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 17 of 25 · 499 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Hydropure Lubricating Eye DropsGLYCERINOTE North America17f5b6e5-dc14-45c7-e063-6294a90af43d2025-02-14WarningsExact identifier
application number: M018
Walgreens Soothing Eye Relief Lubricant Eye DropsPOLYVINYL ALCOHOL, POVIDONEWalgreens Co.29b7387b-ad65-3a11-e063-6394a90a6a152025-02-14WarningsExact identifier
application number: M018
Eyesaline Eyewash ConcentratePURIFIED WATERHoneywell Safety Products, Inc.2d90c8e8-f479-3535-e063-6394a90af1222025-02-07WarningsExact identifier
application number: M018
Code Red Eye Drops Redness ReliefPOLYETHYLENE GLYCOL 400, TETRAHYDROZOLINE HCL4 Trees, LLC0aa08018-cc2d-d947-e063-6394a90a914a2025-02-07WarningsExact identifier
application number: M018
Tyson 2.0 Mike Red Eye Drops For Dry High EyesGLYCERIN, NAPHAZOLINE HCLJbrands Pharma L.L.C.288e9c85-0562-89bf-e063-6394a90a110d2025-02-07WarningsExact identifier
application number: M018
Sodium Chloride Normal SaltSODIUM CHLORIDECitragen Pharmaceuticals Incaae783b2-18fe-69ca-e053-2a95a90a08002025-01-30WarningsExact identifier
application number: M018
Sodium Chloride Normal SaltSODIUM CHLORIDECitragen Pharmaceuticals Inc82c29f1d-a018-7483-e053-2a91aa0a8f7e2025-01-30WarningsExact identifier
application number: M018
OASIS Tears Lubricant EyeGLYCERINOASIS Medical, Inc.00071697-4ac6-4962-8eee-388b8b52bd402025-01-22WarningsExact identifier
application number: M018
ImproVue LubricantHYPROMELLOSE 2208 (15000 MPA.S)Oculus Surgical, Inc.63b82129-4848-47c5-bf92-ec4b1a9e99742025-01-22WarningsExact identifier
application number: M018
VISCO SHIELD LubricantHYPROMELLOSE 2208 (15000 MPA.S)OASIS Medical, Inc.72d22610-d8ab-4f24-b304-8b013430a7d72025-01-22WarningsExact identifier
application number: M018
OASIS Tears Plus Preservative-Free Lubricant EyeGLYCERINOASIS Medical, Inc.ea931c0f-c61e-4771-84f1-0274b1c3e28e2025-01-22WarningsExact identifier
application number: M018
Medics Choice Soothing Eye WashPURIFIED WATERKC Pharmaceuticals, Inc.10e49808-161e-f4ec-e063-6294a90a17752025-01-19WarningsExact identifier
application number: M018
Sodium Chloride Hypertonicity Ophthalmic Solution, 5%SODIUM CHLORIDE HYPERTONICITY OPHTHALMIC SOLUTION, 5%Reliable 1 Laboritories LLC29175c17-223e-5e92-e063-6294a90a71d22025-01-15WarningsExact identifier
application number: M018
Lubricating TearsCARBOXYMETHYLCELLULOSE SODIUM 0.5% SOLUTIONReliable 1 Laboritories LLC29023a57-eba3-4241-e063-6294a90a70482025-01-15WarningsExact identifier
application number: M018
Aurodone Povidone Iodine 5 % Opthalmic SolutionPOVIDONE IODINE 5 % TOPICAL SOLUTIONAurolabf3444446-1dad-79ff-e053-2a95a90af4112025-01-06WarningsExact identifier
application number: M018
Hypromellose Eye Drops 0.7%HYPROMELLOSE EYE DROPS 0.7%Aurolabd35313d0-b190-5fb0-e053-2a95a90a52832025-01-02WarningsExact identifier
application number: M018
VISTA MEIBO TEARS Propylene Glycol 0.6% w/v Advanced Dry Eye Relief Lubricating Drops 10 mlPROPYLENE GLYCOLRed Wedding LLCb2c2fd0f-b944-6b0b-e053-2995a90aa2162025-01-01WarningsExact identifier
application number: M018
Rite Aid Hydration Lubricant Eye DropsPOLYETHYLENE GLYCOL 400, PROPYLENE GLYCOLRite Aid Corporationecac1351-e944-21da-e053-2995a90a6d342024-12-31WarningsExact identifier
application number: M018
Lubricant Eye PMMINERAL OIL, WHITE PETROLATUMReliable 1 Laboratories LLCbaec8045-97fe-6f60-e053-2a95a90a050e2024-12-31WarningsExact identifier
application number: M018
Lil Drug Store Eye Drops Redness RelieverTETRAHYDROZOLINE HYDROCHLORIDELil Drug Store Products, Incd2a47e98-a04c-47ec-aded-d1c894f040e22024-12-30WarningsExact 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