genteal tears (moderate)

Generic: dextran 70, glycerin, hypromellose

Labeler: alcon laboratories, inc.
NDC Directory HUMAN OTC DRUG OTC MONOGRAPH DRUG Inactive Finished

Drug Facts

Product Profile

Brand Name genteal tears (moderate)
Generic Name dextran 70, glycerin, hypromellose
Labeler alcon laboratories, inc.
Dosage Form SOLUTION/ DROPS
Routes
OPHTHALMIC
Active Ingredients

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

Manufacturer
Alcon Laboratories, Inc.

Identifiers & Regulatory

Product NDC 0065-0426
Product ID 0065-0426_1a0c59b1-95e8-477f-9c56-26bcd3bd7470
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 00650426
Hyphenated Format 0065-0426

Supplemental Identifiers

RxCUI
900138
UNII
7SA290YK68 PDC6A3C0OX 3NXW29V3WO
NUI
N0000184175 N0000009361 N0000010288 N0000185370 N0000175629 N0000184306 N0000185001 M0000728 M0009417

Packaging Origin

Original Packager
true

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 (moderate) (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 (0065-0426-36) / 15 mL in 1 BOTTLE, DROPPER
  • 2 BOTTLE, DROPPER in 1 CARTON (0065-0426-37) / 15 mL in 1 BOTTLE, DROPPER
source: ndc

Packages (2)

0065-0426-36 1 BOTTLE, DROPPER in 1 CARTON (0065-0426-36) / 15 mL in 1 BOTTLE, DROPPER 0065-0426-37 2 BOTTLE, DROPPER in 1 CARTON (0065-0426-37) / 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 (Moderate) ndc-match (0.9)

Raw FDA Data

View complete raw FDA NDC JSON payload 
{"route": ["OPHTHALMIC"], "spl_id": "1a0c59b1-95e8-477f-9c56-26bcd3bd7470", "openfda": {"nui": ["N0000184175", "N0000009361", "N0000010288", "N0000185370", "N0000175629", "N0000184306", "N0000185001", "M0000728", "M0009417"], "unii": ["7SA290YK68", "PDC6A3C0OX", "3NXW29V3WO"], "rxcui": ["900138"], "spl_set_id": ["a2992597-3490-6a5c-be45-2b6fa15e1547"], "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": ["Alcon Laboratories, Inc."], "is_original_packager": [true]}, "finished": true, "packaging": [{"sample": false, "description": "1 BOTTLE, DROPPER in 1 CARTON (0065-0426-36)  / 15 mL in 1 BOTTLE, DROPPER", "package_ndc": "0065-0426-36", "marketing_start_date": "20160301"}, {"sample": false, "description": "2 BOTTLE, DROPPER in 1 CARTON (0065-0426-37)  / 15 mL in 1 BOTTLE, DROPPER", "package_ndc": "0065-0426-37", "marketing_start_date": "20160301"}], "brand_name": "GenTeal Tears (Moderate)", "product_id": "0065-0426_1a0c59b1-95e8-477f-9c56-26bcd3bd7470", "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": "0065-0426", "generic_name": "Dextran 70, Glycerin, Hypromellose", "labeler_name": "Alcon Laboratories, Inc.", "product_type": "HUMAN OTC DRUG", "brand_name_base": "GenTeal Tears (Moderate)", "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"}