Home NDC 0065-8063 GenTeal Tears Moderate Preservative Free
Product NDC 0065-8063
11-digit product format 000658063
Labeler code 0065
Product ID 0065-8063_f7885429-659f-40b7-bbd7-d8680d1912f2
Type HUMAN OTC DRUG
Nonproprietary name dextran 70, hypromellose 2910
Dosage form SOLUTION/ DROPS
Route OPHTHALMIC
Labeler Alcon Laboratories, Inc.
Application M018
Marketing category OTC MONOGRAPH DRUG
Marketing start 2018-07-03
Substance HYPROMELLOSE 2910 (4000 MPA.S); DEXTRAN 70
Active strength 3; 1 mg/mL; mg/mL
Pharmacologic classes Increased Intravascular Volume [PE], Osmotic Activity [MoA], Plasma Volume Expander [EPC]
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 GenTeal Tears Moderate Preservative Free
Listing expiration 2026-12-31 Active Ingredients# Ingredient, Strength table Ingredient Strength HYPROMELLOSE 2910 (4000 MPA.S) 3 mg/mL DEXTRAN 70 1 mg/mL
Harmonized UNII identifiers# UNII identifiers page 1 of 1 · 2 matching rows.
Identifier, FDA.report destination table Identifier FDA.report destination RN3152OP35 Internal UNII lookup 7SA290YK68 Internal UNII lookup
Harmonized RxCUI identifiers# RxCUI identifiers page 1 of 1 · 1 matching rows.
Identifier, FDA.report destination table Identifier FDA.report destination 309714 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 0065-8063-01 GenTeal Tears Moderate Preservative Free .9 mL in 1 VIAL, SINGLE-DOSE SOLUTION/ DROPS .9 8 0065-8063-01 GenTeal Tears Moderate Preservative Free 36 in 1 CARTON SOLUTION/ DROPS 36 8
DailyMed Dashboard NDC Coverage# NDC, Dashboard title, SPL version table NDC Dashboard title SPL version Validation Dashboard ZIP 0065-8063 GENTEAL TEARS MODERATE PRESERVATIVE FREE (DEXTRAN 70, HYPROMELLOSE 2910) SOLUTION/ DROPS [ALCON LABORATORIES, INC.] 8 Current NDC, Legacy NDC, 2 package rows 20231215_37686e54-e64d-47c8-b082-b944a23cf6f1.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 0065-8063-01 00065806301 36 VIAL, SINGLE-DOSE in 1 CARTON (0065-8063-01) / .9 mL in 1 VIAL, SINGLE-DOSE 2018-07-03 0000-00-00 No No Current