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: acf2d393-53d7-062f-e053-2995a90a0d60
SPL ID: 4526b265-4250-3e71-e063-6294a90a21a8
Version: 12
Effective date: 2025-12-04
Source export date: 2026-10-12
Source partition: 7
Source file: https://download.open.fda.gov/drug/label/drug-label-0007-of-0014.json.zip
Source object key: raw/openfda/drug-label/2026-10-12/ff22b88bd32e56cbc369af80345075227138a42b1b3ba9a84f038fd5493a7a47/drug-label-0007-of-0014.json.zip
Source manifest SHA-256: 7e6b178df8f32cac9a78e0f5d09c588344509b04fe41effb1dde9102e2a45be6
Import run: 20261013T011858Z
Imported at: 2026-10-13 01:57:10

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 · 29 matching rows.

Type, Scope, Identifier table
Type	Scope	Identifier	Source field
application applno	ANDA	075209	derived:openfda.application_number
application number		ANDA075209	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	11523-0007-8	openfda.package_ndc
ndc	package	11523-0007-3	openfda.package_ndc
ndc	package	11523-0007-5	openfda.package_ndc
ndc	package	11523-0007-2	openfda.package_ndc
ndc	package	11523-0007-9	openfda.package_ndc
ndc	package	11523-0007-6	openfda.package_ndc
ndc	package	11523-0007-1	openfda.package_ndc
ndc	package	11523-0007-4	openfda.package_ndc
ndc	package	11523-0007-7	openfda.package_ndc
ndc	product	11523-0007	openfda.product_ndc
ndc11	package	11523000702	derived:openfda.package_ndc
ndc11	package	11523000708	derived:openfda.package_ndc
ndc11	package	11523000701	derived:openfda.package_ndc
ndc11	package	11523000705	derived:openfda.package_ndc
ndc11	package	11523000706	derived:openfda.package_ndc
ndc11	package	11523000707	derived:openfda.package_ndc
ndc11	package	11523000703	derived:openfda.package_ndc
ndc11	package	11523000709	derived:openfda.package_ndc
ndc11	package	11523000704	derived:openfda.package_ndc
rxcui		311372	openfda.rxcui
rxcui		206805	openfda.rxcui
spl id		4526b265-4250-3e71-e063-6294a90a21a8	id
spl set id		acf2d393-53d7-062f-e053-2995a90a0d60	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 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 When using this product do not take more than directed. Taking more than directed may cause drowsiness. Stop use Stop use and ask a doctor if an allergic reaction to this product occurs. Seek medical help right away. If pregnant or breast-feeding If pregnant or breast-feeding , ask a health professional before use. Keep out of reach of children 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.