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: TIME CAP LABORATORIES INC
Product type: HUMAN OTC DRUG
SPL set ID: 85b26cf3-448c-4d4f-93a2-aa89530ec1f1
SPL ID: 6c562c37-86ca-42c2-e053-2a91aa0a8a8a
Version: 4
Effective date: 2018-05-16
Source export date: 2026-09-28
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/2026-09-28/bb1af06e95bcf9567b07e56fcf3a03c0cac3c7c82ff89d4c970881174949e5b7/drug-label-0007-of-0014.json.zip
Source manifest SHA-256: cd2e66336a5cd2223fa3995098fdbdb84c6a7ee5c0a4addb236ccb22dd1e6887
Import run: 20260929T050834Z
Imported at: 2026-09-29 05:43:58

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 · 14 matching rows.

Type, Scope, Identifier table
Type	Scope	Identifier	Source field
application applno	ANDA	206214	derived:openfda.application_number
application number		ANDA206214	openfda.application_number
brand name		LORATADINE	openfda.brand_name
generic name		LORATADINE	openfda.generic_name
manufacturer name		TIME CAP LABORATORIES INC	openfda.manufacturer_name
ndc	package	49483-686-30	openfda.package_ndc
ndc	package	49483-686-07	openfda.package_ndc
ndc	product	49483-686	openfda.product_ndc
ndc11	package	49483068607	derived:openfda.package_ndc
ndc11	package	49483068630	derived:openfda.package_ndc
rxcui		828269	openfda.rxcui
spl id		6c562c37-86ca-42c2-e053-2a91aa0a8a8a	id
spl set id		85b26cf3-448c-4d4f-93a2-aa89530ec1f1	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

DO NOT USE IF YOU HAVE EVER HAD AN ALLERGIC REACTION TO THIS PRODUCT OR ANY OF ITS INGREDIENTS. 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.

Reported adverse events (FAERS/openFDA)#

Adverse event summaries are temporarily unavailable. Other product information remains available.