Home NDC 70000-0011 Leader Artificial Tears 15 mL
Product NDC 70000-0011
11-digit product format 700000011
Labeler code 70000
Product ID 70000-0011_5b120e34-0a0e-e1ae-e063-6294a90a15bc
Type HUMAN OTC DRUG
Nonproprietary name Polyvinyl Alcohol, Povidone
Dosage form SOLUTION/ DROPS
Route OPHTHALMIC
Labeler Cardinal Health
Application M018
Marketing category OTC MONOGRAPH DRUG
Marketing start 2019-07-03
Marketing end 2027-09-30
Substance POLYVINYL ALCOHOL, UNSPECIFIED; POVIDONE
Active strength .5; .6 g/100mL; g/100mL
NDC exclude flag No
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 Artificial Tears 15 mL Active Ingredients# Ingredient, Strength table Ingredient Strength POLYVINYL ALCOHOL, UNSPECIFIED .5 g/100mL POVIDONE .6 g/100mL
Harmonized UNII identifiers# UNII identifiers page 1 of 1 · 2 matching rows.
Identifier, FDA.report destination table Identifier FDA.report destination 532B59J990 Internal UNII lookup FZ989GH94E Internal UNII lookup
Harmonized RxCUI identifiers# RxCUI identifiers page 1 of 1 · 1 matching rows.
Identifier, FDA.report destination table Identifier FDA.report destination 598050 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 70000-0011-1 Leader Artificial Tears 15 mL 1 in 1 BOX SOLUTION/ DROPS 1 4 70000-0011-1 Leader Artificial Tears 15 mL 15 mL in 1 BOTTLE, DROPPER SOLUTION/ DROPS 15 4
DailyMed Dashboard NDC Coverage# NDC, Dashboard title, SPL version table NDC Dashboard title SPL version Validation Dashboard ZIP 70000-0011 LEADER ARTIFICIAL TEARS 15 ML (POLYVINYL ALCOHOL, POVIDONE) SOLUTION/ DROPS [CARDINAL HEALTH] 4 Current NDC, Legacy NDC, 2 package rows 20240104_8cccc589-3a8e-baad-e053-2a95a90ab8c7.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 70000-0011-1 70000001101 1 BOTTLE, DROPPER in 1 BOX (70000-0011-1) / 15 mL in 1 BOTTLE, DROPPER 2019-07-03 2027-09-30 No No Current