Leader Ultra Lubricating Eye Drops

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: Leader Ultra Lubricating Eye Drops
Generic name: POLYETHYLENE GLYCOL 400, PROPYLENE GLYCOL
Manufacturer: Cardinal Health
Product type: HUMAN OTC DRUG
SPL set ID: d7f011a2-05ba-47c3-9519-d31602e105c7
SPL ID: 4ccccdc5-a8f7-6d26-e063-6394a90a8795
Version: 8
Effective date: 2026-03-12
Source export date: 2026-10-30
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/2026-10-30/3b4c9bc1c064560160661a043b9878894ba805e5e90f4733fb76824b6ba7ac42/drug-label-0010-of-0014.json.zip
Source manifest SHA-256: b11f1f6b476c7417db937215bf14307ef1a0b69465b42b411ad52f42ae36ead3
Import run: 20261102T182004Z
Imported at: 2026-11-02 19:21:16

Harmonized routes table
Harmonized routes
OPHTHALMIC

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 number		M018	openfda.application_number
brand name		Leader Ultra Lubricating Eye Drops	openfda.brand_name
generic name		POLYETHYLENE GLYCOL 400, PROPYLENE GLYCOL	openfda.generic_name
manufacturer name		Cardinal Health	openfda.manufacturer_name
ndc	package	70000-0457-2	openfda.package_ndc
ndc	package	70000-0457-1	openfda.package_ndc
ndc	product	70000-0457	openfda.product_ndc
ndc11	package	70000045702	derived:openfda.package_ndc
ndc11	package	70000045701	derived:openfda.package_ndc
rxcui		477589	openfda.rxcui
spl id		4ccccdc5-a8f7-6d26-e063-6394a90a8795	id
spl set id		d7f011a2-05ba-47c3-9519-d31602e105c7	set_id
unii		6DC9Q167V3	openfda.unii
unii		B697894SGQ	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 For external use only Do not use • if this product changes color or becomes cloudy • if you are sensitive to any ingredient in this product When using this product • do not touch the tip of container to any surface to avoid contamination • replace cap after each use Stop use and ask a doctor if • you feel eye pain • changes in vision occur • redness or irritation of the eye(s) gets worse or lasts more than 72 hours

Reported adverse events (FAERS/openFDA)#

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