GENTEAL TEARS

Product NDC
50090-5050
11-digit product format
500905050
Labeler code
50090
Product ID
50090-5050_209fd8a1-720b-4308-abcd-29ca998d5f49
Type
HUMAN OTC DRUG
Nonproprietary name
Dextran 70, Glycerin, Hypromellose
Dosage form
SOLUTION/ DROPS
Route
OPHTHALMIC
Labeler
A-S Medication Solutions
Application
M018
Marketing category
OTC MONOGRAPH DRUG
Marketing start
2016-03-01
Substance
DEXTRAN 70; GLYCERIN; HYPROMELLOSES
Active strength
1; 2; 3 mg/mL; mg/mL; mg/mL
Pharmacologic classes
Allergens [CS], Cell-mediated Immunity [PE], Glycerol [CS], Increased Histamine Release [PE], Increased IgG Production [PE], Increased Intravascular Volume [PE], Non-Standardized Chemical Allergen [EPC], Osmotic Activity [MoA], Plasma Volume Expander [EPC]
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
Listing expiration
2026-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
DEXTRAN 701 mg/mL
GLYCERIN2 mg/mL
HYPROMELLOSES3 mg/mL

Harmonized Identifiers#

Field, Values table
FieldValues
Unii7SA290YK68, PDC6A3C0OX, 3NXW29V3WO
Rxcui900138

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
9e37788c-b1bf-42ae-aac9-b60601606144Product name820260122
030ce964-9b2d-45aa-b5d3-f78ce03ef61cProduct name220250515
30b0ac6e-02aa-0e5c-0d8b-cffdf3a282b2Product name520250304
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

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
50090-5050-02024-06-14C16284748780-1f386c649-a74c-0266-e053-dadaa90a7c1aGENTEAL TEARS
50090-5050-02023-01-30C16284748780-1f386c649-a74c-0266-e053-dadaa90a7c1aGENTEAL TEARS

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
50090-5050-0GENTEAL TEARS15 mL in 1 BOTTLE, DROPPERSOLUTION/ DROPS157
50090-5050-0GENTEAL TEARS1 in 1 CARTONSOLUTION/ DROPS17

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
50090-5050-0ML - Milliliter50090-5050d9e68000-ed5a-4353-a5cb-d0faafd3438712024-07-12

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
50090-5050GENTEAL TEARS (DEXTRAN 70, GLYCERIN, HYPROMELLOSE) SOLUTION/ DROPS [A-S MEDICATION SOLUTIONS]7Current NDC, Legacy NDC, 2 package rows20240615_a2b715e9-332d-4f0b-b8e5-ebc000681586.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
900138dextran 70 0.1 % / glycerin 0.2 % / hypromellose 0.3 % Ophthalmic SolutionPSNa2b715e9-332d-4f0b-b8e5-ebc0006815867
900138dextran 70 1 MG/ML / glycerin 2 MG/ML / hypromellose 3 MG/ML Ophthalmic SolutionSCDa2b715e9-332d-4f0b-b8e5-ebc0006815867
900138dextran 70 0.1 % / glycerin 0.2 % / hypromellose 0.3 % Ophthalmic SolutionSYa2b715e9-332d-4f0b-b8e5-ebc0006815867

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionMarketing startMarketing endSampleExclude flagStatus
50090-5050-0500905050001 BOTTLE, DROPPER in 1 CARTON (50090-5050-0) / 15 mL in 1 BOTTLE, DROPPER2020-05-150000-00-00NoNoCurrent