Home NDC 11716-1104 LEADER ADVANCED FORMULA EYE DROPS
Product NDC 11716-1104
11-digit product format 117161104
Labeler code 11716
Product ID 11716-1104_ddd93887-104b-4d41-8cdb-bf19ef9154a1
Type HUMAN OTC DRUG
Nonproprietary name DEXTRAN 70
Dosage form SOLUTION
Route OPHTHALMIC
Labeler HANLIM PHARM. CO., LTD.
Application part349
Marketing category OTC MONOGRAPH FINAL
Marketing start 2010-05-06
Marketing end 0000-00-00
Substance DEXTRAN 70; POLYETHYLENE GLYCOL 400; POVIDONE; TETRAHYDROZOLINE HYDROCHLORIDE
Active strength 0 mL/mL; mL/mL; mL/mL; mL/mL
NDC exclude flag E
Listing certified through 2018-12-31
Current FDA listing Historical FDA.report record NDC auxiliary status# Explicit status records from FDA unfinished, excluded, and compounder auxiliary files. Absence of a row is not itself a regulatory status.
Dataset, Scope, Product NDC table Dataset Scope Product NDC Package NDC Code Status Reporting period Source date excluded product product 11716-1104 I Inactivated by FDA 2026-07-31 excluded package package 11716-1104 11716-1104-1 I Inactivated by FDA 2026-07-31
openFDA label cross-check# Cross-check layer: openFDA label JSON enriches search and identifies hydration gaps. The DailyMed Structured Product Label remains the canonical label presentation on FDA.report.
Warnings cross-check# openFDA text is shown for search and cross-checking; DailyMed SPL is canonical.
warnings Warnings If pregnant or breast feeding, ask a health professional before use. Keep out of reach of children, if swallowed, get medical help or contact a Poison Control Center right away at 1-800-222-1222.
DailyMed Product Concepts# FDA-Initiated Inactive NDC Indexing# DailyMed Package Descriptions# Package NDC, Product, Description table Package NDC Product Description Form Quantity Strength SPL version 11716-1104-1 LEADER ADVANCED FORMULA EYE DROPS 15 mL in 1 BOTTLE SOLUTION 15 2 11716-1104-1 LEADER ADVANCED FORMULA EYE DROPS 1 in 1 CARTON SOLUTION 1 2
DailyMed Socrata Ingredients# Ingredient, Type, UNII table Ingredient Type UNII DailyMed label SPL version Uploaded DEXTRAN 70 ACTIVE INGREDIENT 7SA290YK68 LEADER ADVANCED FORMULA EYE DROPS (DEXTRAN 70) SOLUTION [HANLIM PHARM. CO., LTD.] 2 POLYETHYLENE GLYCOL 400 ACTIVE INGREDIENT B697894SGQ LEADER ADVANCED FORMULA EYE DROPS (DEXTRAN 70) SOLUTION [HANLIM PHARM. CO., LTD.] 2 POVIDONE ACTIVE INGREDIENT FZ989GH94E LEADER ADVANCED FORMULA EYE DROPS (DEXTRAN 70) SOLUTION [HANLIM PHARM. CO., LTD.] 2 TETRAHYDROZOLINE HYDROCHLORIDE ACTIVE INGREDIENT 0YZT43HS7D LEADER ADVANCED FORMULA EYE DROPS (DEXTRAN 70) SOLUTION [HANLIM PHARM. CO., LTD.] 2 DEXTRAN 70 ACTIVE MOIETY 7SA290YK68 LEADER ADVANCED FORMULA EYE DROPS (DEXTRAN 70) SOLUTION [HANLIM PHARM. CO., LTD.] 2 POLYETHYLENE GLYCOL 400 ACTIVE MOIETY B697894SGQ LEADER ADVANCED FORMULA EYE DROPS (DEXTRAN 70) SOLUTION [HANLIM PHARM. CO., LTD.] 2 POVIDONE ACTIVE MOIETY FZ989GH94E LEADER ADVANCED FORMULA EYE DROPS (DEXTRAN 70) SOLUTION [HANLIM PHARM. CO., LTD.] 2 TETRAHYDROZOLINE ACTIVE MOIETY S9U025Y077 LEADER ADVANCED FORMULA EYE DROPS (DEXTRAN 70) SOLUTION [HANLIM PHARM. CO., LTD.] 2 BENZALKONIUM CHLORIDE INACTIVE INGREDIENT F5UM2KM3W7 LEADER ADVANCED FORMULA EYE DROPS (DEXTRAN 70) SOLUTION [HANLIM PHARM. CO., LTD.] 2 BORIC ACID INACTIVE INGREDIENT R57ZHV85D4 LEADER ADVANCED FORMULA EYE DROPS (DEXTRAN 70) SOLUTION [HANLIM PHARM. CO., LTD.] 2 EDETATE DISODIUM INACTIVE INGREDIENT 7FLD91C86K LEADER ADVANCED FORMULA EYE DROPS (DEXTRAN 70) SOLUTION [HANLIM PHARM. CO., LTD.] 2 SODIUM BORATE INACTIVE INGREDIENT 91MBZ8H3QO LEADER ADVANCED FORMULA EYE DROPS (DEXTRAN 70) SOLUTION [HANLIM PHARM. CO., LTD.] 2 SODIUM CHLORIDE INACTIVE INGREDIENT 451W47IQ8X LEADER ADVANCED FORMULA EYE DROPS (DEXTRAN 70) SOLUTION [HANLIM PHARM. CO., LTD.] 2 WATER INACTIVE INGREDIENT 059QF0KO0R LEADER ADVANCED FORMULA EYE DROPS (DEXTRAN 70) SOLUTION [HANLIM PHARM. CO., LTD.] 2
DailyMed Dashboard NDC Coverage# NDC, Dashboard title, SPL version table NDC Dashboard title SPL version Validation Dashboard ZIP 11716-1104 LEADER ADVANCED FORMULA EYE DROPS (DEXTRAN 70) SOLUTION [HANLIM PHARM. CO., LTD.] 2 Legacy NDC, 2 package rows 20100511_01d4b9b9-7a16-428c-9194-d9437e17b133.zip
DailyMed RxNorm Mappings# Packages# Package NDC, 11-digit format, Description table Package NDC 11-digit format Description Units Status 11716-1104-1 11716110401 15 mL in 1 BOTTLE 15 ml Historical