Home NDC 0065-0426 GenTeal Tears (Moderate)
Product NDC 0065-0426
11-digit product format 000650426
Labeler code 0065
Product ID 0065-0426_1a0c59b1-95e8-477f-9c56-26bcd3bd7470
Type HUMAN OTC DRUG
Nonproprietary name Dextran 70, Glycerin, Hypromellose
Dosage form SOLUTION/ DROPS
Route OPHTHALMIC
Labeler Alcon Laboratories, Inc.
Application M018
Marketing category OTC MONOGRAPH DRUG
Marketing start 2016-03-01
Substance DEXTRAN 70; GLYCERIN; HYPROMELLOSES
Active strength 1; 2; 3 mg/mL; mg/mL; mg/mL
Pharmacologic classes Allergens [CS], Cell-mediated Immunity [PE], Glycerol [CS], Increased Histamine Release [PE], Increased IgG Production [PE], Increased Intravascular Volume [PE], Non-Standardized Chemical Allergen [EPC], Osmotic Activity [MoA], Plasma Volume Expander [EPC]
NDC exclude flag No
Listing certified through 2026-12-31
Current FDA listing Yes Observed NDC auxiliary status history# This history shows the information present in each captured FDA auxiliary file. It is not a continuous regulatory timeline, and a missing record does not establish a status.
Historic NDC status page 1 of 1 · 24 matching rows.
View current auxiliary records. · View the auxiliary file history.
Captured / source date, Dataset, Scope table Captured / source date Dataset Scope Package NDC Snapshot Source SHA-256 2025-12-14 17:58 UTC · source 2025-12-05 excluded product product d630ba8d3edf…732f749b63fb…2025-12-14 17:58 UTC · source 2025-12-05 excluded package package 0065-0426-22 d630ba8d3edf…732f749b63fb…2025-08-27 00:01 UTC · source 2025-08-26 excluded product product f5e01cc5f278…a2eaf40c39c3…2025-08-27 00:01 UTC · source 2025-08-26 excluded package package 0065-0426-22 f5e01cc5f278…a2eaf40c39c3…2025-04-01 02:39 UTC · source 2025-03-31 excluded product product 2ef7874e63bc…57b86245f4fa…2025-04-01 02:39 UTC · source 2025-03-31 excluded package package 0065-0426-22 2ef7874e63bc…57b86245f4fa…2025-03-28 20:22 UTC · source 2025-03-28 excluded product product a1b67e2a42f9…c4cf2c586c0d…2025-03-28 20:22 UTC · source 2025-03-28 excluded package package 0065-0426-22 a1b67e2a42f9…c4cf2c586c0d…2025-03-22 03:12 UTC · source 2025-03-21 excluded product product cfe11265f3b6…090c488252e2…2025-03-22 03:12 UTC · source 2025-03-21 excluded package package 0065-0426-22 cfe11265f3b6…090c488252e2…2025-03-10 12:48 UTC · source 2025-03-10 excluded product product cdf11ea48f46…ba0047e9e063…2025-03-10 12:48 UTC · source 2025-03-10 excluded package package 0065-0426-22 cdf11ea48f46…ba0047e9e063…2025-02-02 03:52 UTC · source 2025-01-31 excluded product product 302b2466d912…e7b80fea0513…2025-02-02 03:52 UTC · source 2025-01-31 excluded package package 0065-0426-22 302b2466d912…e7b80fea0513…2025-01-20 13:05 UTC · source 2025-01-20 excluded product product ed331223b511…672a5bd82f5f…2025-01-20 13:05 UTC · source 2025-01-20 excluded package package 0065-0426-22 ed331223b511…672a5bd82f5f…2025-01-11 03:41 UTC · source 2025-01-10 excluded product product 0efc9e666f02…f202fb6c5f17…2025-01-11 03:41 UTC · source 2025-01-10 excluded package package 0065-0426-22 0efc9e666f02…f202fb6c5f17…2024-11-09 02:27 UTC · source 2024-11-08 excluded product product ad56d346431e…cc804d4bbf1e…2024-11-09 02:27 UTC · source 2024-11-08 excluded package package 0065-0426-22 ad56d346431e…cc804d4bbf1e…2024-10-04 04:10 UTC · source 2024-10-03 excluded product product 367a005e9d99…383a685ebd0f…2024-10-04 04:10 UTC · source 2024-10-03 excluded package package 0065-0426-22 367a005e9d99…383a685ebd0f…2024-07-10 04:00 UTC · source 2024-07-09 excluded product product 557ba5c1ecfa…9c80585c8c6e…2024-07-10 04:00 UTC · source 2024-07-09 excluded package package 0065-0426-22 557ba5c1ecfa…9c80585c8c6e…
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)
Listing expiration 2026-12-31 Active Ingredients# Ingredient, Strength table Ingredient Strength DEXTRAN 70 1 mg/mL GLYCERIN 2 mg/mL HYPROMELLOSES 3 mg/mL
Harmonized UNII identifiers# UNII identifiers page 1 of 1 · 3 matching rows.
Identifier, FDA.report destination table Identifier FDA.report destination 7SA290YK68 Internal UNII lookup PDC6A3C0OX Internal UNII lookup 3NXW29V3WO Internal UNII lookup
Harmonized RxCUI identifiers# RxCUI identifiers page 1 of 1 · 1 matching rows.
Identifier, FDA.report destination table Identifier FDA.report destination 900138 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 0065-0426-36 GenTeal Tears (Moderate) 1 in 1 CARTON SOLUTION/ DROPS 1 11 0065-0426-36 GenTeal Tears (Moderate) 15 mL in 1 BOTTLE, DROPPER SOLUTION/ DROPS 15 11 0065-0426-37 GenTeal Tears (Moderate) 2 in 1 CARTON SOLUTION/ DROPS 2 11 0065-0426-37 GenTeal Tears (Moderate) 15 mL in 1 BOTTLE, DROPPER SOLUTION/ DROPS 15 11
DailyMed Dashboard NDC Coverage# NDC, Dashboard title, SPL version table NDC Dashboard title SPL version Validation Dashboard ZIP 0065-0426 GENTEAL TEARS (MODERATE) (DEXTRAN 70, GLYCERIN, HYPROMELLOSE) SOLUTION/ DROPS [ALCON LABORATORIES, INC.] 11 Current NDC, Legacy NDC, 4 package rows 20231216_a2992597-3490-6a5c-be45-2b6fa15e1547.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 17 of 25 · 494 matching rows.
Brand, Generic, Manufacturer table Brand Generic Manufacturer SPL set ID Effective date Available safety fields Join Eyesaline Eyewash Concentrate PURIFIED WATER Honeywell Safety Products, Inc. 2d90c8e8-f479-3535-e063-6394a90af122 2025-02-07 Warnings Exact identifier application number: M018 Code Red Eye Drops Redness Relief POLYETHYLENE GLYCOL 400, TETRAHYDROZOLINE HCL 4 Trees, LLC 0aa08018-cc2d-d947-e063-6394a90a914a 2025-02-07 Warnings Exact identifier application number: M018 Tyson 2.0 Mike Red Eye Drops For Dry High Eyes GLYCERIN, NAPHAZOLINE HCL Jbrands Pharma L.L.C. 288e9c85-0562-89bf-e063-6394a90a110d 2025-02-07 Warnings Exact identifier application number: M018 Sodium Chloride Normal Salt SODIUM CHLORIDE Citragen Pharmaceuticals Inc aae783b2-18fe-69ca-e053-2a95a90a0800 2025-01-30 Warnings Exact identifier application number: M018 Sodium Chloride Normal Salt SODIUM CHLORIDE Citragen Pharmaceuticals Inc 82c29f1d-a018-7483-e053-2a91aa0a8f7e 2025-01-30 Warnings Exact identifier application number: M018 OASIS Tears Lubricant Eye GLYCERIN OASIS Medical, Inc. 00071697-4ac6-4962-8eee-388b8b52bd40 2025-01-22 Warnings Exact identifier application number: M018 ImproVue Lubricant HYPROMELLOSE 2208 (15000 MPA.S) Oculus Surgical, Inc. 63b82129-4848-47c5-bf92-ec4b1a9e9974 2025-01-22 Warnings Exact identifier application number: M018 VISCO SHIELD Lubricant HYPROMELLOSE 2208 (15000 MPA.S) OASIS Medical, Inc. 72d22610-d8ab-4f24-b304-8b013430a7d7 2025-01-22 Warnings Exact identifier application number: M018 OASIS Tears Plus Preservative-Free Lubricant Eye GLYCERIN OASIS Medical, Inc. ea931c0f-c61e-4771-84f1-0274b1c3e28e 2025-01-22 Warnings Exact identifier application number: M018 Medics Choice Soothing Eye Wash PURIFIED WATER KC Pharmaceuticals, Inc. 10e49808-161e-f4ec-e063-6294a90a1775 2025-01-19 Warnings Exact identifier application number: M018 Sodium Chloride Hypertonicity Ophthalmic Solution, 5% SODIUM CHLORIDE HYPERTONICITY OPHTHALMIC SOLUTION, 5% Reliable 1 Laboritories LLC 29175c17-223e-5e92-e063-6294a90a71d2 2025-01-15 Warnings Exact identifier application number: M018 Lubricating Tears CARBOXYMETHYLCELLULOSE SODIUM 0.5% SOLUTION Reliable 1 Laboritories LLC 29023a57-eba3-4241-e063-6294a90a7048 2025-01-15 Warnings Exact identifier application number: M018 Aurodone Povidone Iodine 5 % Opthalmic Solution POVIDONE IODINE 5 % TOPICAL SOLUTION Aurolab f3444446-1dad-79ff-e053-2a95a90af411 2025-01-06 Warnings Exact identifier application number: M018 Hypromellose Eye Drops 0.7% HYPROMELLOSE EYE DROPS 0.7% Aurolab d35313d0-b190-5fb0-e053-2a95a90a5283 2025-01-02 Warnings Exact identifier application number: M018 VISTA MEIBO TEARS Propylene Glycol 0.6% w/v Advanced Dry Eye Relief Lubricating Drops 10 ml PROPYLENE GLYCOL Red Wedding LLC b2c2fd0f-b944-6b0b-e053-2995a90aa216 2025-01-01 Warnings Exact identifier application number: M018 Rite Aid Hydration Lubricant Eye Drops POLYETHYLENE GLYCOL 400, PROPYLENE GLYCOL Rite Aid Corporation ecac1351-e944-21da-e053-2995a90a6d34 2024-12-31 Warnings Exact identifier application number: M018 Lubricant Eye PM MINERAL OIL, WHITE PETROLATUM Reliable 1 Laboratories LLC baec8045-97fe-6f60-e053-2a95a90a050e 2024-12-31 Warnings Exact identifier application number: M018 Lil Drug Store Eye Drops Redness Reliever TETRAHYDROZOLINE HYDROCHLORIDE Lil Drug Store Products, Inc d2a47e98-a04c-47ec-aded-d1c894f040e2 2024-12-30 Warnings Exact identifier application number: M018 Rain Renewal Eye Drops CARBOXYMETHYLCELLULOSE SODIUM Rain Eye Drops, LLC af7a5768-7d1d-3d93-e053-2a95a90a38f6 2024-12-29 Warnings Exact identifier application number: M018 Glitch Advanced Relief Eye Drops POLYETHYLENE GLYCOL 400, TETRAHYDROZOLINE HCL Misemer Pharmaceutical, Inc 03778509-3374-2168-e063-6294a90a9505 2024-12-23 Warnings Exact identifier application number: M018
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 0065-0426-36 00065042636 1 BOTTLE, DROPPER in 1 CARTON (0065-0426-36) / 15 mL in 1 BOTTLE, DROPPER 2016-03-01 0000-00-00 No No Current 0065-0426-37 00065042637 2 BOTTLE, DROPPER in 1 CARTON (0065-0426-37) / 15 mL in 1 BOTTLE, DROPPER 2016-03-01 0000-00-00 No No Current