systane

Generic: polyethylene glycol and propylene glycol

Labeler: alcon research ltd
NDC Directory HUMAN OTC DRUG OTC MONOGRAPH DRUG Inactive Finished

Drug Facts

Product Profile

Brand Name systane
Generic Name polyethylene glycol and propylene glycol
Labeler alcon research ltd
Dosage Form SOLUTION/ DROPS
Routes
OPHTHALMIC
Active Ingredients

polyethylene glycol 400 4 mg/mL, propylene glycol 3 mg/mL

Manufacturer
Alcon Research Ltd

Identifiers & Regulatory

Product NDC 0065-0431
Product ID 0065-0431_5c7432b0-b4b8-49a1-89b7-6e3befa25917
Product Type HUMAN OTC DRUG
Marketing Category OTC MONOGRAPH DRUG
Application Number M018
Listing Expiration 2026-12-31
Marketing Start 2015-10-30

Normalized Code Variants

Searchable formats for this product NDC code

Digits Only 00650431
Hyphenated Format 0065-0431

Supplemental Identifiers

RxCUI
477589
UNII
B697894SGQ 6DC9Q167V3

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 systane (source: ndc)
Generic Name polyethylene glycol and propylene glycol (source: ndc)
Application Number M018 (source: ndc)
Routes
OPHTHALMIC
source: ndc

Resolved Composition

Strengths
  • 4 mg/mL
  • 3 mg/mL
source: ndc
Packaging
  • 30 VIAL in 1 CARTON (0065-0431-33) / .7 mL in 1 VIAL
source: ndc

Packages (1)

0065-0431-33 30 VIAL in 1 CARTON (0065-0431-33) / .7 mL in 1 VIAL

Ingredients (2)

polyethylene glycol 400 (4 mg/mL) propylene glycol (3 mg/mL)

Linked Drug Pages (1)

Systane ndc-match (0.9)

Raw FDA Data

View complete raw FDA NDC JSON payload 
{"route": ["OPHTHALMIC"], "spl_id": "5c7432b0-b4b8-49a1-89b7-6e3befa25917", "openfda": {"unii": ["B697894SGQ", "6DC9Q167V3"], "rxcui": ["477589"], "spl_set_id": ["14916d2c-a63d-491e-bd91-a61f300af38a"], "manufacturer_name": ["Alcon Research Ltd"], "is_original_packager": [true]}, "finished": true, "packaging": [{"sample": false, "description": "30 VIAL in 1 CARTON (0065-0431-33)  / .7 mL in 1 VIAL", "package_ndc": "0065-0431-33", "marketing_start_date": "20151030"}], "brand_name": "Systane", "product_id": "0065-0431_5c7432b0-b4b8-49a1-89b7-6e3befa25917", "dosage_form": "SOLUTION/ DROPS", "product_ndc": "0065-0431", "generic_name": "polyethylene glycol and propylene glycol", "labeler_name": "Alcon Research Ltd", "product_type": "HUMAN OTC DRUG", "brand_name_base": "Systane", "active_ingredients": [{"name": "POLYETHYLENE GLYCOL 400", "strength": "4 mg/mL"}, {"name": "PROPYLENE GLYCOL", "strength": "3 mg/mL"}], "application_number": "M018", "marketing_category": "OTC MONOGRAPH DRUG", "marketing_start_date": "20151030", "listing_expiration_date": "20261231"}