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 11 of 25 · 494 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
CareOne Maximum Redness Relief Eye DropsGLYCERIN, NAPHAZOLINE HCIRetail Business Services, LLC9ab96aed-21d3-11b6-e053-2995a90a72252025-12-30WarningsExact identifier
application number: M018
CVS Lubricant Eye Drops 30 ctCARBOXYMETHYLCELLULOSE SODUIMCVS Pharmacy, Inc.8dbca077-c989-767a-e053-2995a90a7cf52025-12-30WarningsExact identifier
application number: M018
Foster and Thrive Original Formula Eye DropsTETRAHYDROZOLINE HCLStrategic Sourcing Services LLC002da62b-aec6-8e2a-e063-6294a90a5efc2025-12-30WarningsExact identifier
application number: M018
CareOne Artificial Tears Eye Drops 15mLPOLYVINYL ALCOHOL, POVIDONERetail Business Services, LLC92fded6b-91fd-d82e-e053-2a95a90ab5232025-12-30WarningsExact identifier
application number: M018
Foster and Thrive Long Lasting Lubricant Eye DropsPOLYETHYLENE GLYCOL 400, PROPYLENE GLYCOLStrategic Sourcing Services LLC00546df0-17d8-0e3c-e063-6294a90ae7b22025-12-30WarningsExact identifier
application number: M018
Meijer Multi-Symptom ReliefPOLYETHYLENE GLYCOL 400, TETRAHYDROZOLINE HCL, ZINC SULFATEMeijer, Inc.e7a5677a-ff33-c039-e053-2a95a90ae6c72025-12-30WarningsExact identifier
application number: M018
TopCare Health Lubricant Eye DropsCARBOXYMETHYLCELLULOSE SODIUMTopcare Associates LLCe8e9dfe5-3540-a4df-e053-2a95a90aaf982025-12-30WarningsExact identifier
application number: M018
Meijer Lubricant Eye DropsCARBOXYMETHYLCELLULOSE SODIUMMeijer Distribution, Inc.b245f99f-785a-efdc-e053-2995a90a49112025-12-30WarningsExact identifier
application number: M018
Equate Original Eye DropsTETRAHYDROZOLINE HCLWalmart, Inc.eb8e5beb-4454-58c2-e053-2a95a90a66e02025-12-30WarningsExact identifier
application number: M018
Avenova Lubricant Eye Drops High PerformancePOLYETHYLENE GLYCOL 400, PROPYLENE GLYCOLNovaBay Pharmaceuticals, Inc.cd17f037-5aa5-0ef8-e053-2a95a90a39cb2025-12-30WarningsExact identifier
application number: M018
Equate Redness and Dry Eye Relief Eye DropsGLYCERIN, NAPHAZOLINE HCLWal-Mart Stores, Inc.ae228018-9238-2cbd-e053-2995a90a8d992025-12-30WarningsExact identifier
application number: M018
Equate Lubricant Eye DropsPOLYETHYLENE GLYCOL 400, PROPYLENE GLYCOLWalmart, Inc.deebaf7f-f20d-4d7f-e053-2a95a90a4b4f2025-12-30WarningsExact identifier
application number: M018
Quality Choice Artificial Tears Lubricant Eye DropsPOLYVINYL ALCOHOL, POVIDONEChain Drug Marketing Association, Inc.1f669655-4bc7-0175-e063-6294a90a305a2025-12-30WarningsExact identifier
application number: M018
Equate Artificial TearsPOLYVINYL ALCOHOL, POVIDONEWalmart, Inc.ead9f271-0f15-1fff-e053-2a95a90a93ac2025-12-30WarningsExact identifier
application number: M018
Equate Multi-Symptom Relief Eye DropsPOLYETHYLENE GLYCOL 400,TETRAHYDROZOLINE HCL, ZINC SULFATEWalmart, Inc.eb8ed76b-9cd7-3636-e053-2a95a90a95832025-12-30WarningsExact identifier
application number: M018
CorneaCare Recover Lubricant Eye DropsPOLYETHYLENE GLYCOL 400, PROPYLENE GLYCOLCorneaCare Inc.1fd3a5ed-8963-5c8e-e063-6394a90a65272025-12-30WarningsExact identifier
application number: M018
Eye Love Heyedrate Long Lasting HydrationGLYCERIN, POVIDONEPhysician Recommended Neutraceuticals, L.P.f321dea1-3251-eaa8-e053-2995a90aaf952025-12-30WarningsExact identifier
application number: M018
Quality Choice Lubricant Eye Drops High PerformancePOLYETHYLENE GLYCOL 400, PROPYLENE GLYCOLChain Drug Marketing Assoc., Inc.0cd1b36a-a07a-a1db-e063-6294a90a59942025-12-30WarningsExact identifier
application number: M018
Quality Choice Eye Drops Irritation ReliefTETRAHYDROZOLINE HCL, ZINC SULFATEQuality Choice1f682079-6e91-e14b-e063-6394a90a3f122025-12-30WarningsExact identifier
application number: M018
Quality Choice Moisturizing Relief Eye DropsDEXTRAN 70, POLYETHYLENE GLYCOL 400, POVIDONE, TETRAHYDROZOLINE HCLChain Drug Marketing Association, Inc.1fb81759-5931-59c8-e063-6294a90a22772025-12-30WarningsExact 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