genteal tears (50090-5050)

Drug Facts

Product Profile

Brand Name genteal tears

Generic Name dextran 70, glycerin, hypromellose

Labeler a-s medication solutions

Dosage Form SOLUTION/ DROPS

Routes

OPHTHALMIC

Active Ingredients

dextran 70 1 mg/mL, glycerin 2 mg/mL, hypromelloses 3 mg/mL

Manufacturer

A-S Medication Solutions

Identifiers & Regulatory

Product NDC 50090-5050

Product ID 50090-5050_209fd8a1-720b-4308-abcd-29ca998d5f49

Product Type HUMAN OTC DRUG

Marketing Category OTC MONOGRAPH DRUG

Application Number M018

Listing Expiration 2026-12-31

Marketing Start 2016-03-01

Pharmacologic Class

Established (EPC)

plasma volume expander [epc] non-standardized chemical allergen [epc]

Mechanism of Action

osmotic activity [moa]

Chemical Structure

allergens [cs] glycerol [cs]

Physiologic Effect

increased intravascular volume [pe] increased histamine release [pe] cell-mediated immunity [pe] increased igg production [pe]

Normalized Code Variants

Searchable formats for this product NDC code

Digits Only 500905050

Hyphenated Format 50090-5050

Supplemental Identifiers

RxCUI

900138

UNII

7SA290YK68 PDC6A3C0OX 3NXW29V3WO

NUI

N0000184175 N0000009361 N0000010288 N0000185370 N0000175629 N0000184306 N0000185001 M0000728 M0009417

Resolved Product View

Precedence rule: structured NDC data is preferred, falling back to linked label metadata when unavailable. Source tags show the origin of each value.

Resolved Identity

Brand Name genteal tears (source: ndc)

Generic Name dextran 70, glycerin, hypromellose (source: ndc)

Application Number M018 (source: ndc)

Routes

OPHTHALMIC

source: ndc

Resolved Composition

Strengths

1 mg/mL
2 mg/mL
3 mg/mL

source: ndc

Packaging

1 BOTTLE, DROPPER in 1 CARTON (50090-5050-0) / 15 mL in 1 BOTTLE, DROPPER

source: ndc

Packages (1)

50090-5050-0 1 BOTTLE, DROPPER in 1 CARTON (50090-5050-0) / 15 mL in 1 BOTTLE, DROPPER

Ingredients (3)

dextran 70 (1 mg/mL) glycerin (2 mg/mL) hypromelloses (3 mg/mL)

Linked Drug Pages (1)

GENTEAL TEARS ndc-match (0.9)

Raw FDA Data

View complete raw FDA NDC JSON payload

{"route": ["OPHTHALMIC"], "spl_id": "209fd8a1-720b-4308-abcd-29ca998d5f49", "openfda": {"nui": ["N0000184175", "N0000009361", "N0000010288", "N0000185370", "N0000175629", "N0000184306", "N0000185001", "M0000728", "M0009417"], "unii": ["7SA290YK68", "PDC6A3C0OX", "3NXW29V3WO"], "rxcui": ["900138"], "spl_set_id": ["a2b715e9-332d-4f0b-b8e5-ebc000681586"], "pharm_class_cs": ["Allergens [CS]", "Glycerol [CS]"], "pharm_class_pe": ["Increased Intravascular Volume [PE]", "Increased Histamine Release [PE]", "Cell-mediated Immunity [PE]", "Increased IgG Production [PE]"], "pharm_class_epc": ["Plasma Volume Expander [EPC]", "Non-Standardized Chemical Allergen [EPC]"], "pharm_class_moa": ["Osmotic Activity [MoA]"], "manufacturer_name": ["A-S Medication Solutions"]}, "finished": true, "packaging": [{"sample": false, "description": "1 BOTTLE, DROPPER in 1 CARTON (50090-5050-0)  / 15 mL in 1 BOTTLE, DROPPER", "package_ndc": "50090-5050-0", "marketing_start_date": "20200515"}], "brand_name": "GENTEAL TEARS", "product_id": "50090-5050_209fd8a1-720b-4308-abcd-29ca998d5f49", "dosage_form": "SOLUTION/ DROPS", "pharm_class": ["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]"], "product_ndc": "50090-5050", "generic_name": "Dextran 70, Glycerin, Hypromellose", "labeler_name": "A-S Medication Solutions", "product_type": "HUMAN OTC DRUG", "brand_name_base": "GENTEAL TEARS", "active_ingredients": [{"name": "DEXTRAN 70", "strength": "1 mg/mL"}, {"name": "GLYCERIN", "strength": "2 mg/mL"}, {"name": "HYPROMELLOSES", "strength": "3 mg/mL"}], "application_number": "M018", "marketing_category": "OTC MONOGRAPH DRUG", "marketing_start_date": "20160301", "listing_expiration_date": "20261231"}