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 20 of 24 · 463 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
basic care allergy relief	LORATADINE	Amazon.com Services LLC	a4a7f024-972b-4a16-9cb8-28954c2a74c6	2022-10-18	Warnings	Exact identifier rxcui: 311372 unii: 7AJO3BO7QN
dg health allergy relief	LORATADINE	Dolgencorp, LLC	04258018-3d57-46d7-9595-04786da3f51a	2022-10-13	Warnings	Exact identifier unii: 7AJO3BO7QN
welby childrens allergy relief	LORATADINE	Aldi Inc	402c635d-4116-4767-baa9-e956fed02884	2022-09-26	Warnings	Exact identifier unii: 7AJO3BO7QN
Loratadine	LORATADINE	Winco Foods, LLC.	2a6cf697-0084-4522-bc89-b3e0f96a598d	2022-08-17	Warnings	Exact identifier rxcui: 311372 unii: 7AJO3BO7QN
Loratadine	LORATADINE	WALGREENS CO.	71adc5b3-3a91-4a1f-acb3-78922a7d9d5a	2022-08-09	Warnings	Exact identifier unii: 7AJO3BO7QN
Loratadine ODT	LORATADINE	Aurohealth LLC	a6e04fe7-23d3-47d7-9f18-5c4298fbc28b	2022-06-20	Warnings	Exact identifier unii: 7AJO3BO7QN
Loratadine	LORATADINE	BluePoint Laboratories	adc506ed-7a7a-facc-e053-2a95a90ae147	2022-06-20	Warnings	Exact identifier rxcui: 311372 unii: 7AJO3BO7QN
Loratadine	LORATADINE	Aurohealth LLC	c6bfb54a-04d8-41c1-9fa9-5d4bae0a66d1	2022-06-18	Warnings	Exact identifier rxcui: 311372 unii: 7AJO3BO7QN
Dye-Free Childrens Loratadine	LORATADINE	RITE AID	322d9a03-a908-4858-b25e-6eba2411fa03	2022-06-02	Warnings	Exact identifier unii: 7AJO3BO7QN
Loratadine and Pseudoephedrine	LORATADINE AND PSEUDOEPHEDRINE SULFATE	Rite Aid	bb0f7653-378f-40b1-8ead-77999fcbd87b	2022-05-09	Warnings	Exact identifier unii: 7AJO3BO7QN
Allergy Relief	LORATADINE	AAA PHARMACEUTICAL, INC.	9c8535e3-6a60-4640-b37e-a2260936d9af	2022-04-21	Warnings	Exact identifier rxcui: 311372 unii: 7AJO3BO7QN
signature care allergy relief	LORATADINE	Safeway	0a4b8eef-762e-42cc-84ee-0018a9a3be58	2022-04-04	Warnings	Exact identifier unii: 7AJO3BO7QN
Loratadine antihistamine	LORATADINE	Proficient Rx LP	e9b87f79-ebed-4677-8e50-00cb4282ee56	2022-04-01	Warnings	Exact identifier rxcui: 311372 unii: 7AJO3BO7QN
Leader Allergy Relief D-24	LORATADINE AND PSEUDOEPHEDRINE SULFATE	Cardinal Health	f1bcd2aa-e8cd-4364-87b4-c544537cdb50	2022-03-22	Warnings	Exact identifier unii: 7AJO3BO7QN
Loratadine	LORATADINE	Rising Pharmaceuticals, Inc	d28128a3-af54-440e-9bd4-0fccf393d18a	2022-03-10	Warnings	Exact identifier application number: ANDA214684 ndc (product): 16571-822 rxcui: 311372 spl id: 8b088034-c702-4b88-b4e3-421aa9739ec8 spl set id: d28128a3-af54-440e-9bd4-0fccf393d18a unii: 7AJO3BO7QN
topcare childrens allergy	LORATADINE	Topco Associates LLC	6e175fae-05dd-45c2-b9ab-7d49369a3c05	2022-02-28	Warnings	Exact identifier unii: 7AJO3BO7QN
topcare allergy and congestion relief	LORATADINE, PSEUDOEPHEDRINE SULFATE	Topco Associates LLC	dd93d172-2a3a-4e4c-a237-7668acbd537d	2022-02-16	Warnings	Exact identifier unii: 7AJO3BO7QN
Loratadine	LORATADINE	SAFEWAY INC.	1092b8af-25f2-4c25-b3bc-5ffb14e96024	2021-12-21	Warnings	Exact identifier rxcui: 311372 unii: 7AJO3BO7QN
Loratadine and Pseudoephedrine Sulfate	LORATADINE AND PSEUDOEPHEDRINE SULFATE	Safeway Inc.	c1e1e0ca-30df-4ace-a7b6-c66a3c5ab676	2021-12-21	Warnings	Exact identifier unii: 7AJO3BO7QN
Loratadine	LORATADINE	CVS Pharmacy	e63f082c-ff50-43ed-ad2c-598b352413e8	2021-12-21	Warnings	Exact identifier rxcui: 311372 unii: 7AJO3BO7QN

Reported adverse events (FAERS/openFDA)#

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