FDA.reportPublic FDA data

Visine Red Eye Total Comfort Multi-Symptom

Product NDC
69968-0360
11-digit product format
699680360
Labeler code
69968
Product ID
69968-0360_51c6d5f8-8e6f-161e-e063-6394a90ab0ec
Type
HUMAN OTC DRUG
Nonproprietary name
TETRAHYDROZOLINE HYDROCHLORIDE, POLYETHYLENE GLYCOL 400, and ZINC SULFATE, UNSPECIFIED FORM
Dosage form
SOLUTION/ DROPS
Route
OPHTHALMIC
Labeler
Kenvue Brands LLC
Application
M018
Marketing category
OTC MONOGRAPH DRUG
Marketing start
2020-04-27
Substance
TETRAHYDROZOLINE HYDROCHLORIDE; POLYETHYLENE GLYCOL 400; ZINC SULFATE, UNSPECIFIED FORM
Active strength
.5; 10; 2.5 mg/mL; mg/mL; mg/mL
Pharmacologic classes
Copper Absorption Inhibitor [EPC], Decreased Copper Ion Absorption [PE]
NDC exclude flag
No
Listing certified through
2027-12-31
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
Visine Red Eye Total Comfort Multi-Symptom
Listing expiration
2027-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
TETRAHYDROZOLINE HYDROCHLORIDE.5 mg/mL
POLYETHYLENE GLYCOL 40010 mg/mL
ZINC SULFATE, UNSPECIFIED FORM2.5 mg/mL

Harmonized UNII identifiers#

UNII identifiers page 1 of 1 · 3 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
0YZT43HS7DInternal UNII lookup
B697894SGQInternal UNII lookup
89DS0H96TBInternal UNII lookup

Harmonized RxCUI identifiers#

RxCUI identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
2360903Internal RxNorm lookup

Harmonized SPL set identifiers#

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

Identifier, FDA.report destination table
IdentifierFDA.report destination
5747edef-7a87-41d7-9594-6c78508b9ba2Available on FDA.report

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
f47a510b-6679-4664-b2d6-47b5c4afe7ccProduct name420260217
9e37788c-b1bf-42ae-aac9-b60601606144Product name820260122
030ce964-9b2d-45aa-b5d3-f78ce03ef61cProduct name220250515
726062af-1135-4707-a1d7-57256991bbf9Product name220250226
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
0306390c-dd77-4363-afe0-63c58088b2a1Product name120220120
503ea967-4b9c-48cf-9e87-c7975295849dProduct name220220120
f1e0dc7e-7d61-4625-b6d9-4894927679d7Product name220211025
9badc7be-250a-44ab-aa36-926af3f02679Product name120210527
e4870509-7e28-6f92-f0be-dd3dd889a9cfProduct name520200810
0ec3537a-6c9b-432a-896c-b9ea8723049aProduct name920200701
6e9d4a47-c464-b93e-aebc-ad7bffc9c4cdProduct name220190619
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
c5cd4727-ac49-4409-82b1-5bd8006c3ec7Product name120171122
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
190f2a5b-bbc8-65c7-fcb0-97891307b917Product name120140508
19c71a3d-ed9c-166b-a7e5-38c250c35631Product name120140508
27945931-b6e2-158e-d615-4ef21e2af974Product name120140508
5668b646-cd56-c3c7-bdea-3f6b1a8840dbProduct name120140508
597b1cfd-7b31-5048-62be-ca5cd740da2fProduct name120140508
684ea482-2e8b-14af-5664-b98f1e402036Product name120140508
810ab97e-f109-f41c-7c83-6a652a9cbf43Product name120140508
87711080-88eb-65c5-b2dd-bf99e700a372Product name120140508
8dbefedf-0a0d-a224-5a3c-66dc9e11c2ddProduct name120140508
b060cc1a-fe47-856b-0b77-4448b5963de8Product 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
69968-0360-1Visine Red Eye Total Comfort Multi-Symptom1 in 1 CARTONSOLUTION/ DROPS14
69968-0360-1Visine Red Eye Total Comfort Multi-Symptom15 mL in 1 BOTTLE, DROPPERSOLUTION/ DROPS154
69968-0360-1Visine Red Eye Total Comfort and Tears Dry Eye Relief1 in 1 CARTONSOLUTION/ DROPS0.5 mg in 1mL2
69968-0360-1Visine Red Eye Total Comfort and Tears Dry Eye Relief15 mL in 1 BOTTLE, DROPPERSOLUTION/ DROPS15 mL0.5 mg in 1mL2

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
69968-0360VISINE RED EYE TOTAL COMFORT MULTI-SYMPTOM (TETRAHYDROZOLINE HYDROCHLORIDE, POLYETHYLENE GLYCOL 400, AND ZINC SULFATE, UNSPECIFIED FORM) SOLUTION/ DROPS [KENVUE BRANDS LLC]4Current NDC, Legacy NDC, 2 package rows20241115_5747edef-7a87-41d7-9594-6c78508b9ba2.zip
69968-0360VISINE RED EYE TOTAL COMFORT AND TEARS DRY EYE RELIEF (TETRAHYDROZOLINE HCL, POLYETHYLENE GLYCOL 400, ZINC SULFATE) KIT [KENVUE BRANDS LLC]2Current NDC, Legacy NDC20241116_0bc0d6e7-9195-db6b-e063-6294a90aef04.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 · 486 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
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
Meijer Maximum Redness Relief and LubricantGLYCERIN, NAPHAZOLINE HCIMeijer Distribution, Inc.9feb1818-c79b-23bf-e053-2995a90a10842023-12-22WarningsExact identifier
application number: M018
Meijer Redness ReliefTETRAHYDROZOLINE HCIMeijer Distribution, Inc.9fea27a5-b81b-1598-e053-2995a90a6b622023-12-22WarningsExact identifier
application number: M018
Meijer Seasonal Itching and Redness ReliefTETRAHYDROZOLINE HCI, ZINC SULFATEMeijer Distribution, Inc.9fead2de-2fe6-4dab-e053-2995a90a27422023-12-22WarningsExact identifier
application number: M018
Meijer Artificial TearsPOLYVINYL ALCOHOL, POVIDONEMeijer Distribution, Inc.9feb3eec-a36f-8fc7-e053-2a95a90adcd32023-12-22WarningsExact identifier
application number: M018
Meijer Redness ReliefGLYCERIN, NAPHAZOLINE HCIMeijer Distribution, Inc.9fea4e43-7525-bb66-e053-2a95a90acee92023-12-22WarningsExact identifier
application number: M018
Meijer Ultra Lubricant Eye Drops High PerformancePOLYETHYLENE GLYCOL 400, PROPYLENE GLYCOLMeijer Distribution, Inc.a0846e3e-687c-fd55-e053-2995a90a673e2023-12-22WarningsExact identifier
application number: M018
Meijer Advanced Redness and Irritation ReliefDEXTRAN 70, POLYETHYLENE GLYCOL 400, POVIDONE, TETRAHYDROZOLINE HCIMeijer Distribution, Inc.9fea6d7a-a2cd-d26e-e053-2995a90a15f82023-12-22WarningsExact identifier
application number: M018
Meijer Dry Eye ReliefGLYCERIN, HYPROMELLOSE, POLYETHYLENE GLYCOL 400Meijer Distribution, Inc.9feaa5e2-6aca-96e8-e053-2a95a90a54bd2023-12-22WarningsExact identifier
application number: M018

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
2360903polyethylene glycol 400 1 % / tetrahydrozoline hydrochloride 0.05 % / zinc sulfate 0.25 % Ophthalmic SolutionPSN5747edef-7a87-41d7-9594-6c78508b9ba24
2360903polyethylene glycol 400 10 MG/ML / tetrahydrozoline hydrochloride 0.5 MG/ML / zinc sulfate 2.5 MG/ML Ophthalmic SolutionSCD5747edef-7a87-41d7-9594-6c78508b9ba24
2360903polyethylene glycol 400 1 % / tetrahydrozoline hydrochloride 0.05 % / zinc sulfate 0.25 % Ophthalmic SolutionSY5747edef-7a87-41d7-9594-6c78508b9ba24
2360903polyethylene glycol 400 10 MG/ML / tetrahydrozoline hydrochloride 0.5 MG/ML / ZnSO4 2.5 MG/ML Ophthalmic SolutionSY5747edef-7a87-41d7-9594-6c78508b9ba24
2360903polyethylene glycol 400 1 % / tetrahydrozoline hydrochloride 0.05 % / zinc sulfate 0.25 % Ophthalmic SolutionPSN0bc0d6e7-9195-db6b-e063-6294a90aef042
2360899polyethylene glycol 400 1 % Ophthalmic SolutionPSN0bc0d6e7-9195-db6b-e063-6294a90aef042
2360903polyethylene glycol 400 10 MG/ML / tetrahydrozoline hydrochloride 0.5 MG/ML / zinc sulfate 2.5 MG/ML Ophthalmic SolutionSCD0bc0d6e7-9195-db6b-e063-6294a90aef042
2360899polyethylene glycol 400 10 MG/ML Ophthalmic SolutionSCD0bc0d6e7-9195-db6b-e063-6294a90aef042
2360903polyethylene glycol 400 1 % / tetrahydrozoline hydrochloride 0.05 % / zinc sulfate 0.25 % Ophthalmic SolutionSY0bc0d6e7-9195-db6b-e063-6294a90aef042
2360899polyethylene glycol 400 1 % Ophthalmic SolutionSY0bc0d6e7-9195-db6b-e063-6294a90aef042
2360903polyethylene glycol 400 10 MG/ML / tetrahydrozoline hydrochloride 0.5 MG/ML / ZnSO4 2.5 MG/ML Ophthalmic SolutionSY0bc0d6e7-9195-db6b-e063-6294a90aef042

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionMarketing startMarketing endSampleExclude flagStatus
69968-0360-1699680360011 BOTTLE, DROPPER in 1 CARTON (69968-0360-1) / 15 mL in 1 BOTTLE, DROPPER2020-04-270000-00-00NoNoCurrent