Home NDC 70000-0456 Leader Advanced Relief Eye Drops
Product NDC 70000-0456
11-digit product format 700000456
Labeler code 70000
Product ID 70000-0456_4ccce313-8eec-8a62-e063-6394a90aa128
Type HUMAN OTC DRUG
Nonproprietary name DEXTRAN 70, POLYETHYLENE GLYCOL 400, POVIDONE, TETRAHYDROZOLINE HCl
Dosage form SOLUTION/ DROPS
Route OPHTHALMIC
Labeler Cardinal Health
Application M018
Marketing category OTC MONOGRAPH DRUG
Marketing start 2019-02-19
Marketing end 2027-01-31
Substance DEXTRAN 70; POLYETHYLENE GLYCOL 400; POVIDONE; TETRAHYDROZOLINE HYDROCHLORIDE
Active strength 100; 1000; 1000; 50 mg/100mL; mg/100mL; mg/100mL; mg/100mL
Pharmacologic classes Increased Intravascular Volume [PE], Osmotic Activity [MoA], Plasma Volume Expander [EPC]
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 Advanced Relief Eye Drops Active Ingredients# Ingredient, Strength table Ingredient Strength DEXTRAN 70 100 mg/100mL POLYETHYLENE GLYCOL 400 1000 mg/100mL POVIDONE 1000 mg/100mL TETRAHYDROZOLINE HYDROCHLORIDE 50 mg/100mL
Harmonized UNII identifiers# UNII identifiers page 1 of 1 · 4 matching rows.
Harmonized RxCUI identifiers# RxCUI identifiers page 1 of 1 · 1 matching rows.
Identifier, FDA.report destination table Identifier FDA.report destination 996202 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 70000-0456-1 Leader Advanced Relief Eye Drops 15 mL in 1 BOTTLE, DROPPER SOLUTION/ DROPS 15 7 70000-0456-1 Leader Advanced Relief Eye Drops 1 in 1 BOX SOLUTION/ DROPS 1 7
DailyMed Dashboard NDC Coverage# NDC, Dashboard title, SPL version table NDC Dashboard title SPL version Validation Dashboard ZIP 70000-0456 LEADER ADVANCED RELIEF EYE DROPS (DEXTRAN 70, POLYETHYLENE GLYCOL 400, POVIDONE, TETRAHYDROZOLINE HCL) SOLUTION/ DROPS [CARDINAL HEALTH] 5 Current NDC, Legacy NDC, 2 package rows 20231224_5c5d6c13-9b51-48f0-8627-b60b0f707fd3.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 70000-0456-1 70000045601 1 BOTTLE, DROPPER in 1 BOX (70000-0456-1) / 15 mL in 1 BOTTLE, DROPPER 2019-02-19 2027-01-31 No No Current