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: Dr. Reddy's Laboratories Inc.
Product type: HUMAN OTC DRUG
SPL set ID: 9357186a-9452-e139-01d8-6b8c6f6a2c6b
SPL ID: 33224371-b336-2c1e-63dd-7a8ce9d195ff
Version: 1
Effective date: 2023-02-24
Source export date: 2026-09-28
Source partition: 3
Source file: https://download.open.fda.gov/drug/label/drug-label-0003-of-0014.json.zip
Source object key: raw/openfda/drug-label/2026-09-28/fd09911bd1bc81f7f2faeb048e63855fe224e494376ae919a0035190e315c050/drug-label-0003-of-0014.json.zip
Source manifest SHA-256: cd2e66336a5cd2223fa3995098fdbdb84c6a7ee5c0a4addb236ccb22dd1e6887
Import run: 20260929T050834Z
Imported at: 2026-09-29 05:17:53

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 · 14 matching rows.

Type, Scope, Identifier table
Type	Scope	Identifier	Source field
application applno	ANDA	212795	derived:openfda.application_number
application number		ANDA212795	openfda.application_number
brand name		Loratadine	openfda.brand_name
generic name		LORATADINE	openfda.generic_name
manufacturer name		Dr. Reddy's Laboratories Inc.	openfda.manufacturer_name
ndc	package	43598-756-30	openfda.package_ndc
ndc	package	43598-756-10	openfda.package_ndc
ndc	product	43598-756	openfda.product_ndc
ndc11	package	43598075610	derived:openfda.package_ndc
ndc11	package	43598075630	derived:openfda.package_ndc
rxcui		672558	openfda.rxcui
spl id		33224371-b336-2c1e-63dd-7a8ce9d195ff	id
spl set id		9357186a-9452-e139-01d8-6b8c6f6a2c6b	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.

Reported adverse events (FAERS/openFDA)#

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