Systane

Product NDC: 0065-0431
11-digit product format: 000650431
Labeler code: 0065
Product ID: 0065-0431_5c7432b0-b4b8-49a1-89b7-6e3befa25917
Type: HUMAN OTC DRUG
Nonproprietary name: polyethylene glycol and propylene glycol
Dosage form: SOLUTION/ DROPS
Route: OPHTHALMIC
Labeler: Alcon Research Ltd
Application: M018
Marketing category: OTC MONOGRAPH DRUG
Marketing start: 2015-10-30
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	0065-0431	0065-0431-04	D	Discontinued by firm	2026-09-14
excluded package	package	0065-0431	0065-0431-32	D	Discontinued by firm	2026-09-14
excluded package	package	0065-0431	0065-0431-57	D	Discontinued by firm	2026-09-14

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	0065-0431-04	`d630ba8d3edf…`	`732f749b63fb…`
2025-12-14 17:58 UTC · source 2025-12-05	0065-0431-57	`d630ba8d3edf…`	`732f749b63fb…`
2025-12-14 17:58 UTC · source 2025-12-05	0065-0431-32	`d630ba8d3edf…`	`732f749b63fb…`
2025-08-27 00:01 UTC · source 2025-08-26	0065-0431-04	`f5e01cc5f278…`	`a2eaf40c39c3…`
2025-08-27 00:01 UTC · source 2025-08-26	0065-0431-57	`f5e01cc5f278…`	`a2eaf40c39c3…`
2025-08-27 00:01 UTC · source 2025-08-26	0065-0431-32	`f5e01cc5f278…`	`a2eaf40c39c3…`
2025-04-01 02:39 UTC · source 2025-03-31	0065-0431-04	`2ef7874e63bc…`	`57b86245f4fa…`
2025-04-01 02:39 UTC · source 2025-03-31	0065-0431-57	`2ef7874e63bc…`	`57b86245f4fa…`
2025-04-01 02:39 UTC · source 2025-03-31	0065-0431-32	`2ef7874e63bc…`	`57b86245f4fa…`
2025-03-28 20:22 UTC · source 2025-03-28	0065-0431-04	`a1b67e2a42f9…`	`c4cf2c586c0d…`
2025-03-28 20:22 UTC · source 2025-03-28	0065-0431-57	`a1b67e2a42f9…`	`c4cf2c586c0d…`
2025-03-28 20:22 UTC · source 2025-03-28	0065-0431-32	`a1b67e2a42f9…`	`c4cf2c586c0d…`
2025-03-22 03:12 UTC · source 2025-03-21	0065-0431-04	`cfe11265f3b6…`	`090c488252e2…`
2025-03-22 03:12 UTC · source 2025-03-21	0065-0431-57	`cfe11265f3b6…`	`090c488252e2…`
2025-03-22 03:12 UTC · source 2025-03-21	0065-0431-32	`cfe11265f3b6…`	`090c488252e2…`
2025-03-10 12:48 UTC · source 2025-03-10	0065-0431-04	`cdf11ea48f46…`	`ba0047e9e063…`
2025-03-10 12:48 UTC · source 2025-03-10	0065-0431-57	`cdf11ea48f46…`	`ba0047e9e063…`
2025-03-10 12:48 UTC · source 2025-03-10	0065-0431-32	`cdf11ea48f46…`	`ba0047e9e063…`
2025-02-02 03:52 UTC · source 2025-01-31	0065-0431-04	`302b2466d912…`	`e7b80fea0513…`
2025-02-02 03:52 UTC · source 2025-01-31	0065-0431-57	`302b2466d912…`	`e7b80fea0513…`
2025-02-02 03:52 UTC · source 2025-01-31	0065-0431-32	`302b2466d912…`	`e7b80fea0513…`
2025-01-20 13:05 UTC · source 2025-01-20	0065-0431-04	`ed331223b511…`	`672a5bd82f5f…`
2025-01-20 13:05 UTC · source 2025-01-20	0065-0431-57	`ed331223b511…`	`672a5bd82f5f…`
2025-01-20 13:05 UTC · source 2025-01-20	0065-0431-32	`ed331223b511…`	`672a5bd82f5f…`
2025-01-11 03:41 UTC · source 2025-01-10	0065-0431-04	`0efc9e666f02…`	`f202fb6c5f17…`
2025-01-11 03:41 UTC · source 2025-01-10	0065-0431-57	`0efc9e666f02…`	`f202fb6c5f17…`
2025-01-11 03:41 UTC · source 2025-01-10	0065-0431-32	`0efc9e666f02…`	`f202fb6c5f17…`
2024-11-09 02:27 UTC · source 2024-11-08	0065-0431-04	`ad56d346431e…`	`cc804d4bbf1e…`
2024-11-09 02:27 UTC · source 2024-11-08	0065-0431-57	`ad56d346431e…`	`cc804d4bbf1e…`
2024-11-09 02:27 UTC · source 2024-11-08	0065-0431-32	`ad56d346431e…`	`cc804d4bbf1e…`
2024-10-04 04:10 UTC · source 2024-10-03	0065-0431-04	`367a005e9d99…`	`383a685ebd0f…`
2024-10-04 04:10 UTC · source 2024-10-03	0065-0431-57	`367a005e9d99…`	`383a685ebd0f…`
2024-10-04 04:10 UTC · source 2024-10-03	0065-0431-32	`367a005e9d99…`	`383a685ebd0f…`
2024-07-10 04:00 UTC · source 2024-07-09	0065-0431-04	`557ba5c1ecfa…`	`9c80585c8c6e…`
2024-07-10 04:00 UTC · source 2024-07-09	0065-0431-57	`557ba5c1ecfa…`	`9c80585c8c6e…`
2024-07-10 04:00 UTC · source 2024-07-09	0065-0431-32	`557ba5c1ecfa…`	`9c80585c8c6e…`

Additional Listing Data#

Finished product: Yes
Brand name base: Systane
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
14916d2c-a63d-491e-bd91-a61f300af38a	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
030ce964-9b2d-45aa-b5d3-f78ce03ef61c	Product name	2	20250515
30b0ac6e-02aa-0e5c-0d8b-cffdf3a282b2	Product name	5	20250304
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
f1e0dc7e-7d61-4625-b6d9-4894927679d7	Product name	2	20211025
9badc7be-250a-44ab-aa36-926af3f02679	Product name	1	20210527
e4870509-7e28-6f92-f0be-dd3dd889a9cf	Product name	5	20200810
0ec3537a-6c9b-432a-896c-b9ea8723049a	Product name	9	20200701
6e9d4a47-c464-b93e-aebc-ad7bffc9c4cd	Product name	2	20190619
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
684ea482-2e8b-14af-5664-b98f1e402036	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
b060cc1a-fe47-856b-0b77-4448b5963de8	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
0065-0431-04	Systane	0.4 mL in 1 VIAL	SOLUTION/ DROPS	0.4	11
0065-0431-04	Systane	4 in 1 CARTON	SOLUTION/ DROPS	4	11
0065-0431-32	Systane	0.4 mL in 1 VIAL	SOLUTION/ DROPS	0.4	11
0065-0431-32	Systane	28 in 1 CARTON	SOLUTION/ DROPS	28	11
0065-0431-33	Systane	0.7 mL in 1 VIAL	SOLUTION/ DROPS	0.7	11
0065-0431-33	Systane	30 in 1 CARTON	SOLUTION/ DROPS	30	11
0065-0431-57	Systane	40 in 1 CARTON	SOLUTION/ DROPS	40	11
0065-0431-57	Systane	0.4 mL in 1 VIAL	SOLUTION/ DROPS	0.4	11

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDC	Billing unit	Product NDC	DailyMed indexing SPL	SPL version	Effective
0065-0431-32	EA - Each	0065-0431	bb099009-f768-4448-96cd-c58e8be1ce4c	1	2012-07-24

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
Ingredient	Type	UNII	DailyMed label	SPL version
Polyethylene Glycol 400	ACTIVE INGREDIENT	B697894SGQ	SYSTANE (POLYETHYLENE GLYCOL AND PROPYLENE GLYCOL) SOLUTION/ DROPS [ALCON RESEARCH LTD]	3
PROPYLENE GLYCOL	ACTIVE INGREDIENT	6DC9Q167V3	SYSTANE (POLYETHYLENE GLYCOL AND PROPYLENE GLYCOL) SOLUTION/ DROPS [ALCON RESEARCH LTD]	3
Polyethylene Glycols	ACTIVE MOIETY	3WJQ0SDW1A	SYSTANE (POLYETHYLENE GLYCOL AND PROPYLENE GLYCOL) SOLUTION/ DROPS [ALCON RESEARCH LTD]	3
PROPYLENE GLYCOL	ACTIVE MOIETY	6DC9Q167V3	SYSTANE (POLYETHYLENE GLYCOL AND PROPYLENE GLYCOL) SOLUTION/ DROPS [ALCON RESEARCH LTD]	3
BORIC ACID	INACTIVE INGREDIENT	R57ZHV85D4	SYSTANE (POLYETHYLENE GLYCOL AND PROPYLENE GLYCOL) SOLUTION/ DROPS [ALCON RESEARCH LTD]	3
CALCIUM CHLORIDE	INACTIVE INGREDIENT	M4I0D6VV5M	SYSTANE (POLYETHYLENE GLYCOL AND PROPYLENE GLYCOL) SOLUTION/ DROPS [ALCON RESEARCH LTD]	3
GUAR GUM	INACTIVE INGREDIENT	E89I1637KE	SYSTANE (POLYETHYLENE GLYCOL AND PROPYLENE GLYCOL) SOLUTION/ DROPS [ALCON RESEARCH LTD]	3
HYDROCHLORIC ACID	INACTIVE INGREDIENT	QTT17582CB	SYSTANE (POLYETHYLENE GLYCOL AND PROPYLENE GLYCOL) SOLUTION/ DROPS [ALCON RESEARCH LTD]	3
MAGNESIUM CHLORIDE	INACTIVE INGREDIENT	02F3473H9O	SYSTANE (POLYETHYLENE GLYCOL AND PROPYLENE GLYCOL) SOLUTION/ DROPS [ALCON RESEARCH LTD]	3
POTASSIUM CHLORIDE	INACTIVE INGREDIENT	660YQ98I10	SYSTANE (POLYETHYLENE GLYCOL AND PROPYLENE GLYCOL) SOLUTION/ DROPS [ALCON RESEARCH LTD]	3
SODIUM CHLORIDE	INACTIVE INGREDIENT	451W47IQ8X	SYSTANE (POLYETHYLENE GLYCOL AND PROPYLENE GLYCOL) SOLUTION/ DROPS [ALCON RESEARCH LTD]	3
SODIUM HYDROXIDE	INACTIVE INGREDIENT	55X04QC32I	SYSTANE (POLYETHYLENE GLYCOL AND PROPYLENE GLYCOL) SOLUTION/ DROPS [ALCON RESEARCH LTD]	3
WATER	INACTIVE INGREDIENT	059QF0KO0R	SYSTANE (POLYETHYLENE GLYCOL AND PROPYLENE GLYCOL) SOLUTION/ DROPS [ALCON RESEARCH LTD]	3
ZINC CHLORIDE	INACTIVE INGREDIENT	86Q357L16B	SYSTANE (POLYETHYLENE GLYCOL AND PROPYLENE GLYCOL) SOLUTION/ DROPS [ALCON RESEARCH LTD]	3

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
0065-0431	SYSTANE (POLYETHYLENE GLYCOL AND PROPYLENE GLYCOL) SOLUTION/ DROPS [ALCON RESEARCH LTD]	11	Current NDC, Legacy NDC, 8 package rows	20231216_14916d2c-a63d-491e-bd91-a61f300af38a.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 1 of 26 · 509 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
TheraTears	CARBOXYMETHYLCELLULOSE SODIUM	MEDTECH PRODUCTS INC	17a01236-130f-495b-9f8d-92b6a23b2dc5	2026-09-09	Warnings	Exact identifier application number: M018
Leader Eye Drops Redness Relief	GLYCERIN, NAPHAZOLINE HYDROCHLORIDE	Cardinal Health	aee4bbe2-4f11-4c54-be8b-df48b3ba4f3a	2026-09-09	Warnings	Exact identifier application number: M018
Leader Artificial Tears 15 mL	POLYVINYL ALCOHOL, POVIDONE	Cardinal Health	8cccc589-3a8e-baad-e053-2a95a90ab8c7	2026-09-09	Warnings	Exact identifier application number: M018
Clear Eyes Nighttime	GLYCERIN	Prestige Brands Holdings, Inc.	af75e2f7-81dd-43e0-a390-b52bbfbebf62	2026-09-08	Warnings	Exact identifier application number: M018
FRESHKOTE PRESERVATIVE FREE LUBRICANT EYE DROPS	POVIDONE, POLYVINYL ALCOHOL SOLUTION	Harrow Eye, LLC	049e9cc9-0663-53bc-e063-6294a90a2c4f	2026-09-04	Warnings	Exact identifier application number: M018
Dr.Harry EYES PROTECTION	POLYETHYLENE GLYCOL 400 1% EYES PROTECTION	Wenzhou Yuyuan Pharmaceutical Co., Ltd.	5a9fe033-89d3-da62-e063-6294a90a4503	2026-09-03	Warnings	Exact identifier application number: M018
REFRESH LIQUIGEL	CARBOXYMETHYLCELLULOSE SODIUM	Allergan, Inc.	4b8b2f6a-4b89-446c-9e5b-9b83c453a01d	2026-08-28	Warnings	Exact identifier application number: M018
Rohto Optic Glow	NAPHAZOLINE HYDROCHLORIDE, POVIDONE, PROPYLENE GLYCOL	The Mentholatum Company	df9c5f7c-96e6-4b2b-b8cb-21a6a3342dff	2026-08-20	Warnings	Exact identifier application number: M018
Rohto All-In-One	HYPROMELLOSE, TETRAHYDROZOLINE HYDROCHLORIDE, ZINC SULFATE	The Mentholatum Company	43e690e4-b381-46e3-838c-33aef5bdadde	2026-08-20	Warnings	Exact identifier application number: M018
Rohto Max Strength	NAPHAZOLINE HYDROCHLORIDE, POLYSORBATE 80	The Mentholatum Company	e4b49550-1ca3-4bd7-854d-409b53fa5e26	2026-08-20	Warnings	Exact identifier application number: M018
Sodium Chloride	SODIUM CHLORIDE	YYBA CORP	597f3347-647c-3545-e063-6294a90abab2	2026-08-20	Warnings	Exact identifier application number: M018
Mineral Oil/White Petrolatum	MINERAL OIL/WHITE PETROLATUM	YYBA CORP	5967ef02-6770-bfd7-e063-6294a90a7904	2026-08-19	Warnings	Exact identifier application number: M018
Rohto Preservative Free Dry Aid	POVIDONE, PROPYLENE GLYCOL	The Mentholatum Company	f4b1974c-2412-45f6-b79d-88b8a0bcb608	2026-08-18	Warnings	Exact identifier application number: M018
Rohto Dry-Aid	POVIDONE, PROPYLENE GLYCOL	The Mentholatum Company	8ea5c6c9-48f4-406a-a2cb-9280c546d87d	2026-08-18	Warnings	Exact identifier application number: M018
Leader Dry Eye Relief Eye Drops	GLYCERIN, HYPROMELLOSE, POLYETHYLENE GLYCOL 400	CARDINAL HEALTH 110, LLC. DBA LEADER	2ded4bda-b3c3-4521-8701-5c8446fd148b	2026-08-17	Warnings	Exact identifier application number: M018
Mineral Oil/White Petrolatum	MINERAL OIL/WHITE PETROLATUM	YYBA CORP	5905b300-6f1f-a61f-e063-6394a90a1123	2026-08-14	Warnings	Exact identifier application number: M018
SYSTANE HYDRATION PF PRESERVATIVE FREE	POLYETHYLENE GLYCOL 400 AND PROPYLENE GLYCOL	Alcon Laboratories, Inc.	8936f66f-10fe-44ab-a26e-dd8b05dfa997	2026-08-10	Warnings	Exact identifier application number: M018
Dr. Shitong Photon Energy Eye Care Liquid	TETRAHYDROZOLINE HCL 0.05% HYPROMELLOSE 0.3% DR. SHITONG PHOTON ENERGY EYE CARE LIQUID	Wenzhou Yuyuan Pharmaceutical Co., Ltd.	58ace434-55ef-17ef-e063-6294a90aa878	2026-08-10	Warnings	Exact identifier application number: M018
Systane Pro PF	PROPYLENE GLYCOL	Alcon Laboratories, Inc.	23b3515f-fbe5-4398-b2df-8b2eccdd01e2	2026-08-10	Warnings	Exact identifier application number: M018
Leader Lubricant Eye Drops 30ct	POLYETHYLENE GLYCOL 400, PROPYLENE GLYCOL	CARDINAL HEALTH 110, LLC. DBA LEADER	8df69f2c-40c4-245c-e053-2a95a90a5406	2026-08-05	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	14916d2c-a63d-491e-bd91-a61f300af38a	11
477589	polyethylene glycol 400 4 MG/ML / propylene glycol 3 MG/ML Ophthalmic Solution	SCD	14916d2c-a63d-491e-bd91-a61f300af38a	11
477589	PEG 400 0.4 % / propylene glycol 0.3 % Ophthalmic Solution	SY	14916d2c-a63d-491e-bd91-a61f300af38a	11

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Units	Marketing start	Marketing end	Sample	Exclude flag	Status
0065-0431-04	00065043104	0.4 mL in 1 VIAL	0.4 ml					Historical
0065-0431-32	00065043132	0.4 mL in 1 VIAL	0.4 ml					Historical
0065-0431-33	00065043133	30 VIAL in 1 CARTON (0065-0431-33) / .7 mL in 1 VIAL	30 vial	2015-10-30	0000-00-00	No	No	Current
0065-0431-57	00065043157	40 in 1 CARTON						Historical

Title, Manufacturer, Effective date table
Title	Manufacturer	Effective date	Type	Version
Systane Lubricant Eye Drops	Alcon Research Ltd \| Kaysersberg Pharmaceuticals	2023-12-15	HUMAN OTC DRUG LABEL	11