FDA.reportPublic FDA data

Leader Dry Eye Relief Eye Drops

Product NDC
70000-0502
11-digit product format
700000502
Labeler code
70000
Product ID
70000-0502_5944f7bf-c84b-497f-e063-6394a90aed1f
Type
HUMAN OTC DRUG
Nonproprietary name
Glycerin, Hypromellose, Polyethylene glycol 400
Dosage form
SOLUTION/ DROPS
Route
OPHTHALMIC
Labeler
CARDINAL HEALTH 110, LLC. DBA LEADER
Application
M018
Marketing category
OTC MONOGRAPH DRUG
Marketing start
2019-04-30
Marketing end
2027-02-28
Substance
GLYCERIN; HYPROMELLOSE, UNSPECIFIED; POLYETHYLENE GLYCOL 400
Active strength
.2; .2; 1 g/100mL; g/100mL; g/100mL
Pharmacologic classes
Allergens [CS], Cell-mediated Immunity [PE], Glycerol [CS], Increased Histamine Release [PE], Increased IgG Production [PE], Non-Standardized Chemical Allergen [EPC]
NDC exclude flag
No
Current FDA listing
Yes

NDC auxiliary status#

These records are reproduced from FDA’s unfinished, excluded, and compounder listings. They describe what appeared in the source files; a missing record does not establish a regulatory status. View all current auxiliary records, including entries without an NDC. · View the auxiliary file history.

Current NDC status page 1 of 1 · 1 matching rows.

Dataset, Scope, Product NDC table
DatasetScopeProduct NDCPackage NDCCodeStatusReporting periodSource date
excluded packagepackage70000-050270000-0502-2DDiscontinued by firm2026-10-15

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 · 2 matching rows.

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

Captured / source date, Dataset, Scope table
Captured / source dateDatasetScopeProduct NDCPackage NDCCodeStatusReporting periodArchiveSnapshotSource SHA-256
2025-12-14 17:58 UTC · source 2025-12-05excluded packagepackage70000-050270000-0502-2DDiscontinued by firmexcluded / ndc_excluded.zipd630ba8d3edf…732f749b63fb…
2025-08-27 00:01 UTC · source 2025-08-26excluded packagepackage70000-050270000-0502-2DDiscontinued by firmexcluded / ndc_excluded.zipf5e01cc5f278…a2eaf40c39c3…

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
Leader Dry Eye Relief Eye Drops

Active Ingredients#

Ingredient, Strength table
IngredientStrength
GLYCERIN.2 g/100mL
HYPROMELLOSE, UNSPECIFIED.2 g/100mL
POLYETHYLENE GLYCOL 4001 g/100mL

Harmonized UNII identifiers#

UNII identifiers page 1 of 1 · 3 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
PDC6A3C0OXInternal UNII lookup
3NXW29V3WOInternal UNII lookup
B697894SGQInternal UNII lookup

Harmonized RxCUI identifiers#

RxCUI identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
259581Internal RxNorm lookup

Harmonized SPL set identifiers#

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

Identifier, FDA.report destination table
IdentifierFDA.report destination
2ded4bda-b3c3-4521-8701-5c8446fd148bAvailable on FDA.report

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
fb7ab793-2c12-4079-b100-a64f73bef25aProduct name420240712
362d7abb-94e6-4c60-9a58-266894157713Product name120231023
b0cbf770-6cc3-4aa4-9158-755110c2b9f7Product name220230717
dc7c5daa-021f-40dd-b00d-63982cb2067aProduct name120230426
9fcb7a91-de07-4f00-aabf-e4d6fda403d5Product name820230322
6bd95106-a412-1dad-b9cc-4cb74bfb27ceProduct name220230315
9badc7be-250a-44ab-aa36-926af3f02679Product name120210527
08ffbcbf-26df-b99c-1dab-64fc4cfae89fProduct name520200925
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
08ffbcbf-26df-b99c-1dab-64fc4cfae89fProduct name220160823
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
70000-0502-1Leader Dry Eye Relief Eye Drops1 in 1 CARTONSOLUTION/ DROPS17
70000-0502-1Leader Dry Eye Relief Eye Drops15 mL in 1 BOTTLE, PLASTICSOLUTION/ DROPS157
70000-0502-2Leader Dry Eye Relief Eye Drops2 in 1 CARTONSOLUTION/ DROPS27
70000-0502-2Leader Dry Eye Relief Eye Drops15 mL in 1 BOTTLE, PLASTICSOLUTION/ DROPS157

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
70000-0502-1ML - Milliliter70000-05021f203b31-da5d-4e94-9c33-96546f6e91ec12020-02-13
70000-0502-2ML - Milliliter70000-0502cf12542e-c79c-433c-bb69-279435fa1c4812020-04-20

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
70000-0502LEADER DRY EYE RELIEF EYE DROPS (GLYCERIN, HYPROMELLOSE, POLYETHYLENE GLYCOL 400) SOLUTION/ DROPS [CARDINAL HEALTH]5Current NDC, Legacy NDC, 4 package rows20240104_2ded4bda-b3c3-4521-8701-5c8446fd148b.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 21 of 25 · 494 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Discount Drug Mart Redness Relief Eye DropsGLYCERIN, NAPHAZOLINE HYDROCHLORIDEDiscount Drug Mart, Inc.31a98e6c-42df-6b56-e063-6294a90a35642024-01-01WarningsExact identifier
application number: M018
Harris Teeter Ultra Lubricant Eye DropsPOLYETHYLENE GLYCOL 400, PROPYLENE GLYCOLHarris Teeter, LLC.31ac6883-ffc6-39de-e063-6294a90a52dd2024-01-01WarningsExact identifier
application number: M018
Exchange Select High Performance Lubricant Eye DropsPOLYETHYLENE GLYCOL 400, PROPYLENE GLYCOLArmy and Air Force Exchange Service31ac8bd2-c2e9-6f2c-e063-6394a90adc722024-01-01WarningsExact identifier
application number: M018
CVS Health Fast Acting Lubricant Eye DropsPOLYETHYLENE GLYCOL 400, PROPYLENE GLYCOLCVS Pharmacy, Inc.31addfd2-52f2-05b3-e063-6294a90a337f2024-01-01WarningsExact identifier
application number: M018
Equate Eye Drops Dry Eye ReliefGLYCERIN, HYPROMELLOSE, POLYETHYLENE GLYCOL 400Wal-Mart Stores, Inc.91fb8fb5-b871-4535-e053-2995a90a9b162023-12-23WarningsExact identifier
application number: M018
Equate Lubricant Eye Drops Preservative-FreeCARBOXYMETHYLCELLULOSE SODIUMWal-Mart Stores, Inc.9228a39b-38d2-1dfc-e053-2a95a90a3c902023-12-23WarningsExact identifier
application number: M018
Equate Restore Plus Lubricant Eye DropsCARBOXYMETHYLCELLULOSE SODIUMWalmart, Inc.9e665ca2-4fa6-fdb4-e053-2a95a90abcca2023-12-23WarningsExact identifier
application number: M018
Sunmark Eye Drops Advanced Moisturizer/LubricantDEXTRAN, POLYETHYLENE GLYCOL 400, POVIDONE, TETRAHYDROZOLINEStrategic Sourcing Services LLC0daa4e39-0447-44b6-a7d7-370b12bf94512023-12-23WarningsExact identifier
application number: M018
Equate Lubricant Eye Drops High PerformancePOLYETHYLENE GLYCOL 400, PROPYLENE GLYCOLWal-Mart Stores, Inc.91f85a72-5270-e4db-e053-2995a90aeb212023-12-23WarningsExact identifier
application number: M018
Equate Lubricant Eye DropsPOLYETHYLENE GLYCOL 400, PROPYLENE GLYCOLWal-Mart Stores, Inc.e32233ef-ea15-45b8-8e83-b658cf4c56a02023-12-23WarningsExact identifier
application number: M018
Sunmark Eye Drops Original FormulaTETRAHYDROZOLINE HCLStrategic Sourcing Services LLC33efa7e9-4c3a-4d72-af31-c5e35095c2ff2023-12-23WarningsExact identifier
application number: M018
Sunmark Lubricant Eye DropsPOLYPROPYLENE GLYCOL 400, PROPYLENE GLYCOLStrategic Sourcing Services LLCb117ff0a-1a48-4022-96e6-52bc45f056fc2023-12-23WarningsExact identifier
application number: M018
Sunmark Dry Eye ReliefGLYCERIN, HYPROMELLOSE, POLYETHYLENE GLYCOL 400Strategic Sourcing Services LLC043ccc34-44ee-416a-88bc-f247774e90752023-12-23WarningsExact identifier
application number: M018
Sunmark Lubricating TearsPOLYETHYLENE GLYCOL 400, PROPYLENE GLYCOLStrategic Sourcing Services LLC58f0b6d7-6072-40fd-ba72-b3ed688347912023-12-23WarningsExact identifier
application number: M018
Leader Lubricant Eye DropsCARBOXYMETHYLCELLULOSE SODIUMCardinal Health8d9a4eec-bf0e-6c3b-e053-2995a90ae9aa2023-12-23WarningsExact identifier
application number: M018
Leader Eye WashPURIFIED WATERCardinal Health8d3ad11f-1945-f838-e053-2995a90a7aa52023-12-23WarningsExact identifier
application number: M018
Good Neighbor Pharmacy Lubricant Eye DropsCARBOXYMETHYLCELLULOSE SODIUMAmerisource Bergen Drug Corp.fd2dc23f-6ccc-2644-e053-6294a90a889e2023-12-23WarningsExact identifier
application number: M018
Rite Aid Eye Drops Dry Eye ReliefGLYCERIN, HYPROMELLOSE, POLYETHYLENE GLYCOL 400Rite Aid Corporationfa1b5b66-9643-e9a7-e053-6394a90ae3cf2023-12-23WarningsExact identifier
application number: M018
Signature Care Lubricant Eye Drops Long LastingPOLYETHYLENE GLYCOL 400, PROPYLENE GLYCOLBetter Living Brands, LLC05a63929-fccd-2936-e063-6294a90aeac52023-12-23WarningsExact identifier
application number: M018
Meijer Lubricant Eye DropsPOLYETHYLENE GLYCOL 400, PROPYLENE GLYCOLMeijer Distribution, Inc.9feadde4-fbe5-0c9e-e053-2995a90a9b302023-12-22WarningsExact identifier
application number: M018

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
259581glycerin 0.2 % / hypromellose 0.2 % / polyethylene glycol 400 1 % Ophthalmic SolutionPSN2ded4bda-b3c3-4521-8701-5c8446fd148b7
259581glycerin 2 MG/ML / hypromellose 2 MG/ML / polyethylene glycol 400 10 MG/ML Ophthalmic SolutionSCD2ded4bda-b3c3-4521-8701-5c8446fd148b7
259581glycerin 0.2 % / hypromellose 0.2 % / PEG 400 1 % Ophthalmic SolutionSY2ded4bda-b3c3-4521-8701-5c8446fd148b7

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionMarketing startMarketing endSampleExclude flagStatus
70000-0502-1700000502011 BOTTLE, PLASTIC in 1 CARTON (70000-0502-1) / 15 mL in 1 BOTTLE, PLASTIC2019-04-302027-02-28NoNoCurrent
70000-0502-2700000502022 BOTTLE, PLASTIC in 1 CARTON (70000-0502-2) > 15 mL in 1 BOTTLE, PLASTIC2019-04-300000-00-00NoNoCurrent