systane ultra

Generic: polyethylene glycol 400 and propylene glycol

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

Drug Facts

Product Profile

Brand Name systane ultra
Generic Name polyethylene glycol 400 and propylene glycol
Labeler alcon laboratories, inc.
Dosage Form SOLUTION/ DROPS
Routes
OPHTHALMIC
Active Ingredients

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

Manufacturer
Alcon Laboratories, Inc.

Identifiers & Regulatory

Product NDC 0065-1431
Product ID 0065-1431_85a171a8-6208-4d82-8e8f-472b6c480866
Product Type HUMAN OTC DRUG
Marketing Category OTC MONOGRAPH DRUG
Application Number M018
Listing Expiration 2026-12-31
Marketing Start 2014-10-01

Normalized Code Variants

Searchable formats for this product NDC code

Digits Only 00651431
Hyphenated Format 0065-1431

Supplemental Identifiers

RxCUI
477589
UPC
0300651431056
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 ultra (source: ndc)
Generic Name polyethylene glycol 400 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
  • 1 BOTTLE, DROPPER in 1 CARTON (0065-1431-01) / 1.5 mL in 1 BOTTLE, DROPPER
  • 1 BOTTLE, DROPPER in 1 CARTON (0065-1431-05) / 10 mL in 1 BOTTLE, DROPPER
  • 3 BOTTLE, DROPPER in 1 CARTON (0065-1431-18) / 10 mL in 1 BOTTLE, DROPPER
  • 1 BOTTLE, DROPPER in 1 CARTON (0065-1431-21) / 3 mL in 1 BOTTLE, DROPPER
  • 2 BOTTLE, DROPPER in 1 CARTON (0065-1431-28) / 4 mL in 1 BOTTLE, DROPPER
  • 1 BOTTLE, DROPPER in 1 CARTON (0065-1431-31) / 4 mL in 1 BOTTLE, DROPPER
  • 2 BOTTLE, DROPPER in 1 CARTON (0065-1431-41) / 10 mL in 1 BOTTLE, DROPPER
  • 1 BOTTLE, DROPPER in 1 CARTON (0065-1431-80) / 3 mL in 1 BOTTLE, DROPPER
source: ndc

Packages (8)

0065-1431-01 1 BOTTLE, DROPPER in 1 CARTON (0065-1431-01) / 1.5 mL in 1 BOTTLE, DROPPER 0065-1431-05 1 BOTTLE, DROPPER in 1 CARTON (0065-1431-05) / 10 mL in 1 BOTTLE, DROPPER 0065-1431-18 3 BOTTLE, DROPPER in 1 CARTON (0065-1431-18) / 10 mL in 1 BOTTLE, DROPPER 0065-1431-21 1 BOTTLE, DROPPER in 1 CARTON (0065-1431-21) / 3 mL in 1 BOTTLE, DROPPER 0065-1431-28 2 BOTTLE, DROPPER in 1 CARTON (0065-1431-28) / 4 mL in 1 BOTTLE, DROPPER 0065-1431-31 1 BOTTLE, DROPPER in 1 CARTON (0065-1431-31) / 4 mL in 1 BOTTLE, DROPPER 0065-1431-41 2 BOTTLE, DROPPER in 1 CARTON (0065-1431-41) / 10 mL in 1 BOTTLE, DROPPER 0065-1431-80 1 BOTTLE, DROPPER in 1 CARTON (0065-1431-80) / 3 mL in 1 BOTTLE, DROPPER

Ingredients (2)

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

Linked Drug Pages (1)

Systane Ultra ndc-match (0.9)

Raw FDA Data

View complete raw FDA NDC JSON payload 
{"route": ["OPHTHALMIC"], "spl_id": "85a171a8-6208-4d82-8e8f-472b6c480866", "openfda": {"upc": ["0300651431056"], "unii": ["B697894SGQ", "6DC9Q167V3"], "rxcui": ["477589"], "spl_set_id": ["0537c23a-15f7-be64-1231-a6c93468e9a8"], "manufacturer_name": ["Alcon Laboratories, Inc."], "is_original_packager": [true]}, "finished": true, "packaging": [{"sample": false, "description": "1 BOTTLE, DROPPER in 1 CARTON (0065-1431-01)  / 1.5 mL in 1 BOTTLE, DROPPER", "package_ndc": "0065-1431-01", "marketing_start_date": "20141001"}, {"sample": false, "description": "1 BOTTLE, DROPPER in 1 CARTON (0065-1431-05)  / 10 mL in 1 BOTTLE, DROPPER", "package_ndc": "0065-1431-05", "marketing_start_date": "20141001"}, {"sample": false, "description": "3 BOTTLE, DROPPER in 1 CARTON (0065-1431-18)  / 10 mL in 1 BOTTLE, DROPPER", "package_ndc": "0065-1431-18", "marketing_start_date": "20141001"}, {"sample": false, "description": "1 BOTTLE, DROPPER in 1 CARTON (0065-1431-21)  / 3 mL in 1 BOTTLE, DROPPER", "package_ndc": "0065-1431-21", "marketing_start_date": "20141001"}, {"sample": false, "description": "2 BOTTLE, DROPPER in 1 CARTON (0065-1431-28)  / 4 mL in 1 BOTTLE, DROPPER", "package_ndc": "0065-1431-28", "marketing_start_date": "20141001"}, {"sample": false, "description": "1 BOTTLE, DROPPER in 1 CARTON (0065-1431-31)  / 4 mL in 1 BOTTLE, DROPPER", "package_ndc": "0065-1431-31", "marketing_start_date": "20141001"}, {"sample": false, "description": "2 BOTTLE, DROPPER in 1 CARTON (0065-1431-41)  / 10 mL in 1 BOTTLE, DROPPER", "package_ndc": "0065-1431-41", "marketing_start_date": "20141001"}, {"sample": false, "description": "1 BOTTLE, DROPPER in 1 CARTON (0065-1431-80)  / 3 mL in 1 BOTTLE, DROPPER", "package_ndc": "0065-1431-80", "marketing_start_date": "20141001"}], "brand_name": "Systane Ultra", "product_id": "0065-1431_85a171a8-6208-4d82-8e8f-472b6c480866", "dosage_form": "SOLUTION/ DROPS", "product_ndc": "0065-1431", "generic_name": "Polyethylene Glycol 400 and Propylene Glycol", "labeler_name": "Alcon Laboratories, Inc.", "product_type": "HUMAN OTC DRUG", "brand_name_base": "Systane Ultra", "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": "20141001", "listing_expiration_date": "20261231"}