Home NDC 0065-1530 Systane COMPLETE PF
Product NDC 0065-1530
11-digit product format 000651530
Labeler code 0065
Product ID 0065-1530_303d12ca-c965-4ba2-9723-6162f86fa351
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 2022-02-01
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 Dashboard NDC Coverage# NDC, Dashboard title, SPL version table NDC Dashboard title SPL version Validation Dashboard ZIP 0065-1530 SYSTANE COMPLETE PF (PROPYLENE GLYCOL) EMULSION [ALCON LABORATORIES, INC.] 5 Current NDC, Legacy NDC 20231215_7eaa93ca-c843-4c89-921b-c76659410dce.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 0065-1530-01 00065153001 5 VIAL, SINGLE-DOSE in 1 CARTON (0065-1530-01) / .5 mL in 1 VIAL, SINGLE-DOSE 2022-02-01 0000-00-00 No No Current 0065-1530-04 00065153004 30 VIAL, SINGLE-DOSE in 1 CARTON (0065-1530-04) / .5 mL in 1 VIAL, SINGLE-DOSE 2023-12-14 No No Current 0065-1530-28 00065153028 5 VIAL, SINGLE-DOSE in 1 CARTON (0065-1530-28) > .5 mL in 1 VIAL, SINGLE-DOSE 2022-02-01 0000-00-00 No No Current