systane balance

Generic: propylene glycol

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

Drug Facts

Product Profile

Brand Name systane balance
Generic Name propylene glycol
Labeler alcon laboratories, inc.
Dosage Form EMULSION
Routes
OPHTHALMIC
Active Ingredients

propylene glycol .06 mg/mL

Manufacturer
Alcon Laboratories, Inc.

Identifiers & Regulatory

Product NDC 0065-1433
Product ID 0065-1433_f81c8282-0871-46fb-8124-83666457a4f2
Product Type HUMAN OTC DRUG
Marketing Category OTC MONOGRAPH DRUG
Application Number M018
Listing Expiration 2026-12-31
Marketing Start 2010-06-25

Normalized Code Variants

Searchable formats for this product NDC code

Digits Only 00651433
Hyphenated Format 0065-1433

Supplemental Identifiers

UNII
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 balance (source: ndc)
Generic Name propylene glycol (source: ndc)
Application Number M018 (source: ndc)
Routes
OPHTHALMIC
source: ndc

Resolved Composition

Strengths
  • .06 mg/mL
source: ndc
Packaging
  • 1 BOTTLE, DROPPER in 1 CARTON (0065-1433-02) / 10 mL in 1 BOTTLE, DROPPER
  • 2 BOTTLE, DROPPER in 1 CARTON (0065-1433-07) / 10 mL in 1 BOTTLE, DROPPER
  • 1 BOTTLE, DROPPER in 1 CARTON (0065-1433-11) / 1.5 mL in 1 BOTTLE, DROPPER
source: ndc

Packages (3)

0065-1433-02 1 BOTTLE, DROPPER in 1 CARTON (0065-1433-02) / 10 mL in 1 BOTTLE, DROPPER 0065-1433-07 2 BOTTLE, DROPPER in 1 CARTON (0065-1433-07) / 10 mL in 1 BOTTLE, DROPPER 0065-1433-11 1 BOTTLE, DROPPER in 1 CARTON (0065-1433-11) / 1.5 mL in 1 BOTTLE, DROPPER

Ingredients (1)

propylene glycol (.06 mg/mL)

Linked Drug Pages (1)

Systane Balance ndc-match (0.9)

Raw FDA Data

View complete raw FDA NDC JSON payload 
{"route": ["OPHTHALMIC"], "spl_id": "f81c8282-0871-46fb-8124-83666457a4f2", "openfda": {"unii": ["6DC9Q167V3"], "spl_set_id": ["c7b1a03a-a5f2-409e-a34a-d6f166671de5"], "manufacturer_name": ["Alcon Laboratories, Inc."], "is_original_packager": [true]}, "finished": true, "packaging": [{"sample": false, "description": "1 BOTTLE, DROPPER in 1 CARTON (0065-1433-02)  / 10 mL in 1 BOTTLE, DROPPER", "package_ndc": "0065-1433-02", "marketing_start_date": "20100625"}, {"sample": false, "description": "2 BOTTLE, DROPPER in 1 CARTON (0065-1433-07)  / 10 mL in 1 BOTTLE, DROPPER", "package_ndc": "0065-1433-07", "marketing_start_date": "20100625"}, {"sample": false, "description": "1 BOTTLE, DROPPER in 1 CARTON (0065-1433-11)  / 1.5 mL in 1 BOTTLE, DROPPER", "package_ndc": "0065-1433-11", "marketing_start_date": "20100625"}], "brand_name": "Systane Balance", "product_id": "0065-1433_f81c8282-0871-46fb-8124-83666457a4f2", "dosage_form": "EMULSION", "product_ndc": "0065-1433", "generic_name": "propylene glycol", "labeler_name": "Alcon Laboratories, Inc.", "product_type": "HUMAN OTC DRUG", "brand_name_base": "Systane Balance", "active_ingredients": [{"name": "PROPYLENE GLYCOL", "strength": ".06 mg/mL"}], "application_number": "M018", "marketing_category": "OTC MONOGRAPH DRUG", "marketing_start_date": "20100625", "listing_expiration_date": "20261231"}