Claritin

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: Claritin
Generic name: LORATADINE
Manufacturer: Bayer HealthCare LLC.
Product type: HUMAN OTC DRUG
SPL set ID: 37732ca2-b454-4215-91a2-c62e0f7a56af
SPL ID: 453703bf-d4b7-d090-e063-6394a90a7ebf
Version: 14
Effective date: 2025-12-05
Source export date: 2026-10-27
Source partition: 10
Source file: https://download.open.fda.gov/drug/label/drug-label-0010-of-0014.json.zip
Source object key: raw/openfda/drug-label/2026-10-27/eeb012fd0992efa4f76b2aef09dd5f84150b96392c46717c44deabcc4e3581c1/drug-label-0010-of-0014.json.zip
Source manifest SHA-256: 6be3667a3beefe6c0ead4c723ea963050533a2bc725a8044d58b07d18b258c55
Import run: 20261027T193451Z
Imported at: 2026-10-27 20:41:26

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 · 34 matching rows.

Type, Scope, Identifier table
Type	Scope	Identifier	Source field
application applno	NDA	021891	derived:openfda.application_number
application number		NDA021891	openfda.application_number
brand name		Claritin	openfda.brand_name
generic name		LORATADINE	openfda.generic_name
manufacturer name		Bayer HealthCare LLC.	openfda.manufacturer_name
ndc	package	11523-4328-5	openfda.package_ndc
ndc	package	11523-4328-7	openfda.package_ndc
ndc	package	11523-4331-6	openfda.package_ndc
ndc	package	11523-4328-2	openfda.package_ndc
ndc	package	11523-4328-4	openfda.package_ndc
ndc	package	11523-4331-2	openfda.package_ndc
ndc	package	11523-4328-6	openfda.package_ndc
ndc	package	11523-4328-9	openfda.package_ndc
ndc	package	11523-4331-1	openfda.package_ndc
ndc	package	11523-4328-1	openfda.package_ndc
ndc	package	11523-4328-3	openfda.package_ndc
ndc	product	11523-4331	openfda.product_ndc
ndc	product	11523-4328	openfda.product_ndc
ndc11	package	11523432802	derived:openfda.package_ndc
ndc11	package	11523433106	derived:openfda.package_ndc
ndc11	package	11523432803	derived:openfda.package_ndc
ndc11	package	11523432805	derived:openfda.package_ndc
ndc11	package	11523433101	derived:openfda.package_ndc
ndc11	package	11523432804	derived:openfda.package_ndc
ndc11	package	11523432801	derived:openfda.package_ndc
ndc11	package	11523432809	derived:openfda.package_ndc
ndc11	package	11523432807	derived:openfda.package_ndc
ndc11	package	11523433102	derived:openfda.package_ndc
ndc11	package	11523432806	derived:openfda.package_ndc
rxcui		668469	openfda.rxcui
rxcui		665078	openfda.rxcui
spl id		453703bf-d4b7-d090-e063-6394a90a7ebf	id
spl set id		37732ca2-b454-4215-91a2-c62e0f7a56af	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.