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 23 of 25 · 499 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Walgreens Lubricant Eye Drops Dry Eye 15mL and twin packPOLYETHYLENE GLYCOL 400, PROPYLENE GLYCOLWalgreen Company94f6e1cd-073c-61ca-e053-2a95a90ae7252023-12-20WarningsExact identifier
application number: M018
Lubricant Eye Drops Preservative FreeCARBOXYMETHYLCELLULOSE SODIUMTarget Corporation454ce049-49e5-48b1-8499-048e5e7d72d32023-12-20WarningsExact identifier
application number: M018
Rugby Lubricant Eye DropsCARBOXYMETHYLCELLULOSE SODIUMRugby Laboratoriesf9292d5d-e0a3-9287-e053-6294a90a43e92023-12-20WarningsExact identifier
application number: M018
Rugby Eye WashWATER, PURIFIEDRugby Laboratories1fee974b-4c29-4965-bd3d-da5e219eb13a2023-12-20WarningsExact identifier
application number: M018
Signature Care Eye Drops Advanced ReliefDEXTRAN 70, POLYETHYLENE GLYCOL 400, POVIDONE, TETRAHYDROZOLINE HCLBetter Living Brands LLC5d7228ce-f108-4cc2-9aec-8b4548c3a1552023-12-20WarningsExact identifier
application number: M018
Target Eye Drops Maximum Redness Relief EyeGLYCERIN, NAPHAZOLINE HYDROCHLORIDETarget Corporation1b26cd3b-4a05-4623-b320-01f22b3106ff2023-12-20WarningsExact identifier
application number: M018
Kroger High Performance Lubricant Eye DropsPOLYETHYLENE GLYCOL 400, PROPYLENE GLYCOLKrogerd2aa8963-1922-02f3-e053-2a95a90a7d932023-12-20WarningsExact identifier
application number: M018
Kroger Eye Drops Seasonal ReliefTETRAHYDROZOLINE HCL, ZINC SULFATEKrogerf6829be4-e3b7-7ff2-e053-2995a90a80fc2023-12-20WarningsExact identifier
application number: M018
Rite Aid Multi-Symptom Relief Eye DropsPOLYETHYLENE GLYCOL 400, TETRAHYDROZOLINE HCL, ZINC SULFATERite Aid Corporationefa7d208-9d42-13c7-e053-2a95a90a11b32023-12-20WarningsExact identifier
application number: M018
Signature Care Lubricant Eye DropsCARBOXYMETHYLCELLULOSE SODIUMBetter Living Brands LLCea358e01-f03e-454b-bae1-6c83da44c3692023-12-20WarningsExact identifier
application number: M018
TopCare Health Original Eye DropsTETRAHYDROZOLINE HCLTopco Associates LLC9c61a56a-c1a9-2846-e053-2995a90a755b2023-12-20WarningsExact identifier
application number: M018
Signature Care Eye Drops A.C.TETRAHYDROZOLINE HCL, ZINC SULFATEBetter Living Brands LLCf685aca4-93d0-26d9-e053-2995a90a6e512023-12-20WarningsExact identifier
application number: M018
Kroger Lubricant EyeCARBOXYMETHYLCELLULOSE SODIUMThe Kroger Co.046f4ebc-d8f9-4755-b6ba-790fe86f31282023-12-20WarningsExact identifier
application number: M018
Kroger Eye Drops Advanced ReliefDEXTRAN 70, POLYETHYLENE GLYCOL 400, POVIDONE, TETRAHYDROZOLINE HYDROCHLORIDEKroger Companyf7ad77fc-d890-25b9-e053-6394a90a2b122023-12-20WarningsExact identifier
application number: M018
TopCare Health Dry Eye Relief Eye DropsGLYCERIN, HYPROMELLOSE, POLYETHYLENE GLYCOL 400Topco Associates LLC9c617e34-fc66-1a5b-e053-2995a90ace2c2023-12-20WarningsExact identifier
application number: M018
Equaline Advanced Relief Eye DropsDEXTRAN 70, POLYETHYLENE GLYCOL 400, POVIDONE, TETRAHYDROZOLINE HYDROCHLORIDEUnited Natural Foods, Inc.f7602789-179a-edfc-e053-6294a90a08442023-12-20WarningsExact identifier
application number: M018
Topcare Health Ultra Itch Relief Astringent Eye DropsTETRAHYDROZOLINE HCL, ZINC SULFATETopco Associates LLC9c617e34-fc64-1a5b-e053-2995a90ace2c2023-12-20WarningsExact identifier
application number: M018
Topcare Health Artificial TearsPOLYVINYL ALCOHOL, POVIDONETopco Associates LLC9c614c0e-5862-682f-e053-2a95a90abc092023-12-20WarningsExact identifier
application number: M018
Topcare Health Lubricant Eye DropsPOLYETHYLENE GLYCOL 400, PROPYLENE GLYCOLTopco Assoc LLC9c6284f9-00bb-37b5-e053-2a95a90ae2ee2023-12-20WarningsExact identifier
application number: M018
HEB Dry Eye Eye DropsGLYCERIN, HYPROMELLOSE, POLYETHYLENE GLYCOL 400HEBf80023cf-8e42-780a-e053-6294a90a66cd2023-12-20WarningsExact 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