FDA.reportPublic FDA data

NDC 69968-0355-01 - Visine Red Eye Comfort

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
69968-0355
Requested NDC
69968-0355-01
Package NDCs from labels
69968-0355-1, 69968-0355-01
Manufacturer
Kenvue Brands LLC
Effective date
2024-11-13
Current FDA listing
Not matched in FDA.report NDC product tables

DailyMed Labels#

Label, Manufacturer, Effective date table
LabelManufacturerEffective dateType
Visine Red Eye Comfort - Kenvue Brands LLCKenvue Brands LLC2024-11-13HUMAN OTC DRUG LABEL

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
69968-0355-1Visine Red Eye Comfort1 in 1 CARTONSOLUTION/ DROPS14
69968-0355-1Visine Red Eye Comfort15 mL in 1 BOTTLE, DROPPERSOLUTION/ DROPS154

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
69968-0355VISINE RED EYE COMFORT (TETRAHYDROZOLINE HYDROCHLORIDE) SOLUTION/ DROPS [KENVUE BRANDS LLC]4Current NDC, Legacy NDC, 2 package rows20241115_d7abd7cb-e094-481f-bea5-a5983e2c9ef4.zip

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
69968-0355-1ML - Milliliter69968-035571d06d08-2543-4101-956a-84cde895c2a312025-05-14

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 3 of 86 · 1,707 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
BM BM164 DROPSARUM TRYPH, CAUSTICUM, BALSAMUM PERU, HELONIAS DIO, ACID PHOS, GLYCERINUM, EQUISETUMBM Private Limited5902770f-eb01-d099-e063-6394a90ad3eb2026-08-14WarningsExact identifier
unii: PDC6A3C0OX
BM BM165 DROPSANGELICA ATRO, BALSAM PER, BARIUM MUR, GRINDELIA, KALI BICH, KALI IOD, KALI MUR, SILPHIUM LACBM Private Limited590301da-8f93-3b1e-e063-6394a90a1e722026-08-14WarningsExact identifier
unii: 660YQ98I10
Mineral Oil/White PetrolatumMINERAL OIL/WHITE PETROLATUMYYBA CORP5905b300-6f1f-a61f-e063-6394a90a11232026-08-14WarningsExact identifier
application number: M018
Lymphastat FECHINACEA (ANGUSTIFOLIA), TABEBUIA IMPETIGINOSA, ABIES NIGRA, BORAX, LYCOPODIUM CLAVATUM, NUX VOMICA, PHOSPHORUS, PULSATILLA (VULGARIS), SEPIA, THUJA OCCIDENTALIS, SKATOLUM, CANDIDA ALBICANSEnergique, Inc97467eb0-a08b-4223-b54a-af1d910577e82026-08-11WarningsExact identifier
unii: 91MBZ8H3QO
Hepatic-ToneCARDUUS MARIANUS, CEANOTHUS AMERICANUS, CHELIDONIUM MAJUS, CHIONANTHUS VIRGINICA, CITRICUM ACIDUM, CYSTEINUM, HEPAR SUIS, LEPTANDRA VIRGINICA, MAGNESIA MURIATICA, NATRUM SULPHURICUM, NUX VOMICA, PHOSPHORUS, QUASSIA (AMARA), TARAXACUM OFFICINALEEnergetix Corporationd5f61f13-7e9f-4e46-8ad8-0336f36288df2026-08-11WarningsExact identifier
unii: 02F3473H9O
MycoCan-ChordALUMINA, AVENA SATIVA, BORAX, CANDIDA ALBICANS, CARBOLICUM ACIDUM, CEANOTHUS AMERICANUS, ECHINACEA, GAULTHERIA PROCUMBENS, GLANDULA SUPRARENALIS SUIS, HYDRASTIS CANADENSIS, LINUM USITATISSIMUM, LITHIUM CARBONICUM, MEDULLA OSSIS SUIS, NATRUM MURIATICUM, PHOSPHORICUM ACIDUM, PHYTOLACCA DECANDRA, SARCOLACTICUM ACIDUM, SEPIA, SILICEA, SOLIDAGO VIRGAUREA, TELLURIUM METALLICUM, TEUCRIUM MARUM, ZINCUM METALLICUMEnergetix Corporation227199f8-a45e-44ff-892d-ade4fefea3542026-08-11WarningsExact identifier
unii: 91MBZ8H3QO
M-Natal PlusVITAMIN A, VITAMIN C, VITAMIN D, VITAMIN E, THIAMINE, RIBOFLAVIN, NIACIN, VITAMIN B6, FOLIC ACID, VITAMIN B12, CALCIUM, IRON, ZINC, COPPERREMEDYREPACK INC.5d67a268-437b-403d-9d05-6524c4a7c4992026-08-11WarningsExact identifier
unii: PQ6CK8PD0R
SYSTANE HYDRATION PF PRESERVATIVE FREEPOLYETHYLENE GLYCOL 400 AND PROPYLENE GLYCOLAlcon Laboratories, Inc.8936f66f-10fe-44ab-a26e-dd8b05dfa9972026-08-10WarningsExact identifier
application number: M018
Dr. Shitong Photon Energy Eye Care LiquidTETRAHYDROZOLINE HCL 0.05% HYPROMELLOSE 0.3% DR. SHITONG PHOTON ENERGY EYE CARE LIQUIDWenzhou Yuyuan Pharmaceutical Co., Ltd.58ace434-55ef-17ef-e063-6294a90aa8782026-08-10WarningsExact identifier
application number: M018
unii: 0YZT43HS7D
Systane Pro PFPROPYLENE GLYCOLAlcon Laboratories, Inc.23b3515f-fbe5-4398-b2df-8b2eccdd01e22026-08-10WarningsExact identifier
application number: M018
Sterile WaterWATERCardinal Health 107, LLC48d75a7c-8329-48a8-bea0-a8c144ddf6372026-08-07Warnings, Adverse reactionsExact identifier
unii: 059QF0KO0R
PNV PrenatolMULTIVITAMINPureTek Corporation583f0194-0306-f31b-e063-6394a90a2a102026-08-06Warnings, Adverse reactionsExact identifier
unii: PQ6CK8PD0R
Leader Lubricant Eye Drops 30ctPOLYETHYLENE GLYCOL 400, PROPYLENE GLYCOLCARDINAL HEALTH 110, LLC. DBA LEADER8df69f2c-40c4-245c-e053-2a95a90a54062026-08-05WarningsExact identifier
application number: M018
CVS GlycerinGLYCERIN SUPPOISITORYCVS Pharmacy, Incca6d13db-60e8-4fcc-b7b3-3eb280b8c4352026-08-04WarningsExact identifier
unii: PDC6A3C0OX
Potassium ChloridePOTASSIUM CHLORIDEAmneal Pharmaceuticals LLCf9965f73-e189-423f-bd10-c4a0ed12b4852026-08-01Warnings, Adverse reactionsExact identifier
unii: 660YQ98I10
Potassium ChloridePOTASSIUM CHLORIDEREMEDYREPACK INC.16c775e4-0dd8-4e9f-b2bf-dd2b639374cf2026-07-31Warnings, Adverse reactionsExact identifier
unii: 660YQ98I10
Potassium Chloride Extended-ReleasePOTASSIUM CHLORIDEREMEDYREPACK INC.7ec22e8e-6643-44fe-804d-ca0b0b2666632026-07-31Warnings, Adverse reactionsExact identifier
unii: 660YQ98I10
VedlubeMINERAL OIL AND WHITE PETROLATUM LUBRICANT EYE OINTMENTVEDCO INC55d126fa-7489-4307-824e-b6957e57d4e92026-07-31WarningsExact identifier
application number: M018
GarzulysINSULIN ASPART-FSANMeitheal Pharmaceuticals Inc.30c64769-d2f7-4604-ac9e-2a6bc09506c92026-07-31Warnings, Adverse reactionsExact identifier
unii: 059QF0KO0R
BioplasmaSILICON DIOXIDE,POTASSIUM CHLORIDE,SODIUM SULFATE,FERROSOFERRIC PHOSPHATE,MAGNESIUM PHOSPHATE, DIBASIC TRIHYDRATE,SODIUM PHOSPHATE, DIBASIC, HEPTAHYDRATE,TRIBASIC CALCIUM PHOSPHATE,POTASSIUM PHOSPHATE, DIBASIC,POTASSIUM SULFATE,SODIUM CHLORIDE,CALCIUM SULFATE ANHYDROUS,CALCIUM FLUORIDEHyland's Inc.dd0a7ed2-d112-4b96-e053-2995a90ac6b62026-07-30WarningsExact identifier
unii: 660YQ98I10

Reported adverse events (FAERS/openFDA)#

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