FDA.reportPublic FDA data

Systane

Product NDC
0065-0474
Requested package NDC
0065-0474-01
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

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
IngredientStrength
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
IdentifierFDA.report destination
RN3152OP35Internal UNII lookup

Harmonized RxCUI identifiers#

RxCUI identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
310932Internal RxNorm lookup

Harmonized SPL set identifiers#

SPL set identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
5f74b161-ae41-d0e2-6ed9-8deca55d2c0fAvailable on FDA.report

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
0065-0474-01Systane10 g in 1 TUBEGEL109
0065-0474-01Systane1 in 1 CARTONGEL19
0065-0474-02Systane3.5 g in 1 TUBEGEL3.59
0065-0474-02Systane1 in 1 CARTONGEL19

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
0065-0474-01GM - Gram0065-0474315f0943-1ba5-4252-9ab2-ff36639f9cb112013-03-03

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
Hypromellose 2910 (4000 Mpa.s)ACTIVE INGREDIENTRN3152OP35SYSTANE (HYPROMELLOSE) GEL [ALCON LABORATORIES, INC.]1
Hypromellose 2910 (4000 Mpa.s)ACTIVE MOIETYRN3152OP35SYSTANE (HYPROMELLOSE) GEL [ALCON LABORATORIES, INC.]1
Carbomer Homopolymer Type C (allyl Pentaerythritol Crosslinked)INACTIVE INGREDIENT4Q93RCW27ESYSTANE (HYPROMELLOSE) GEL [ALCON LABORATORIES, INC.]1
Phosphonic AcidINACTIVE INGREDIENT35V6A8JW8ESYSTANE (HYPROMELLOSE) GEL [ALCON LABORATORIES, INC.]1
Sodium HydroxideINACTIVE INGREDIENT55X04QC32ISYSTANE (HYPROMELLOSE) GEL [ALCON LABORATORIES, INC.]1
Sodium PerborateINACTIVE INGREDIENTY52BK1W96CSYSTANE (HYPROMELLOSE) GEL [ALCON LABORATORIES, INC.]1
SorbitolINACTIVE INGREDIENT506T60A25RSYSTANE (HYPROMELLOSE) GEL [ALCON LABORATORIES, INC.]1
WaterINACTIVE INGREDIENT059QF0KO0RSYSTANE (HYPROMELLOSE) GEL [ALCON LABORATORIES, INC.]1

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
0065-0474SYSTANE (HYPROMELLOSE) GEL [ALCON LABORATORIES, INC.]9Current NDC, Legacy NDC, 4 package rows20231216_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
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
carboxymethylcellulose sodiumCARBOXYMETHYLCELLULOSE SODIUMAvPAKb479d2ae-4b59-916a-e053-2995a90af8ec2025-11-11WarningsExact identifier
application number: M018
Sodium ChlorideSODIUM CHLORIDERising Pharma Holdings, Inc.42870188-b1d7-4934-a6c0-310530497dac2025-11-07WarningsExact identifier
application number: M018
Systane Complete PFPROPYLENE GLYCOL EMULSIONAlcon Laboratories, Inc.798ffdde-1dba-4a3f-a0b6-937f9e958cca2025-11-03WarningsExact identifier
application number: M018
LACRIFRESH HYDRAPFGLYCERIN, POVIDONEAVIZOR, S.A.41bbd23e-0ec8-eb18-e063-6294a90a46d12025-10-27WarningsExact identifier
application number: M018
LACRIFRESH HYDRAMAXPFGLYCERIN, POVIDONEAVIZOR, S.A.41be1604-89b4-7ec3-e063-6294a90a33312025-10-27WarningsExact identifier
application number: M018
Up and Up Dry Eye Relief Lubricant Eye DropsCARBOXYMETHYLCELLULOSE SODIUMTarget Corporation3b1834e6-75cf-5380-e063-6294a90ad1d52025-10-25WarningsExact identifier
application number: M018
Up and Up Dry Eye Relief Lubricant Eye DropsCARBOXYMETHYLCELLULOSE SODIUMHanlim420274c6-7bf0-0920-e063-6294a90a30be2025-10-25WarningsExact identifier
application number: M018
StyePOLYVINYL ALCOHOL AND POVIDONEMedtech Products Inc.60c11d3d-df20-4d1c-b425-49a84fecea302025-10-23WarningsExact identifier
application number: M018
TheraTears LubricantCARBOXYMETHYLCELLULOSE SODIUMMEDTECH PRODUCTS INC797b0394-2f0f-4733-8d20-ec5bdf3e085d2025-10-23WarningsExact identifier
application number: M018
Advanced Eye Relief Dry Eye RejuvenationGLYCERIN PROPYLENE GLYCOLBausch & Lomb Incorporated027969ee-64e4-4b08-bab7-c4cc8ed22f5f2025-10-23WarningsExact identifier
application number: M018
TheraTears LubricantCARBOXYMETHYLCELLULOSE SODIUMMEDTECH PRODUCTS INC661d8764-8ae6-4229-9485-867553ee8e162025-10-23WarningsExact identifier
application number: M018
Refresh Relieva Preservative FreeCARBOXYMETHYLCELLULOSE SODIUM AND GLYCERINAllergan, Inc.3481f9b3-5a90-40d3-80f8-81f51cc864be2025-10-22WarningsExact identifier
application number: M018
Sodium Chloride Normal SaltSODIUM CHLORIDEMethod Pharmaceuticalsce84727a-3677-4bf0-e053-2995a90a3ec82025-10-21WarningsExact identifier
application number: M018
iVIZIA Dry EyePOVIDONEThea Pharma Inc.1ef73cb1-da48-a713-e063-6294a90afa9d2025-10-20WarningsExact identifier
application number: M018
Walgreens Ultra LubricantPOLYETHYLENE GLYCOL 400, AND PROPYLENE GLYCOLWalgreens21dfe061-4533-2061-e063-6394a90a6e732025-10-17WarningsExact identifier
application number: M018
WalgreensSODIUM CHLORIDEWalgreen Company21dfc2cf-65ae-c3fb-e063-6294a90a0a942025-10-17Exact identifier
application number: M018
Xpect Industrial Eye ReliefGLYCERIN, NAPHAZOLINE HCLCintas Corporationa0167d06-7adb-36f4-e053-2a95a90af9ef2025-09-30WarningsExact identifier
application number: M018
Xpect EyewashEYEWASHCintas Corporation1d69365d-662b-4248-8fa9-1629451b549a2025-09-30WarningsExact identifier
application number: M018
REFRESH OPTIVE DropsCARBOXYMETHYLCELLULOSE SODIUM AND GLYCERINAllergan, Inc.80275190-d717-40ea-905b-5c8fbe986eac2025-09-15WarningsExact identifier
application number: M018
Refresh Relieva PF XtraCARBOXYMETHYLCELLULOSE SODIUM AND GLYCERINAllergan, Inc.b51b8a75-8faa-430f-8f7e-ee58d3d13f2e2025-09-15WarningsExact identifier
application number: M018

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
310932hypromellose 0.3 % Ophthalmic GelPSN5f74b161-ae41-d0e2-6ed9-8deca55d2c0f9
310932hypromellose 0.003 MG/MG Ophthalmic GelSCD5f74b161-ae41-d0e2-6ed9-8deca55d2c0f9
310932hypromellose 0.3 % Ophthalmic GelSY5f74b161-ae41-d0e2-6ed9-8deca55d2c0f9

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
0065-0474-01000650474011 TUBE in 1 CARTON (0065-0474-01) / 10 g in 1 TUBE1 tube2012-12-150000-00-00NoNoCurrent