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

NDC auxiliary status#

These records are reproduced from FDA’s unfinished, excluded, and compounder listings. They describe what appeared in the source files; a missing record does not establish a regulatory status. View all current auxiliary records, including entries without an NDC. · View the auxiliary file history.

Current NDC status page 1 of 1 · 4 matching rows.

Dataset, Scope, Product NDC table
Dataset	Scope	Product NDC	Package NDC	Code	Status	Source date
excluded product	product	0065-1433		D	Discontinued by firm	2026-10-12
excluded package	package	0065-1433	0065-1433-43	D	Discontinued by firm	2026-10-12
excluded package	package	0065-1433	0065-1433-45	D	Discontinued by firm	2026-10-12
excluded package	package	0065-1433	0065-1433-46	D	Discontinued by firm	2026-10-12

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.

Captured / source date, Dataset, Scope table
Captured / source date	Dataset	Scope	Package NDC	Snapshot	Source SHA-256
2025-12-14 17:58 UTC · source 2025-12-05	excluded product	product		`d630ba8d3edf…`	`732f749b63fb…`
2025-12-14 17:58 UTC · source 2025-12-05	excluded package	package	0065-1433-43	`d630ba8d3edf…`	`732f749b63fb…`
2025-12-14 17:58 UTC · source 2025-12-05	excluded package	package	0065-1433-46	`d630ba8d3edf…`	`732f749b63fb…`
2025-12-14 17:58 UTC · source 2025-12-05	excluded package	package	0065-1433-45	`d630ba8d3edf…`	`732f749b63fb…`
2025-08-27 00:01 UTC · source 2025-08-26	excluded product	product		`f5e01cc5f278…`	`a2eaf40c39c3…`
2025-08-27 00:01 UTC · source 2025-08-26	excluded package	package	0065-1433-43	`f5e01cc5f278…`	`a2eaf40c39c3…`
2025-08-27 00:01 UTC · source 2025-08-26	excluded package	package	0065-1433-46	`f5e01cc5f278…`	`a2eaf40c39c3…`
2025-08-27 00:01 UTC · source 2025-08-26	excluded package	package	0065-1433-45	`f5e01cc5f278…`	`a2eaf40c39c3…`
2025-04-01 02:39 UTC · source 2025-03-31	excluded product	product		`2ef7874e63bc…`	`57b86245f4fa…`
2025-04-01 02:39 UTC · source 2025-03-31	excluded package	package	0065-1433-43	`2ef7874e63bc…`	`57b86245f4fa…`
2025-04-01 02:39 UTC · source 2025-03-31	excluded package	package	0065-1433-46	`2ef7874e63bc…`	`57b86245f4fa…`
2025-04-01 02:39 UTC · source 2025-03-31	excluded package	package	0065-1433-45	`2ef7874e63bc…`	`57b86245f4fa…`
2025-03-28 20:22 UTC · source 2025-03-28	excluded product	product		`a1b67e2a42f9…`	`c4cf2c586c0d…`
2025-03-28 20:22 UTC · source 2025-03-28	excluded package	package	0065-1433-43	`a1b67e2a42f9…`	`c4cf2c586c0d…`
2025-03-28 20:22 UTC · source 2025-03-28	excluded package	package	0065-1433-46	`a1b67e2a42f9…`	`c4cf2c586c0d…`
2025-03-28 20:22 UTC · source 2025-03-28	excluded package	package	0065-1433-45	`a1b67e2a42f9…`	`c4cf2c586c0d…`
2025-03-22 03:12 UTC · source 2025-03-21	excluded product	product		`cfe11265f3b6…`	`090c488252e2…`
2025-03-22 03:12 UTC · source 2025-03-21	excluded package	package	0065-1433-43	`cfe11265f3b6…`	`090c488252e2…`
2025-03-22 03:12 UTC · source 2025-03-21	excluded package	package	0065-1433-46	`cfe11265f3b6…`	`090c488252e2…`
2025-03-22 03:12 UTC · source 2025-03-21	excluded package	package	0065-1433-45	`cfe11265f3b6…`	`090c488252e2…`
2025-03-10 12:48 UTC · source 2025-03-10	excluded product	product		`cdf11ea48f46…`	`ba0047e9e063…`
2025-03-10 12:48 UTC · source 2025-03-10	excluded package	package	0065-1433-43	`cdf11ea48f46…`	`ba0047e9e063…`
2025-03-10 12:48 UTC · source 2025-03-10	excluded package	package	0065-1433-46	`cdf11ea48f46…`	`ba0047e9e063…`
2025-03-10 12:48 UTC · source 2025-03-10	excluded package	package	0065-1433-45	`cdf11ea48f46…`	`ba0047e9e063…`
2025-02-02 03:52 UTC · source 2025-01-31	excluded product	product		`302b2466d912…`	`e7b80fea0513…`
2025-02-02 03:52 UTC · source 2025-01-31	excluded package	package	0065-1433-43	`302b2466d912…`	`e7b80fea0513…`
2025-02-02 03:52 UTC · source 2025-01-31	excluded package	package	0065-1433-46	`302b2466d912…`	`e7b80fea0513…`
2025-02-02 03:52 UTC · source 2025-01-31	excluded package	package	0065-1433-45	`302b2466d912…`	`e7b80fea0513…`
2025-01-20 13:05 UTC · source 2025-01-20	excluded product	product		`ed331223b511…`	`672a5bd82f5f…`
2025-01-20 13:05 UTC · source 2025-01-20	excluded package	package	0065-1433-43	`ed331223b511…`	`672a5bd82f5f…`
2025-01-20 13:05 UTC · source 2025-01-20	excluded package	package	0065-1433-46	`ed331223b511…`	`672a5bd82f5f…`
2025-01-20 13:05 UTC · source 2025-01-20	excluded package	package	0065-1433-45	`ed331223b511…`	`672a5bd82f5f…`
2025-01-11 03:41 UTC · source 2025-01-10	excluded product	product		`0efc9e666f02…`	`f202fb6c5f17…`
2025-01-11 03:41 UTC · source 2025-01-10	excluded package	package	0065-1433-43	`0efc9e666f02…`	`f202fb6c5f17…`
2025-01-11 03:41 UTC · source 2025-01-10	excluded package	package	0065-1433-46	`0efc9e666f02…`	`f202fb6c5f17…`
2025-01-11 03:41 UTC · source 2025-01-10	excluded package	package	0065-1433-45	`0efc9e666f02…`	`f202fb6c5f17…`
2024-11-09 02:27 UTC · source 2024-11-08	excluded product	product		`ad56d346431e…`	`cc804d4bbf1e…`
2024-11-09 02:27 UTC · source 2024-11-08	excluded package	package	0065-1433-43	`ad56d346431e…`	`cc804d4bbf1e…`
2024-11-09 02:27 UTC · source 2024-11-08	excluded package	package	0065-1433-46	`ad56d346431e…`	`cc804d4bbf1e…`
2024-11-09 02:27 UTC · source 2024-11-08	excluded package	package	0065-1433-45	`ad56d346431e…`	`cc804d4bbf1e…`
2024-10-04 04:10 UTC · source 2024-10-03	excluded product	product		`367a005e9d99…`	`383a685ebd0f…`
2024-10-04 04:10 UTC · source 2024-10-03	excluded package	package	0065-1433-43	`367a005e9d99…`	`383a685ebd0f…`
2024-10-04 04:10 UTC · source 2024-10-03	excluded package	package	0065-1433-46	`367a005e9d99…`	`383a685ebd0f…`
2024-10-04 04:10 UTC · source 2024-10-03	excluded package	package	0065-1433-45	`367a005e9d99…`	`383a685ebd0f…`
2024-07-10 04:00 UTC · source 2024-07-09	excluded product	product		`557ba5c1ecfa…`	`9c80585c8c6e…`
2024-07-10 04:00 UTC · source 2024-07-09	excluded package	package	0065-1433-43	`557ba5c1ecfa…`	`9c80585c8c6e…`
2024-07-10 04:00 UTC · source 2024-07-09	excluded package	package	0065-1433-46	`557ba5c1ecfa…`	`9c80585c8c6e…`
2024-07-10 04:00 UTC · source 2024-07-09	excluded package	package	0065-1433-45	`557ba5c1ecfa…`	`9c80585c8c6e…`

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.

Identifier, FDA.report destination table
Identifier	FDA.report destination
c7b1a03a-a5f2-409e-a34a-d6f166671de5	Available on FDA.report

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDC	Product	Description	Form	Quantity	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 Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDC	Billing unit	Product NDC	DailyMed indexing SPL	SPL version	Effective
0065-1433-02	ML - Milliliter	0065-1433	f20bcd99-ce3e-4284-902c-4a9d6bfe2012	1	2012-07-24
0065-1433-07	ML - Milliliter	0065-1433	96f7134b-7666-4307-bd08-b5a10f070b9f	1	2016-02-04
0065-1433-43	ML - Milliliter	0065-1433	3d6143e4-8e60-4cda-9bd5-d599c1d09986	1	2017-04-05

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
Ingredient	Type	UNII	DailyMed label	SPL version
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 7 of 25 · 494 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
Vis Guard Lubricant Eye Drops	POLYVINYL ALCOHOL 1.4%	Ulai Health LLC	e9b0ed39-60c8-1093-e053-2a95a90a705b	2026-01-13	Warnings	Exact identifier application number: M018
carboxymethylcellulose sodium	CARBOXYMETHYLCELLULOSE SODIUM	AvPAK	b4697319-438e-2ec8-e053-2a95a90abb56	2026-01-08	Warnings	Exact identifier application number: M018
carboxymethylcellulose sodium	CARBOXYMETHYLCELLULOSE SODIUM	AvPAK	b478a695-ded0-2e5f-e053-2995a90ac45e	2026-01-08	Warnings	Exact identifier application number: M018
Lubricant Eye Drops Solution	POLYETHYLENE GLYCOL 400 AND PROPYLENE GLYCOL	AvPAK	f5743b38-e3d2-a065-e053-2995a90a4b9a	2026-01-08	Warnings	Exact identifier application number: M018
Plus Rinse Emergency Eyewash	PURIFIED WATER	INNOVATIVE SAFETY SUPPLY INC.	b3f47d26-39e4-4aea-bb92-358def52b652	2026-01-08	Warnings	Exact identifier application number: M018
pH Neutral Emergency Eyewash	WATER	INNOVATIVE SAFETY SUPPLY INC.	29a1bd1e-d0dd-478f-e063-6394a90ab0aa	2026-01-08	Warnings	Exact identifier application number: M018
Polyvinyl Alcohol Eye Drops 1,4 % w/v	POLYVINYL ALCOHOL EYE DROPS 1,4 % W/V	Aurolab	e8e09719-6e06-612b-e053-2995a90a79fc	2026-01-08	Warnings	Exact identifier application number: M018
Aurovisc	HYPROMELLOSE OPHTHALMIC SOLUTION 2% W/V	Aurolab	e9100312-b105-50a6-e053-2a95a90ac31f	2026-01-08	Warnings	Exact identifier application number: M018
TheraTears Dry and Tired	CARBOXYMETHYLCELLULOSE SODIUM	MEDTECH PRODUCTS INC	02b70e2d-8159-4637-a282-9eac1468e786	2026-01-07	Warnings	Exact identifier application number: M018
VISTA Hypromellose Dry Eye Relief	HYPROMELLOSE	Red Wedding LLC	b2c4954c-ed53-778a-e053-2a95a90ae0d0	2026-01-01	Warnings	Exact identifier application number: M018
Colirio Ojo De Aguila Eye Drops	GLYCERIN, NAPHAZOLINE HYDROCHLORIDE	Grandall Distributing Co., Inc.	31aa07e9-0cc9-2a77-e063-6394a90a4b9d	2025-12-31	Warnings	Exact identifier application number: M018
Value Health by Prodose Eye Drops	TETRAHYDROZOLINE HYDROCHLORIDE AND POLYETHYLENE GLYCOL 400	Prodose, Inc.	3fafa362-a8a6-3f91-e063-6394a90a98b3	2025-12-31	Warnings	Exact identifier application number: M018
Signature Care Eye Drops High Performance	POLYETHYLENE GLYCOL 400, PROPYLENE GLYCOL	Better Living Brands LLC	6f1f4f58-3208-4b06-9afb-c4beeed09314	2025-12-30	Warnings	Exact identifier application number: M018
Target Lubricant Eye Drops High Performance	POLYETHYLENE GLYCOL 400, PROPYLENE GLYCOL	Target Corporation	6c449374-8847-4c4a-9073-1951ff31d404	2025-12-30	Warnings	Exact identifier application number: M018
Target Lubricant Eye Drops High Performance	POLYETHYLENE GLYCOL 400, PROPYLENE GLYCOL	Target Corporation	ddc15dac-fbd8-42fa-80db-79f49fc6b9eb	2025-12-30	Warnings	Exact identifier application number: M018
Nighttime Relief Lubricant	LIGHT MINERAL OIL, WHITE PETROLATUM	Amerisource Bergen Drug Corp.	fd6b2be8-7e00-3765-e053-6294a90a4061	2025-12-30	Warnings	Exact identifier application number: M018
Rugby Carboxymethylcellulose Sodium 0.5% Eye Drops	CARBOXYMETHYLCELLULOSE SODIUM	Rugby Laboratories	fb84fc0b-9a62-812a-e053-6394a90aba0a	2025-12-30	Warnings	Exact identifier application number: M018
Rugby Polyvinyl Alcohol 1.4% Lubricating Eye Drops	POLYVINYL ALCOHOL	Rugby Laboratories	081673b2-5c74-1200-e063-6394a90ae363	2025-12-30	Warnings	Exact identifier application number: M018
Medi-First Lubricant Eye Drops	CARBOXYMETHYLCELLULOSE SODIUM	Unifirst First Aid Corporation	a4e651cc-adf0-af9e-e053-2995a90ace5a	2025-12-30	Warnings	Exact identifier application number: M018
Green Guard Lubricant Eye Drops	CARBOXYMETHYLCELLULOSE SODIUM	UniFirst First Aid Corporation	c3f04fdb-9fc1-797d-e053-2995a90afe80	2025-12-30	Warnings	Exact identifier application number: M018

UNII, Preferred term, Registry number table
UNII	Preferred term	Registry number	Matched term
6DC9Q167V3	PROPYLENE GLYCOL	57-55-6	PROPYLENE GLYCOL

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

Title, Manufacturer, Effective date table
Title	Manufacturer	Effective date	Type	Version
SYSTANE ® BALANCE Lubricant Eye Drops	Alcon Laboratories, Inc. \| Alcon Research LLC \| Alcon Singapore Manufacturing Pte. Ltd.	2025-08-07	HUMAN OTC DRUG LABEL	11