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		2026-08-10

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…`

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 1 of 26 · 512 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
Vedlube	MINERAL OIL AND WHITE PETROLATUM LUBRICANT EYE OINTMENT	VEDCO INC	55d126fa-7489-4307-824e-b6957e57d4e9	2026-07-31	Warnings	Exact identifier application number: M018
Neutraflush	EYEWASH STATION ADDITIVE CONCENTRATE	Aero Healthcare	1d9ff2ef-9c9b-f367-e063-6294a90afa0e	2026-07-24	Warnings	Exact identifier application number: M018
Droptics Dry Eye Relief	CARBOXYMETHYLCELLULOSE SODIUM,GLYCERIN,POLYSORBATE 80	Droptics LLC	29d7614b-f4b7-48e2-97c5-d1bff27731d2	2026-07-22	Warnings	Exact identifier application number: M018
GOOD NEIGHBOR PHARMACY ARTIFICAL TEARS LUBRICANT EYE DROPS	POLYVINYL ALCOHOL, POVIDONE	AmerisourceBergen	ce6852a8-c5e6-403d-a7b4-a2e85d1ebb1f	2026-07-22	Warnings	Exact identifier application number: M018
Eyewash Station Additive Concentrate	CHLORHEXIDINE GLUCONATE AND PROPYLENE GLYCOL	Global Equipment Company	bc93a1e8-aa3c-6735-e053-2995a90ad6e8	2026-07-16	Warnings	Exact identifier application number: M018
Revitalize Energizing Eye Drops	NAPHAZOLINE HYDROCHLORIDE ,PROPYLENE GLYCOL	Revitalize Energy Inc.	518aac87-1642-4b2f-bca1-b74d21261eea	2026-07-16	Warnings	Exact identifier application number: M018
Polyvinyl Alcohol	POLYVINYL ALCOHOL	AvPAK	f18b61da-4033-341a-e053-2a95a90a8ebf	2026-07-07	Warnings	Exact identifier application number: M018
Artificial Tears	ARTIFICIAL TEARS	AvPAK	f18bebf2-1936-658f-e053-2a95a90a5012	2026-07-07	Warnings	Exact identifier application number: M018
Retaine CMC	CARBOXYMETHYLCELLULOSE SODIUM	OCuSOFT LLC	a3698c71-0c80-4246-be52-5e7d96f6c540	2026-07-06	Warnings	Exact identifier application number: M018
Eyesaline Eyewash Concentrate	PURIFIED WATER	Protective Industrial Products, Inc.	558e5926-9027-d3f6-e063-6294a90ab121	2026-07-02	Warnings	Exact identifier application number: M018
Fendall 2000 Pure Flow	PURIFIED WATER	Protective Industrial Products, Inc.	55a1d07e-0006-0c75-e063-6394a90a7acc	2026-07-02	Warnings	Exact identifier application number: M018
Fendall 1000 Pure Flow	PURIFIED WATER	Protective Industrial Products, Inc.	55a2f4da-bb1e-8ead-e063-6394a90af72e	2026-07-02	Warnings	Exact identifier application number: M018
Sterile Eyesaline Eyewash	STERILE EYESALINE EYEWASH	Protective Industrial Products, Inc.	55a290e8-8310-8be4-e063-6394a90abdce	2026-07-02	Warnings	Exact identifier application number: M018
Eyesaline Emergency Eyewash	PURIFIED WATER	Protective Industrial Products, Inc.	55a261c2-725d-6765-e063-6294a90a3260	2026-07-02	Warnings	Exact identifier application number: M018
OHTrust Artifical Eyedrop	SODIUM CHLORIDE	Nanoplus Technology Co., Limited	2ea26d96-704b-17bb-e063-6394a90a7e27	2026-07-01	Warnings	Exact identifier application number: M018
Fendall 2000 Pure Flow	PURIFIED WATER	Honeywell Safety Products USA, Inc.	37dead3e-60cb-88ae-e063-6294a90a8f70	2026-06-24	Warnings	Exact identifier application number: M018
Rohto Cool Relief	NAPHAZOLINE HYDROCHLORIDE, POLYSORBATE 80	The Mentholatum Company	dc8f1ff3-87ae-47ca-815f-5a0e34f8cf30	2026-06-19	Warnings	Exact identifier application number: M018
Rohto Sun and Sport	HYPROMELLOSE, POVIDONE	The Mentholatum Company	8bcc8882-b886-4b55-9bc4-d4b92a41358f	2026-06-19	Warnings	Exact identifier application number: M018
Rohto Dual Light Relief	HYPROMELLOSE, POVIDONE	The Mentholatum Company	1b597f83-d7f1-cf93-e063-6394a90a99f7	2026-06-19	Warnings	Exact identifier application number: M018
Lubricant Eye	CARBOXYMETHYLCELLULOSE SODIUM 0.5%	CARDINAL HEALTH 110, LLC. DBA LEADER	51a2d74f-5ff3-9921-e063-6294a90a345a	2026-06-15	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