Home NDC 0065-1433 Systane Balance
Product NDC 0065-1433
11-digit product format 000651433
Labeler code 0065
Product ID 0065-1433_f81c8282-0871-46fb-8124-83666457a4f2
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 2010-06-25
Substance PROPYLENE GLYCOL
Active strength .06 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 · 48 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 Balance
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 0065-1433-02 Systane Balance 1 in 1 CARTON EMULSION 1 11 0065-1433-02 Systane Balance 10 mL in 1 BOTTLE, DROPPER EMULSION 10 11 0065-1433-07 Systane Balance 2 in 1 CARTON EMULSION 2 11 0065-1433-07 Systane Balance 10 mL in 1 BOTTLE, DROPPER EMULSION 10 11 0065-1433-11 Systane Balance 1 in 1 CARTON EMULSION 1 11 0065-1433-11 Systane Balance 1.5 mL in 1 BOTTLE, DROPPER EMULSION 1.5 11
DailyMed Socrata Ingredients# Ingredient, Type, UNII table Ingredient Type UNII DailyMed label SPL version Uploaded PROPYLENE GLYCOL ACTIVE INGREDIENT 6DC9Q167V3 SYSTANE BALANCE (PROPYLENE GLYCOL) EMULSION [ALCON LABORATORIES, INC.] 1 PROPYLENE GLYCOL ACTIVE MOIETY 6DC9Q167V3 SYSTANE BALANCE (PROPYLENE GLYCOL) EMULSION [ALCON LABORATORIES, INC.] 1 BORIC ACID INACTIVE INGREDIENT R57ZHV85D4 SYSTANE BALANCE (PROPYLENE GLYCOL) EMULSION [ALCON LABORATORIES, INC.] 1 DIMYRISTOYLPHOSPHATIDYLGLYCEROL, DL- INACTIVE INGREDIENT BI71WT9P3R SYSTANE BALANCE (PROPYLENE GLYCOL) EMULSION [ALCON LABORATORIES, INC.] 1 EDETATE DISODIUM INACTIVE INGREDIENT 7FLD91C86K SYSTANE BALANCE (PROPYLENE GLYCOL) EMULSION [ALCON LABORATORIES, INC.] 1 GUAR GUM INACTIVE INGREDIENT E89I1637KE SYSTANE BALANCE (PROPYLENE GLYCOL) EMULSION [ALCON LABORATORIES, INC.] 1 HYDROCHLORIC ACID INACTIVE INGREDIENT QTT17582CB SYSTANE BALANCE (PROPYLENE GLYCOL) EMULSION [ALCON LABORATORIES, INC.] 1 MINERAL OIL INACTIVE INGREDIENT T5L8T28FGP SYSTANE BALANCE (PROPYLENE GLYCOL) EMULSION [ALCON LABORATORIES, INC.] 1 POLYOXYL 40 STEARATE INACTIVE INGREDIENT 13A4J4NH9I SYSTANE BALANCE (PROPYLENE GLYCOL) EMULSION [ALCON LABORATORIES, INC.] 1 SODIUM HYDROXIDE INACTIVE INGREDIENT 55X04QC32I SYSTANE BALANCE (PROPYLENE GLYCOL) EMULSION [ALCON LABORATORIES, INC.] 1 SORBITAN TRISTEARATE INACTIVE INGREDIENT 6LUM696811 SYSTANE BALANCE (PROPYLENE GLYCOL) EMULSION [ALCON LABORATORIES, INC.] 1 SORBITOL INACTIVE INGREDIENT 506T60A25R SYSTANE BALANCE (PROPYLENE GLYCOL) EMULSION [ALCON LABORATORIES, INC.] 1 WATER INACTIVE INGREDIENT 059QF0KO0R SYSTANE BALANCE (PROPYLENE GLYCOL) EMULSION [ALCON LABORATORIES, INC.] 1
DailyMed Dashboard NDC Coverage# NDC, Dashboard title, SPL version table NDC Dashboard title SPL version Validation Dashboard ZIP 0065-1433 SYSTANE BALANCE (PROPYLENE GLYCOL) EMULSION [ALCON LABORATORIES, INC.] 10 Current NDC, Legacy NDC, 6 package rows 20231216_c7b1a03a-a5f2-409e-a34a-d6f166671de5.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 0065-1433-02 00065143302 1 BOTTLE, DROPPER in 1 CARTON (0065-1433-02) / 10 mL in 1 BOTTLE, DROPPER 2010-06-25 0000-00-00 No No Current 0065-1433-07 00065143307 2 BOTTLE, DROPPER in 1 CARTON (0065-1433-07) / 10 mL in 1 BOTTLE, DROPPER 2010-06-25 0000-00-00 No No Current 0065-1433-11 00065143311 1 BOTTLE, DROPPER in 1 CARTON (0065-1433-11) / 1.5 mL in 1 BOTTLE, DROPPER 2010-06-25 0000-00-00 No No Current