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: Chain Drug Marketing Association Inc.
Product type: HUMAN OTC DRUG
SPL set ID: b4edf5b1-398d-405a-8a42-76044b31ebb7
SPL ID: 08f2bf78-eba5-41ce-bcb0-733e2760d44b
Version: 2
Effective date: 2018-08-27
Source export date: 2026-10-12
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/2026-10-12/edd23646015c9adc800cdbe2b778398a2d2b70e90dce5721ef2b191499a0397f/drug-label-0012-of-0014.json.zip
Source manifest SHA-256: 7e6b178df8f32cac9a78e0f5d09c588344509b04fe41effb1dde9102e2a45be6
Import run: 20261013T011858Z
Imported at: 2026-10-13 02:51:54

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 · 16 matching rows.

Type, Scope, Identifier table
Type	Scope	Identifier	Source field
application applno	ANDA	076134	derived:openfda.application_number
application number		ANDA076134	openfda.application_number
brand name		Loratadine	openfda.brand_name
generic name		LORATADINE	openfda.generic_name
manufacturer name		Chain Drug Marketing Association Inc.	openfda.manufacturer_name
ndc	package	63868-151-30	openfda.package_ndc
ndc	package	63868-151-01	openfda.package_ndc
ndc	package	63868-151-10	openfda.package_ndc
ndc	product	63868-151	openfda.product_ndc
ndc11	package	63868015101	derived:openfda.package_ndc
ndc11	package	63868015130	derived:openfda.package_ndc
ndc11	package	63868015110	derived:openfda.package_ndc
rxcui		311372	openfda.rxcui
spl id		08f2bf78-eba5-41ce-bcb0-733e2760d44b	id
spl set id		b4edf5b1-398d-405a-8a42-76044b31ebb7	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.