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 22 of 25 · 494 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
Meijer Maximum Redness Relief and Lubricant	GLYCERIN, NAPHAZOLINE HCI	Meijer Distribution, Inc.	9feb1818-c79b-23bf-e053-2995a90a1084	2023-12-22	Warnings	Exact identifier application number: M018
Meijer Redness Relief	TETRAHYDROZOLINE HCI	Meijer Distribution, Inc.	9fea27a5-b81b-1598-e053-2995a90a6b62	2023-12-22	Warnings	Exact identifier application number: M018
Meijer Seasonal Itching and Redness Relief	TETRAHYDROZOLINE HCI, ZINC SULFATE	Meijer Distribution, Inc.	9fead2de-2fe6-4dab-e053-2995a90a2742	2023-12-22	Warnings	Exact identifier application number: M018
Meijer Artificial Tears	POLYVINYL ALCOHOL, POVIDONE	Meijer Distribution, Inc.	9feb3eec-a36f-8fc7-e053-2a95a90adcd3	2023-12-22	Warnings	Exact identifier application number: M018
Meijer Redness Relief	GLYCERIN, NAPHAZOLINE HCI	Meijer Distribution, Inc.	9fea4e43-7525-bb66-e053-2a95a90acee9	2023-12-22	Warnings	Exact identifier application number: M018
Meijer Ultra Lubricant Eye Drops High Performance	POLYETHYLENE GLYCOL 400, PROPYLENE GLYCOL	Meijer Distribution, Inc.	a0846e3e-687c-fd55-e053-2995a90a673e	2023-12-22	Warnings	Exact identifier application number: M018
Meijer Advanced Redness and Irritation Relief	DEXTRAN 70, POLYETHYLENE GLYCOL 400, POVIDONE, TETRAHYDROZOLINE HCI	Meijer Distribution, Inc.	9fea6d7a-a2cd-d26e-e053-2995a90a15f8	2023-12-22	Warnings	Exact identifier application number: M018
Meijer Dry Eye Relief	GLYCERIN, HYPROMELLOSE, POLYETHYLENE GLYCOL 400	Meijer Distribution, Inc.	9feaa5e2-6aca-96e8-e053-2a95a90a54bd	2023-12-22	Warnings	Exact identifier application number: M018
Walgreens Multi-Symptom Relief Eye Drops	GLYCERIN, HYPROMELLOSE, POLYETHYLENE GLYCOL 400, TETRAHYDROZOLINE HCL, ZINC SULFATE	Walgreen Co.	a03789ce-66bd-7b12-e053-2995a90af85a	2023-12-20	Warnings	Exact identifier application number: M018
Walgreens Lubricant Eye Drops Preservative Free	DEXTRAN 70, HYPROMELLOSE	Walgreen Company	9b383e41-e116-1c12-e053-2a95a90ab25f	2023-12-20	Warnings	Exact identifier application number: M018
Walgreens Eye Drops Maximum Redness Relief 15mL	GLYCERIN, NAPHAZOLINE HCI	Walgreen Company	949d4a4d-b0f8-81f8-e053-2995a90a818d	2023-12-20	Warnings	Exact identifier application number: M018
Walgreens Eye Drops Seasonal Relief 15mL	TETRAHYDROZOLINE HCI, ZINC SULFATE	Walgreen Co.	947f3706-ef5e-2c53-e053-2a95a90a82bd	2023-12-20	Warnings	Exact identifier application number: M018
Walgreens Eye Drops Advanced Relief 15mL	DEXTRAN 70, POLYETHYLENE GLYCOL 400, POVIDONE, TETRAHYDROZOLINE HCI	Walgreen Company	949f5560-fba7-2da8-e053-2995a90a23c2	2023-12-20	Warnings	Exact identifier application number: M018
Walgreens Lubricant Eye Drops Preservative Free	CARBOXYMETHYLCELLULOSE SODIUM	Walgreen Company	9912b773-e7a5-3a82-e053-2995a90a5b2c	2023-12-20	Warnings	Exact identifier application number: M018
Walgreens Lubricant Eye Drops High Performance 15mL and twin pack	POLYETHYLENE GLYCOL 400, PROPYLENE GLYCOL	Walgreen Company	94ee8310-1c19-dfd4-e053-2a95a90a8356	2023-12-20	Warnings	Exact identifier application number: M018
Walgreens Redness Relief Eye Drops 15mL	GLYCERIN, NAPHAZOLINE HCI	Walgreen Company	94a0d08a-a6db-1088-e053-2995a90ab4fd	2023-12-20	Warnings	Exact identifier application number: M018
Walgreens Eye Drops Original 15mL and twin pack	TETRAHYDROZOLINE HCI	Walgreens Company	94e391f7-db4b-47d2-e053-2a95a90a1b11	2023-12-20	Warnings	Exact identifier application number: M018
Walgreens Lubricant Eye Drops Dry Eye 15mL and twin pack	POLYETHYLENE GLYCOL 400, PROPYLENE GLYCOL	Walgreen Company	94f6e1cd-073c-61ca-e053-2a95a90ae725	2023-12-20	Warnings	Exact identifier application number: M018
Lubricant Eye Drops Preservative Free	CARBOXYMETHYLCELLULOSE SODIUM	Target Corporation	454ce049-49e5-48b1-8499-048e5e7d72d3	2023-12-20	Warnings	Exact identifier application number: M018
Rugby Lubricant Eye Drops	CARBOXYMETHYLCELLULOSE SODIUM	Rugby Laboratories	f9292d5d-e0a3-9287-e053-6294a90a43e9	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