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 7 of 25 · 494 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
Vis Guard Lubricant Eye Drops	POLYVINYL ALCOHOL 1.4%	Ulai Health LLC	e9b0ed39-60c8-1093-e053-2a95a90a705b	2026-01-13	Warnings	Exact identifier application number: M018
carboxymethylcellulose sodium	CARBOXYMETHYLCELLULOSE SODIUM	AvPAK	b4697319-438e-2ec8-e053-2a95a90abb56	2026-01-08	Warnings	Exact identifier application number: M018
carboxymethylcellulose sodium	CARBOXYMETHYLCELLULOSE SODIUM	AvPAK	b478a695-ded0-2e5f-e053-2995a90ac45e	2026-01-08	Warnings	Exact identifier application number: M018
Lubricant Eye Drops Solution	POLYETHYLENE GLYCOL 400 AND PROPYLENE GLYCOL	AvPAK	f5743b38-e3d2-a065-e053-2995a90a4b9a	2026-01-08	Warnings	Exact identifier application number: M018
Plus Rinse Emergency Eyewash	PURIFIED WATER	INNOVATIVE SAFETY SUPPLY INC.	b3f47d26-39e4-4aea-bb92-358def52b652	2026-01-08	Warnings	Exact identifier application number: M018
pH Neutral Emergency Eyewash	WATER	INNOVATIVE SAFETY SUPPLY INC.	29a1bd1e-d0dd-478f-e063-6394a90ab0aa	2026-01-08	Warnings	Exact identifier application number: M018
Polyvinyl Alcohol Eye Drops 1,4 % w/v	POLYVINYL ALCOHOL EYE DROPS 1,4 % W/V	Aurolab	e8e09719-6e06-612b-e053-2995a90a79fc	2026-01-08	Warnings	Exact identifier application number: M018
Aurovisc	HYPROMELLOSE OPHTHALMIC SOLUTION 2% W/V	Aurolab	e9100312-b105-50a6-e053-2a95a90ac31f	2026-01-08	Warnings	Exact identifier application number: M018
TheraTears Dry and Tired	CARBOXYMETHYLCELLULOSE SODIUM	MEDTECH PRODUCTS INC	02b70e2d-8159-4637-a282-9eac1468e786	2026-01-07	Warnings	Exact identifier application number: M018
VISTA Hypromellose Dry Eye Relief	HYPROMELLOSE	Red Wedding LLC	b2c4954c-ed53-778a-e053-2a95a90ae0d0	2026-01-01	Warnings	Exact identifier application number: M018
Colirio Ojo De Aguila Eye Drops	GLYCERIN, NAPHAZOLINE HYDROCHLORIDE	Grandall Distributing Co., Inc.	31aa07e9-0cc9-2a77-e063-6394a90a4b9d	2025-12-31	Warnings	Exact identifier application number: M018
Value Health by Prodose Eye Drops	TETRAHYDROZOLINE HYDROCHLORIDE AND POLYETHYLENE GLYCOL 400	Prodose, Inc.	3fafa362-a8a6-3f91-e063-6394a90a98b3	2025-12-31	Warnings	Exact identifier application number: M018
Signature Care Eye Drops High Performance	POLYETHYLENE GLYCOL 400, PROPYLENE GLYCOL	Better Living Brands LLC	6f1f4f58-3208-4b06-9afb-c4beeed09314	2025-12-30	Warnings	Exact identifier application number: M018
Target Lubricant Eye Drops High Performance	POLYETHYLENE GLYCOL 400, PROPYLENE GLYCOL	Target Corporation	6c449374-8847-4c4a-9073-1951ff31d404	2025-12-30	Warnings	Exact identifier application number: M018
Target Lubricant Eye Drops High Performance	POLYETHYLENE GLYCOL 400, PROPYLENE GLYCOL	Target Corporation	ddc15dac-fbd8-42fa-80db-79f49fc6b9eb	2025-12-30	Warnings	Exact identifier application number: M018
Nighttime Relief Lubricant	LIGHT MINERAL OIL, WHITE PETROLATUM	Amerisource Bergen Drug Corp.	fd6b2be8-7e00-3765-e053-6294a90a4061	2025-12-30	Warnings	Exact identifier application number: M018
Rugby Carboxymethylcellulose Sodium 0.5% Eye Drops	CARBOXYMETHYLCELLULOSE SODIUM	Rugby Laboratories	fb84fc0b-9a62-812a-e053-6394a90aba0a	2025-12-30	Warnings	Exact identifier application number: M018
Rugby Polyvinyl Alcohol 1.4% Lubricating Eye Drops	POLYVINYL ALCOHOL	Rugby Laboratories	081673b2-5c74-1200-e063-6394a90ae363	2025-12-30	Warnings	Exact identifier application number: M018
Medi-First Lubricant Eye Drops	CARBOXYMETHYLCELLULOSE SODIUM	Unifirst First Aid Corporation	a4e651cc-adf0-af9e-e053-2995a90ace5a	2025-12-30	Warnings	Exact identifier application number: M018
Green Guard Lubricant Eye Drops	CARBOXYMETHYLCELLULOSE SODIUM	UniFirst First Aid Corporation	c3f04fdb-9fc1-797d-e053-2995a90afe80	2025-12-30	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