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 15 of 25 · 499 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
REFRESH OPTIVE DropsCARBOXYMETHYLCELLULOSE SODIUM AND GLYCERINAllergan, Inc.80275190-d717-40ea-905b-5c8fbe986eac2025-09-15WarningsExact identifier
application number: M018
Refresh Relieva PF XtraCARBOXYMETHYLCELLULOSE SODIUM AND GLYCERINAllergan, Inc.b51b8a75-8faa-430f-8f7e-ee58d3d13f2e2025-09-15WarningsExact identifier
application number: M018
Refresh RelievaCARBOXYMETHYLCELLULOSE SODIUM, GLYCERINAllergan, Inc.6b984fa2-4187-45ef-b7d3-15e720abc6672025-09-15WarningsExact identifier
application number: M018
Dry eye reliefPOLYETHYLENE GLYCOL AND PROPYLENE GLYCOLCARDINAL HEALTH 110, LLC. DBA LEADERf8da3af5-9172-4023-be82-0fd5bd8916162025-09-12WarningsExact identifier
application number: M018
Oasis Tears PF Preservative-Free Lubricant EyeGLYCERINOASIS Medical, Inc.640f95f4-c2e8-48ad-ad40-f76bbaddb0dc2025-09-12WarningsExact identifier
application number: M018
Lubricant DropsCARBOXYMETHYLCELLULOSE SODIUMCARDINAL HEALTH 110, LLC. DBA LEADER1ac2fe24-9ff6-48c1-b123-fbc0e48f53042025-09-12WarningsExact identifier
application number: M018
Eyes Irritation ReliefPOLYVINYL ALCOHOL AND POVIDONE AND TETRAHYDROZOLINE HYDROCHLORIDECARDINAL HEALTH 110, LLC. DBA LEADERbd2608c6-ffdf-352a-e053-2995a90a26a82025-09-12WarningsExact identifier
application number: M018
Dry Eye ReliefCARBOXYMETHYLCELLULOSE SODIUMCARDINAL HEALTH 110, LLC. DBA LEADERbd262028-32e9-052d-e053-2a95a90a53032025-09-12WarningsExact identifier
application number: M018
Oasis TEARS PF PLUS Preservative-Free Lubricant EyeGLYCERINOASIS Medical, Inc.5d080191-423d-4c0a-b5ae-2ccf5c4a67cb2025-09-08WarningsExact identifier
application number: M018
Physicians Care EyewashEYEWASHAcme United Corporation3e239b12-9a75-339d-e063-6294a90a72ae2025-09-06WarningsExact identifier
application number: M018
Splash RefreshHYPROMELLOSELABORATORIOS SOPHIA, S.A. DE C.V.3c1c453e-2644-622a-e063-6394a90a8a942025-09-02WarningsExact identifier
application number: M018
Refresh RELIEVA PFCARBOXYMETHYLCELLULOSE SODIUM AND GLYCERINAllergan, Inc.d5d3df4a-a311-4f2d-9a24-edfec1a6c9f92025-08-22WarningsExact identifier
application number: M018
Refresh OptiveCARBOXYMETHYLCELLULOSE SODIUM, GLYCERINAllergan, Inc.37e99aa8-02d6-4efb-a862-90bc7fcd5ca52025-08-22WarningsExact identifier
application number: M018
StyeMINERAL OIL AND PETROLATUMInsight Pharmaceuticals LLCf7eb8466-d8ea-4833-9bed-244ead38a3bf2025-08-11WarningsExact identifier
application number: M018
Systane COMPLETEPROPYLENE GLYCOLAlcon Laboratories, Inc.2df0de02-a3e2-471a-9e10-040c3fba75fe2025-08-08WarningsExact identifier
application number: M018
Medics Choice Fresh and SootheCARBOXYMETHYLCELLULOSE SODIUM, GLYCERINUnimed3bcd8394-f486-d306-e063-6294a90a4e9a2025-08-07WarningsExact identifier
application number: M018
Systane BalancePROPYLENE GLYCOLAlcon Laboratories, Inc.c7b1a03a-a5f2-409e-a34a-d6f166671de52025-08-07WarningsExact identifier
application number: M018
Medics Choice Fresh and SootheCARBOXYMETHYLCELLULOSE SODIUM, GLYCERINKC Pharmaceuticals, Inc.3bc03d54-6b31-5921-e063-6294a90af5992025-08-01WarningsExact identifier
application number: M018
LubriFresh PMLIGHT MINERAL OIL, WHITE PETROLATUMHanlim Pharm Co. , LTD3b329232-a562-6893-e063-6394a90aa41f2025-07-31WarningsExact identifier
application number: M018
Systane UltraPOLYETHYLENE GLYCOL 400 AND PROPYLENE GLYCOLAlcon Laboratories, Inc.0537c23a-15f7-be64-1231-a6c93468e9a82025-07-30WarningsExact 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