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	2026-10-15
excluded package	package	0065-1433	0065-1433-43	D	Discontinued by firm	2026-10-15
excluded package	package	0065-1433	0065-1433-45	D	Discontinued by firm	2026-10-15
excluded package	package	0065-1433	0065-1433-46	D	Discontinued by firm	2026-10-15

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 11 of 25 · 494 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
CareOne Maximum Redness Relief Eye Drops	GLYCERIN, NAPHAZOLINE HCI	Retail Business Services, LLC	9ab96aed-21d3-11b6-e053-2995a90a7225	2025-12-30	Warnings	Exact identifier application number: M018
CVS Lubricant Eye Drops 30 ct	CARBOXYMETHYLCELLULOSE SODUIM	CVS Pharmacy, Inc.	8dbca077-c989-767a-e053-2995a90a7cf5	2025-12-30	Warnings	Exact identifier application number: M018
Foster and Thrive Original Formula Eye Drops	TETRAHYDROZOLINE HCL	Strategic Sourcing Services LLC	002da62b-aec6-8e2a-e063-6294a90a5efc	2025-12-30	Warnings	Exact identifier application number: M018
CareOne Artificial Tears Eye Drops 15mL	POLYVINYL ALCOHOL, POVIDONE	Retail Business Services, LLC	92fded6b-91fd-d82e-e053-2a95a90ab523	2025-12-30	Warnings	Exact identifier application number: M018
Foster and Thrive Long Lasting Lubricant Eye Drops	POLYETHYLENE GLYCOL 400, PROPYLENE GLYCOL	Strategic Sourcing Services LLC	00546df0-17d8-0e3c-e063-6294a90ae7b2	2025-12-30	Warnings	Exact identifier application number: M018
Meijer Multi-Symptom Relief	POLYETHYLENE GLYCOL 400, TETRAHYDROZOLINE HCL, ZINC SULFATE	Meijer, Inc.	e7a5677a-ff33-c039-e053-2a95a90ae6c7	2025-12-30	Warnings	Exact identifier application number: M018
TopCare Health Lubricant Eye Drops	CARBOXYMETHYLCELLULOSE SODIUM	Topcare Associates LLC	e8e9dfe5-3540-a4df-e053-2a95a90aaf98	2025-12-30	Warnings	Exact identifier application number: M018
Meijer Lubricant Eye Drops	CARBOXYMETHYLCELLULOSE SODIUM	Meijer Distribution, Inc.	b245f99f-785a-efdc-e053-2995a90a4911	2025-12-30	Warnings	Exact identifier application number: M018
Equate Original Eye Drops	TETRAHYDROZOLINE HCL	Walmart, Inc.	eb8e5beb-4454-58c2-e053-2a95a90a66e0	2025-12-30	Warnings	Exact identifier application number: M018
Avenova Lubricant Eye Drops High Performance	POLYETHYLENE GLYCOL 400, PROPYLENE GLYCOL	NovaBay Pharmaceuticals, Inc.	cd17f037-5aa5-0ef8-e053-2a95a90a39cb	2025-12-30	Warnings	Exact identifier application number: M018
Equate Redness and Dry Eye Relief Eye Drops	GLYCERIN, NAPHAZOLINE HCL	Wal-Mart Stores, Inc.	ae228018-9238-2cbd-e053-2995a90a8d99	2025-12-30	Warnings	Exact identifier application number: M018
Equate Lubricant Eye Drops	POLYETHYLENE GLYCOL 400, PROPYLENE GLYCOL	Walmart, Inc.	deebaf7f-f20d-4d7f-e053-2a95a90a4b4f	2025-12-30	Warnings	Exact identifier application number: M018
Quality Choice Artificial Tears Lubricant Eye Drops	POLYVINYL ALCOHOL, POVIDONE	Chain Drug Marketing Association, Inc.	1f669655-4bc7-0175-e063-6294a90a305a	2025-12-30	Warnings	Exact identifier application number: M018
Equate Artificial Tears	POLYVINYL ALCOHOL, POVIDONE	Walmart, Inc.	ead9f271-0f15-1fff-e053-2a95a90a93ac	2025-12-30	Warnings	Exact identifier application number: M018
Equate Multi-Symptom Relief Eye Drops	POLYETHYLENE GLYCOL 400,TETRAHYDROZOLINE HCL, ZINC SULFATE	Walmart, Inc.	eb8ed76b-9cd7-3636-e053-2a95a90a9583	2025-12-30	Warnings	Exact identifier application number: M018
CorneaCare Recover Lubricant Eye Drops	POLYETHYLENE GLYCOL 400, PROPYLENE GLYCOL	CorneaCare Inc.	1fd3a5ed-8963-5c8e-e063-6394a90a6527	2025-12-30	Warnings	Exact identifier application number: M018
Eye Love Heyedrate Long Lasting Hydration	GLYCERIN, POVIDONE	Physician Recommended Neutraceuticals, L.P.	f321dea1-3251-eaa8-e053-2995a90aaf95	2025-12-30	Warnings	Exact identifier application number: M018
Quality Choice Lubricant Eye Drops High Performance	POLYETHYLENE GLYCOL 400, PROPYLENE GLYCOL	Chain Drug Marketing Assoc., Inc.	0cd1b36a-a07a-a1db-e063-6294a90a5994	2025-12-30	Warnings	Exact identifier application number: M018
Quality Choice Eye Drops Irritation Relief	TETRAHYDROZOLINE HCL, ZINC SULFATE	Quality Choice	1f682079-6e91-e14b-e063-6394a90a3f12	2025-12-30	Warnings	Exact identifier application number: M018
Quality Choice Moisturizing Relief Eye Drops	DEXTRAN 70, POLYETHYLENE GLYCOL 400, POVIDONE, TETRAHYDROZOLINE HCL	Chain Drug Marketing Association, Inc.	1fb81759-5931-59c8-e063-6294a90a2277	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