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 4 of 25 · 494 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
SODIUM CHLORIDE 1 GRAM	SODIUM CHLORIDE	Gendose Pharmaceuticals, LLC	ce988ae5-61c6-4324-90e1-a94c8a54d0d0	2026-04-13	Warnings	Exact identifier application number: M018
Artificial Tears Lubricant Eye Drops	GLYCERIN, PROPYLENE GLYCOL	CVS Pharmacy	28297fee-8185-4869-8f39-5bfbf8bf8bfd	2026-04-13	Warnings	Exact identifier application number: M018
blink boost	GLYCERIN	Bausch & Lomb Incorporated	e765c224-1718-488f-99b2-976eb60c1d63	2026-04-13	Warnings	Exact identifier application number: M018
Retaine Ultra PF	POLYETHYLENE GLYCOL	OCuSOFT LLC	a5aaaf06-772d-44d3-8601-f978ddc48ad7	2026-04-13	Warnings	Exact identifier application number: M018
Exovisse Preservative-Free Artificial Tears	LUBRICANT EYE GEL DROPS	YD BIO USA, INC.	4f20191a-9124-2525-e063-6294a90a8428	2026-04-10	Warnings	Exact identifier application number: M018
WE FRESH Lubricating Eye Drops	GLYCERIN	Oculus Surgical, Inc.	4f253b5d-001b-091e-e063-6394a90a9d39	2026-04-09	Warnings	Exact identifier application number: M018
FreshKote Preservative Free Lubricant Eye Drops	POVIDONE, POLYVINYL ALCOHOL	Eyevance Pharmaceuticals	f51c50c3-43ae-4169-9d2b-22b239461dd1	2026-04-08	Warnings	Exact identifier application number: M018
Walgreens Sodium Chloride Ophthalmic 5 Percent Hypertonicity Eye	SODIUM CHLORIDE	Walgreen Company	bda3b9db-5fc4-408c-a5ae-d1eeb3ee308d	2026-04-06	Warnings	Exact identifier application number: M018
LensMate Preservative-Free Artificial Tears	LUBRICANT EYE DROPS	YD BIO USA, INC.	4ebacb2b-9b2d-6bc1-e063-6294a90a3426	2026-04-05	Warnings	Exact identifier application number: M018
Exovisse Preservative-Free Artificial Tears	LUBRICANT EYE GEL DROPS	YD BIO USA, INC.	4ebc154b-128b-9dde-e063-6294a90ae00e	2026-04-05	Warnings	Exact identifier application number: M018
Sodium Chloride Ophthalmic 5 Percent Hypertonicity Eye	SODIUM CHLORIDE	Hanlim	4ee80e16-1bb1-8238-e063-6294a90aa719	2026-04-04	Warnings	Exact identifier application number: M018
Redness Relief	GLYCERIN, NAPHAZOLINE HCL	Pharmadel LLC	4c113bb9-814f-d92d-e063-6294a90a8302	2026-03-30	Warnings	Exact identifier application number: M018
Moisture Oyster	GLYCERIN	Moisture Oyster Inc	4e45317a-437f-4d88-e063-6294a90a98d0	2026-03-30	Warnings	Exact identifier application number: M018
Crocodile Tears Lubricant Eye Drops	GLYCERIN, HYPROMELLOSE, POLYETHYLENE GLYCOL 400	Crocodile Tears LLC	4df29336-ea0c-0484-e063-6294a90a685a	2026-03-26	Warnings	Exact identifier application number: M018
Artificial Tears Lubricant Eye Drops	GLYCERIN, HYPROMELLOSE, POLYETHYLENE GLYCOL 400	KC Pharmaceuticals, Inc	4de5c844-85ca-ff9f-e063-6394a90ac12c	2026-03-25	Warnings	Exact identifier application number: M018
NOVEHA NIGHTTIME	WHITE PETROLATUM	Bullet Point LLC	4da24578-e98b-8ce1-e063-6294a90a8bf6	2026-03-24	Warnings	Exact identifier application number: M018
BLINK TRIPLE CARE	POLYETHYLENE GLYCOL 400	Bausch & Lomb Incorporated	a2b34eb0-001b-4f42-a8cc-c2a0150fafcc	2026-03-20	Warnings	Exact identifier application number: M018
SODIUM CHLORIDE HYPERTONICITY	SODIUM CHLORIDE	YYBA CORP	439653b9-99b8-4799-8d67-4a2ada9c6783	2026-03-20	Warnings	Exact identifier application number: M018
Altachlore Sodium Chloride Hypertonicity Ophthalmic 5 Percent	SODIUM CHLORIDE	Altaire Pharmaceuticals Inc.	e13fd053-9420-490c-a43e-e14b0930cb4e	2026-03-18	Warnings	Exact identifier application number: M018
Lubricant Eye Drops	CARBOXYMETHYLCELLULOSE SODIUM	KC Pharmaceuticals, Inc.	4d1d9b3a-ac5f-db27-e063-6294a90afc3f	2026-03-16	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