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 6 of 25 · 494 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
Optase	GLYCERIN	Scope Health Inc	d81c1a4f-87b0-ee8c-e053-2995a90af9e5	2026-01-30	Warnings	Exact identifier application number: M018
Optase	GLYCERIN	Scope Health Inc	f452a2c4-c869-7bf5-e053-2995a90ac1a0	2026-01-30	Warnings	Exact identifier application number: M018
Regener-Eyes Ophthalmic Solution LITE XL	GLYCERIN OPHTHALMIC SOLUTION	M & M PRODUCTS, L.L.C.	47ab9609-4291-30b2-e063-6394a90a421e	2026-01-29	Warnings	Exact identifier application number: M018
Regener-Eyes Ophthalmic Solution PROFESSIONAL STRENGTH XL	GLYCERIN OPHTHALMIC SOLUTION	M & M PRODUCTS, L.L.C.	48d6dc98-66e8-b499-e063-6394a90ae935	2026-01-29	Warnings	Exact identifier application number: M018
Optase	GLYCERIN	Scope Health Inc	86c14327-ffc7-806e-e053-2991aa0aaf92	2026-01-29	Warnings	Exact identifier application number: M018
Regener-Eyes Ophthalmic Solution PROFESSIONAL	GLYCERIN OPHTHALMIC SOLUTION	M & M PRODUCTS, LLC	49771efa-6682-51d0-e063-6294a90a18a5	2026-01-28	Warnings	Exact identifier application number: M018
Regener-Eyes Ophthalmic Solution LITE	GLYCERIN OPHTHALMIC SOLUTION	M & M PRODUCTS, LLC	497763ee-dc70-bb48-e063-6294a90afb3d	2026-01-28	Warnings	Exact identifier application number: M018
Aurovisc Lubricant HYPROMELLOSE 2208 (15000 MPA.S) Gel/Drops	HYPROMELLOSE OPHTHALMIC SOLUTION 2% W/V	Aurolab	f27a6799-e2f1-ee8d-e053-2a95a90aead1	2026-01-27	Warnings	Exact identifier application number: M018
Carboxymethylcellulose Sodium Eye Drops 0.5%	CARBOXYMETHYLCELLULOSE SODIUM EYE DROPS 0.5%	Aurolab	e8b4df3b-3d81-b3ca-e053-2a95a90af2ec	2026-01-27	Warnings	Exact identifier application number: M018
Aurovisc OE	HYPROMELLOSE OPHTHALMIC SOLUTION 2% W/V	Aurolab	3142c6df-77ac-ec41-e063-6294a90aee47	2026-01-27	Warnings	Exact identifier application number: M018
AURO-CMC	CARBOXYMETHYLCELLULOSE EYE DROPS 0.5%	Aurolab	e90b397f-fe64-8674-e053-2995a90a223f	2026-01-27	Warnings	Exact identifier application number: M018
Optase Allegro	HYDROXYETHYL CELLULOSE	Scope Health Inc	f7999928-f5c1-98d6-e053-6294a90a57db	2026-01-27	Warnings	Exact identifier application number: M018
Family Care Single Use Lubricant Eye Drop 0.4mL 5ct	CARBOXYMETHYLCELLULOSE SODIUM	United Exchange Corp	48879feb-b5ae-a9e6-e063-6394a90a03b2	2026-01-16	Warnings	Exact identifier application number: M018
Family Care Single Use Lubricant Eye Drop 0.4mL 30ct	CARBOXYMETHYL CELLULOSE 0.5%	United Exchange Corp	488b3363-8d06-7dcc-e063-6294a90ab44c	2026-01-16	Warnings	Exact identifier application number: M018
retaine PM	MINERAL OIL, WHITE PETROLATUM	OCuSOFT LLC	ac75e5c9-94ae-698d-40da-dffe4458a098	2026-01-15	Warnings	Exact identifier application number: M018
Sodium Chloride Hypertonicity	SODIUM CHLORIDE	CVS Pharmacy	9245d842-7f78-42d8-83ba-8eb9ec8dbc0d	2026-01-15	Warnings	Exact identifier application number: M018
Sodium Chloride Hypertonicity	SODIUM CHLORIDE	CVS PHARMACY	d5cc6cd1-ddf8-4f5b-a021-204cdda0db94	2026-01-15	Warnings	Exact identifier application number: M018
retaine MGD	MINERAL OIL	OCuSOFT LLC	06f57d46-96c7-4093-84aa-874ff4b2131d	2026-01-15	Warnings	Exact identifier application number: M018
Walgreens Sterile Soothing Eye Wash	PURIFIED WATER	Walgreens	a62e3294-abd6-48dc-81b1-62a809bdc968	2026-01-14	Warnings	Exact identifier application number: M018
Vis Guard Lubricant EyeOintment PM	MINERAL OIL, WHITE PETROLATUM OINTMENT	Ulai Health LLC	1040a92b-d342-a9fd-e063-6294a90a45ef	2026-01-13	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