Home NDC 0065-1507 Systane Ultra Preservative Free
Product NDC 0065-1507
11-digit product format 000651507
Labeler code 0065
Product ID 0065-1507_c459712f-30d9-4084-a6ff-f157d6e604a9
Type HUMAN OTC DRUG
Nonproprietary name Polyethylene Glycol 400 and Propylene Glycol
Dosage form SOLUTION/ DROPS
Route OPHTHALMIC
Labeler Alcon Laboratories, Inc.
Application M018
Marketing category OTC MONOGRAPH DRUG
Marketing start 2022-02-15
Substance POLYETHYLENE GLYCOL 400; PROPYLENE GLYCOL
Active strength 4; 3 mg/mL; 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 Ultra Preservative Free
Listing expiration 2026-12-31 Active Ingredients# Ingredient, Strength table Ingredient Strength POLYETHYLENE GLYCOL 400 4 mg/mL PROPYLENE GLYCOL 3 mg/mL
Harmonized UNII identifiers# UNII identifiers page 1 of 1 · 2 matching rows.
Identifier, FDA.report destination table Identifier FDA.report destination B697894SGQ Internal UNII lookup 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 477589 Internal RxNorm lookup
Harmonized SPL set identifiers# SPL set identifiers page 1 of 1 · 1 matching rows.
DailyMed Product Concepts# DailyMed Package Descriptions# Package NDC, Product, Description table Package NDC Product Description Form Quantity Strength SPL version 0065-1507-82 Systane Ultra Preservative Free 10 mL in 1 BOTTLE, DROPPER SOLUTION/ DROPS 10 5 0065-1507-82 Systane Ultra Preservative Free 1 in 1 CARTON SOLUTION/ DROPS 1 5 0065-1507-92 Systane Ultra Preservative Free 10 mL in 1 BOTTLE, DROPPER SOLUTION/ DROPS 10 5 0065-1507-92 Systane Ultra Preservative Free 2 in 1 CARTON SOLUTION/ DROPS 2 5
DailyMed Dashboard NDC Coverage# NDC, Dashboard title, SPL version table NDC Dashboard title SPL version Validation Dashboard ZIP 0065-1507 SYSTANE ULTRA PRESERVATIVE FREE (POLYETHYLENE GLYCOL 400 AND PROPYLENE GLYCOL) SOLUTION/ DROPS [ALCON LABORATORIES, INC.] 4 Current NDC, Legacy NDC, 4 package rows 20231216_751fb85f-6683-4b0a-a650-324d4a74c5de.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 Marketing end Sample Exclude flag Status 0065-1507-82 00065150782 1 BOTTLE, DROPPER in 1 CARTON (0065-1507-82) / 10 mL in 1 BOTTLE, DROPPER 2022-02-15 0000-00-00 No No Current 0065-1507-92 00065150792 2 BOTTLE, DROPPER in 1 CARTON (0065-1507-92) / 10 mL in 1 BOTTLE, DROPPER 2023-04-11 No No Current