FDA.reportPublic FDA data

GenTeal Tears

Product NDC
0065-8064
11-digit product format
000658064
Labeler code
0065
Product ID
0065-8064_750c99c5-ade3-4759-870b-cb59248e9fa0
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
2019-12-31
Substance
HYPROMELLOSE 2910 (4000 MPA.S)
Active strength
.003 g/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
GenTeal Tears
Brand name suffix
Severe
Listing expiration
2026-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
HYPROMELLOSE 2910 (4000 MPA.S).003 g/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 · 2 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
310932Internal RxNorm lookup
793204Internal RxNorm lookup

Harmonized SPL set identifiers#

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

Identifier, FDA.report destination table
IdentifierFDA.report destination
a57854fc-f3a2-4fbb-b718-cd06f87a721eAvailable on FDA.report

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
0065-8064-01GenTeal Tears Severe10 g in 1 TUBEGEL104
0065-8064-01GenTeal Tears Severe1 in 1 CARTONGEL14

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
0065-8064-01GM - Gram0065-8064283b0849-8d39-4911-9da6-6a448e5f9f6112020-04-20

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
0065-8064GENTEAL TEARS SEVERE (HYPROMELLOSE) GEL [ALCON LABORATORIES, INC.]4Current NDC, Legacy NDC, 2 package rows20231215_a57854fc-f3a2-4fbb-b718-cd06f87a721e.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
793204GenTeal Severe 0.3 % Ophthalmic GelPSNa57854fc-f3a2-4fbb-b718-cd06f87a721e4
310932hypromellose 0.3 % Ophthalmic GelPSNa57854fc-f3a2-4fbb-b718-cd06f87a721e4
793204hypromellose 0.003 MG/MG Ophthalmic Gel [GenTeal]SBDa57854fc-f3a2-4fbb-b718-cd06f87a721e4
310932hypromellose 0.003 MG/MG Ophthalmic GelSCDa57854fc-f3a2-4fbb-b718-cd06f87a721e4
793204GenTeal 0.003 MG/MG Ophthalmic GelSYa57854fc-f3a2-4fbb-b718-cd06f87a721e4
793204GenTeal 0.3 % Ophthalmic GelSYa57854fc-f3a2-4fbb-b718-cd06f87a721e4
310932hypromellose 0.3 % Ophthalmic GelSYa57854fc-f3a2-4fbb-b718-cd06f87a721e4

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
0065-8064-01000658064011 TUBE in 1 CARTON (0065-8064-01) / 10 g in 1 TUBE1 tube2019-12-310000-00-00NoNoCurrent