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	2026-10-16
excluded package	package	0065-1432	0065-1432-02	D	Discontinued by firm	2026-10-16
excluded package	package	0065-1432	0065-1432-03	D	Discontinued by firm	2026-10-16

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 24 of 25 · 494 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
HEB Advanced Eye Drops	DEXTRAN 70, POLYETHYLENE GLYCOL 400, POVIDONE, TETRAHYDROZOLINE HYDROCHLORIDE	HEB Grocery Company, LP	f76281d6-3aea-349b-e053-6394a90afca2	2023-12-20	Warnings	Exact identifier application number: M018
Equaline Eye Drops A.C.	TETRAHYDROZOLINE HCL, ZINC SULFATE	United Natural Foods, Inc.	f5f894f0-1ab0-4cad-e053-2995a90a7cba	2023-12-20	Warnings	Exact identifier application number: M018
Cleareyes Redness Relief	NAPHAZOLINE HYDROCHLORIDE AND GLYCERIN	Lil' Drug Store Products, Inc.	39e4ab2b-ae12-4339-b219-109cf0f7f06a	2023-12-15	Warnings	Exact identifier application number: M018
GenTeal Tears (Moderate)	DEXTRAN 70, GLYCERIN, HYPROMELLOSE	Alcon Laboratories, Inc.	a2992597-3490-6a5c-be45-2b6fa15e1547	2023-12-15	Warnings	Exact identifier application number: M018
SYSTANE HYDRATION PF PRESERVATIVE FREE	POLYETHYLENE GLYCOL 400 AND PROPYLENE GLYCOL	Alcon Laboratories, Inc.	db3a6c68-320b-46b0-83fa-6c29297a84a6	2023-12-15	Warnings	Exact identifier application number: M018
Systane	POLYETHYLENE GLYCOL AND PROPYLENE GLYCOL	Alcon Research Ltd	14916d2c-a63d-491e-bd91-a61f300af38a	2023-12-15	Warnings	Exact identifier application number: M018
Systane	HYPROMELLOSE	Alcon Laboratories, Inc.	5f74b161-ae41-d0e2-6ed9-8deca55d2c0f	2023-12-15	Warnings	Exact identifier application number: M018
Systane Day and Night Value Pack	POLYETHYLENE GLYCOL 400, PROPYLENE GLYCOL 0.3%	Alcon Laboratories, Inc.	df13ca6f-7ce1-455a-ae13-9bbc5e9d2e07	2023-12-15	Warnings	Exact identifier application number: M018
Systane Lubricant	POLYETHYLENE GLYCOL 400 AND PROPYLENE GLYCOL	Alcon Laboratories, Inc.	15bc06ec-f3dc-3180-ca1a-106769a770ea	2023-12-15	Warnings	Exact identifier application number: M018
Systane ULTRA	POLYETHYLENE GLYCOL 400 AND PROPYLENE GLYCOL	Alcon Laboratories, Inc.	a5c1c194-3db5-4f18-9cd1-97f7f84c3cff	2023-12-15	Warnings	Exact identifier application number: M018 ndc (product): 0065-1432
Systane COMPLETE PF	PROPYLENE GLYCOL	Alcon Laboratories, Inc.	7eaa93ca-c843-4c89-921b-c76659410dce	2023-12-14	Warnings	Exact identifier application number: M018
BION TEARS	DEXTRAN, HYPROMELLOSE	Alcon Laboratories, Inc.	e48d82f0-2f18-e514-4caa-e397d6713b99	2023-12-14	Warnings	Exact identifier application number: M018
GenTeal Tears Severe	HYPROMELLOSE	Alcon Laboratories, Inc.	a57854fc-f3a2-4fbb-b718-cd06f87a721e	2023-12-14	Warnings	Exact identifier application number: M018
BION TEARS	DEXTRAN, HYPROMELLOSE	Alcon Laboratories, Inc.	538c2a89-efb5-4132-b678-5a78f23cb713	2023-12-14	Warnings	Exact identifier application number: M018
GenTeal Tears Gel Drops	POLYETHYLENE GLYCOL 400 AND PROPYLENE GLYCOL	Alcon Laboratories, Inc.	84388a75-9d11-48ce-bf5a-88f0580d2d03	2023-12-14	Warnings	Exact identifier application number: M018
Alcon Tears Lubricant Eye Drops	HYPROMELLOSE 2910	Alcon Laboratories, Inc.	89302e2b-882b-48d5-8df7-be37859b48ba	2023-12-14	Warnings	Exact identifier application number: M018
GenTeal Tears Moderate Preservative Free	DEXTRAN 70, HYPROMELLOSE 2910	Alcon Laboratories, Inc.	37686e54-e64d-47c8-b082-b944a23cf6f1	2023-12-14	Warnings	Exact identifier application number: M018
Altachlore Sodium Chloride Hypertonicity	SODIUM CHLORIDE	Altaire Pharmaceuticals Inc.	dc0d94d8-4475-4956-8ded-bdb9496074e4	2023-12-09	Warnings	Exact identifier application number: M018
Altalube	MINERAL OIL AND PETROLATUM	Altaire Pharmaceuticals Inc.	eb65004c-c3a7-4079-bd75-f2857d30c68a	2023-12-09	Warnings	Exact identifier application number: M018
Good Neighbor Pharmacy Artifical Tears Lubricant Eye Drops	POLYVINYL ALCOHOL, POVIDONE	Proficient Rx LP	73e12596-6dd5-4cd2-83ed-992e1211b4b8	2023-12-01	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