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
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 9 of 25 · 486 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
Medics Choice Eye Drops Maximum Redness Relief	GLYCERIN, NAPHAZOLINE HYDROCHLORIDE	K.C. Pharmaceuticals, Inc.	f7131707-47af-d70a-e053-6394a90a418f	2025-12-30	Warnings	Exact identifier application number: M018
DG Original Eye Drops	TETRAHYDROZOLINE HCL	Dolgencorp LLC	9cb2123c-3ed4-ce8f-e053-2995a90a0ab8	2025-12-30	Warnings	Exact identifier application number: M018
Artificial Tears	POLYVINYL ALCOHOL, POVIDONE	KC Pharmaceuticals, Inc.	eb6eb6c4-1609-407b-84e4-c7509811f3c0	2025-12-30	Warnings	Exact identifier application number: M018
Medics Choice Eye Drops Advanced	TETRAHYDROZOLINE HYDROCHLORIDE, POLYETHYLENE GLYCOL 400, DEXTRAN 70, POVIDONE	KC Pharmaceuticals, Inc.	ab906fd8-265c-4359-a920-d626366e245c	2025-12-30	Warnings	Exact identifier application number: M018
Medics Choice Fresh and Soothe Lubricant Eye Drops	POLYETHYLENE GLYCOL 400, PROPYLENE GLYCOL	KC Pharmaceuticals, Inc.	1f65b91a-4eac-65c2-e063-6394a90a0295	2025-12-30	Warnings	Exact identifier application number: M018
DG Health Dry Eye Relief	GLYCERIN, HYPROMELLOSE, POLYPROPYLENE GLYCOL 400	Dolgencorp LLC	9cb20c3b-bf6d-8c7c-e053-2995a90aa485	2025-12-30	Warnings	Exact identifier application number: M018
DG Lubricant Eye Drops	POLYETHYLENE GLYCOL 400, PROPYLENE GLYCOL	Dolgencorp LLC	9cb27899-6c36-3c37-e053-2995a90a1d43	2025-12-30	Warnings	Exact identifier application number: M018
Publix Artificial Tears Eye Drops	POLYVINYL ALCOHOL, POVIDONE	Publix Super Markets, Inc.	f5d1394b-0fe8-c372-e053-2a95a90a1f78	2025-12-30	Warnings	Exact identifier application number: M018
Best Choice Artificial Tears	POLYVINYL ALCOHOL, POVIDONE	Best Choice	f5ba63f3-7966-81fe-e053-2995a90a342c	2025-12-30	Warnings	Exact identifier application number: M018
DG Maximum Strength Redness Relief	GLYCERIN, NAPHAZOLINE HCL	Dolgencorp, Inc	9cb261ed-b708-1189-e053-2a95a90a547d	2025-12-30	Warnings	Exact identifier application number: M018
Publix Advanced Relief Eye Drops	DEXTRAN 70, POLYETHYLENE GLYCOL 400, POVIDONE, TETRAHYDROZOLINE HYDROCHLORIDE	Publix Super Markets, Inc.	f7b0c3d6-0324-46c3-e053-6394a90a8241	2025-12-30	Warnings	Exact identifier application number: M018
Publix Moisturizing Relief Eye Drops	CARBOXYMETHYLCELLULOSE SODIUM	Publix Super Markets, Inc.	9b391400-c53b-7c7b-e053-2995a90a2731	2025-12-30	Warnings	Exact identifier application number: M018
Publix High Performance Eye Drops	POLYETHYLENE GLYCOL 400, PROPYLENE GLYCOL	Publix Super Markets, Inc.	9b402aa8-87cb-3928-e053-2995a90afa3c	2025-12-30	Warnings	Exact identifier application number: M018
Kroger Eye Drops Artificial Tears	POLYVINYL ALCOHOL, POVIDONE	The Kroger Company	f76f08c5-0111-8bc5-e053-6294a90a16ee	2025-12-30	Warnings	Exact identifier application number: M018
Health Mart Lubricating Tears	POLYETHYLENE GLYCOL 400, PROPYLENE GLYCOL	Strategic Sourcing Services LLC	c8be678f-2b4a-4d39-9cb4-910d36d72174	2025-12-30	Warnings	Exact identifier application number: M018
Winco Maximum Redness Relief Eye Drops	GLYCERIN, NAPHAZOLINE HCL	WinCo Foods, LLC	ff3651d4-42ce-4db1-a318-15f7592baf86	2025-12-30	Warnings	Exact identifier application number: M018
Winco Original Formula Eye Drops	TETRAHYDROZOLINE HCL	WinCo Foods, LLC	44266952-4054-4c12-b3fc-d0543fe54fe2	2025-12-30	Warnings	Exact identifier application number: M018
Winco Irritation Relief Eye	TETRAHYDROZOLINE HCL, ZINC SULFATE	WinCo Foods, LLC	60565184-5745-43a5-92b2-ab45b27e8bc6	2025-12-30	Warnings	Exact identifier application number: M018
Core Values Eye Drops Dry Eye Relief	GLYCERIN, HYPROMELLOSE, POLYETHYLENE GLYCOL 400	Liberty Procurement Co. Inc.	f8285f68-c40c-19a8-e053-6394a90aacad	2025-12-30	Warnings	Exact identifier application number: M018
Core Values Eye Drops Advanced Relief	DEXTRAN 70, POLYETHYLENE GLYCOL 400, POVIDONE, TETRAHYDROZOLINE HYDROCHLORIDE	Liberty Procurement Co., Inc.	f76dfeca-4e86-0b5d-e053-6294a90a29b9	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
0065-1433-07	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

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