unit	Product NDC	DailyMed indexing SPL	SPL version	Effective
80425-0352-1	EA - Each	80425-0352	f9390c79-9ee4-4e64-97a1-db6be06a7328	1	2023-09-05

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 24 of 24 · 463 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
Childrens Allergy	LORATADINE	CVS Pharmacy	dc5f58ef-baf0-4de4-9f6d-aedee419b59b	2017-10-02	Warnings	Exact identifier unii: 7AJO3BO7QN
Allergy	LORATADINE	Selder, S.A. de C.V.	afdb0117-dd2d-4ab1-a2f4-2a88b6bf5251	2016-12-22	Warnings	Exact identifier rxcui: 311372 unii: 7AJO3BO7QN
Loratadine	LORATADINE	Mylan Pharmaceuticals Inc.	3b307aea-5a68-4c82-959a-cda4ffbd0a4a	2013-11-15	Warnings	Exact identifier rxcui: 311372 unii: 7AJO3BO7QN

Reported adverse events (FAERS/openFDA)#

Adverse event summaries are temporarily unavailable. Other product information remains available.