Home NDC 50090-5050 GENTEAL TEARS
Product NDC 50090-5050
11-digit product format 500905050
Labeler code 50090
Product ID 50090-5050_209fd8a1-720b-4308-abcd-29ca998d5f49
Type HUMAN OTC DRUG
Nonproprietary name Dextran 70, Glycerin, Hypromellose
Dosage form SOLUTION/ DROPS
Route OPHTHALMIC
Labeler A-S Medication Solutions
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 · 6 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 2024-05-28 21:12 UTC · source 2024-05-28 excluded product product 8af77b9d5b6f…d9bbb34c5368…2024-05-28 21:12 UTC · source 2024-05-28 excluded package package 50090-5050-0 8af77b9d5b6f…d9bbb34c5368…2024-05-15 03:39 UTC · source 2024-05-14 excluded product product 834df4deac94…adcc014656a3…2024-05-15 03:39 UTC · source 2024-05-14 excluded package package 50090-5050-0 834df4deac94…adcc014656a3…2024-03-11 06:39 UTC · source 2024-03-08 excluded product product 1332a3947898…d4bfe170f9cd…2024-03-11 06:39 UTC · source 2024-03-08 excluded package package 50090-5050-0 1332a3947898…d4bfe170f9cd…
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
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# FDA-Initiated Inactive NDC Indexing# DailyMed Package Descriptions# Package NDC, Product, Description table Package NDC Product Description Form Quantity Strength SPL version 50090-5050-0 GENTEAL TEARS 15 mL in 1 BOTTLE, DROPPER SOLUTION/ DROPS 15 7 50090-5050-0 GENTEAL TEARS 1 in 1 CARTON SOLUTION/ DROPS 1 7
DailyMed Dashboard NDC Coverage# NDC, Dashboard title, SPL version table NDC Dashboard title SPL version Validation Dashboard ZIP 50090-5050 GENTEAL TEARS (DEXTRAN 70, GLYCERIN, HYPROMELLOSE) SOLUTION/ DROPS [A-S MEDICATION SOLUTIONS] 7 Current NDC, Legacy NDC, 2 package rows 20240615_a2b715e9-332d-4f0b-b8e5-ebc000681586.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 50090-5050-0 50090505000 1 BOTTLE, DROPPER in 1 CARTON (50090-5050-0) / 15 mL in 1 BOTTLE, DROPPER 2020-05-15 0000-00-00 No No Current