Home NDC 70000-0501 Leader Preservative-Free Ultra Lubricating Eye Drops
Product NDC 70000-0501
11-digit product format 700000501
Labeler code 70000
Product ID 70000-0501_21ad0d2c-69b0-b7c3-e063-6294a90aaec0
Type HUMAN OTC DRUG
Nonproprietary name Polyethylene glycol 400, propylene glycol
Dosage form SOLUTION/ DROPS
Route OPHTHALMIC
Labeler Cardinal Health
Application M018
Marketing category OTC MONOGRAPH DRUG
Marketing start 2019-04-30
Substance POLYETHYLENE GLYCOL 400; PROPYLENE GLYCOL
Active strength .4; .3 g/100mL; g/100mL
NDC exclude flag No
Listing certified through 2026-12-31
Current FDA listing Yes Reported adverse events (FAERS/openFDA)# Adverse event summaries are temporarily unavailable. Other product information remains available.
Additional Listing Data#
Finished product Yes
Brand name base Leader Preservative-Free Ultra Lubricating Eye Drops
Listing expiration 2026-12-31 Active Ingredients# Ingredient, Strength table Ingredient Strength POLYETHYLENE GLYCOL 400 .4 g/100mL PROPYLENE GLYCOL .3 g/100mL
Harmonized UNII identifiers# UNII identifiers page 1 of 1 · 2 matching rows.
Identifier, FDA.report destination table Identifier FDA.report destination B697894SGQ Internal UNII lookup 6DC9Q167V3 Internal UNII lookup
Harmonized RxCUI identifiers# RxCUI identifiers page 1 of 1 · 1 matching rows.
Identifier, FDA.report destination table Identifier FDA.report destination 477589 Internal RxNorm lookup
Harmonized SPL set identifiers# SPL set identifiers page 1 of 1 · 1 matching rows.
DailyMed Product Concepts# DailyMed Package Descriptions# Package NDC, Product, Description table Package NDC Product Description Form Quantity Strength SPL version 70000-0501-1 Leader Preservative-Free Ultra Lubricating Eye Drops 0.4 mL in 1 VIAL, SINGLE-USE SOLUTION/ DROPS 0.4 8 70000-0501-1 Leader Preservative-Free Ultra Lubricating Eye Drops 25 in 1 BOX SOLUTION/ DROPS 25 8
DailyMed Dashboard NDC Coverage# NDC, Dashboard title, SPL version table NDC Dashboard title SPL version Validation Dashboard ZIP 70000-0501 LEADER PRESERVATIVE-FREE ULTRA LUBRICATING EYE DROPS (POLYETHYLENE GLYCOL 400, PROPYLENE GLYCOL) SOLUTION/ DROPS [CARDINAL HEALTH] 8 Current NDC, Legacy NDC, 2 package rows 20240910_2a2aa620-ca63-4698-88fd-fc263b8fa0d1.zip
openFDA label cross-check# OpenFDA label data provides additional search and identifier links. DailyMed’s Structured Product Label is the canonical label on FDA.report. Matching records are deduplicated before they are shown below.
Matched openFDA labels page 6 of 25 · 494 matching rows.
DailyMed RxNorm Mappings# Packages# Package NDC, 11-digit format, Description table Package NDC 11-digit format Description Marketing start Marketing end Sample Exclude flag Status 70000-0501-1 70000050101 25 VIAL, SINGLE-USE in 1 BOX (70000-0501-1) / .4 mL in 1 VIAL, SINGLE-USE 2019-04-30 0000-00-00 No No Current