Loratadine Allergy Relief

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 Allergy Relief
Generic name: LORATADINE
Manufacturer: Asclemed USA, Inc.
Product type: HUMAN OTC DRUG
SPL set ID: 332bda00-1350-2d33-e063-6394a90a8bd7
SPL ID: 359e8af9-0b81-5837-e063-6394a90a58a1
Version: 2
Effective date: 2025-05-21
Source export date: 2026-11-06
Source partition: 6
Source file: https://download.open.fda.gov/drug/label/drug-label-0006-of-0014.json.zip
Source object key: raw/openfda/drug-label/2026-11-06/10387d7618367cd955339e75d48af3d11f99f789153db05c529d9fad6eccc645/drug-label-0006-of-0014.json.zip
Source manifest SHA-256: 4a7570ba105b5a039a8e1c94a85e7f085b9047a8882a35a96bf1e4516c5ffc97
Import run: 20261108T063105Z
Imported at: 2026-11-08 07:19:05

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 · 30 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 Allergy Relief	openfda.brand_name
generic name		LORATADINE	openfda.generic_name
manufacturer name		Asclemed USA, Inc.	openfda.manufacturer_name
ndc	package	76420-330-30	openfda.package_ndc
ndc	package	76420-330-01	openfda.package_ndc
ndc	package	76420-330-20	openfda.package_ndc
ndc	package	76420-330-60	openfda.package_ndc
ndc	package	76420-330-11	openfda.package_ndc
ndc	package	76420-330-90	openfda.package_ndc
ndc	package	76420-330-03	openfda.package_ndc
ndc	package	76420-330-31	openfda.package_ndc
ndc	package	76420-330-05	openfda.package_ndc
ndc	package	76420-330-10	openfda.package_ndc
ndc	product	76420-330	openfda.product_ndc
ndc11	package	76420033010	derived:openfda.package_ndc
ndc11	package	76420033011	derived:openfda.package_ndc
ndc11	package	76420033020	derived:openfda.package_ndc
ndc11	package	76420033005	derived:openfda.package_ndc
ndc11	package	76420033030	derived:openfda.package_ndc
ndc11	package	76420033003	derived:openfda.package_ndc
ndc11	package	76420033001	derived:openfda.package_ndc
ndc11	package	76420033031	derived:openfda.package_ndc
ndc11	package	76420033090	derived:openfda.package_ndc
ndc11	package	76420033060	derived:openfda.package_ndc
rxcui		311372	openfda.rxcui
spl id		359e8af9-0b81-5837-e063-6394a90a58a1	id
spl set id		332bda00-1350-2d33-e063-6394a90a8bd7	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.