GenTeal Tears Gel Drops

Product NDC
0065-8067
11-digit product format
000658067
Labeler code
0065
Product ID
0065-8067_b702ef77-f1ce-4064-9512-31098bd4479f
Type
HUMAN OTC DRUG
Nonproprietary name
polyethylene glycol 400 and propylene glycol
Dosage form
GEL
Route
OPHTHALMIC
Labeler
Alcon Laboratories, Inc.
Application
M018
Marketing category
OTC MONOGRAPH DRUG
Marketing start
2021-02-04
Substance
POLYETHYLENE GLYCOL 400; PROPYLENE GLYCOL
Active strength
4; 3 mg/mL; mg/mL
NDC exclude flag
No
Listing certified through
2026-12-31
Current FDA listing
Yes

Additional Listing Data#

Finished product
Yes
Brand name base
GenTeal Tears Gel Drops
Listing expiration
2026-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
POLYETHYLENE GLYCOL 4004 mg/mL
PROPYLENE GLYCOL3 mg/mL

Harmonized Identifiers#

Field, Values table
FieldValues
UniiB697894SGQ, 6DC9Q167V3
Rxcui895753

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
9e37788c-b1bf-42ae-aac9-b60601606144Product name820260122
1527ac37-808d-43be-a63e-74e1258dbe46Product name920250219
bed0530e-f939-4541-956b-6928a2f6404fProduct name120241008
cefa60e2-a5b5-493e-9c54-24735b7dc509Product name620240814
362d7abb-94e6-4c60-9a58-266894157713Product name120231023
9fcb7a91-de07-4f00-aabf-e4d6fda403d5Product name820230322
6bd95106-a412-1dad-b9cc-4cb74bfb27ceProduct name220230315
9badc7be-250a-44ab-aa36-926af3f02679Product name120210527
0ec3537a-6c9b-432a-896c-b9ea8723049aProduct name920200701
444b3e50-f226-46ef-bfca-2e7035d140cdProduct name120190611
816b97af-edc5-4060-aff1-b814bdbcad50Product name120190415
7cda52fc-125f-421c-8fea-bc1974370c49Product name220180703
7916de40-e296-41f0-b811-6d0df1a33e2cProduct name920180627
cefa60e2-a5b5-493e-9c54-24735b7dc509Product name220171212
419aab54-5d5a-4146-9453-026d4a9991beProduct name220170525
d5e51f11-ad28-caa4-4b49-4143974782adProduct name120150831
290f523a-f9db-9774-b5a9-e1f908ac1782Product name120150828
0ca1d589-929b-4b33-bc5b-1d84abdafa6aProduct name120150324
fc363c46-397b-4476-ac0f-70e43e8e4592Product name120150324
89dac932-b90a-4410-9ab1-84c53e57de25Product name120150316
5668b646-cd56-c3c7-bdea-3f6b1a8840dbProduct name120140508
810ab97e-f109-f41c-7c83-6a652a9cbf43Product name120140508
87711080-88eb-65c5-b2dd-bf99e700a372Product name120140508
8dbefedf-0a0d-a224-5a3c-66dc9e11c2ddProduct name120140508
c6b65c52-69c7-df49-550a-a50c137f6218Product name120140508
ec2149b3-5c6d-5344-f757-c86411073075Product name120140508
ed912195-5da0-0f2f-6f4b-3ef17710cbe3Product name120140508

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
0065-8067-01GenTeal Tears Gel Drops8 mL in 1 BOTTLE, DROPPERGEL84

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
0065-8067-01ML - Milliliter0065-80672c61a42b-d190-4131-b854-d44d39402a0012021-03-02

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
0065-8067GENTEAL TEARS GEL DROPS (POLYETHYLENE GLYCOL 400 AND PROPYLENE GLYCOL) GEL [ALCON LABORATORIES, INC.]4Current NDC, Legacy NDC, 1 package rows20231215_84388a75-9d11-48ce-bf5a-88f0580d2d03.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
895753polyethylene glycol 400 0.4 % / propylene glycol 0.3 % Ophthalmic GelPSN84388a75-9d11-48ce-bf5a-88f0580d2d034
895753polyethylene glycol 400 0.004 MG/MG / propylene glycol 0.003 MG/MG Ophthalmic GelSCD84388a75-9d11-48ce-bf5a-88f0580d2d034
895753polyethylene glycol 400 0.4 % / propylene glycol 0.3 % Ophthalmic GelSY84388a75-9d11-48ce-bf5a-88f0580d2d034

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
0065-8067-01000658067018 mL in 1 BOTTLE, DROPPER (0065-8067-01) 8 ml2021-02-040000-00-00NoNoCurrent