FDA.reportPublic FDA data

Systane Balance

Product NDC
0065-1433
Requested package NDC
0065-1433-07
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

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
IngredientStrength
PROPYLENE GLYCOL.06 mg/mL

Harmonized UNII identifiers#

UNII identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
6DC9Q167V3Internal UNII lookup

Harmonized SPL set identifiers#

SPL set identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
c7b1a03a-a5f2-409e-a34a-d6f166671de5Available on FDA.report

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
0065-1433-02Systane Balance1 in 1 CARTONEMULSION111
0065-1433-02Systane Balance10 mL in 1 BOTTLE, DROPPEREMULSION1011
0065-1433-07Systane Balance2 in 1 CARTONEMULSION211
0065-1433-07Systane Balance10 mL in 1 BOTTLE, DROPPEREMULSION1011
0065-1433-11Systane Balance1 in 1 CARTONEMULSION111
0065-1433-11Systane Balance1.5 mL in 1 BOTTLE, DROPPEREMULSION1.511

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
0065-1433-02ML - Milliliter0065-1433f20bcd99-ce3e-4284-902c-4a9d6bfe201212012-07-24
0065-1433-07ML - Milliliter0065-143396f7134b-7666-4307-bd08-b5a10f070b9f12016-02-04
0065-1433-43ML - Milliliter0065-14333d6143e4-8e60-4cda-9bd5-d599c1d0998612017-04-05

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
PROPYLENE GLYCOLACTIVE INGREDIENT6DC9Q167V3SYSTANE BALANCE (PROPYLENE GLYCOL) EMULSION [ALCON LABORATORIES, INC.]1
PROPYLENE GLYCOLACTIVE MOIETY6DC9Q167V3SYSTANE BALANCE (PROPYLENE GLYCOL) EMULSION [ALCON LABORATORIES, INC.]1
BORIC ACIDINACTIVE INGREDIENTR57ZHV85D4SYSTANE BALANCE (PROPYLENE GLYCOL) EMULSION [ALCON LABORATORIES, INC.]1
DIMYRISTOYLPHOSPHATIDYLGLYCEROL, DL-INACTIVE INGREDIENTBI71WT9P3RSYSTANE BALANCE (PROPYLENE GLYCOL) EMULSION [ALCON LABORATORIES, INC.]1
EDETATE DISODIUMINACTIVE INGREDIENT7FLD91C86KSYSTANE BALANCE (PROPYLENE GLYCOL) EMULSION [ALCON LABORATORIES, INC.]1
GUAR GUMINACTIVE INGREDIENTE89I1637KESYSTANE BALANCE (PROPYLENE GLYCOL) EMULSION [ALCON LABORATORIES, INC.]1
HYDROCHLORIC ACIDINACTIVE INGREDIENTQTT17582CBSYSTANE BALANCE (PROPYLENE GLYCOL) EMULSION [ALCON LABORATORIES, INC.]1
MINERAL OILINACTIVE INGREDIENTT5L8T28FGPSYSTANE BALANCE (PROPYLENE GLYCOL) EMULSION [ALCON LABORATORIES, INC.]1
POLYOXYL 40 STEARATEINACTIVE INGREDIENT13A4J4NH9ISYSTANE BALANCE (PROPYLENE GLYCOL) EMULSION [ALCON LABORATORIES, INC.]1
SODIUM HYDROXIDEINACTIVE INGREDIENT55X04QC32ISYSTANE BALANCE (PROPYLENE GLYCOL) EMULSION [ALCON LABORATORIES, INC.]1
SORBITAN TRISTEARATEINACTIVE INGREDIENT6LUM696811SYSTANE BALANCE (PROPYLENE GLYCOL) EMULSION [ALCON LABORATORIES, INC.]1
SORBITOLINACTIVE INGREDIENT506T60A25RSYSTANE BALANCE (PROPYLENE GLYCOL) EMULSION [ALCON LABORATORIES, INC.]1
WATERINACTIVE INGREDIENT059QF0KO0RSYSTANE BALANCE (PROPYLENE GLYCOL) EMULSION [ALCON LABORATORIES, INC.]1

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
0065-1433SYSTANE BALANCE (PROPYLENE GLYCOL) EMULSION [ALCON LABORATORIES, INC.]10Current NDC, Legacy NDC, 6 package rows20231216_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 7 of 25 · 494 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Vis Guard Lubricant Eye DropsPOLYVINYL ALCOHOL 1.4%Ulai Health LLCe9b0ed39-60c8-1093-e053-2a95a90a705b2026-01-13WarningsExact identifier
application number: M018
carboxymethylcellulose sodiumCARBOXYMETHYLCELLULOSE SODIUMAvPAKb4697319-438e-2ec8-e053-2a95a90abb562026-01-08WarningsExact identifier
application number: M018
carboxymethylcellulose sodiumCARBOXYMETHYLCELLULOSE SODIUMAvPAKb478a695-ded0-2e5f-e053-2995a90ac45e2026-01-08WarningsExact identifier
application number: M018
Lubricant Eye Drops SolutionPOLYETHYLENE GLYCOL 400 AND PROPYLENE GLYCOLAvPAKf5743b38-e3d2-a065-e053-2995a90a4b9a2026-01-08WarningsExact identifier
application number: M018
Plus Rinse Emergency EyewashPURIFIED WATERINNOVATIVE SAFETY SUPPLY INC.b3f47d26-39e4-4aea-bb92-358def52b6522026-01-08WarningsExact identifier
application number: M018
pH Neutral Emergency EyewashWATERINNOVATIVE SAFETY SUPPLY INC.29a1bd1e-d0dd-478f-e063-6394a90ab0aa2026-01-08WarningsExact identifier
application number: M018
Polyvinyl Alcohol Eye Drops 1,4 % w/vPOLYVINYL ALCOHOL EYE DROPS 1,4 % W/VAurolabe8e09719-6e06-612b-e053-2995a90a79fc2026-01-08WarningsExact identifier
application number: M018
AuroviscHYPROMELLOSE OPHTHALMIC SOLUTION 2% W/VAurolabe9100312-b105-50a6-e053-2a95a90ac31f2026-01-08WarningsExact identifier
application number: M018
TheraTears Dry and TiredCARBOXYMETHYLCELLULOSE SODIUMMEDTECH PRODUCTS INC02b70e2d-8159-4637-a282-9eac1468e7862026-01-07WarningsExact identifier
application number: M018
VISTA Hypromellose Dry Eye ReliefHYPROMELLOSERed Wedding LLCb2c4954c-ed53-778a-e053-2a95a90ae0d02026-01-01WarningsExact identifier
application number: M018
Colirio Ojo De Aguila Eye DropsGLYCERIN, NAPHAZOLINE HYDROCHLORIDEGrandall Distributing Co., Inc.31aa07e9-0cc9-2a77-e063-6394a90a4b9d2025-12-31WarningsExact identifier
application number: M018
Value Health by Prodose Eye DropsTETRAHYDROZOLINE HYDROCHLORIDE AND POLYETHYLENE GLYCOL 400Prodose, Inc.3fafa362-a8a6-3f91-e063-6394a90a98b32025-12-31WarningsExact identifier
application number: M018
Signature Care Eye Drops High PerformancePOLYETHYLENE GLYCOL 400, PROPYLENE GLYCOLBetter Living Brands LLC6f1f4f58-3208-4b06-9afb-c4beeed093142025-12-30WarningsExact identifier
application number: M018
Target Lubricant Eye Drops High PerformancePOLYETHYLENE GLYCOL 400, PROPYLENE GLYCOLTarget Corporation6c449374-8847-4c4a-9073-1951ff31d4042025-12-30WarningsExact identifier
application number: M018
Target Lubricant Eye Drops High PerformancePOLYETHYLENE GLYCOL 400, PROPYLENE GLYCOLTarget Corporationddc15dac-fbd8-42fa-80db-79f49fc6b9eb2025-12-30WarningsExact identifier
application number: M018
Nighttime Relief LubricantLIGHT MINERAL OIL, WHITE PETROLATUMAmerisource Bergen Drug Corp.fd6b2be8-7e00-3765-e053-6294a90a40612025-12-30WarningsExact identifier
application number: M018
Rugby Carboxymethylcellulose Sodium 0.5% Eye DropsCARBOXYMETHYLCELLULOSE SODIUMRugby Laboratoriesfb84fc0b-9a62-812a-e053-6394a90aba0a2025-12-30WarningsExact identifier
application number: M018
Rugby Polyvinyl Alcohol 1.4% Lubricating Eye DropsPOLYVINYL ALCOHOLRugby Laboratories081673b2-5c74-1200-e063-6394a90ae3632025-12-30WarningsExact identifier
application number: M018
Medi-First Lubricant Eye DropsCARBOXYMETHYLCELLULOSE SODIUMUnifirst First Aid Corporationa4e651cc-adf0-af9e-e053-2995a90ace5a2025-12-30WarningsExact identifier
application number: M018
Green Guard Lubricant Eye DropsCARBOXYMETHYLCELLULOSE SODIUMUniFirst First Aid Corporationc3f04fdb-9fc1-797d-e053-2995a90afe802025-12-30WarningsExact identifier
application number: M018

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionMarketing startMarketing endSampleExclude flagStatus
0065-1433-07000651433072 BOTTLE, DROPPER in 1 CARTON (0065-1433-07) / 10 mL in 1 BOTTLE, DROPPER2010-06-250000-00-00NoNoCurrent