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 20 of 25 · 494 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
Clear Eyes Natural Tears	POLYVINYL ALCOHOL AND POVIDONE	Prestige Brands Holdings, Inc.	efba3eb0-798d-4635-b19b-4970e45b3cc9	2024-04-01	Warnings	Exact identifier application number: M018
Polyvinyl Alcohol	POLYVINYL ALCOHOL	A-S Medication Solutions	c77589fd-f68d-48b7-bd12-51f6b4cc9402	2024-03-20	Warnings	Exact identifier application number: M018
REFRESH CLASSIC	POLYVINYL ALCOHOL, POVIDONE	A-S Medication Solutions	3bf6193c-56db-45ad-844c-58eb8c33cba9	2024-03-14	Warnings	Exact identifier application number: M018
GOODSENSE ARTIFICIAL TEARS	POLYVINYL ALCOHOL	Proficient Rx LP	f29c792c-6cb2-449f-b97d-6304a58dec2a	2024-02-01	Warnings	Exact identifier application number: M018
GoodSense Artifical Tears	POLYVINYL ALCOHOL, AND POVIDONE	Proficient Rx LP	cd24da78-fd90-4a9c-8e5f-f7fc56ec0fc9	2024-02-01	Warnings	Exact identifier application number: M018
GENTEAL TEARS	DEXTRAN 70, GLYCERIN, HYPROMELLOSE	A-S Medication Solutions	a2b715e9-332d-4f0b-b8e5-ebc000681586	2024-01-21	Warnings	Exact identifier application number: M018
Visine Red Eye Hydrating Comfort, CVP	TETRAHYDROZOLINE HYDROCHLORIDE AND POLYETHYLENE GLYCOL 400 SOLUTION/ DROPS	Lil' Drug Store Products, Inc.	0f50bcc8-3658-8c2c-e063-6294a90a8e13	2024-01-19	Warnings	Exact identifier application number: M018
Fendall 2000 Pure Flow	PURIFIED WATER	Honeywell Safety Products USA, Inc.	b56ef662-fec2-4d94-e053-2995a90aba2b	2024-01-06	Warnings	Exact identifier application number: M018
Exchange Select Maximum Redness Relief Eye Drops	GLYCERIN, NAPHAZOLINE HCL	Army and Air Force Exchange Service	318bc025-c936-a066-e063-6294a90a4712	2024-01-01	Warnings	Exact identifier application number: M018
Kroger Eye Drops Original	TETRAHYDROZOLINE HCL	The Kroger Co.	318c17a1-fe08-508b-e063-6394a90a2e08	2024-01-01	Warnings	Exact identifier application number: M018
HEB Original Eye Drops	TETRAHYDROZOLINE HCL	HEB Grocery Company, LP	318cb457-bb2d-a1ee-e063-6294a90a8019	2024-01-01	Warnings	Exact identifier application number: M018
Discount Drug Mart Eye Drops Multi-Symptom Relief	POLYETHYLENE GLYCOL 400, TETRAHYDROZOLINE HCL, ZINC SULFATE	Discount Drug Mart, Inc.	318dc92a-0707-d6a4-e063-6294a90ab78a	2024-01-01	Warnings	Exact identifier application number: M018
Kroger Eye Drops Redness Relief	GLYCERIN, NAPHAZOLINE HYDROCHLORIDE	The Kroger Co.	318dea21-2656-36a3-e063-6294a90ac9c4	2024-01-01	Warnings	Exact identifier application number: M018
Harris Teeter Eye Drops Original	TETRAHYDROZOLINE HCL	Harris Teeter, LLC.P	31a1b962-27ad-97b1-e063-6294a90a77f1	2024-01-01	Warnings	Exact identifier application number: M018
CVP Sterile Eye Drops	TETRAHYDROZOLINE HCL	Salado Sales, Inc.	31a216f8-28e9-ec8f-e063-6394a90aec49	2024-01-01	Warnings	Exact identifier application number: M018
Equaline Sterile Eye Drops	TETRAHYDROZOLINE HCL	United Natural Foods, Inc.	31a25efb-a627-1a13-e063-6394a90a2ca3	2024-01-01	Warnings	Exact identifier application number: M018
Best Choice Eye Drops Original	TETRAHYDROZOLINE HCL	Valu Merchandisers Company	31a2a42a-bcfe-4f22-e063-6294a90ac60e	2024-01-01	Warnings	Exact identifier application number: M018
Discount Drug Mart Eye Drops Original	TETRAHYDROZOLINE HCL	Discount Drug Mart, Inc.	31a2efb2-3924-6a12-e063-6394a90ab0e2	2024-01-01	Warnings	Exact identifier application number: M018
Equaline Redness Relief Lubricant Eye Drops	GLYCERIN, NAPHAZOLINE HYDROCHLORIDE	United Natural Foods, Inc	31a30b00-9f4b-717a-e063-6394a90a8a87	2024-01-01	Warnings	Exact identifier application number: M018
Harris Teeter Redness Relief Eye Drops	GLYCERIN, NAPHAZOLINE HYDROCHLORIDE	Harris Teeter, LLC.	31a3d575-10f1-5feb-e063-6294a90ac478	2024-01-01	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