Loratadine antihistamine

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 antihistamine
Generic name: LORATADINE
Manufacturer: Padagis Israel Pharmaceuticals Ltd
Product type: HUMAN OTC DRUG
SPL set ID: c72d8a30-520e-4d25-8f02-0c891e070a1a
SPL ID: 497be46d-b620-41ae-bac0-95ef0bd94fe4
Version: 10
Effective date: 2025-09-12
Source export date: 2026-10-30
Source partition: 5
Source file: https://download.open.fda.gov/drug/label/drug-label-0005-of-0014.json.zip
Source object key: raw/openfda/drug-label/2026-10-30/a900515c00f4d0d29f88cc94ee68daf127f036296f87a6b4a8a3f964cd0433c0/drug-label-0005-of-0014.json.zip
Source manifest SHA-256: b11f1f6b476c7417db937215bf14307ef1a0b69465b42b411ad52f42ae36ead3
Import run: 20261102T182004Z
Imported at: 2026-11-02 18:49:44

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 · 18 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 antihistamine	openfda.brand_name
generic name		LORATADINE	openfda.generic_name
manufacturer name		Padagis Israel Pharmaceuticals Ltd	openfda.manufacturer_name
ndc	package	45802-650-65	openfda.package_ndc
ndc	package	45802-650-87	openfda.package_ndc
ndc	package	45802-650-78	openfda.package_ndc
ndc	package	45802-650-75	openfda.package_ndc
ndc	product	45802-650	openfda.product_ndc
ndc11	package	45802065065	derived:openfda.package_ndc
ndc11	package	45802065087	derived:openfda.package_ndc
ndc11	package	45802065075	derived:openfda.package_ndc
ndc11	package	45802065078	derived:openfda.package_ndc
rxcui		311372	openfda.rxcui
spl id		497be46d-b620-41ae-bac0-95ef0bd94fe4	id
spl set id		c72d8a30-520e-4d25-8f02-0c891e070a1a	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.