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 10 of 25 · 494 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
Winco Original Formula Eye Drops	TETRAHYDROZOLINE HCL	WinCo Foods, LLC	44266952-4054-4c12-b3fc-d0543fe54fe2	2025-12-30	Warnings	Exact identifier application number: M018
Winco Irritation Relief Eye	TETRAHYDROZOLINE HCL, ZINC SULFATE	WinCo Foods, LLC	60565184-5745-43a5-92b2-ab45b27e8bc6	2025-12-30	Warnings	Exact identifier application number: M018
Core Values Eye Drops Dry Eye Relief	GLYCERIN, HYPROMELLOSE, POLYETHYLENE GLYCOL 400	Liberty Procurement Co. Inc.	f8285f68-c40c-19a8-e053-6394a90aacad	2025-12-30	Warnings	Exact identifier application number: M018
Core Values Eye Drops Advanced Relief	DEXTRAN 70, POLYETHYLENE GLYCOL 400, POVIDONE, TETRAHYDROZOLINE HYDROCHLORIDE	Liberty Procurement Co., Inc.	f76dfeca-4e86-0b5d-e053-6294a90a29b9	2025-12-30	Warnings	Exact identifier application number: M018
Best Choice Eye Drops A.C.	TETRAHYDROZOLINE HCL, ZINC SULFATE	Best Choice (Valu Merchandisers Company)	f5e665e4-ebd7-8c35-e053-2995a90a8811	2025-12-30	Warnings	Exact identifier application number: M018
Harris Teeter Eye Drops Artificial Tears	GLYCERIN, HYPROMELLOSE, POLYETHYLENE GLYCOL 400	Harris Teeter, LLC.	f82957d9-c4ad-a914-e053-6294a90aac50	2025-12-30	Warnings	Exact identifier application number: M018
Best Choice Eye Drops Advanced Relief	DEXTRAN 70, POLYETHYLENE GLYCOL 400, POVIDONE, TETRAHYDROZOLINE HYDROCHLORIDE	Valu Merchandisers, Co.	f7491a17-8035-5a3c-e053-6294a90a615c	2025-12-30	Warnings	Exact identifier application number: M018
Winco Advanced Relief Eye Drops	DEXTRAN 70, POLYETHYLENE GLYCOL 400, POVIDONE, TETRAHYDROZOLINE HCL	WinCo Foods, LLC	f10778c8-14fe-4852-8b73-42db502fd2bc	2025-12-30	Warnings	Exact identifier application number: M018
Harris Teeter Eye Drops Maximum Redness Relief	GLYCERIN, NAPHAZOLINE HYDROCHLORIDE	Harris Teeter, LLC	f710d107-0403-21c5-e053-6394a90a0372	2025-12-30	Warnings	Exact identifier application number: M018
CVS Astringent Eye	TETRAHYDROZOLINE HCL, ZINC SULFATE	CVS Pharmacy, Inc.	07e1a56b-fdad-408d-bf5a-7a0144ece131	2025-12-30	Warnings	Exact identifier application number: M018
Harris Teeter Eye Drops Advanced Relief	DEXTRAN 70, POLYETHYLENE GLYCOL 400, POVIDONE, TETRAHYDROZOLINE HYDROCHLORIDE	Harris Teeter, LLC	f76e2831-5c6c-7a62-e053-6294a90a937b	2025-12-30	Warnings	Exact identifier application number: M018
CVS Gentle Tears	DEXTRAN 70, HYPROMELLOSE	CVS Pharmacy, Inc.	9b1ea0eb-c34f-6603-e053-2995a90a6a95	2025-12-30	Warnings	Exact identifier application number: M018
CVS Lubricant Eye Drops	CARBOXYMETHYLCELLULOSE SODIUM	CVS Pharmacy, Inc.	8eef499d-c60e-9468-e053-2995a90a8714	2025-12-30	Warnings	Exact identifier application number: M018
Foster and Thrive Lubricating Tears Lubricant Eye Drops	POLYETHYLENE GLYCOL 400, PROPYLENE GLYCOL	Strategic Sourcing Services LLC	0042337b-c22a-157a-e063-6394a90a202e	2025-12-30	Warnings	Exact identifier application number: M018
CVS Lubricant Eye Drops Original	POLYETHYLENE GLYCOL 400, PROPYLENE GLYCOL	CVS	bb1ad35a-79ea-639f-e053-2995a90a96f3	2025-12-30	Warnings	Exact identifier application number: M018
Foster and Thrive Advanced Relief Eye Drops	POLYETHYLENE GLYCOL 400, TETRAHYDROZOLINE HCL	Strategic Sourcing Services LLC	0019cd99-b245-2ffc-e063-6294a90a9f27	2025-12-30	Warnings	Exact identifier application number: M018
CVS Multi-Symptom Eye Drops	POLYETHYLENE GLYCOL 400, TETRAHYDROZOLINE HCL, ZINC SULFATE	CVS Pharmacy, Inc.	be3d7855-cc66-ace8-e053-2a95a90ab8f4	2025-12-30	Warnings	Exact identifier application number: M018
Foster and Thrive Dry Eye Relief	POLYETHYLENE GLYCOL 400	Strategic Sourcing Services LLC	0018ade9-5856-db6c-e063-6394a90a2ccf	2025-12-30	Warnings	Exact identifier application number: M018
CareOne Itchy Relief Eye Drops 15mL	TETRAHYDROZOLINE HCI, ZINC SULFATE	Retail Business Services, LLC.	997f16ff-2632-2e9d-e053-2995a90a6f51	2025-12-30	Warnings	Exact identifier application number: M018
Foster and Thrive Redness Relief Eye Drops	GLYCERIN, NAPHAZOLINE HCL	Strategic Sourcing Services LLC	0042e9a0-9693-d7e0-e063-6294a90ae6c6	2025-12-30	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