NDC 0065-1437

SYSTANE HYDRATION PF PRESERVATIVE FREE

Polyethylene Glycol 400 And Propylene Glycol

SYSTANE HYDRATION PF PRESERVATIVE FREE is a Ophthalmic Solution/ Drops in the Human Otc Drug category. It is labeled and distributed by Alcon Laboratories, Inc.. The primary component is Polyethylene Glycol 400; Propylene Glycol.

Product ID0065-1437_383010b3-d509-4a12-84c1-3882df4dbd43
NDC0065-1437
Product TypeHuman Otc Drug
Proprietary NameSYSTANE HYDRATION PF PRESERVATIVE FREE
Generic NamePolyethylene Glycol 400 And Propylene Glycol
Dosage FormSolution/ Drops
Route of AdministrationOPHTHALMIC
Marketing Start Date2020-02-01
Marketing CategoryOTC MONOGRAPH FINAL / OTC MONOGRAPH FINAL
Application Numberpart349
Labeler NameAlcon Laboratories, Inc.
Substance NamePOLYETHYLENE GLYCOL 400; PROPYLENE GLYCOL
Active Ingredient Strength4 mg/mL; mg/mL
NDC Exclude FlagN
Listing Certified Through2022-12-31

Packaging

NDC 0065-1437-04

30 VIAL, SINGLE-DOSE in 1 CARTON (0065-1437-04) > .7 mL in 1 VIAL, SINGLE-DOSE
Marketing Start Date2020-02-01
NDC Exclude FlagN
Sample Package?N

NDC SPL Data Element Entries

NDC 0065-1437-04 [00065143704]

SYSTANE HYDRATION PF PRESERVATIVE FREE SOLUTION/ DROPS
Marketing CategoryOTC monograph final
Application Numberpart349
Product TypeHUMAN OTC DRUG
Billing UnitEA
Marketing Start Date2020-02-01

NDC 0065-1437-05 [00065143705]

SYSTANE HYDRATION PF PRESERVATIVE FREE SOLUTION/ DROPS
Marketing CategoryOTC monograph final
Application Numberpart349
Product TypeHUMAN OTC DRUG
Marketing Start Date2020-02-01

Drug Details

Active Ingredients

IngredientStrength
POLYETHYLENE GLYCOL 4004 mg/mL

OpenFDA Data

SPL SET ID:db3a6c68-320b-46b0-83fa-6c29297a84a6
Manufacturer
UNII
RxNorm Concept Unique ID - RxCUI
  • 477589
  • 707566

    • NDC Crossover Matching brand name "SYSTANE HYDRATION PF PRESERVATIVE FREE" or generic name "Polyethylene Glycol 400 And Propylene Glycol"

    NDCBrand NameGeneric Name
    0065-1437SYSTANE HYDRATION PF PRESERVATIVE FREEPolyethylene Glycol 400 and Propylene Glycol
    0065-1510SYSTANE HYDRATION PF PRESERVATIVE FREEPolyethylene Glycol 400 and Propylene Glycol
    0065-8067GenTeal Tears Gel Dropspolyethylene glycol 400 and propylene glycol
    11673-522Lubricant dropsPolyethylene Glycol 400 and Propylene Glycol
    0363-0307Lubricant EyePolyethylene Glycol 400 and Propylene Glycol
    0363-6451Lubricant EyePolyethylene Glycol 400 and Propylene Glycol
    11822-2701lubricant eyePolyethylene Glycol 400 and Propylene Glycol
    30142-327lubricating reliefPolyethylene Glycol 400 and Propylene Glycol
    46122-199PEG-Phen Lubricant Eye DropsPolyethylene Glycol 400 and Propylene Glycol
    46122-201PEG-Phen Ultra Lubricant Eye DropsPolyethylene Glycol 400 and Propylene Glycol
    11822-4540RITE AID lubricant dropspolyethylene glycol 400 and propylene glycol
    0065-0454Systanepolyethylene glycol 400 and propylene glycol
    0065-1432Systanepolyethylene glycol 400 and propylene glycol
    0065-0429Systane Lubricantpolyethylene glycol 400 and Propylene Glycol
    0065-1431Systane UltraPolyethylene Glycol 400 and Propylene Glycol
    0065-1507Systane Ultra Preservative FreePolyethylene Glycol 400 and Propylene Glycol
    0363-7267Walgreens Lubricant EyePolyethylene Glycol 400 and Propylene Glycol
    © 2025 FDA.report
    This site is not affiliated with or endorsed by the FDA.