FDA.reportPublic FDA data

NDC 69968-0363-01 - Visine Red Eye Total Comfort and Tears Dry Eye Relief

This NDC is not currently matched to an FDA NDC product listing in FDA.report, but it is a valid NDC-form code. FDA.report is showing the available DailyMed label context for the product root.

Product NDC
69968-0363
Requested NDC
69968-0363-01
Package NDCs from labels
69968-0363-1, 69968-0363-2, 69968-0363-01
Manufacturer
Kenvue Brands LLC
Effective date
2024-11-14
Current FDA listing
Not matched in FDA.report NDC product tables

DailyMed Labels#

Label, Manufacturer, Effective date table
LabelManufacturerEffective dateType
Visine Red Eye Total Comfort and Tears Dry Eye Relief - Kenvue Brands LLCKenvue Brands LLC2024-11-14HUMAN OTC DRUG LABEL
Visine Dry Eye Relief - Kenvue Brands LLCKenvue Brands LLC2024-11-13HUMAN OTC DRUG LABEL

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
69968-0363-1Visine Dry Eye Relief1 in 1 CARTONSOLUTION/ DROPS15
69968-0363-1Visine Dry Eye Relief15 mL in 1 BOTTLE, DROPPERSOLUTION/ DROPS155
69968-0363-2Visine Dry Eye Relief2 in 1 CARTONSOLUTION/ DROPS25
69968-0363-2Visine Dry Eye Relief15 mL in 1 BOTTLE, DROPPERSOLUTION/ DROPS155
69968-0363-1Visine Red Eye Total Comfort and Tears Dry Eye Relief15 mL in 1 BOTTLE, DROPPERSOLUTION/ DROPS15 mL10 mg in 1mL2
69968-0363-1Visine Red Eye Total Comfort and Tears Dry Eye Relief1 in 1 CARTONSOLUTION/ DROPS10 mg in 1mL2

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
69968-0363VISINE DRY EYE RELIEF (POLYETHYLENE GLYCOL 400) SOLUTION/ DROPS [KENVUE BRANDS LLC]5Current NDC, Legacy NDC, 4 package rows20241115_2de7a41d-661d-495f-89b4-5690664a3a3d.zip
69968-0363VISINE RED EYE TOTAL COMFORT AND TEARS DRY EYE RELIEF (TETRAHYDROZOLINE HCL, POLYETHYLENE GLYCOL 400, ZINC SULFATE) KIT [KENVUE BRANDS LLC]2Current NDC, Legacy NDC20241116_0bc0d6e7-9195-db6b-e063-6294a90aef04.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 8 of 172 · 3,428 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Topwin Speedy EnemaGLYCERINHealth Chemical Pharmaceutical Co., Ltd3ba8c3d2-1780-42e1-bec5-8f98771d475e2026-07-27WarningsExact identifier
unii: PDC6A3C0OX
DelflexDEXTROSE MONOHYDRATE, SODIUM CHLORIDE, SODIUM LACTATE, CALCIUM CHLORIDE, MAGNESIUM CHLORIDEFresenius Medical Care de Mexico, S.A. de C.V.a98facd6-9daa-4d37-8209-63a0599dbfaa2026-07-27Warnings, Adverse reactionsExact identifier
unii: 02F3473H9O
unii: TU7HW0W0QT
unii: 451W47IQ8X
Sodium ChlorideSODIUM CHLORIDEFresenius Medical Care de Mexico, S.A. de C.V.9a1220fb-6853-45ae-838c-10d8596e1af72026-07-27Warnings, Adverse reactionsExact identifier
unii: 451W47IQ8X
Sodium ChlorideSODIUM CHLORIDEFresenius Medical Care Renal Therapies Group, LLCaf5cdf1a-19f4-11e2-892e-0800200c9a662026-07-27Warnings, Adverse reactionsExact identifier
unii: 451W47IQ8X
AEROBURNLIDOCAINE HYDROCHLORIDEAero Healthcare US LLCa32cbc19-ec30-4634-b70d-664f2a2edd952026-07-24WarningsExact identifier
unii: F5UM2KM3W7
AEROAIDBENZALKONIUM CHLORIDEAero Healthcare US LLCc9d55d86-0a4e-4c44-96e8-8d13fd16c54d2026-07-24WarningsExact identifier
unii: F5UM2KM3W7
NeutraflushEYEWASH STATION ADDITIVE CONCENTRATEAero Healthcare1d9ff2ef-9c9b-f367-e063-6294a90afa0e2026-07-24WarningsExact identifier
application number: M018
Potassium Chloride Extended-ReleasePOTASSIUM CHLORIDEUpsher-Smith Laboratories, LLC02707146-331f-4511-a187-0152fc8bca852026-07-24Warnings, Adverse reactionsExact identifier
unii: 660YQ98I10
PEG 3350 and ElectrolytesPOLYETHYLENE GLYCOL 3350, SODIUM SULFATE ANHYDROUS, SODIUM BICARBONATE, SODIUM CHLORIDE, POTASSIUM CHLORIDEA-S Medication Solutions19daf830-7270-4661-81b1-ded38f867f282026-07-24Warnings, Adverse reactionsExact identifier
unii: 451W47IQ8X
unii: 660YQ98I10
PNV-DHAASCORBIC ACID, CHOLECALCIFEROL, .ALPHA.-TOCOPHEROL ACETATE, DL-, PYRIDOXINE, FOLIC ACID, CYANOCOBALAMIN, CALCIUM, FERROUS FUMARATE, MAGNESIUM, DOCONEXENTAcella Pharmaceuticals, LLC038fe2e7-dc16-485c-b5fb-746db72313472026-07-23Boxed warning, Adverse reactionsExact identifier
unii: PQ6CK8PD0R
FRESH THEORY ANTIBACTERIAL HAND WIPES - Vanilla, Strawberry, FreshBENZALKONIUM CHLORIDEQuest USA Corp5719809b-1c74-4bf3-e063-6294a90ab0082026-07-23WarningsExact identifier
unii: F5UM2KM3W7
Droptics Dry Eye ReliefCARBOXYMETHYLCELLULOSE SODIUM,GLYCERIN,POLYSORBATE 80Droptics LLC29d7614b-f4b7-48e2-97c5-d1bff27731d22026-07-22WarningsExact identifier
application number: M018
unii: PDC6A3C0OX
PNV-OmegaASCORBIC ACID, CHOLECALCIFEROL, .ALPHA.-TOCOPHEROL, PYRIDOXINE HYDROCHLORIDE, FOLIC ACID, CYANOCOBALAMIN, CALCIUM CORBONATE, FERROUS FUMARATE, POTASSIUM IODIDE, MAGNESIUM, DOCONEXENT, ICOSAPENTAcella Pharmaceuticals, LLC735c5531-137f-4cee-8c68-ae121045a8ff2026-07-22Boxed warning, Warnings, Adverse reactionsExact identifier
unii: PQ6CK8PD0R
KeepGoing Non Sting Cleaning WipeBENZALKONIUM CHLORIDEJ&A Digital Inc.1a6303ce-8df7-4e8b-93f2-e162fdd2540c2026-07-22WarningsExact identifier
unii: F5UM2KM3W7
GOOD NEIGHBOR PHARMACY ARTIFICAL TEARS LUBRICANT EYE DROPSPOLYVINYL ALCOHOL, POVIDONEAmerisourceBergence6852a8-c5e6-403d-a7b4-a2e85d1ebb1f2026-07-22WarningsExact identifier
application number: M018
Germfree24 Hand SanitizerBENZALKONIUM CHLORIDEEnviro Specialty Chemicals Incfb43545b-6ddc-49fb-86dd-17cd1a925a782026-07-22WarningsExact identifier
unii: F5UM2KM3W7
Pharma-Care Skin Preparation ClothsBENZALKONIUM CHLORIDEEnviro Specialty Chemicals Inc324ec648-59f9-46c2-ab7a-7ec6ba42dd422026-07-22WarningsExact identifier
unii: F5UM2KM3W7
My-Shield Hand SanitizerBENZALKONIUM CHLORIDEEnviro Specialty Chemicals Inc0c73f042-47e5-4eba-ba59-52aabf8f45312026-07-22WarningsExact identifier
unii: F5UM2KM3W7
DOCTOR INK TOPICAL ANTISEPTIC WITH PAIN RELIEFBENZALKONIUM CHLORIDE, LIDOCAINEEnviro Specialty Chemicals Incf7abe66c-dc2d-4ef7-9b11-5b87157fd3022026-07-21WarningsExact identifier
unii: F5UM2KM3W7
MY-SHIELD SANITIZINGBENZALKONIUM CHLORIDEEnviro Specialty Chemicals Inc91655320-7d8e-4024-b8f3-511d33d059f92026-07-21WarningsExact identifier
unii: F5UM2KM3W7

Reported adverse events (FAERS/openFDA)#

Adverse event summaries are temporarily unavailable. Other product information remains available.