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 23 of 25 · 494 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
Signature Care Eye Drops Advanced Relief	DEXTRAN 70, POLYETHYLENE GLYCOL 400, POVIDONE, TETRAHYDROZOLINE HCL	Better Living Brands LLC	5d7228ce-f108-4cc2-9aec-8b4548c3a155	2023-12-20	Warnings	Exact identifier application number: M018
Target Eye Drops Maximum Redness Relief Eye	GLYCERIN, NAPHAZOLINE HYDROCHLORIDE	Target Corporation	1b26cd3b-4a05-4623-b320-01f22b3106ff	2023-12-20	Warnings	Exact identifier application number: M018
Kroger High Performance Lubricant Eye Drops	POLYETHYLENE GLYCOL 400, PROPYLENE GLYCOL	Kroger	d2aa8963-1922-02f3-e053-2a95a90a7d93	2023-12-20	Warnings	Exact identifier application number: M018
Kroger Eye Drops Seasonal Relief	TETRAHYDROZOLINE HCL, ZINC SULFATE	Kroger	f6829be4-e3b7-7ff2-e053-2995a90a80fc	2023-12-20	Warnings	Exact identifier application number: M018
Rite Aid Multi-Symptom Relief Eye Drops	POLYETHYLENE GLYCOL 400, TETRAHYDROZOLINE HCL, ZINC SULFATE	Rite Aid Corporation	efa7d208-9d42-13c7-e053-2a95a90a11b3	2023-12-20	Warnings	Exact identifier application number: M018
Signature Care Lubricant Eye Drops	CARBOXYMETHYLCELLULOSE SODIUM	Better Living Brands LLC	ea358e01-f03e-454b-bae1-6c83da44c369	2023-12-20	Warnings	Exact identifier application number: M018
TopCare Health Original Eye Drops	TETRAHYDROZOLINE HCL	Topco Associates LLC	9c61a56a-c1a9-2846-e053-2995a90a755b	2023-12-20	Warnings	Exact identifier application number: M018
Signature Care Eye Drops A.C.	TETRAHYDROZOLINE HCL, ZINC SULFATE	Better Living Brands LLC	f685aca4-93d0-26d9-e053-2995a90a6e51	2023-12-20	Warnings	Exact identifier application number: M018
Kroger Lubricant Eye	CARBOXYMETHYLCELLULOSE SODIUM	The Kroger Co.	046f4ebc-d8f9-4755-b6ba-790fe86f3128	2023-12-20	Warnings	Exact identifier application number: M018
Kroger Eye Drops Advanced Relief	DEXTRAN 70, POLYETHYLENE GLYCOL 400, POVIDONE, TETRAHYDROZOLINE HYDROCHLORIDE	Kroger Company	f7ad77fc-d890-25b9-e053-6394a90a2b12	2023-12-20	Warnings	Exact identifier application number: M018
TopCare Health Dry Eye Relief Eye Drops	GLYCERIN, HYPROMELLOSE, POLYETHYLENE GLYCOL 400	Topco Associates LLC	9c617e34-fc66-1a5b-e053-2995a90ace2c	2023-12-20	Warnings	Exact identifier application number: M018
Equaline Advanced Relief Eye Drops	DEXTRAN 70, POLYETHYLENE GLYCOL 400, POVIDONE, TETRAHYDROZOLINE HYDROCHLORIDE	United Natural Foods, Inc.	f7602789-179a-edfc-e053-6294a90a0844	2023-12-20	Warnings	Exact identifier application number: M018
Topcare Health Ultra Itch Relief Astringent Eye Drops	TETRAHYDROZOLINE HCL, ZINC SULFATE	Topco Associates LLC	9c617e34-fc64-1a5b-e053-2995a90ace2c	2023-12-20	Warnings	Exact identifier application number: M018
Topcare Health Artificial Tears	POLYVINYL ALCOHOL, POVIDONE	Topco Associates LLC	9c614c0e-5862-682f-e053-2a95a90abc09	2023-12-20	Warnings	Exact identifier application number: M018
Topcare Health Lubricant Eye Drops	POLYETHYLENE GLYCOL 400, PROPYLENE GLYCOL	Topco Assoc LLC	9c6284f9-00bb-37b5-e053-2a95a90ae2ee	2023-12-20	Warnings	Exact identifier application number: M018
HEB Dry Eye Eye Drops	GLYCERIN, HYPROMELLOSE, POLYETHYLENE GLYCOL 400	HEB	f80023cf-8e42-780a-e053-6294a90a66cd	2023-12-20	Warnings	Exact identifier application number: M018
TopCare Health Advanced Moisturizing Plus Redness Relief	DEXTRAN 70, POLYETHYLENE GLYCOL 400, POVIDONE, TETRAHYDROZOLINE HCL	Topco Associates LLC	9c6193a6-d822-1b27-e053-2995a90ab3cf	2023-12-20	Warnings	Exact identifier application number: M018
Topcare Maximum Redness Relief Eye Drops	GLYCERIN, NAPHAZOLINE HYDROCHLORIDE	Topco Assoc LLC	9c6193a6-d824-1b27-e053-2995a90ab3cf	2023-12-20	Warnings	Exact identifier application number: M018
HEB Lubricant Eye Drops	CARBOXYMETHYLCELLULOSE SODIUM	HEB	5d522e4d-d647-486f-a947-25c14b1417fa	2023-12-20	Warnings	Exact identifier application number: M018
HEB A.C. Eye Drops	TETRAHYDROZOLINE HCL, ZINC SULFATE	HEB Grocery Company., LP	f680a8c1-dc91-7a52-e053-2a95a90a571e	2023-12-20	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