systane hydration pf preservative free

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 hydration pf preservative free
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 0065-1510
Product ID 0065-1510_aeb3df48-7af2-464e-a87d-fe9027452a85
Product Type HUMAN OTC DRUG
Marketing Category OTC MONOGRAPH DRUG
Application Number M018
Listing Expiration 2026-12-31
Marketing Start 2021-02-01

Normalized Code Variants

Searchable formats for this product NDC code

Digits Only 00651510
Hyphenated Format 0065-1510

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 hydration pf preservative free (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
  • 2 BOTTLE in 1 CARTON (0065-1510-00) / 10 mL in 1 BOTTLE
  • 1 BOTTLE in 1 CARTON (0065-1510-06) / 10 mL in 1 BOTTLE
source: ndc

Packages (2)

0065-1510-00 2 BOTTLE in 1 CARTON (0065-1510-00) / 10 mL in 1 BOTTLE 0065-1510-06 1 BOTTLE in 1 CARTON (0065-1510-06) / 10 mL in 1 BOTTLE

Ingredients (2)

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

Linked Drug Pages (1)

SYSTANE HYDRATION PF PRESERVATIVE FREE ndc-match (0.9)

Raw FDA Data

View complete raw FDA NDC JSON payload 
{"route": ["OPHTHALMIC"], "spl_id": "aeb3df48-7af2-464e-a87d-fe9027452a85", "openfda": {"unii": ["B697894SGQ", "6DC9Q167V3"], "rxcui": ["477589"], "spl_set_id": ["8936f66f-10fe-44ab-a26e-dd8b05dfa997"], "manufacturer_name": ["Alcon Laboratories, Inc."], "is_original_packager": [true]}, "finished": true, "packaging": [{"sample": false, "description": "2 BOTTLE in 1 CARTON (0065-1510-00)  / 10 mL in 1 BOTTLE", "package_ndc": "0065-1510-00", "marketing_start_date": "20230111"}, {"sample": false, "description": "1 BOTTLE in 1 CARTON (0065-1510-06)  / 10 mL in 1 BOTTLE", "package_ndc": "0065-1510-06", "marketing_start_date": "20210201"}], "brand_name": "SYSTANE HYDRATION PF PRESERVATIVE FREE", "product_id": "0065-1510_aeb3df48-7af2-464e-a87d-fe9027452a85", "dosage_form": "SOLUTION/ DROPS", "product_ndc": "0065-1510", "generic_name": "Polyethylene Glycol 400 and Propylene Glycol", "labeler_name": "Alcon Laboratories, Inc.", "product_type": "HUMAN OTC DRUG", "brand_name_base": "SYSTANE HYDRATION PF PRESERVATIVE FREE", "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": "20210201", "listing_expiration_date": "20261231"}