FDA.reportPublic FDA data

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

Observed NDC auxiliary status history#

This history shows the information present in each captured FDA auxiliary file. It is not a continuous regulatory timeline, and a missing record does not establish a status.

Historic NDC status page 1 of 1 · 6 matching rows.

View current auxiliary records. · View the auxiliary file history.

Captured / source date, Dataset, Scope table
Captured / source dateDatasetScopePackage NDCSnapshotSource SHA-256
2024-05-28 21:12 UTC · source 2024-05-28excluded productproduct8af77b9d5b6f…d9bbb34c5368…
2024-05-28 21:12 UTC · source 2024-05-28excluded packagepackage50090-5050-08af77b9d5b6f…d9bbb34c5368…
2024-05-15 03:39 UTC · source 2024-05-14excluded productproduct834df4deac94…adcc014656a3…
2024-05-15 03:39 UTC · source 2024-05-14excluded packagepackage50090-5050-0834df4deac94…adcc014656a3…
2024-03-11 06:39 UTC · source 2024-03-08excluded productproduct1332a3947898…d4bfe170f9cd…
2024-03-11 06:39 UTC · source 2024-03-08excluded packagepackage50090-5050-01332a3947898…d4bfe170f9cd…

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
Listing expiration
2026-12-31

Active Ingredients#

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

Harmonized UNII identifiers#

UNII identifiers page 1 of 1 · 3 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
7SA290YK68Internal UNII lookup
PDC6A3C0OXInternal UNII lookup
3NXW29V3WOInternal UNII lookup

Harmonized RxCUI identifiers#

RxCUI identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
900138Internal RxNorm lookup

Harmonized SPL set identifiers#

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

Identifier, FDA.report destination table
IdentifierFDA.report destination
a2b715e9-332d-4f0b-b8e5-ebc000681586Available on FDA.report

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

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 12 of 25 · 494 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Quality Choice Lubricant Eye Drops Long LastingPOLYETHYLENE GLYCOL 400, PROPYLENE GLYCOLChain Drug Marketing Assoc., Inc.0cd91c45-88a2-f88c-e063-6294a90ad1272025-12-30WarningsExact identifier
application number: M018
Quality Choice Eye WashWATERChain Drug Marketing Assoc., Inc.1fb8a109-351b-7039-e063-6394a90a73112025-12-30WarningsExact identifier
application number: M018
Rite Aid Eye WashPURIFIED WATERRite Aid28a18e04-d735-a511-e063-6394a90af6bb2025-12-30WarningsExact identifier
application number: M018
Preferred Plus Pharmacy Redness Relief Eye DropsTETRAHYDROZOLINE HCLKinray9ffd67c4-b5c1-d587-e053-2a95a90ae3d02025-12-30WarningsExact identifier
application number: M018
Leader Lubricant Eye Drops Soothing ReliefCARBOXYMETHYLCELLULOSE SODIUMLEADER/Cardinal Health 110, Inc.218629d4-2704-a503-e063-6294a90a39532025-12-30WarningsExact identifier
application number: M018
Foster and Thrive Lubricant Eye DropsCARBOXYMETHYLCELLULOSE SODIUMStrategic Sourcing Services LLCfb85ebc0-1570-972b-e053-6294a90a3dc42025-12-30WarningsExact identifier
application number: M018
Archies Dry Eye ReliefPOLYETHYLENE GLYCOL 400, PROPYLENE GLYCOLArchie's Remedies07da099b-6b7f-984d-e063-6294a90a12ac2025-12-30WarningsExact identifier
application number: M018
Equate Optimal Hydration Lubricant Eye DropsCARBOXYMETHYLCELLULOSE SODIUM, GLYCERINWalmart, Inc.151b9723-5d5e-ac2b-e063-6294a90af0732025-12-30WarningsExact identifier
application number: M018
Equate Nighttime Relief LubricantLIGHT MINERAL OIL, WHITE PETROLATUMWalmart Inc.152171db-2f2a-9d36-e063-6394a90a72252025-12-30WarningsExact identifier
application number: M018
Equate Moisturizing Comfort Lubricant Eye DropsCARBOXYMETHYLCELLULOSE SODIUMWalmart Inc.152028bd-0429-720a-e063-6294a90a14652025-12-30WarningsExact identifier
application number: M018
Equaline Multi-Symptom Eye DropsPOLYETHYLENE GLYCOL 400, TETRAHYDROZOLINE HCL, ZINC SULFATEUnited Natural Foods, Inc.fe467606-6d66-b695-e053-6294a90aab5d2025-12-30WarningsExact identifier
application number: M018
OCUFRESHWATEROptics Laboratory Inc.b8e477a9-66b9-496b-92fb-3d4bbd7b36b52025-12-29WarningsExact identifier
application number: M018
Kollourion Eyesalve EyewashPURIFIED WATER 98.3%Miracle Eye Pharmaceuticalsb56d2ab9-169b-b490-e053-2a95a90a80b32025-12-28WarningsExact identifier
application number: M018
Equate Lubricant Eye DropsCARBOXYMETHYLCELLULOSE SODIUM, GLYCERINHanlim46851e7c-8910-6456-e063-6394a90abafb2025-12-22WarningsExact identifier
application number: M018
Equate Lubricant Eye DropsCARBOXYMETHYLCELLULOSE SODIUMHanlim46854996-a0b9-46b4-e063-6294a90aa4332025-12-22WarningsExact identifier
application number: M018
Equate Nighttime Relief LubricantLIGHT MINERAL OIL, WHITE PETROLATUMHanlim Pharm Co. LTD468559a0-9586-9982-e063-6394a90af4662025-12-22WarningsExact identifier
application number: M018
Redness and Dry Eye ReliefGLYCERIN, NAPHAZOLINE HYDROCHLORIDEKC Pharmaceuticals, Inc4682f68d-6bdd-d860-e063-6394a90a2b522025-12-21WarningsExact identifier
application number: M018
Original Redness RelieverTETRAHYDROLIZINE HCLKC Pharmaceuticals4683b850-b0fc-5093-e063-6294a90aef442025-12-21WarningsExact identifier
application number: M018
Equate Nighttime Relief LubricantLIGHT MINERAL OIL, WHITE PETROLATUMWalmart4449a55b-2cd4-0cb9-e063-6294a90aafbc2025-12-20WarningsExact identifier
application number: M018
Equate Lubricant Eye DropsCARBOXYMETHYLCELLULOSE SODIUMWalmart44494842-e38d-617c-e063-6294a90afaf82025-12-20WarningsExact identifier
application number: M018

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