FDA.reportPublic FDA data

Visine A.C. Itchy Eye Relief

Product NDC
69968-0366
11-digit product format
699680366
Labeler code
69968
Product ID
69968-0366_21d8bf17-920a-739e-e063-6294a90a2882
Type
HUMAN OTC DRUG
Nonproprietary name
Tetrahydrozoline Hydrochloride and Zinc Sulfate, Unspecified Form
Dosage form
SOLUTION/ DROPS
Route
OPHTHALMIC
Labeler
Kenvue Brands LLC
Application
M018
Marketing category
OTC MONOGRAPH DRUG
Marketing start
2019-05-06
Substance
TETRAHYDROZOLINE HYDROCHLORIDE; ZINC SULFATE, UNSPECIFIED FORM
Active strength
.5; 2.5 mg/mL; mg/mL
Pharmacologic classes
Copper Absorption Inhibitor [EPC], Decreased Copper Ion Absorption [PE]
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 A.C. Itchy Eye Relief
Listing expiration
2026-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
TETRAHYDROZOLINE HYDROCHLORIDE.5 mg/mL
ZINC SULFATE, UNSPECIFIED FORM2.5 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
89DS0H96TBInternal UNII lookup

Harmonized RxCUI identifiers#

RxCUI identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
1043249Internal RxNorm lookup

Harmonized SPL set identifiers#

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

Identifier, FDA.report destination table
IdentifierFDA.report destination
257b9666-0163-499b-9673-bf6f4d6899b1Available on FDA.report

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
f47a510b-6679-4664-b2d6-47b5c4afe7ccProduct name420260217
030ce964-9b2d-45aa-b5d3-f78ce03ef61cProduct name220250515
0306390c-dd77-4363-afe0-63c58088b2a1Product name120220120
503ea967-4b9c-48cf-9e87-c7975295849dProduct name220220120
190f2a5b-bbc8-65c7-fcb0-97891307b917Product name120140508
27945931-b6e2-158e-d615-4ef21e2af974Product name120140508

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
69968-0366-1Visine A.C. Itchy Eye Relief1 in 1 CARTONSOLUTION/ DROPS13
69968-0366-1Visine A.C. Itchy Eye Relief15 mL in 1 BOTTLESOLUTION/ DROPS153

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
69968-0366VISINE A.C. ITCHY EYE RELIEF (TETRAHYDROZOLINE HYDROCHLORIDE AND ZINC SULFATE, UNSPECIFIED FORM) SOLUTION/ DROPS [KENVUE BRANDS LLC]3Current NDC, Legacy NDC, 2 package rows20241115_257b9666-0163-499b-9673-bf6f4d6899b1.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 13 of 25 · 499 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
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
Equate Lubricant Eye DropsCARBOXYMETHYLCELLULOSE SODIUM, GLYCERINWalmart443e214b-2680-79a9-e063-6294a90a68ba2025-12-20WarningsExact identifier
application number: M018
Equate Redness and Dry Eye ReliefGLYCERIN, NAPHAZOLINE HYDROCHLORIDEWalmart44155cf8-6fd9-d16f-e063-6394a90ac7312025-12-20WarningsExact identifier
application number: M018
Original Redness RelieverTETRAHYDROLIZINE HCLWalmart4414f768-0c69-d041-e063-6294a90a5bd92025-12-20WarningsExact identifier
application number: M018
Walgreens LubricantPOLYETHYLENE GLYCOL 400, AND PROPYLENE GLYCOLWalgreens21dfe061-4538-2061-e063-6394a90a6e732025-12-19WarningsExact identifier
application number: M018
Artificial TearsGLYCERINGeri-Care Pharmaceuticals, Corp7cc437e3-bad9-59be-e053-2991aa0a1da32025-12-19WarningsExact identifier
application number: M018
Signature Care Eye Drops Redness and Dry Eye ReliefGLYCERIN, NAPHAZOLINE HYDROCHLORIDEBetter Living Brands LLC901f3bbe-e1bb-4e44-879c-711e59813a7f2025-12-19WarningsExact identifier
application number: M018
STYE RELIEF SERUMCARBOXYMETHYLCELLULOSE SODIUM(CMC)Guangzhou Shimei Cosmetics Co., Ltd.45fa7962-b489-4613-e063-6394a90a59b02025-12-15WarningsExact identifier
application number: M018
Gentle Eyes Lubricant Eye DropsCARBOXYMETHYLCELLULOSE SODIUMTRP Company13f99af6-b7d8-a092-e063-6394a90a5daa2025-12-15WarningsExact identifier
application number: M018
Artificial TearsGLYCERINNuCare Pharmaceuticals,Inc.97a3d8e2-b2c0-3f5d-e053-2a95a90ac49d2025-12-15WarningsExact identifier
application number: M018
Eyelash SerumEYELASH SERUMFlexiGo Inc4544adf7-bb24-cb10-e063-6294a90aa4142025-12-06WarningsExact identifier
application number: M018
Redness Reliever, Circle KTETRAHYDROZOLINE HYDROCHLORIDE LIQUIDLil' Drug Store products, Inc.44e95d70-f633-1e4e-e063-6294a90a9f212025-12-01WarningsExact identifier
application number: M018
Splash Pure PFPROPYLENE GLYCOLLABORATORIOS SOPHIA, S.A. DE C.V.40ad7ae5-1f2a-e3b1-e063-6294a90a6f842025-11-26WarningsExact identifier
application number: M018
Eyewash Station Additive ConcentrateCHLORHEXIDINE GLUCONATE AND PROPYLENE GLYCOLNiagara Pharmaceuticals Inc.362a6b6d-862d-4322-87a8-5b3a07fbe1742025-11-24WarningsExact identifier
application number: M018
Rain Daily Hydration and Comfort For Dry EyesGLYCERINRain Eye Drops, LLC31d7c204-fb74-fb28-e063-6294a90ab3302025-11-23WarningsExact identifier
application number: M018
Eyewash Additive ConcentrateWATER AND PROPYLENE GLYCOLHaws Corporationdd168403-398c-41ff-b1df-d93e4ff39de32025-11-20WarningsExact identifier
application number: M018
Walgreens Lubricant Eye DropsCARBOXYMETHYLCELLULOSE SODIUMWalgreen Companya39864a3-2407-7b7e-e053-2a95a90ab92f2025-11-19WarningsExact identifier
application number: M018
Walgreens Lubricant Eye DropsCARBOXYMETHYLCELLULOSE SODIUMWalgreen Companya39919d5-84db-05df-e053-2995a90ab1d22025-11-19WarningsExact identifier
application number: M018
Sodium ChlorideSODIUM CHLORIDEWalgreen Companyd112a344-33cc-41d3-bae6-492631ebdba72025-11-19WarningsExact identifier
application number: M018

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
1043249tetrahydrozoline HCl 0.05 % / zinc sulfate 0.25 % Ophthalmic SolutionPSN257b9666-0163-499b-9673-bf6f4d6899b13
1043249tetrahydrozoline hydrochloride 0.5 MG/ML / zinc sulfate 2.5 MG/ML Ophthalmic SolutionSCD257b9666-0163-499b-9673-bf6f4d6899b13
1043249tetrahydrozoline HCl 0.05 % / zinc sulfate 0.25 % Ophthalmic SolutionSY257b9666-0163-499b-9673-bf6f4d6899b13
1043249Tetrahydrozoline hydrochloride 0.5 MG/ML / ZnSO4 2.5 MG/ML Ophthalmic SolutionSY257b9666-0163-499b-9673-bf6f4d6899b13

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
69968-0366-1699680366011 BOTTLE in 1 CARTON (69968-0366-1) / 15 mL in 1 BOTTLE1 bottle2019-05-060000-00-00NoNoCurrent