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 14 of 25 · 494 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
carboxymethylcellulose sodium	CARBOXYMETHYLCELLULOSE SODIUM	AvPAK	b479d2ae-4b59-916a-e053-2995a90af8ec	2025-11-11	Warnings	Exact identifier application number: M018
Sodium Chloride	SODIUM CHLORIDE	Rising Pharma Holdings, Inc.	42870188-b1d7-4934-a6c0-310530497dac	2025-11-07	Warnings	Exact identifier application number: M018
Systane Complete PF	PROPYLENE GLYCOL EMULSION	Alcon Laboratories, Inc.	798ffdde-1dba-4a3f-a0b6-937f9e958cca	2025-11-03	Warnings	Exact identifier application number: M018
LACRIFRESH HYDRAPF	GLYCERIN, POVIDONE	AVIZOR, S.A.	41bbd23e-0ec8-eb18-e063-6294a90a46d1	2025-10-27	Warnings	Exact identifier application number: M018
LACRIFRESH HYDRAMAXPF	GLYCERIN, POVIDONE	AVIZOR, S.A.	41be1604-89b4-7ec3-e063-6294a90a3331	2025-10-27	Warnings	Exact identifier application number: M018
Up and Up Dry Eye Relief Lubricant Eye Drops	CARBOXYMETHYLCELLULOSE SODIUM	Target Corporation	3b1834e6-75cf-5380-e063-6294a90ad1d5	2025-10-25	Warnings	Exact identifier application number: M018
Up and Up Dry Eye Relief Lubricant Eye Drops	CARBOXYMETHYLCELLULOSE SODIUM	Hanlim	420274c6-7bf0-0920-e063-6294a90a30be	2025-10-25	Warnings	Exact identifier application number: M018
Stye	POLYVINYL ALCOHOL AND POVIDONE	Medtech Products Inc.	60c11d3d-df20-4d1c-b425-49a84fecea30	2025-10-23	Warnings	Exact identifier application number: M018
TheraTears Lubricant	CARBOXYMETHYLCELLULOSE SODIUM	MEDTECH PRODUCTS INC	797b0394-2f0f-4733-8d20-ec5bdf3e085d	2025-10-23	Warnings	Exact identifier application number: M018
Advanced Eye Relief Dry Eye Rejuvenation	GLYCERIN PROPYLENE GLYCOL	Bausch & Lomb Incorporated	027969ee-64e4-4b08-bab7-c4cc8ed22f5f	2025-10-23	Warnings	Exact identifier application number: M018
TheraTears Lubricant	CARBOXYMETHYLCELLULOSE SODIUM	MEDTECH PRODUCTS INC	661d8764-8ae6-4229-9485-867553ee8e16	2025-10-23	Warnings	Exact identifier application number: M018
Refresh Relieva Preservative Free	CARBOXYMETHYLCELLULOSE SODIUM AND GLYCERIN	Allergan, Inc.	3481f9b3-5a90-40d3-80f8-81f51cc864be	2025-10-22	Warnings	Exact identifier application number: M018
Sodium Chloride Normal Salt	SODIUM CHLORIDE	Method Pharmaceuticals	ce84727a-3677-4bf0-e053-2995a90a3ec8	2025-10-21	Warnings	Exact identifier application number: M018
iVIZIA Dry Eye	POVIDONE	Thea Pharma Inc.	1ef73cb1-da48-a713-e063-6294a90afa9d	2025-10-20	Warnings	Exact identifier application number: M018
Walgreens Ultra Lubricant	POLYETHYLENE GLYCOL 400, AND PROPYLENE GLYCOL	Walgreens	21dfe061-4533-2061-e063-6394a90a6e73	2025-10-17	Warnings	Exact identifier application number: M018
Walgreens	SODIUM CHLORIDE	Walgreen Company	21dfc2cf-65ae-c3fb-e063-6294a90a0a94	2025-10-17		Exact identifier application number: M018
Xpect Industrial Eye Relief	GLYCERIN, NAPHAZOLINE HCL	Cintas Corporation	a0167d06-7adb-36f4-e053-2a95a90af9ef	2025-09-30	Warnings	Exact identifier application number: M018
Xpect Eyewash	EYEWASH	Cintas Corporation	1d69365d-662b-4248-8fa9-1629451b549a	2025-09-30	Warnings	Exact identifier application number: M018
REFRESH OPTIVE Drops	CARBOXYMETHYLCELLULOSE SODIUM AND GLYCERIN	Allergan, Inc.	80275190-d717-40ea-905b-5c8fbe986eac	2025-09-15	Warnings	Exact identifier application number: M018
Refresh Relieva PF Xtra	CARBOXYMETHYLCELLULOSE SODIUM AND GLYCERIN	Allergan, Inc.	b51b8a75-8faa-430f-8f7e-ee58d3d13f2e	2025-09-15	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