Systane

Product NDC: 0065-0474
11-digit product format: 000650474
Labeler code: 0065
Product ID: 0065-0474_634b9bdb-004a-462e-ba48-1ab306157e02
Type: HUMAN OTC DRUG
Nonproprietary name: hypromellose
Dosage form: GEL
Route: OPHTHALMIC
Labeler: Alcon Laboratories, Inc.
Application: M018
Marketing category: OTC MONOGRAPH DRUG
Marketing start: 2012-12-15
Substance: HYPROMELLOSE 2910 (4000 MPA.S)
Active strength: 3 mg/g
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 · 1 matching rows.

Dataset, Scope, Product NDC table
Dataset	Scope	Product NDC	Package NDC	Code	Status	Reporting period	Source date
excluded package	package	0065-0474	0065-0474-02	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 · 12 matching rows.

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

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

Active Ingredients#

Ingredient, Strength table
Ingredient	Strength
HYPROMELLOSE 2910 (4000 MPA.S)	3 mg/g

Harmonized UNII identifiers#

UNII identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
Identifier	FDA.report destination
RN3152OP35	Internal UNII lookup

Harmonized RxCUI identifiers#

RxCUI identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
Identifier	FDA.report destination
310932	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
5f74b161-ae41-d0e2-6ed9-8deca55d2c0f	Available on FDA.report

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDC	Product	Description	Form	Quantity	SPL version
0065-0474-01	Systane	10 g in 1 TUBE	GEL	10	9
0065-0474-01	Systane	1 in 1 CARTON	GEL	1	9
0065-0474-02	Systane	3.5 g in 1 TUBE	GEL	3.5	9
0065-0474-02	Systane	1 in 1 CARTON	GEL	1	9

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDC	Billing unit	Product NDC	DailyMed indexing SPL	SPL version	Effective
0065-0474-01	GM - Gram	0065-0474	315f0943-1ba5-4252-9ab2-ff36639f9cb1	1	2013-03-03

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
Ingredient	Type	UNII	DailyMed label	SPL version
Hypromellose 2910 (4000 Mpa.s)	ACTIVE INGREDIENT	RN3152OP35	SYSTANE (HYPROMELLOSE) GEL [ALCON LABORATORIES, INC.]	1
Hypromellose 2910 (4000 Mpa.s)	ACTIVE MOIETY	RN3152OP35	SYSTANE (HYPROMELLOSE) GEL [ALCON LABORATORIES, INC.]	1
Carbomer Homopolymer Type C (allyl Pentaerythritol Crosslinked)	INACTIVE INGREDIENT	4Q93RCW27E	SYSTANE (HYPROMELLOSE) GEL [ALCON LABORATORIES, INC.]	1
Phosphonic Acid	INACTIVE INGREDIENT	35V6A8JW8E	SYSTANE (HYPROMELLOSE) GEL [ALCON LABORATORIES, INC.]	1
Sodium Hydroxide	INACTIVE INGREDIENT	55X04QC32I	SYSTANE (HYPROMELLOSE) GEL [ALCON LABORATORIES, INC.]	1
Sodium Perborate	INACTIVE INGREDIENT	Y52BK1W96C	SYSTANE (HYPROMELLOSE) GEL [ALCON LABORATORIES, INC.]	1
Sorbitol	INACTIVE INGREDIENT	506T60A25R	SYSTANE (HYPROMELLOSE) GEL [ALCON LABORATORIES, INC.]	1
Water	INACTIVE INGREDIENT	059QF0KO0R	SYSTANE (HYPROMELLOSE) GEL [ALCON LABORATORIES, INC.]	1

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
0065-0474	SYSTANE (HYPROMELLOSE) GEL [ALCON LABORATORIES, INC.]	9	Current NDC, Legacy NDC, 4 package rows	20231216_5f74b161-ae41-d0e2-6ed9-8deca55d2c0f.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 18 of 25 · 494 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
OASIS Tears Preservative-Free Lubricant Eye	GLYCERIN	OASIS Medical, Inc.	d9d71b1d-82a6-42e7-9ef2-2d041daef936	2024-12-23	Warnings	Exact identifier application number: M018
Ancient Secrets Breathe Again	SODIUM CHLORIDE	LOTUS BRANDS, INC.	c6d2bab0-d363-4c09-a71b-ae15db915b37	2024-12-18	Warnings	Exact identifier application number: M018
TheraTears Extra	CARBOXYMETHYLCELLULOSE SODIUM, UNSPECIFIED FORM	MEDTECH PRODUCTS INC	77f504c1-b8e0-4371-ac3e-9d453d84714b	2024-12-13	Warnings	Exact identifier application number: M018
TheraTears Extra	CARBOXYMETHYLCELLULOSE SODIUM, UNSPECIFIED	MEDTECH PRODUCTS INC	f1845041-9d8d-42a0-a2cb-68def7a5aac7	2024-12-13	Warnings	Exact identifier application number: M018
Fendall Pure Flow	PURIFIED WATER	Honeywell Safety Products USA, Inc.	afda6fc3-7615-b0be-e053-2995a90a6208	2024-12-10	Warnings	Exact identifier application number: M018
Systane Nighttime	MINERAL OIL AND WHITE PETROLATUM	Alcon Laboratories, Inc.	4689c59c-5721-3f91-6c85-e41501998fd0	2024-12-05	Warnings	Exact identifier application number: M018
GenTeal Tears NIGHT-TIME	MINERAL OIL, WHITE PETROLATUM	Alcon Laboratories, Inc.	9d5998a7-4f59-4293-87da-8419650a524d	2024-12-05	Warnings	Exact identifier application number: M018
Visine Red Eye Total Comfort and Tears Dry Eye Relief	TETRAHYDROZOLINE HCL, POLYETHYLENE GLYCOL 400, ZINC SULFATE	Kenvue Brands LLC	0bc0d6e7-9195-db6b-e063-6294a90aef04	2024-11-14	Warnings	Exact identifier application number: M018
Visine Red Eye Comfort	TETRAHYDROZOLINE HYDROCHLORIDE	Kenvue Brands LLC	d7abd7cb-e094-481f-bea5-a5983e2c9ef4	2024-11-13	Warnings	Exact identifier application number: M018
Visine Red Eye Hydrating Comfort Eye Drops	TETRAHYDROZOLINE HYDROCHLORIDE AND POLYETHYLENE GLYCOL 400	Kenvue Brands LLC	a9a90de6-3172-4d34-984b-f4442f880e3d	2024-11-13	Warnings	Exact identifier application number: M018
Visine Dry Eye Relief	POLYETHYLENE GLYCOL 400	Kenvue Brands LLC	2de7a41d-661d-495f-89b4-5690664a3a3d	2024-11-13	Warnings	Exact identifier application number: M018
Visine Dry Eye Relief Eye Drops	POLYETHYLENE GLYCOL 400	Kenvue Brands LLC	d9d3f000-3ce4-4ba2-a7fb-491b44eb3fa1	2024-11-13	Warnings	Exact identifier application number: M018
Visine Dry Eye Relief	POLYETHYLENE GLYCOL 400	Kenvue Brands LLC	a4c57620-778f-4434-9105-ead2f85c5884	2024-11-13	Warnings	Exact identifier application number: M018
Visine A.C. Itchy Eye Relief	TETRAHYDROZOLINE HYDROCHLORIDE AND ZINC SULFATE, UNSPECIFIED FORM	Kenvue Brands LLC	257b9666-0163-499b-9673-bf6f4d6899b1	2024-11-13	Warnings	Exact identifier application number: M018
Eyewash Station Additive Concentrate	CHLORHEXIDINE GLUCONATE AND PROPYLENE GLYCOL	Acme United Corporation	f19fbe28-b928-7c6e-e053-2995a90a43cb	2024-11-09	Warnings	Exact identifier application number: M018
RUGBY EYE WASH	WATER, PURIFIED	A-S Medication Solutions	0773e558-2f46-494c-888a-3bc517202b65	2024-11-08	Warnings	Exact identifier application number: M018
Clear Eyes Triple Relief	POLYVINYL ALCOHOL AND POVIDONE AND TETRAHYDROZOLINE HYDROCHLORIDE	Prestige Brands Holdings, Inc.	1269a1a6-843d-4d08-bb3c-c1f3d2e7080d	2024-10-25	Warnings	Exact identifier application number: M018
Clear Eyes Cooling Redness Relief	GLYCERIN AND NAPHAZOLINE HYDROCHLORIDE	Prestige Brands Holdings, Inc.	38d14e99-e4c8-431b-b106-578eeb38bf3c	2024-10-25	Warnings	Exact identifier application number: M018
EyS Eye Wash	WATER	Eyes-Plus LLC	1443f6bf-3a77-4a19-8585-0ec58efe042f	2024-10-15	Warnings	Exact identifier application number: M018
Eye Wash	WATER SOLUTION	Kroger Company	354402ad-581d-47e7-9fd3-933bef281ff4	2024-10-11	Warnings	Exact identifier application number: M018

UNII, Preferred term, Registry number table
UNII	Preferred term	Registry number	Matched term
RN3152OP35	HYPROMELLOSE 2910 (4000 MPA.S)	9004-65-3	HYPROMELLOSE 2910 (4000 MPA.S)

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUI	RxNorm string	TTY	DailyMed	SPL version
310932	hypromellose 0.3 % Ophthalmic Gel	PSN	5f74b161-ae41-d0e2-6ed9-8deca55d2c0f	9
310932	hypromellose 0.003 MG/MG Ophthalmic Gel	SCD	5f74b161-ae41-d0e2-6ed9-8deca55d2c0f	9
310932	hypromellose 0.3 % Ophthalmic Gel	SY	5f74b161-ae41-d0e2-6ed9-8deca55d2c0f	9

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Units	Marketing start	Marketing end	Sample	Exclude flag	Status
0065-0474-01	00065047401	1 TUBE in 1 CARTON (0065-0474-01) / 10 g in 1 TUBE	1 tube	2012-12-15	0000-00-00	No	No	Current
0065-0474-02	00065047402	3.5 g in 1 TUBE	3.5 g					Historical