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: WALGREEN COMPANY
Product type: HUMAN OTC DRUG
SPL set ID: 645c26ab-08ab-4a69-ae7d-7802d8ec5922
SPL ID: 2a760d97-9a3c-7ae0-e063-6394a90a4644
Version: 3
Effective date: 2024-12-29
Source export date: 2026-10-30
Source partition: 12
Source file: https://download.open.fda.gov/drug/label/drug-label-0012-of-0014.json.zip
Source object key: raw/openfda/drug-label/2026-10-30/a3e33fe073aa0aa94eb690c6684c74434c63cebfbf7c5530205a2c3e957ecb8b/drug-label-0012-of-0014.json.zip
Source manifest SHA-256: b11f1f6b476c7417db937215bf14307ef1a0b69465b42b411ad52f42ae36ead3
Import run: 20261102T182004Z
Imported at: 2026-11-02 19:39:28

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 · 12 matching rows.

Type, Scope, Identifier table
Type	Scope	Identifier	Source field
application applno	ANDA	210088	derived:openfda.application_number
application number		ANDA210088	openfda.application_number
brand name		Loratadine	openfda.brand_name
generic name		LORATADINE	openfda.generic_name
manufacturer name		WALGREEN COMPANY	openfda.manufacturer_name
ndc	package	0363-0752-30	openfda.package_ndc
ndc	product	0363-0752	openfda.product_ndc
ndc11	package	00363075230	derived:openfda.package_ndc
rxcui		665078	openfda.rxcui
spl id		2a760d97-9a3c-7ae0-e063-6394a90a4644	id
spl set id		645c26ab-08ab-4a69-ae7d-7802d8ec5922	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.