Systane Pro PF

Product NDC
0065-9308
11-digit product format
000659308
Labeler code
0065
Product ID
0065-9308_504aba5a-b1fc-4d22-868e-d1a3ac351a24
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
2025-03-14
Substance
PROPYLENE GLYCOL
Active strength
6 mg/mL
NDC exclude flag
No
Listing certified through
2027-12-31
Current FDA listing
Yes

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 Identifiers#

Field, Values table
FieldValues
Unii6DC9Q167V3
Rxcui2265162

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
0065-9308-05Systane Pro PF5 in 1 CARTONEMULSION54
0065-9308-05Systane Pro PF0.5 mL in 1 VIAL, SINGLE-DOSEEMULSION0.54
0065-9308-06Systane Pro PF0.5 mL in 1 VIAL, SINGLE-DOSEEMULSION0.54
0065-9308-06Systane Pro PF32 in 1 CARTONEMULSION324

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
0065-9308SYSTANE PRO PF (PROPYLENE GLYCOL) EMULSION [ALCON LABORATORIES, INC.]2Current NDC, 4 package rows20250501_a12baf3d-f22b-4c9f-a4c8-4e0d09f6d6f1.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
2265162propylene glycol 0.6 % Ophthalmic SuspensionPSNa12baf3d-f22b-4c9f-a4c8-4e0d09f6d6f14
2265162propylene glycol 6 MG/ML Ophthalmic SuspensionSCDa12baf3d-f22b-4c9f-a4c8-4e0d09f6d6f14
2265162propylene glycol 0.6 % Ophthalmic SuspensionSYa12baf3d-f22b-4c9f-a4c8-4e0d09f6d6f14

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionMarketing startSampleExclude flagStatus
0065-9308-05000659308055 VIAL, SINGLE-DOSE in 1 CARTON (0065-9308-05) / .5 mL in 1 VIAL, SINGLE-DOSE2025-03-14NoNoCurrent
0065-9308-060006593080632 VIAL, SINGLE-DOSE in 1 CARTON (0065-9308-06) / .5 mL in 1 VIAL, SINGLE-DOSE2026-01-10NoNoCurrent