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: Strides Pharma Inc
Product type: HUMAN OTC DRUG
SPL set ID: a54cdbe9-32ec-45ca-948f-9cefbb8e3cbf
SPL ID: 0df121d3-d783-620c-e063-6294a90acdab
Version: 9
Effective date: 2024-01-02
Source export date: 2026-10-27
Source partition: 5
Source file: https://download.open.fda.gov/drug/label/drug-label-0005-of-0014.json.zip
Source object key: raw/openfda/drug-label/2026-10-27/35717de05250cd386420cc8ede3b6010b48d18eea2af59afb0617fcabca634ec/drug-label-0005-of-0014.json.zip
Source manifest SHA-256: 6be3667a3beefe6c0ead4c723ea963050533a2bc725a8044d58b07d18b258c55
Import run: 20261027T193451Z
Imported at: 2026-10-27 20:04:15

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 · 22 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		Strides Pharma Inc	openfda.manufacturer_name
ndc	package	59556-301-05	openfda.package_ndc
ndc	package	59556-301-04	openfda.package_ndc
ndc	package	59556-301-02	openfda.package_ndc
ndc	package	59556-301-01	openfda.package_ndc
ndc	package	59556-301-06	openfda.package_ndc
ndc	package	59556-301-03	openfda.package_ndc
ndc	product	59556-301	openfda.product_ndc
ndc11	package	59556030102	derived:openfda.package_ndc
ndc11	package	59556030104	derived:openfda.package_ndc
ndc11	package	59556030106	derived:openfda.package_ndc
ndc11	package	59556030105	derived:openfda.package_ndc
ndc11	package	59556030101	derived:openfda.package_ndc
ndc11	package	59556030103	derived:openfda.package_ndc
rxcui		672558	openfda.rxcui
spl id		0df121d3-d783-620c-e063-6294a90acdab	id
spl set id		a54cdbe9-32ec-45ca-948f-9cefbb8e3cbf	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.