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: Tenshi Kaizen Pvt Ltd
Product type: HUMAN OTC DRUG
SPL set ID: 9c168fbb-6668-4a9d-9c7e-d3441e60eb95
SPL ID: 17deb249-05f1-80b0-e063-6294a90a2535
Version: 1
Effective date: 2024-05-07
Source export date: 2026-10-12
Source partition: 4
Source file: https://download.open.fda.gov/drug/label/drug-label-0004-of-0014.json.zip
Source object key: raw/openfda/drug-label/2026-10-12/b939c18fdf51df171cf60ce5558819d08ac66bb16bb9991d48cbec91028d783e/drug-label-0004-of-0014.json.zip
Source manifest SHA-256: 7e6b178df8f32cac9a78e0f5d09c588344509b04fe41effb1dde9102e2a45be6
Import run: 20261013T011858Z
Imported at: 2026-10-13 01:37:08

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	213294	derived:openfda.application_number
application number		ANDA213294	openfda.application_number
brand name		LORATADINE	openfda.brand_name
generic name		LORATADINE	openfda.generic_name
manufacturer name		Tenshi Kaizen Pvt Ltd	openfda.manufacturer_name
ndc	package	72983-503-06	openfda.package_ndc
ndc	product	72983-503	openfda.product_ndc
ndc11	package	72983050306	derived:openfda.package_ndc
rxcui		311373	openfda.rxcui
spl id		17deb249-05f1-80b0-e063-6294a90a2535	id
spl set id		9c168fbb-6668-4a9d-9c7e-d3441e60eb95	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 use more than directed. Taking more than recommended 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.

Reported adverse events (FAERS/openFDA)#

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