Loratadine

openFDA label record#

This page contains supplementary openFDA label data. For the canonical label presentation, use the corresponding DailyMed Structured Product Label.

Verified complete openFDA source JSON (canonical bytes are SHA-256 checked before publication)

Brand name: Loratadine
Generic name: LORATADINE
Manufacturer: Major Pharmaceuticals
Product type: HUMAN OTC DRUG
SPL set ID: dee25423-377b-4b94-a4a8-0dfb8f51aaab
SPL ID: 7c3836c3-7476-49b8-ac03-11718d17c813
Version: 9
Effective date: 2025-12-08
Source export date: 2026-10-22
Source partition: 2
Source file: https://download.open.fda.gov/drug/label/drug-label-0002-of-0014.json.zip
Source object key: raw/openfda/drug-label/2026-10-22/6983e0043e02b7c5b54ab7cac56ed79eae60cfdeef16cfdd964bf5591555d29c/drug-label-0002-of-0014.json.zip
Source manifest SHA-256: 5de9d3c3492926d1703b492ae4d29b036ac5be73edfcb92a6cd5eb95a2acef9c
Import run: 20261023T001338Z
Imported at: 2026-10-23 00:22:18

Harmonized routes table
Harmonized routes
ORAL

Harmonized identifier links#

Every typed identifier imported from the complete openFDA harmonization object is paginated here; values are not reduced to a first match.

Harmonized identifiers page 1 of 1 · 20 matching rows.

Type, Scope, Identifier table
Type	Scope	Identifier	Source field
application applno	ANDA	076301	derived:openfda.application_number
application number		ANDA076301	openfda.application_number
brand name		Loratadine	openfda.brand_name
generic name		LORATADINE	openfda.generic_name
manufacturer name		Major Pharmaceuticals	openfda.manufacturer_name
ndc	package	0904-6852-72	openfda.package_ndc
ndc	package	0904-6852-89	openfda.package_ndc
ndc	package	0904-6852-60	openfda.package_ndc
ndc	package	0904-6852-61	openfda.package_ndc
ndc	package	0904-6852-07	openfda.package_ndc
ndc	product	0904-6852	openfda.product_ndc
ndc11	package	00904685207	derived:openfda.package_ndc
ndc11	package	00904685289	derived:openfda.package_ndc
ndc11	package	00904685261	derived:openfda.package_ndc
ndc11	package	00904685272	derived:openfda.package_ndc
ndc11	package	00904685260	derived:openfda.package_ndc
rxcui		311372	openfda.rxcui
spl id		7c3836c3-7476-49b8-ac03-11718d17c813	id
spl set id		dee25423-377b-4b94-a4a8-0dfb8f51aaab	set_id
unii		7AJO3BO7QN	openfda.unii

Warnings cross-check#

openFDA text is shown for search and cross-checking; DailyMed SPL is canonical.

Warnings sections page 1 of 1 · 1 matching rows.

warnings

Warnings Do not use if you have ever had an allergic reaction to this product or any of its ingredients Ask a doctor before use if you have liver or kidney disease. Your doctor should determine if you need a different dose. When using this product do not take more than directed. Taking more than directed may cause drowsiness. Stop use and ask a doctor if an allergic reaction to this product occurs. Seek medical help right away. If pregnant or breast-feeding, ask a health professional before use. Keep out of reach of children. In case of overdose, get medical help or contact a Poison Control Center right away. (1-800-222-1222)

Reported adverse events (FAERS/openFDA)#

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