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		2026-10-12

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 · 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 5 of 25 · 494 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
Lubricant Eye Drops	CARBOXYMETHYLCELLULOSE SODIUM	Redicare LLC	4d1e5089-22b0-7b3f-e063-6294a90a346a	2026-03-16	Warnings	Exact identifier application number: M018
Leader Ultra Lubricating Eye Drops	POLYETHYLENE GLYCOL 400, PROPYLENE GLYCOL	Cardinal Health	d7f011a2-05ba-47c3-9519-d31602e105c7	2026-03-12	Warnings	Exact identifier application number: M018
Leader Restorative Formula Lubricant Eye Drops	PROPYLENE GLYCOL	Cardinal Health	87fef7e4-e5a8-4aad-94d2-f80f34826d97	2026-03-12	Warnings	Exact identifier application number: M018
Leader Advanced Relief Eye Drops	DEXTRAN 70, POLYETHYLENE GLYCOL 400, POVIDONE, TETRAHYDROZOLINE HCL	Cardinal Health	5c5d6c13-9b51-48f0-8627-b60b0f707fd3	2026-03-12	Warnings	Exact identifier application number: M018
Focus PI	HYPROMELLOSE EYE DROPS 0.7%	COVALENT MEDICAL	e9b2afdd-049a-3987-e053-2a95a90a6cbb	2026-03-09	Warnings	Exact identifier application number: M018
Rain Renewal Eye Drops	CARBOXYMETHYLCELLULOSE SODIUM	Rain Eye Drops, LLC	bb451b22-c4f6-291d-e053-2a95a90a7801	2026-03-06	Warnings	Exact identifier application number: M018
Complete Eye Relief Sterile Lubricant Eye Drops	HYDROXYETHYL CELLULOSE	Similasan Corporation	4c49493a-70f9-0fde-e063-6394a90aea20	2026-03-05	Warnings	Exact identifier application number: M018
Dry Eye Relief Sterile Lubricant Eye Drops	GLYCERIN	Similasan Corporation	4c4cce1c-392e-354d-e063-6294a90a0ca3	2026-03-05	Warnings	Exact identifier application number: M018
Irritated Eye Relief Sterile Lubricant Eye Drops	HYDROXYETHYL CELLULOSE	Similasan Corporation	4c4ddcdf-3037-c9cd-e063-6294a90a16d5	2026-03-05	Warnings	Exact identifier application number: M018
Refresh Optive Mega-3 PF	CARBOXYMETHYLCELLULOSE SODIUM, GLYCERIN, POLYSORBATE 80	Allergan, Inc.	326cb5d6-c784-404f-9a13-6d69262dda6e	2026-03-01	Warnings	Exact identifier application number: M018
Discount Drug Mart Lubricant Eye Drops	CARBOXYMETHYLCELLULOSE SODIUM	Discount Drug Mart	4ba1b369-54e2-5224-e063-6394a90a4769	2026-02-25	Warnings	Exact identifier application number: M018
Lubricant Eye Drops	CARBOXYMETHYLCELLULOSE SODIUM	KC Pharmaceuticals, Inc.	4bafa882-50b7-e3e2-e063-6294a90a76e3	2026-02-25	Warnings	Exact identifier application number: M018
Viva Hydration Boost	GLYCERIN	Nomax Inc	174193b2-65eb-b5fd-e063-6394a90a9cd0	2026-02-10	Warnings	Exact identifier application number: M018
Droptics Performance Eye Drops	NAPHAZOLINE HYDROCHLORIDE, PROPYLENE GLYCOL	Droptics LLC	20fd6822-a7fd-4593-92bb-0a07260893e2	2026-02-09	Warnings	Exact identifier application number: M018
GoodSense Eye Drops Advanced Relief Moisturizer	DEXTRAN, POLYETHYLENE GLYCOL 400, POVIDONE, TETRAHYDROZOLINE HCL	Sportpharm LLC	8d58dcbb-72a0-41f0-9eeb-613072a6d7ae	2026-02-06	Warnings	Exact identifier application number: M018
MINIDROPS	LUBRICANT EYE DROPS	Optics Laboratory, Inc	c13c5f91-50df-471c-a7c9-1747a2ac1250	2026-02-03	Warnings	Exact identifier application number: M018
Optase	WHITE PETROLATUM, LANOLIN	Scope Health Inc	c1991caa-51b9-13d1-e053-2995a90a1293	2026-01-31	Warnings	Exact identifier application number: M018
Optase	GLYCERIN	Scope Health Inc	376e0289-28e9-e87f-e063-6294a90a3b04	2026-01-30	Warnings	Exact identifier application number: M018
Optase	GLYCERIN	Scope Health Inc	10c3e31d-779d-8ff6-e063-6294a90acd39	2026-01-30	Warnings	Exact identifier application number: M018
Optase	GLYCERIN	Scope Health Inc	9e96976b-2990-79e0-e053-2995a90a0f29	2026-01-30	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