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 16 of 25 · 494 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
Systane COMPLETE PF	PROPYLENE GLYCOL	Alcon Laboratories, Inc.	99b63d62-1cf0-4f28-8760-773917c2538a	2025-07-29	Warnings	Exact identifier application number: M018
LubriFresh PM	LIGHT MINERAL OIL, WHITE PETROLATUM	Major Pharmaceuticals	3ab32e69-b8da-f187-e063-6294a90afa9a	2025-07-24	Warnings	Exact identifier application number: M018
Rugby Polyvinyl Alcohol 1.4% Lubricating Eye Drops	POLYVINYL ALCOHOL	A-S Medication Solutions	2653e4fc-4f08-426d-a0a4-31d647c1de56	2025-07-18	Warnings	Exact identifier application number: M018
Focus Tears PF	CARBOXYMETHYLCELLULOSE SODIUM	Covalent Medical	772c7070-82ff-4371-b071-940ff91372c6	2025-07-17	Warnings	Exact identifier application number: M018
SilkTears	GLYCERIN OPHTHALMIC SOLUTION	SilkTears	3866e2c1-051b-0b01-e063-6394a90af5cf	2025-07-16	Warnings	Exact identifier application number: M018
Eyeleve MGD	MINERAL OIL	Bruder Healthcare	145b66e2-00e1-410e-8539-e12ffc4f6f82	2025-07-15	Warnings	Exact identifier application number: M018
Quality Choice Eye Drops Redness Relief	TETRAHYDROZOLINE HCL	Chain Drug Marketing Assoc., Inc.	38d2bc34-c6f0-a09c-e063-6394a90a69e1	2025-06-26	Warnings	Exact identifier application number: M018
Visine Red Eye Hydrating Comfort Eye Drops	TETRAHYDROZOLINE HYDROCHLORIDE AND POLYETHYLENE GLYCOL 400	Morning Star OTC	dcd4164c-aa1e-4f07-ab2c-b439275629db	2025-06-16	Warnings	Exact identifier application number: M018
Code Red Eye Drops Micro	GLYCERIN AND NAPHAZOLINE HYDROCHLORIDE	4 Trees LLC	2a15ea9a-ff67-446b-8b83-6517d25ff38a	2025-05-29	Warnings	Exact identifier application number: M018
Biotrue Hydration Boost	GLYCERIN	Bausch & Lomb Incorporated	e2621477-e6ee-4275-ba0a-939dca2550c4	2025-05-19	Warnings	Exact identifier application number: M018
Eyesaline Emergency Eyewash	STERILE EYESALINE EYEWASH	Honeywell Safety Products USA, Inc.	2d567518-4c54-7448-e063-6294a90a3e64	2025-05-14	Warnings	Exact identifier application number: M018
Splash Redness Reliever	HYPROMELLOSE, NAPHAZOLINE HYDROCHLORIDE	LABORATORIOS SOPHIA, S.A. DE C.V.	fa4140e6-dc80-da99-e053-6294a90a194f	2025-05-09	Warnings	Exact identifier application number: M018
Vista Gonio Eye Lubricant	HYPROMELLOSE OPHTHALMIC SOLUTION	Red Wedding LLC	00da365d-2988-9c9e-e063-6294a90a8931	2025-03-25	Warnings	Exact identifier application number: M018
Sodium Chloride	SODIUM CHLORIDE TABLET	Belleview Bioscience LLC	31195e8f-d4de-9e37-e063-6294a90a4156	2025-03-24	Warnings	Exact identifier application number: M018
Leader Nighttime Relief Lubricant Eye	LIGHT MINERAL OIL, WHITE PETROLATUM	LEADER/Cardinal Health 110, Inc.	308772fc-d6f6-da9f-e063-6394a90a41db	2025-03-12	Warnings	Exact identifier application number: M018
Clear Eyes Maximum Redness Relief	NAPHAZOLINE HYDROCHLORIDE AND GLYCERIN	Prestige Brands Holdings, Inc.	c3b0e344-68dd-4c35-bf46-744e612a5b15	2025-02-28	Warnings	Exact identifier application number: M018
Blink Nourish Dry Eye	GLYCERIN	Bausch & Lomb Incorporated	cf2b4e19-af0a-472e-9a2d-9b4fa3e9c9a4	2025-02-25	Warnings	Exact identifier application number: M018
Advanced Eye Relief Eye Wash	WATER SOLUTION	Bausch & Lomb Incorporated	9caccce1-4530-441d-bf76-244edeb9dedc	2025-02-17	Warnings	Exact identifier application number: M018
Hydropure Lubricating Eye Drops	GLYCERIN	OTE North America	17f5b6e5-dc14-45c7-e063-6294a90af43d	2025-02-14	Warnings	Exact identifier application number: M018
Walgreens Soothing Eye Relief Lubricant Eye Drops	POLYVINYL ALCOHOL, POVIDONE	Walgreens Co.	29b7387b-ad65-3a11-e063-6394a90a6a15	2025-02-14	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