Home NDC 0065-1509 Systane COMPLETE PF
Product NDC 0065-1509
11-digit product format 000651509
Labeler code 0065
Product ID 0065-1509_e3a72a6b-c0f7-4cd6-b316-c9a6674ad1ba
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 2022-01-18
Substance PROPYLENE GLYCOL
Active strength .06 mg/mL
NDC exclude flag No
Listing certified through 2026-12-31
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 COMPLETE PF
Listing expiration 2026-12-31 Active Ingredients# Ingredient, Strength table Ingredient Strength PROPYLENE GLYCOL .06 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 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 0065-1509-28 Systane COMPLETE PF 1 in 1 CARTON EMULSION 1 6 0065-1509-28 Systane COMPLETE PF 10 mL in 1 BOTTLE, DROPPER EMULSION 10 6 0065-1509-29 Systane COMPLETE PF 10 mL in 1 BOTTLE, DROPPER EMULSION 10 6 0065-1509-29 Systane COMPLETE PF 2 in 1 CARTON EMULSION 2 6 0065-1509-77 Systane COMPLETE PF 10 mL in 1 BOTTLE, DROPPER EMULSION 10 6 0065-1509-77 Systane COMPLETE PF 3 in 1 CARTON EMULSION 3 6
DailyMed Dashboard NDC Coverage# NDC, Dashboard title, SPL version table NDC Dashboard title SPL version Validation Dashboard ZIP 0065-1509 SYSTANE COMPLETE PF (PROPYLENE GLYCOL) EMULSION [ALCON LABORATORIES, INC.] 5 Current NDC, Legacy NDC, 6 package rows 20231109_99b63d62-1cf0-4f28-8760-773917c2538a.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.
Packages# Package NDC, 11-digit format, Description table Package NDC 11-digit format Description Marketing start Marketing end Sample Exclude flag Status 0065-1509-28 00065150928 1 BOTTLE, DROPPER in 1 CARTON (0065-1509-28) / 10 mL in 1 BOTTLE, DROPPER 2022-01-18 0000-00-00 No No Current 0065-1509-29 00065150929 2 BOTTLE, DROPPER in 1 CARTON (0065-1509-29) / 10 mL in 1 BOTTLE, DROPPER 2022-01-18 0000-00-00 No No Current 0065-1509-77 00065150977 3 BOTTLE, DROPPER in 1 CARTON (0065-1509-77) / 10 mL in 1 BOTTLE, DROPPER 2023-06-01 No No Current