FDA.reportPublic FDA data

Systane Pro PF

Product NDC
0065-3290
11-digit product format
000653290
Labeler code
0065
Product ID
0065-3290_d9ca8c34-79fe-4faf-8760-3a2ed1285d93
Type
HUMAN OTC DRUG
Nonproprietary name
Propylene Glycol
Dosage form
EMULSION
Route
OPHTHALMIC
Labeler
Alcon Laboratories, Inc.
Application
M018
Marketing category
OTC MONOGRAPH DRUG
Marketing start
2025-01-31
Substance
PROPYLENE GLYCOL
Active strength
6 mg/mL
NDC exclude flag
No
Listing certified through
2027-12-31
Current FDA listing
Yes

Reported adverse events (FAERS/openFDA)#

Adverse event summaries are temporarily unavailable. Other product information remains available.

Additional Listing Data#

Finished product
Yes
Brand name base
Systane Pro PF
Listing expiration
2027-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
PROPYLENE GLYCOL6 mg/mL

Harmonized UNII identifiers#

UNII identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
6DC9Q167V3Internal UNII lookup

Harmonized RxCUI identifiers#

RxCUI identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
2265162Internal RxNorm lookup

Harmonized SPL set identifiers#

SPL set identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
23b3515f-fbe5-4398-b2df-8b2eccdd01e2Available on FDA.report

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
6084a4f4-5437-c9a5-caec-5361ee075a59Product name120140508
90c5639a-61b0-88d6-ddcf-21888e94869aProduct name120140508
9514609b-a2a9-f8ec-6ba6-3f8e5ee89877Product name120140508

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
0065-3290-03Systane Pro PF1 in 1 CARTONEMULSION14
0065-3290-03Systane Pro PF10 mL in 1 BOTTLE, DROPPEREMULSION104
0065-3290-05Systane Pro PF10 mL in 1 BOTTLE, DROPPEREMULSION104
0065-3290-05Systane Pro PF2 in 1 CARTONEMULSION24

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
0065-3290-03ML - Milliliter0065-32909c82314d-dae9-4aa7-933e-6028a27b219f12025-03-04
0065-3290-05ML - Milliliter0065-32900f4fd2bf-1b10-41ce-bdaf-0a3441b24a8212025-03-04

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
0065-3290SYSTANE PRO PF (PROPYLENE GLYCOL) EMULSION [ALCON LABORATORIES, INC.]3Current NDC, 4 package rows20250519_23b3515f-fbe5-4398-b2df-8b2eccdd01e2.zip

openFDA label cross-check#

OpenFDA label data provides additional search and identifier links. DailyMed’s Structured Product Label is the canonical label on FDA.report. Matching records are deduplicated before they are shown below.

Matched openFDA labels page 8 of 25 · 494 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
EYE DROPSCARBOXYMETHYLCELLULOSE SODIUMFoshan Sugar Max Cosmetics CO.,Ltd26dbf100-593e-3778-e063-6394a90adf262025-12-30WarningsExact identifier
application number: M018
GoodSense Eye Drops Original FormulaTETRAHYDROZOLINE HCLGeiss, Destin & Dunn, Inc.9b44de58-6362-3811-e053-2995a90a2f372025-12-30WarningsExact identifier
application number: M018
GoodSense Redness Relief PlusGLLYCERIN, NAPHAZOLINE HYDROCHLORIDEGeiss, Destin & Dunn, Inc.9b37250f-9bdf-574e-e053-2a95a90a013e2025-12-30WarningsExact identifier
application number: M018
CVS Advanced Eye DropsDEXTRAN 70, POLYETHYLENE GLYCOL 400, POVIDONE, TETRAHYDROZOLINE HYDROCHLORIDECVS Pharmacy, Inc.f74a2fca-902c-f68a-e053-6394a90abb882025-12-30WarningsExact identifier
application number: M018
GoodSense Eye Drops Irritation ReliefTETRAHYDROZOLINE HCL, ZINC SULFATEGeiss, Destin & Dunn, Inc.9b24fbdd-780c-1ba2-e053-2a95a90ad60f2025-12-30WarningsExact identifier
application number: M018
CVS Hydration Eye DropsPOLYETYLENE GLYCOL 400, PROPYLENE GLYCOLCVSecab8fa3-6575-0dde-e053-2a95a90abd612025-12-30WarningsExact identifier
application number: M018
Good Sense Artificial TearsPOLYVINYL ALCOHOL, POVIDONEGeiss, Destin & Dunn, Inc.9b243301-2e4b-5706-e053-2995a90a9b902025-12-30WarningsExact identifier
application number: M018
GoodSense Eye Drops Advanced Relief MoisturizerDEXTRAN, POLYETHYLENE GLYCOL 400, POVIDONE, TETRAHYDROZOLINE HCLGeiss, Derstin & Dunn, Inc.9b34de99-13df-201a-e053-2a95a90ae5592025-12-30WarningsExact identifier
application number: M018
Good Sense Lubricating Plus Lubricant Eye DropsCARBOXYMETHYLCELLULOSE SODIUMGoodSenseffd6428e-3bf5-8742-e053-6394a90a4c8f2025-12-30WarningsExact identifier
application number: M018
GoodSense Ultra Lubricant Eye DropsPOLYETHYLENE GLYCOL 400, PROPYLENE GLYCOLGeiss, Destin & Dunn, Inc.9b45ebb5-c43b-c9fb-e053-2a95a90a34112025-12-30WarningsExact identifier
application number: M018
CVS Maximum Redness ReliefGLYCERIN, NAPHAZOLINE HCICVS Pharmacy, Inc.f70f9fc4-4022-336e-e053-6394a90a4d072025-12-30WarningsExact identifier
application number: M018
Discount Drug Mart Eye Drops Advanced ReliefDEXTRAN 70, POLYETHYLENE GLYCOL 400, POVIDONE, TETRAHYDROZOLINE HYDROCHLORIDEDiscount Drug Mart, Inc.f75c2f84-a28c-5807-e053-6294a90a22952025-12-30WarningsExact identifier
application number: M018
Discount Drug Mart Eye Drops Dry Eye ReliefGLYCERIN, HYPROMELLOSE, POLYETHYLENE GLYCOL 400Discount Drug Martf7fd53be-e501-d97f-e053-6394a90ad4092025-12-30WarningsExact identifier
application number: M018
Discount Drug Mart Eye Drops A.C.TETRAHYDROZOLINE HCL, ZINC SULFATEDiscount Drug Martf5f1d3da-5300-8211-e053-2a95a90a323a2025-12-30WarningsExact identifier
application number: M018
Exchange Select Eye Drops Advanced Relief MoisturizerDEXTRAN 70, POLYETHYLENE GLYCOL 400, POVIDONE, TETRAHYDROZOLINE HCLArmy and Air Force Exchange Service9e475240-2df1-9bee-e053-2995a90a8d4b2025-12-30WarningsExact identifier
application number: M018
Family Wellness Maximum Redness Relief Eye DropsGLYCERIN, NAPHAZOLINE HCLFamily Dollar Services, Inc.facd53c4-9cfc-6589-e053-6394a90a180d2025-12-30WarningsExact identifier
application number: M018
Exchange Select Artificial Tears Lubricant Eye DropsGLYCERIN, HYPROMELLOSE, POLYETHYLENE GLYCOL 400Army and Air Force Exchange Service9e478343-8ae7-823e-e053-2995a90a84ed2025-12-30WarningsExact identifier
application number: M018
Family Wellness Advanced Redness Relief Eye DropsPOLYETHYLENE GLYCOL 400, TETRAHYDROZOLINE HCLFamily Dollar Services, Inc.fabec215-a040-3f4e-e053-6394a90ad45f2025-12-30WarningsExact identifier
application number: M018
Family Wellness Original Redness Relief Eye DropsTETRAHYDROZOLINE HCLFamily Dollar Services, Inc.fabf540a-8d5c-bb1c-e053-6394a90a75c22025-12-30WarningsExact identifier
application number: M018
Family Wellness Artificial TearsPOLYVINYL ALCOHOL, POVIDONEFamily Dollar Services, Inc.facd329b-1923-61df-e053-6294a90ab7382025-12-30WarningsExact identifier
application number: M018

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
2265162propylene glycol 0.6 % Ophthalmic SuspensionPSN23b3515f-fbe5-4398-b2df-8b2eccdd01e24
2265162propylene glycol 6 MG/ML Ophthalmic SuspensionSCD23b3515f-fbe5-4398-b2df-8b2eccdd01e24
2265162propylene glycol 0.6 % Ophthalmic SuspensionSY23b3515f-fbe5-4398-b2df-8b2eccdd01e24

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startSampleExclude flagStatus
0065-3290-03000653290031 BOTTLE, DROPPER in 1 CARTON (0065-3290-03) / 10 mL in 1 BOTTLE, DROPPER2025-01-31NoNoCurrent
0065-3290-05000653290052 BOTTLE, DROPPER in 1 CARTON (0065-3290-05) / 10 mL in 1 BOTTLE, DROPPER2025-01-31NoNoCurrent
0065-3290-72000653290721 BOTTLE in 1 CARTON (0065-3290-72) / 3 mL in 1 BOTTLE1 bottle2026-08-31NoNoCurrent