FDA.reportPublic FDA data

Visine Red Eye Hydrating Comfort

Product NDC
69968-0356
11-digit product format
699680356
Labeler code
69968
Product ID
69968-0356_21d7a4ce-7eb1-1416-e063-6294a90a9a98
Type
HUMAN OTC DRUG
Nonproprietary name
TETRAHYDROZOLINE HYDROCHLORIDE and Polyethylene Glycol 400
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
Active strength
.5; 10 mg/mL; mg/mL
NDC exclude flag
No
Listing certified through
2026-12-31
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 Hydrating Comfort
Brand name suffix
Eye Drops
Listing expiration
2026-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
TETRAHYDROZOLINE HYDROCHLORIDE.5 mg/mL
POLYETHYLENE GLYCOL 40010 mg/mL

Harmonized UNII identifiers#

UNII identifiers page 1 of 1 · 2 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
0YZT43HS7DInternal 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
996209Internal RxNorm lookup

Harmonized SPL set identifiers#

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

Identifier, FDA.report destination table
IdentifierFDA.report destination
a9a90de6-3172-4d34-984b-f4442f880e3dAvailable on FDA.report

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
9e37788c-b1bf-42ae-aac9-b60601606144Product name820260122
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
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
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
19c71a3d-ed9c-166b-a7e5-38c250c35631Product name120140508
27945931-b6e2-158e-d615-4ef21e2af974Product name120140508
5668b646-cd56-c3c7-bdea-3f6b1a8840dbProduct name120140508
597b1cfd-7b31-5048-62be-ca5cd740da2fProduct 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
69968-0356-1Visine Red Eye Hydrating ComfortEye Drops8 mL in 1 BOTTLE, DROPPERSOLUTION/ DROPS84
69968-0356-1Visine Red Eye Hydrating ComfortEye Drops700 in 1 CONTAINER, FLEXIBLE INTERMEDIATE BULKSOLUTION/ DROPS7004
69968-0356-2Visine Red Eye Hydrating ComfortEye Drops1 in 1 CARTONSOLUTION/ DROPS14
69968-0356-2Visine Red Eye Hydrating ComfortEye Drops15 mL in 1 BOTTLE, DROPPERSOLUTION/ DROPS154
69968-0356-3Visine Red Eye Hydrating ComfortEye Drops8 mL in 1 BOTTLE, DROPPERSOLUTION/ DROPS84
69968-0356-3Visine Red Eye Hydrating ComfortEye Drops1 in 1 CARTONSOLUTION/ DROPS14
69968-0356-4Visine Red Eye Hydrating ComfortEye Drops8 mL in 1 BOTTLE, DROPPERSOLUTION/ DROPS84
69968-0356-4Visine Red Eye Hydrating ComfortEye Drops1 in 1 BLISTER PACKSOLUTION/ DROPS14

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
69968-0356VISINE RED EYE HYDRATING COMFORT EYE DROPS (TETRAHYDROZOLINE HYDROCHLORIDE AND POLYETHYLENE GLYCOL 400) SOLUTION/ DROPS [KENVUE BRANDS LLC]4Current NDC, Legacy NDC, 8 package rows20241115_a9a90de6-3172-4d34-984b-f4442f880e3d.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 25 of 25 · 494 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Rugby Lubricating DropsPOLYVINYL ALCOHOLA-S Medication Solutionsf2e26f85-4081-425b-9c81-ac2a079a57432023-11-10WarningsExact identifier
application number: M018
SalineNASALGERI-CARE PHARMACEUTICAL CORPd293cc13-4043-0d58-e053-2995a90a3fbc2023-10-24WarningsExact identifier
application number: M018
Eyeganics Organic TearsGLYCERINEyeganics LLC42470af7-a3ae-4e14-88e0-04cd92db4b372023-10-13WarningsExact identifier
application number: M018
Refresh Digital PFCARBOXYMETHYLCELLULOSE SODIUM, GLYCERIN AND POLYSORBATE 80Allergan, Inc.97e83e68-6374-4df4-93f6-d707fc32748d2022-11-28WarningsExact identifier
application number: M018
Refresh DigitalCARBOXYMETHYLCELLULOSE SODIUM, GLYCERIN, POLYSORBATE 80Allergan, Inc.b2bd34d4-fab9-4f4b-9be2-5d30b55f5b812022-11-28WarningsExact identifier
application number: M018
REFRESH OPTIVECARBOXYMETHYLCELLULOSE SODIUM AND GLYCERINAllergan, Inc.7f8d88af-fd3b-4138-af61-f24c59ccebd72022-09-23WarningsExact identifier
application number: M018
REFRESH OPTIVE AdvancedCARBOXYMETHYLCELLULOSE SODIUM, GLYCERIN, POLYSORBATE 80Allergan, Inc.ebd0839e-2e1d-4e0e-986c-19f1f5c763582022-09-15WarningsExact identifier
application number: M018
REFRESH OPTIVE AdvancedCARBOXYMETHYLCELLULOSE SODIUM, GLYCERIN, AND POLYSORBATE 80Allergan, Inc.aaa943e4-7c38-4c5a-b7c0-5a656d8cafc02022-09-01WarningsExact identifier
application number: M018
REFRESH TEARSCARBOXYMETHYLCELLULOSE SODIUMAllergan, Inc.329d1fe0-4432-4565-b7b1-65666bd865262022-06-30WarningsExact identifier
application number: M018
REFRESH Optive Mega-3CARBOXYMETHYLCELLULOSE SODIUM, GLYCERIN AND POLYSORBATE 80Allergan, Inc.c5f2b3f2-2071-45bd-a010-67f848bc02332022-06-30WarningsExact identifier
application number: M018
REFRESH P.M.MINERAL OIL, PETROLATUMAllergan, Inc.24365d64-cd94-41cc-a7e1-033102d981142022-06-30WarningsExact identifier
application number: M018
REFRESH PLUSCARBOXYMETHYLCELLULOSE SODIUMAllergan, Inc.0f6a4b4b-cde6-4518-84b5-ce997f1154a72022-06-28WarningsExact identifier
application number: M018
CIRCLE K sterile eye dropsTETRAHYDROZOLINE HCLLil' Drug Store Products, Inc.2c0e106c-16f6-ff4e-e063-6294a90a7dbb2018-07-30WarningsExact identifier
application number: M018
Lil Drug Store Sterile Eye Drops Redness RelieverTETRAHYDROZOLINE HCLLil' Drug Store Products, Inc.2c0ea35c-ac52-1043-e063-6394a90a061c2018-04-30WarningsExact identifier
application number: M018

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
996209polyethylene glycol 400 1 % / tetrahydrozoline HCl 0.05 % Ophthalmic SolutionPSNa9a90de6-3172-4d34-984b-f4442f880e3d4
996209polyethylene glycol 400 10 MG/ML / tetrahydrozoline hydrochloride 0.5 MG/ML Ophthalmic SolutionSCDa9a90de6-3172-4d34-984b-f4442f880e3d4
996209PEG 400 1 % / tetrahydrozoline hydrochloride 0.05 % Ophthalmic SolutionSYa9a90de6-3172-4d34-984b-f4442f880e3d4
996209polyethylene glycol 400 1 % / tetrahydrozoline HCl 0.05 % Ophthalmic SolutionPSNa70751ff-a313-49a7-e053-2a95a90a54472
996209polyethylene glycol 400 10 MG/ML / tetrahydrozoline hydrochloride 0.5 MG/ML Ophthalmic SolutionSCDa70751ff-a313-49a7-e053-2a95a90a54472
996209PEG 400 1 % / tetrahydrozoline hydrochloride 0.05 % Ophthalmic SolutionSYa70751ff-a313-49a7-e053-2a95a90a54472
996209polyethylene glycol 400 1 % / tetrahydrozoline HCl 0.05 % Ophthalmic SolutionPSNdcd4164c-aa1e-4f07-ab2c-b439275629db1
996209polyethylene glycol 400 1 % / tetrahydrozoline HCl 0.05 % Ophthalmic SolutionPSNf845931b-98f7-4edc-b137-0609c9b114751
996209polyethylene glycol 400 10 MG/ML / tetrahydrozoline hydrochloride 0.5 MG/ML Ophthalmic SolutionSCDdcd4164c-aa1e-4f07-ab2c-b439275629db1
996209polyethylene glycol 400 10 MG/ML / tetrahydrozoline hydrochloride 0.5 MG/ML Ophthalmic SolutionSCDf845931b-98f7-4edc-b137-0609c9b114751
996209PEG 400 1 % / tetrahydrozoline hydrochloride 0.05 % Ophthalmic SolutionSYdcd4164c-aa1e-4f07-ab2c-b439275629db1
996209PEG 400 1 % / tetrahydrozoline hydrochloride 0.05 % Ophthalmic SolutionSYf845931b-98f7-4edc-b137-0609c9b114751

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionMarketing startMarketing endSampleExclude flagStatus
69968-0356-169968035601700 BOTTLE, DROPPER in 1 CONTAINER, FLEXIBLE INTERMEDIATE BULK (69968-0356-1) / 8 mL in 1 BOTTLE, DROPPER2020-04-270000-00-00NoNoCurrent
69968-0356-2699680356021 BOTTLE, DROPPER in 1 CARTON (69968-0356-2) / 15 mL in 1 BOTTLE, DROPPER2020-04-270000-00-00NoNoCurrent
69968-0356-3699680356031 BOTTLE, DROPPER in 1 CARTON (69968-0356-3) / 8 mL in 1 BOTTLE, DROPPER2020-04-270000-00-00NoNoCurrent
69968-0356-4699680356041 BOTTLE, DROPPER in 1 BLISTER PACK (69968-0356-4) / 8 mL in 1 BOTTLE, DROPPER2020-04-270000-00-00NoNoCurrent