Home NDC 0065-9308 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 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 Ingredient Strength PROPYLENE GLYCOL 6 mg/mL
Harmonized UNII identifiers# UNII identifiers page 1 of 1 · 1 matching rows.
Identifier, FDA.report destination table Identifier FDA.report destination 6DC9Q167V3 Internal UNII lookup
Harmonized RxCUI identifiers# RxCUI identifiers page 1 of 1 · 1 matching rows.
Identifier, FDA.report destination table Identifier FDA.report destination 2265162 Internal RxNorm lookup
Harmonized SPL set identifiers# SPL set identifiers page 1 of 1 · 1 matching rows.
DailyMed Package Descriptions# Package NDC, Product, Description table Package NDC Product Description Form Quantity Strength SPL version 0065-9308-05 Systane Pro PF 5 in 1 CARTON EMULSION 5 4 0065-9308-05 Systane Pro PF 0.5 mL in 1 VIAL, SINGLE-DOSE EMULSION 0.5 4 0065-9308-06 Systane Pro PF 0.5 mL in 1 VIAL, SINGLE-DOSE EMULSION 0.5 4 0065-9308-06 Systane Pro PF 32 in 1 CARTON EMULSION 32 4
DailyMed Dashboard NDC Coverage# NDC, Dashboard title, SPL version table NDC Dashboard title SPL version Validation Dashboard ZIP 0065-9308 SYSTANE PRO PF (PROPYLENE GLYCOL) EMULSION [ALCON LABORATORIES, INC.] 2 Current NDC, 4 package rows 20250501_a12baf3d-f22b-4c9f-a4c8-4e0d09f6d6f1.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 6 of 25 · 494 matching rows.
DailyMed RxNorm Mappings# Packages# Package NDC, 11-digit format, Description table Package NDC 11-digit format Description Marketing start Sample Exclude flag Status 0065-9308-05 00065930805 5 VIAL, SINGLE-DOSE in 1 CARTON (0065-9308-05) / .5 mL in 1 VIAL, SINGLE-DOSE 2025-03-14 No No Current 0065-9308-06 00065930806 32 VIAL, SINGLE-DOSE in 1 CARTON (0065-9308-06) / .5 mL in 1 VIAL, SINGLE-DOSE 2026-01-10 No No Current