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 4 of 25 · 494 matching rows.
Brand, Generic, Manufacturer table Brand Generic Manufacturer SPL set ID Effective date Available safety fields Join SODIUM CHLORIDE 1 GRAM SODIUM CHLORIDE Gendose Pharmaceuticals, LLC ce988ae5-61c6-4324-90e1-a94c8a54d0d0 2026-04-13 Warnings Exact identifier application number: M018 Artificial Tears Lubricant Eye Drops GLYCERIN, PROPYLENE GLYCOL CVS Pharmacy 28297fee-8185-4869-8f39-5bfbf8bf8bfd 2026-04-13 Warnings Exact identifier application number: M018 blink boost GLYCERIN Bausch & Lomb Incorporated e765c224-1718-488f-99b2-976eb60c1d63 2026-04-13 Warnings Exact identifier application number: M018 Retaine Ultra PF POLYETHYLENE GLYCOL OCuSOFT LLC a5aaaf06-772d-44d3-8601-f978ddc48ad7 2026-04-13 Warnings Exact identifier application number: M018 Exovisse Preservative-Free Artificial Tears LUBRICANT EYE GEL DROPS YD BIO USA, INC. 4f20191a-9124-2525-e063-6294a90a8428 2026-04-10 Warnings Exact identifier application number: M018 WE FRESH Lubricating Eye Drops GLYCERIN Oculus Surgical, Inc. 4f253b5d-001b-091e-e063-6394a90a9d39 2026-04-09 Warnings Exact identifier application number: M018 FreshKote Preservative Free Lubricant Eye Drops POVIDONE, POLYVINYL ALCOHOL Eyevance Pharmaceuticals f51c50c3-43ae-4169-9d2b-22b239461dd1 2026-04-08 Warnings Exact identifier application number: M018 Walgreens Sodium Chloride Ophthalmic 5 Percent Hypertonicity Eye SODIUM CHLORIDE Walgreen Company bda3b9db-5fc4-408c-a5ae-d1eeb3ee308d 2026-04-06 Warnings Exact identifier application number: M018 LensMate Preservative-Free Artificial Tears LUBRICANT EYE DROPS YD BIO USA, INC. 4ebacb2b-9b2d-6bc1-e063-6294a90a3426 2026-04-05 Warnings Exact identifier application number: M018 Exovisse Preservative-Free Artificial Tears LUBRICANT EYE GEL DROPS YD BIO USA, INC. 4ebc154b-128b-9dde-e063-6294a90ae00e 2026-04-05 Warnings Exact identifier application number: M018 Sodium Chloride Ophthalmic 5 Percent Hypertonicity Eye SODIUM CHLORIDE Hanlim 4ee80e16-1bb1-8238-e063-6294a90aa719 2026-04-04 Warnings Exact identifier application number: M018 Redness Relief GLYCERIN, NAPHAZOLINE HCL Pharmadel LLC 4c113bb9-814f-d92d-e063-6294a90a8302 2026-03-30 Warnings Exact identifier application number: M018 Moisture Oyster GLYCERIN Moisture Oyster Inc 4e45317a-437f-4d88-e063-6294a90a98d0 2026-03-30 Warnings Exact identifier application number: M018 Crocodile Tears Lubricant Eye Drops GLYCERIN, HYPROMELLOSE, POLYETHYLENE GLYCOL 400 Crocodile Tears LLC 4df29336-ea0c-0484-e063-6294a90a685a 2026-03-26 Warnings Exact identifier application number: M018 Artificial Tears Lubricant Eye Drops GLYCERIN, HYPROMELLOSE, POLYETHYLENE GLYCOL 400 KC Pharmaceuticals, Inc 4de5c844-85ca-ff9f-e063-6394a90ac12c 2026-03-25 Warnings Exact identifier application number: M018 NOVEHA NIGHTTIME WHITE PETROLATUM Bullet Point LLC 4da24578-e98b-8ce1-e063-6294a90a8bf6 2026-03-24 Warnings Exact identifier application number: M018 BLINK TRIPLE CARE POLYETHYLENE GLYCOL 400 Bausch & Lomb Incorporated a2b34eb0-001b-4f42-a8cc-c2a0150fafcc 2026-03-20 Warnings Exact identifier application number: M018 SODIUM CHLORIDE HYPERTONICITY SODIUM CHLORIDE YYBA CORP 439653b9-99b8-4799-8d67-4a2ada9c6783 2026-03-20 Warnings Exact identifier application number: M018 Altachlore Sodium Chloride Hypertonicity Ophthalmic 5 Percent SODIUM CHLORIDE Altaire Pharmaceuticals Inc. e13fd053-9420-490c-a43e-e14b0930cb4e 2026-03-18 Warnings Exact identifier application number: M018 Lubricant Eye Drops CARBOXYMETHYLCELLULOSE SODIUM KC Pharmaceuticals, Inc. 4d1d9b3a-ac5f-db27-e063-6294a90afc3f 2026-03-16 Warnings Exact identifier application number: M018
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