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: STRATEGIC SOURCING SERVICES LLC
Product type: HUMAN OTC DRUG
SPL set ID: 6ba7fc5d-81c4-482c-8b38-4a6587853a9f
SPL ID: 3a732db8-8a6f-7361-e063-6394a90ab1b9
Version: 2
Effective date: 2025-07-21
Source export date: 2026-10-12
Source partition: 8
Source file: https://download.open.fda.gov/drug/label/drug-label-0008-of-0014.json.zip
Source object key: raw/openfda/drug-label/2026-10-12/fa098e7c5cff0b1ab653ce934059d1f4b90b860bafc0383a1f66223ce1037518/drug-label-0008-of-0014.json.zip
Source manifest SHA-256: 7e6b178df8f32cac9a78e0f5d09c588344509b04fe41effb1dde9102e2a45be6
Import run: 20261013T011858Z
Imported at: 2026-10-13 02:11:25

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	076805	derived:openfda.application_number
application number		ANDA076805	openfda.application_number
brand name		Loratadine	openfda.brand_name
generic name		LORATADINE	openfda.generic_name
manufacturer name		STRATEGIC SOURCING SERVICES LLC	openfda.manufacturer_name
ndc	package	70677-1057-1	openfda.package_ndc
ndc	product	70677-1057	openfda.product_ndc
ndc11	package	70677105701	derived:openfda.package_ndc
rxcui		692783	openfda.rxcui
spl id		3a732db8-8a6f-7361-e063-6394a90ab1b9	id
spl set id		6ba7fc5d-81c4-482c-8b38-4a6587853a9f	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.