Home NDC 0065-0429 Systane Lubricant
Product NDC 0065-0429
11-digit product format 000650429
Labeler code 0065
Product ID 0065-0429_bbb16c95-87ac-4e07-8060-5e33e6dae0a6
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 2003-02-25
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 Observed NDC auxiliary status history# This history shows the information present in each captured FDA auxiliary file. It is not a continuous regulatory timeline, and a missing record does not establish a status.
Historic NDC status page 1 of 1 · 36 matching rows.
View current auxiliary records. · View the auxiliary file history.
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 Lubricant
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 0065-0429-15 Systane Lubricant 15 mL in 1 BOTTLE, DROPPER SOLUTION/ DROPS 15 14 0065-0429-15 Systane Lubricant 1 in 1 CARTON SOLUTION/ DROPS 1 14 0065-0429-21 Systane Lubricant 2 in 1 CARTON SOLUTION/ DROPS 2 14 0065-0429-21 Systane Lubricant 5 mL in 1 BOTTLE, DROPPER SOLUTION/ DROPS 5 14 0065-0429-30 Systane Lubricant 1 in 1 CARTON SOLUTION/ DROPS 1 14 0065-0429-30 Systane Lubricant 30 mL in 1 BOTTLE, DROPPER SOLUTION/ DROPS 30 14 0065-0429-36 Systane Lubricant 30 mL in 1 BOTTLE, DROPPER SOLUTION/ DROPS 30 14 0065-0429-36 Systane Lubricant 2 in 1 CARTON SOLUTION/ DROPS 2 14 0065-0429-67 Systane Lubricant 2 in 1 CARTON SOLUTION/ DROPS 2 14 0065-0429-67 Systane Lubricant 20 mL in 1 BOTTLE, DROPPER SOLUTION/ DROPS 20 14
DailyMed Socrata Ingredients# Ingredient, Type, UNII table Ingredient Type UNII DailyMed label SPL version Uploaded Polyethylene Glycol 400 ACTIVE INGREDIENT B697894SGQ SYSTANE LUBRICANT (POLYETHYLENE GLYCOL 400 AND PROPYLENE GLYCOL) SOLUTION/ DROPS [ALCON LABORATORIES, INC.] 1 Propylene Glycol ACTIVE INGREDIENT 6DC9Q167V3 SYSTANE LUBRICANT (POLYETHYLENE GLYCOL 400 AND PROPYLENE GLYCOL) SOLUTION/ DROPS [ALCON LABORATORIES, INC.] 1 Polyethylene Glycol 400 ACTIVE MOIETY B697894SGQ SYSTANE LUBRICANT (POLYETHYLENE GLYCOL 400 AND PROPYLENE GLYCOL) SOLUTION/ DROPS [ALCON LABORATORIES, INC.] 1 Propylene Glycol ACTIVE MOIETY 6DC9Q167V3 SYSTANE LUBRICANT (POLYETHYLENE GLYCOL 400 AND PROPYLENE GLYCOL) SOLUTION/ DROPS [ALCON LABORATORIES, INC.] 1 Boric Acid INACTIVE INGREDIENT R57ZHV85D4 SYSTANE LUBRICANT (POLYETHYLENE GLYCOL 400 AND PROPYLENE GLYCOL) SOLUTION/ DROPS [ALCON LABORATORIES, INC.] 1 Calcium Chloride INACTIVE INGREDIENT M4I0D6VV5M SYSTANE LUBRICANT (POLYETHYLENE GLYCOL 400 AND PROPYLENE GLYCOL) SOLUTION/ DROPS [ALCON LABORATORIES, INC.] 1 Guar Gum INACTIVE INGREDIENT E89I1637KE SYSTANE LUBRICANT (POLYETHYLENE GLYCOL 400 AND PROPYLENE GLYCOL) SOLUTION/ DROPS [ALCON LABORATORIES, INC.] 1 Hydrochloric Acid INACTIVE INGREDIENT QTT17582CB SYSTANE LUBRICANT (POLYETHYLENE GLYCOL 400 AND PROPYLENE GLYCOL) SOLUTION/ DROPS [ALCON LABORATORIES, INC.] 1 Magnesium Chloride INACTIVE INGREDIENT 02F3473H9O SYSTANE LUBRICANT (POLYETHYLENE GLYCOL 400 AND PROPYLENE GLYCOL) SOLUTION/ DROPS [ALCON LABORATORIES, INC.] 1 Polidronium Chloride INACTIVE INGREDIENT 6716Z5YR3G SYSTANE LUBRICANT (POLYETHYLENE GLYCOL 400 AND PROPYLENE GLYCOL) SOLUTION/ DROPS [ALCON LABORATORIES, INC.] 1 Potassium Chloride INACTIVE INGREDIENT 660YQ98I10 SYSTANE LUBRICANT (POLYETHYLENE GLYCOL 400 AND PROPYLENE GLYCOL) SOLUTION/ DROPS [ALCON LABORATORIES, INC.] 1 Sodium Chloride INACTIVE INGREDIENT 451W47IQ8X SYSTANE LUBRICANT (POLYETHYLENE GLYCOL 400 AND PROPYLENE GLYCOL) SOLUTION/ DROPS [ALCON LABORATORIES, INC.] 1 Sodium Hydroxide INACTIVE INGREDIENT 55X04QC32I SYSTANE LUBRICANT (POLYETHYLENE GLYCOL 400 AND PROPYLENE GLYCOL) SOLUTION/ DROPS [ALCON LABORATORIES, INC.] 1 Water INACTIVE INGREDIENT 059QF0KO0R SYSTANE LUBRICANT (POLYETHYLENE GLYCOL 400 AND PROPYLENE GLYCOL) SOLUTION/ DROPS [ALCON LABORATORIES, INC.] 1 Zinc Chloride INACTIVE INGREDIENT 86Q357L16B SYSTANE LUBRICANT (POLYETHYLENE GLYCOL 400 AND PROPYLENE GLYCOL) SOLUTION/ DROPS [ALCON LABORATORIES, INC.] 1
DailyMed Dashboard NDC Coverage# NDC, Dashboard title, SPL version table NDC Dashboard title SPL version Validation Dashboard ZIP 0065-0429 SYSTANE LUBRICANT (POLYETHYLENE GLYCOL 400 AND PROPYLENE GLYCOL) SOLUTION/ DROPS [ALCON LABORATORIES, INC.] 14 Current NDC, Legacy NDC, 10 package rows 20231216_15bc06ec-f3dc-3180-ca1a-106769a770ea.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 Units Marketing start Marketing end Sample Exclude flag Status 0065-0429-15 00065042915 1 BOTTLE, DROPPER in 1 CARTON (0065-0429-15) / 15 mL in 1 BOTTLE, DROPPER 2003-02-25 0000-00-00 No No Current 0065-0429-21 00065042921 2 BOTTLE, DROPPER in 1 CARTON (0065-0429-21) > 5 mL in 1 BOTTLE, DROPPER 2003-02-25 0000-00-00 No No Current 0065-0429-30 00065042930 1 BOTTLE, DROPPER in 1 CARTON (0065-0429-30) / 30 mL in 1 BOTTLE, DROPPER 2003-02-25 0000-00-00 No No Current 0065-0429-36 00065042936 30 mL in 1 BOTTLE, DROPPER 30 ml Historical 0065-0429-67 00065042967 2 in 1 CARTON Historical