Home NDC 69968-0360 Visine Red Eye Total Comfort Multi-Symptom
Product NDC 69968-0360
11-digit product format 699680360
Labeler code 69968
Product ID 69968-0360_51c6d5f8-8e6f-161e-e063-6394a90ab0ec
Type HUMAN OTC DRUG
Nonproprietary name TETRAHYDROZOLINE HYDROCHLORIDE, POLYETHYLENE GLYCOL 400, and ZINC SULFATE, UNSPECIFIED FORM
Dosage form SOLUTION/ DROPS
Route OPHTHALMIC
Labeler Kenvue Brands LLC
Application M018
Marketing category OTC MONOGRAPH DRUG
Marketing start 2020-04-27
Substance TETRAHYDROZOLINE HYDROCHLORIDE; POLYETHYLENE GLYCOL 400; ZINC SULFATE, UNSPECIFIED FORM
Active strength .5; 10; 2.5 mg/mL; mg/mL; mg/mL
Pharmacologic classes Copper Absorption Inhibitor [EPC], Decreased Copper Ion Absorption [PE]
NDC exclude flag No
Listing certified through 2027-12-31
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 Red Eye Total Comfort Multi-Symptom
Listing expiration 2027-12-31 Active Ingredients# Ingredient, Strength table Ingredient Strength TETRAHYDROZOLINE HYDROCHLORIDE .5 mg/mL POLYETHYLENE GLYCOL 400 10 mg/mL ZINC SULFATE, UNSPECIFIED FORM 2.5 mg/mL
Harmonized UNII identifiers# UNII identifiers page 1 of 1 · 3 matching rows.
Identifier, FDA.report destination table Identifier FDA.report destination 0YZT43HS7D Internal UNII lookup B697894SGQ Internal UNII lookup 89DS0H96TB Internal UNII lookup
Harmonized RxCUI identifiers# RxCUI identifiers page 1 of 1 · 1 matching rows.
Identifier, FDA.report destination table Identifier FDA.report destination 2360903 Internal RxNorm lookup
Harmonized SPL set identifiers# SPL set identifiers page 1 of 1 · 1 matching rows.
DailyMed Product Concepts# DailyMed Package Descriptions# Package NDC, Product, Description table Package NDC Product Description Form Quantity Strength SPL version 69968-0360-1 Visine Red Eye Total Comfort Multi-Symptom 1 in 1 CARTON SOLUTION/ DROPS 1 4 69968-0360-1 Visine Red Eye Total Comfort Multi-Symptom 15 mL in 1 BOTTLE, DROPPER SOLUTION/ DROPS 15 4 69968-0360-1 Visine Red Eye Total Comfort and Tears Dry Eye Relief 1 in 1 CARTON SOLUTION/ DROPS 0.5 mg in 1mL 2 69968-0360-1 Visine Red Eye Total Comfort and Tears Dry Eye Relief 15 mL in 1 BOTTLE, DROPPER SOLUTION/ DROPS 15 mL 0.5 mg in 1mL 2
DailyMed Dashboard NDC Coverage# NDC, Dashboard title, SPL version table NDC Dashboard title SPL version Validation Dashboard ZIP 69968-0360 VISINE RED EYE TOTAL COMFORT MULTI-SYMPTOM (TETRAHYDROZOLINE HYDROCHLORIDE, POLYETHYLENE GLYCOL 400, AND ZINC SULFATE, UNSPECIFIED FORM) SOLUTION/ DROPS [KENVUE BRANDS LLC] 4 Current NDC, Legacy NDC, 2 package rows 20241115_5747edef-7a87-41d7-9594-6c78508b9ba2.zip 69968-0360 VISINE RED EYE TOTAL COMFORT AND TEARS DRY EYE RELIEF (TETRAHYDROZOLINE HCL, POLYETHYLENE GLYCOL 400, ZINC SULFATE) KIT [KENVUE BRANDS LLC] 2 Current NDC, Legacy NDC 20241116_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 6 of 25 · 494 matching rows.
DailyMed RxNorm Mappings# Packages# Package NDC, 11-digit format, Description table Package NDC 11-digit format Description Marketing start Marketing end Sample Exclude flag Status 69968-0360-1 69968036001 1 BOTTLE, DROPPER in 1 CARTON (69968-0360-1) / 15 mL in 1 BOTTLE, DROPPER 2020-04-27 0000-00-00 No No Current