Systane

Product NDC: 0065-1432
11-digit product format: 000651432
Labeler code: 0065
Product ID: 0065-1432_cce3e663-58ef-4ece-a6d2-c49ecc7ea9cb
Type: HUMAN OTC DRUG
Nonproprietary name: polyethylene glycol 400 and propylene glycol
Dosage form: SOLUTION/ DROPS
Route: OPHTHALMIC
Labeler: Alcon Laboratories, Inc.
Application: M018
Marketing category: OTC MONOGRAPH DRUG
Marketing start: 2009-07-27
Substance: POLYETHYLENE GLYCOL 400; PROPYLENE GLYCOL
Active strength: 4; 3 mg/mL; 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 · 3 matching rows.

Dataset, Scope, Product NDC table
Dataset	Scope	Product NDC	Package NDC	Code	Status	Source date
excluded package	package	0065-1432	0065-1432-01	D	Discontinued by firm	2026-10-12
excluded package	package	0065-1432	0065-1432-02	D	Discontinued by firm	2026-10-12
excluded package	package	0065-1432	0065-1432-03	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 · 36 matching rows.

View current auxiliary records. · View the auxiliary file history.

Captured / source date, Package NDC, Snapshot table
Captured / source date	Package NDC	Snapshot	Source SHA-256
2025-12-14 17:58 UTC · source 2025-12-05	0065-1432-01	`d630ba8d3edf…`	`732f749b63fb…`
2025-12-14 17:58 UTC · source 2025-12-05	0065-1432-03	`d630ba8d3edf…`	`732f749b63fb…`
2025-12-14 17:58 UTC · source 2025-12-05	0065-1432-02	`d630ba8d3edf…`	`732f749b63fb…`
2025-08-27 00:01 UTC · source 2025-08-26	0065-1432-01	`f5e01cc5f278…`	`a2eaf40c39c3…`
2025-08-27 00:01 UTC · source 2025-08-26	0065-1432-03	`f5e01cc5f278…`	`a2eaf40c39c3…`
2025-08-27 00:01 UTC · source 2025-08-26	0065-1432-02	`f5e01cc5f278…`	`a2eaf40c39c3…`
2025-04-01 02:39 UTC · source 2025-03-31	0065-1432-01	`2ef7874e63bc…`	`57b86245f4fa…`
2025-04-01 02:39 UTC · source 2025-03-31	0065-1432-03	`2ef7874e63bc…`	`57b86245f4fa…`
2025-04-01 02:39 UTC · source 2025-03-31	0065-1432-02	`2ef7874e63bc…`	`57b86245f4fa…`
2025-03-28 20:22 UTC · source 2025-03-28	0065-1432-01	`a1b67e2a42f9…`	`c4cf2c586c0d…`
2025-03-28 20:22 UTC · source 2025-03-28	0065-1432-03	`a1b67e2a42f9…`	`c4cf2c586c0d…`
2025-03-28 20:22 UTC · source 2025-03-28	0065-1432-02	`a1b67e2a42f9…`	`c4cf2c586c0d…`
2025-03-22 03:12 UTC · source 2025-03-21	0065-1432-01	`cfe11265f3b6…`	`090c488252e2…`
2025-03-22 03:12 UTC · source 2025-03-21	0065-1432-03	`cfe11265f3b6…`	`090c488252e2…`
2025-03-22 03:12 UTC · source 2025-03-21	0065-1432-02	`cfe11265f3b6…`	`090c488252e2…`
2025-03-10 12:48 UTC · source 2025-03-10	0065-1432-01	`cdf11ea48f46…`	`ba0047e9e063…`
2025-03-10 12:48 UTC · source 2025-03-10	0065-1432-03	`cdf11ea48f46…`	`ba0047e9e063…`
2025-03-10 12:48 UTC · source 2025-03-10	0065-1432-02	`cdf11ea48f46…`	`ba0047e9e063…`
2025-02-02 03:52 UTC · source 2025-01-31	0065-1432-01	`302b2466d912…`	`e7b80fea0513…`
2025-02-02 03:52 UTC · source 2025-01-31	0065-1432-03	`302b2466d912…`	`e7b80fea0513…`
2025-02-02 03:52 UTC · source 2025-01-31	0065-1432-02	`302b2466d912…`	`e7b80fea0513…`
2025-01-20 13:05 UTC · source 2025-01-20	0065-1432-01	`ed331223b511…`	`672a5bd82f5f…`
2025-01-20 13:05 UTC · source 2025-01-20	0065-1432-03	`ed331223b511…`	`672a5bd82f5f…`
2025-01-20 13:05 UTC · source 2025-01-20	0065-1432-02	`ed331223b511…`	`672a5bd82f5f…`
2025-01-11 03:41 UTC · source 2025-01-10	0065-1432-01	`0efc9e666f02…`	`f202fb6c5f17…`
2025-01-11 03:41 UTC · source 2025-01-10	0065-1432-03	`0efc9e666f02…`	`f202fb6c5f17…`
2025-01-11 03:41 UTC · source 2025-01-10	0065-1432-02	`0efc9e666f02…`	`f202fb6c5f17…`
2024-11-09 02:27 UTC · source 2024-11-08	0065-1432-01	`ad56d346431e…`	`cc804d4bbf1e…`
2024-11-09 02:27 UTC · source 2024-11-08	0065-1432-03	`ad56d346431e…`	`cc804d4bbf1e…`
2024-11-09 02:27 UTC · source 2024-11-08	0065-1432-02	`ad56d346431e…`	`cc804d4bbf1e…`
2024-10-04 04:10 UTC · source 2024-10-03	0065-1432-01	`367a005e9d99…`	`383a685ebd0f…`
2024-10-04 04:10 UTC · source 2024-10-03	0065-1432-03	`367a005e9d99…`	`383a685ebd0f…`
2024-10-04 04:10 UTC · source 2024-10-03	0065-1432-02	`367a005e9d99…`	`383a685ebd0f…`
2024-07-10 04:00 UTC · source 2024-07-09	0065-1432-01	`557ba5c1ecfa…`	`9c80585c8c6e…`
2024-07-10 04:00 UTC · source 2024-07-09	0065-1432-03	`557ba5c1ecfa…`	`9c80585c8c6e…`
2024-07-10 04:00 UTC · source 2024-07-09	0065-1432-02	`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
Brand name suffix: ULTRA
Listing expiration: 2026-12-31

Active Ingredients#

Ingredient, Strength table
Ingredient	Strength
POLYETHYLENE GLYCOL 400	4 mg/mL
PROPYLENE GLYCOL	3 mg/mL

Harmonized UNII identifiers#

UNII identifiers page 1 of 1 · 2 matching rows.

Identifier, FDA.report destination table
Identifier	FDA.report destination
B697894SGQ	Internal UNII lookup
6DC9Q167V3	Internal UNII lookup

Harmonized RxCUI identifiers#

RxCUI identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
Identifier	FDA.report destination
477589	Internal RxNorm lookup

Harmonized SPL set identifiers#

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

Identifier, FDA.report destination table
Identifier	FDA.report destination
a5c1c194-3db5-4f18-9cd1-97f7f84c3cff	Available on FDA.report

DailyMed Product Concepts#

Product concept, Relation, Version table
Product concept	Relation	Version	Effective
9e37788c-b1bf-42ae-aac9-b60601606144	Product name	8	20260122
1527ac37-808d-43be-a63e-74e1258dbe46	Product name	9	20250219
bed0530e-f939-4541-956b-6928a2f6404f	Product name	1	20241008
cefa60e2-a5b5-493e-9c54-24735b7dc509	Product name	6	20240814
362d7abb-94e6-4c60-9a58-266894157713	Product name	1	20231023
9fcb7a91-de07-4f00-aabf-e4d6fda403d5	Product name	8	20230322
6bd95106-a412-1dad-b9cc-4cb74bfb27ce	Product name	2	20230315
9badc7be-250a-44ab-aa36-926af3f02679	Product name	1	20210527
0ec3537a-6c9b-432a-896c-b9ea8723049a	Product name	9	20200701
444b3e50-f226-46ef-bfca-2e7035d140cd	Product name	1	20190611
816b97af-edc5-4060-aff1-b814bdbcad50	Product name	1	20190415
7cda52fc-125f-421c-8fea-bc1974370c49	Product name	2	20180703
7916de40-e296-41f0-b811-6d0df1a33e2c	Product name	9	20180627
cefa60e2-a5b5-493e-9c54-24735b7dc509	Product name	2	20171212
419aab54-5d5a-4146-9453-026d4a9991be	Product name	2	20170525
d5e51f11-ad28-caa4-4b49-4143974782ad	Product name	1	20150831
290f523a-f9db-9774-b5a9-e1f908ac1782	Product name	1	20150828
0ca1d589-929b-4b33-bc5b-1d84abdafa6a	Product name	1	20150324
fc363c46-397b-4476-ac0f-70e43e8e4592	Product name	1	20150324
89dac932-b90a-4410-9ab1-84c53e57de25	Product name	1	20150316
5668b646-cd56-c3c7-bdea-3f6b1a8840db	Product name	1	20140508
810ab97e-f109-f41c-7c83-6a652a9cbf43	Product name	1	20140508
87711080-88eb-65c5-b2dd-bf99e700a372	Product name	1	20140508
8dbefedf-0a0d-a224-5a3c-66dc9e11c2dd	Product name	1	20140508
c6b65c52-69c7-df49-550a-a50c137f6218	Product name	1	20140508
ec2149b3-5c6d-5344-f757-c86411073075	Product name	1	20140508
ed912195-5da0-0f2f-6f4b-3ef17710cbe3	Product name	1	20140508

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDC	Product	Description	Form	Quantity	SPL version
0065-1432-01	SystaneULTRA	24 in 1 CARTON	SOLUTION/ DROPS	24	15
0065-1432-01	SystaneULTRA	0.4 mL in 1 VIAL	SOLUTION/ DROPS	0.4	15
0065-1432-02	SystaneULTRA	4 in 1 CARTON	SOLUTION/ DROPS	4	15
0065-1432-02	SystaneULTRA	0.4 mL in 1 VIAL	SOLUTION/ DROPS	0.4	15
0065-1432-03	SystaneULTRA	0.4 mL in 1 VIAL	SOLUTION/ DROPS	0.4	15
0065-1432-03	SystaneULTRA	72 in 1 CARTON	SOLUTION/ DROPS	72	15
0065-1432-04	SystaneULTRA	5 in 1 CARTON	SOLUTION/ DROPS	5	15
0065-1432-04	SystaneULTRA	.7 mL in 1 VIAL	SOLUTION/ DROPS	.7	15
0065-1432-05	SystaneULTRA	.7 mL in 1 VIAL	SOLUTION/ DROPS	.7	15
0065-1432-05	SystaneULTRA	60 in 1 CARTON	SOLUTION/ DROPS	60	15
0065-1432-06	SystaneULTRA	.7 mL in 1 VIAL	SOLUTION/ DROPS	.7	15
0065-1432-06	SystaneULTRA	25 in 1 CARTON	SOLUTION/ DROPS	25	15

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDC	Billing unit	Product NDC	DailyMed indexing SPL	SPL version	Effective
0065-1432-01	EA - Each	0065-1432	14f1c113-d43c-471c-89e7-cad2980b32cd	1	2012-07-24
0065-1432-05	EA - Each	0065-1432	417bc31a-48fa-44c1-8b41-76c88a58e782	1	2018-08-13
0065-1432-06	EA - Each	0065-1432	c4bb8e26-fe99-426e-a250-b66107f54fab	1	2016-01-13

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
Ingredient	Type	UNII	DailyMed label	SPL version
Polyethylene Glycol 400	ACTIVE INGREDIENT	B697894SGQ	SYSTANE ULTRA (POLYETHYLENE GLYCOL 400 AND PROPYLENE GLYCOL) SOLUTION/ DROPS [ALCON LABORATORIES, INC.]	4
PROPYLENE GLYCOL	ACTIVE INGREDIENT	6DC9Q167V3	SYSTANE ULTRA (POLYETHYLENE GLYCOL 400 AND PROPYLENE GLYCOL) SOLUTION/ DROPS [ALCON LABORATORIES, INC.]	4
Polyethylene Glycols	ACTIVE MOIETY	3WJQ0SDW1A	SYSTANE ULTRA (POLYETHYLENE GLYCOL 400 AND PROPYLENE GLYCOL) SOLUTION/ DROPS [ALCON LABORATORIES, INC.]	4
PROPYLENE GLYCOL	ACTIVE MOIETY	6DC9Q167V3	SYSTANE ULTRA (POLYETHYLENE GLYCOL 400 AND PROPYLENE GLYCOL) SOLUTION/ DROPS [ALCON LABORATORIES, INC.]	4
Aminomethylpropanol	INACTIVE INGREDIENT	LU49E6626Q	SYSTANE ULTRA (POLYETHYLENE GLYCOL 400 AND PROPYLENE GLYCOL) SOLUTION/ DROPS [ALCON LABORATORIES, INC.]	4
BORIC ACID	INACTIVE INGREDIENT	R57ZHV85D4	SYSTANE ULTRA (POLYETHYLENE GLYCOL 400 AND PROPYLENE GLYCOL) SOLUTION/ DROPS [ALCON LABORATORIES, INC.]	4
GUAR GUM	INACTIVE INGREDIENT	E89I1637KE	SYSTANE ULTRA (POLYETHYLENE GLYCOL 400 AND PROPYLENE GLYCOL) SOLUTION/ DROPS [ALCON LABORATORIES, INC.]	4
HYDROCHLORIC ACID	INACTIVE INGREDIENT	QTT17582CB	SYSTANE ULTRA (POLYETHYLENE GLYCOL 400 AND PROPYLENE GLYCOL) SOLUTION/ DROPS [ALCON LABORATORIES, INC.]	4
POTASSIUM CHLORIDE	INACTIVE INGREDIENT	660YQ98I10	SYSTANE ULTRA (POLYETHYLENE GLYCOL 400 AND PROPYLENE GLYCOL) SOLUTION/ DROPS [ALCON LABORATORIES, INC.]	4
SODIUM CHLORIDE	INACTIVE INGREDIENT	451W47IQ8X	SYSTANE ULTRA (POLYETHYLENE GLYCOL 400 AND PROPYLENE GLYCOL) SOLUTION/ DROPS [ALCON LABORATORIES, INC.]	4
SODIUM HYDROXIDE	INACTIVE INGREDIENT	55X04QC32I	SYSTANE ULTRA (POLYETHYLENE GLYCOL 400 AND PROPYLENE GLYCOL) SOLUTION/ DROPS [ALCON LABORATORIES, INC.]	4
SORBITOL	INACTIVE INGREDIENT	506T60A25R	SYSTANE ULTRA (POLYETHYLENE GLYCOL 400 AND PROPYLENE GLYCOL) SOLUTION/ DROPS [ALCON LABORATORIES, INC.]	4
WATER	INACTIVE INGREDIENT	059QF0KO0R	SYSTANE ULTRA (POLYETHYLENE GLYCOL 400 AND PROPYLENE GLYCOL) SOLUTION/ DROPS [ALCON LABORATORIES, INC.]	4

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
0065-1432	SYSTANE ULTRA (POLYETHYLENE GLYCOL 400 AND PROPYLENE GLYCOL) SOLUTION/ DROPS [ALCON LABORATORIES, INC.]	15	Current NDC, Legacy NDC, 12 package rows	20231216_a5c1c194-3db5-4f18-9cd1-97f7f84c3cff.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 · 494 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
Medics Choice Lubricant Eye Drops	CARBOXYMETHYLCELLULOSE SODIUM	K.C. Pharmaceuticals, Inc.	9ddfc275-602f-413b-e053-2995a90a11cb	2025-12-30	Warnings	Exact identifier application number: M018
Medics Choice Eye Drops Seasonal Relief	TETRAHYDROZOLINE HYDROCHLORIDE, ZINC SULFATE	KC Pharmaceuticals, Inc.	92bd8cb4-90ad-4a47-afa4-30d1fa658d62	2025-12-30	Warnings	Exact identifier application number: M018
DG Health Advanced Relief Eye Drops	DEXTRAN 70, POLYETHYLENE GLYCOL 400, POVIDONE, TETRAHYDROZOLINE HCL	Dolgencorp LLC	9c62f8a3-7cf5-40f9-e053-2a95a90afd86	2025-12-30	Warnings	Exact identifier application number: M018
Medics Choice Eye Drops Original Redness Reliever	TETRAHYDROZOLINE HYDROCHLORIDE	KC Pharmaceuticals, Inc.	e42cb1bf-b985-4a1b-9a9b-ac27c2a5d7be	2025-12-30	Warnings	Exact identifier application number: M018
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

UNII, Preferred term, Registry number table
UNII	Preferred term	Registry number	Matched term
B697894SGQ	POLYETHYLENE GLYCOL 400	25322-68-3	POLYETHYLENE GLYCOL 400
6DC9Q167V3	PROPYLENE GLYCOL	57-55-6	PROPYLENE GLYCOL

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUI	RxNorm string	TTY	DailyMed	SPL version
477589	polyethylene glycol 400, 0.4 % / propylene glycol 0.3 % Ophthalmic Solution	PSN	a5c1c194-3db5-4f18-9cd1-97f7f84c3cff	15
477589	polyethylene glycol 400 4 MG/ML / propylene glycol 3 MG/ML Ophthalmic Solution	SCD	a5c1c194-3db5-4f18-9cd1-97f7f84c3cff	15
477589	PEG 400 0.4 % / propylene glycol 0.3 % Ophthalmic Solution	SY	a5c1c194-3db5-4f18-9cd1-97f7f84c3cff	15

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Units	Marketing start	Marketing end	Sample	Exclude flag	Status
0065-1432-01	00065143201	24 in 1 CARTON						Historical
0065-1432-02	00065143202	4 in 1 CARTON						Historical
0065-1432-03	00065143203	0.4 mL in 1 VIAL	0.4 ml					Historical
0065-1432-04	00065143204	5 VIAL in 1 CARTON (0065-1432-04) / .7 mL in 1 VIAL	5 vial	2009-07-27	0000-00-00	No	No	Current
0065-1432-05	00065143205	60 VIAL in 1 CARTON (0065-1432-05) / .7 mL in 1 VIAL	60 vial	2009-07-27	0000-00-00	No	No	Current
0065-1432-06	00065143206	25 VIAL in 1 CARTON (0065-1432-06) / .7 mL in 1 VIAL	25 vial	2009-07-27	0000-00-00	No	No	Current

Title, Manufacturer, Effective date table
Title	Manufacturer	Effective date	Type	Version
Drug Facts	Alcon Laboratories, Inc. \| Kaysersberg Pharmaceuticals \| Laboratoire Unither	2023-12-15	HUMAN OTC DRUG LABEL	15