Home NDC 53209-6001 Visine Red Eye Hydrating Comfort
Product NDC 53209-6001
11-digit product format 532096001
Labeler code 53209
Product ID 53209-6001_37b48b1a-ef42-afdc-e063-6294a90a6610
Type HUMAN OTC DRUG
Nonproprietary name TETRAHYDROZOLINE HYDROCHLORIDE and Polyethylene Glycol 400
Dosage form SOLUTION/ DROPS
Route OPHTHALMIC
Labeler Morning Star OTC
Application M018
Marketing category OTC MONOGRAPH DRUG
Marketing start 2020-04-27
Substance TETRAHYDROZOLINE HYDROCHLORIDE; POLYETHYLENE GLYCOL 400
Active strength .5; 10 mg/mL; mg/mL
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 Red Eye Hydrating Comfort
Brand name suffix Eye Drops
Listing expiration 2026-12-31 Active Ingredients# Ingredient, Strength table Ingredient Strength TETRAHYDROZOLINE HYDROCHLORIDE .5 mg/mL POLYETHYLENE GLYCOL 400 10 mg/mL
Harmonized UNII identifiers# UNII identifiers page 1 of 1 · 2 matching rows.
Identifier, FDA.report destination table Identifier FDA.report destination 0YZT43HS7D Internal UNII lookup B697894SGQ Internal UNII lookup
Harmonized RxCUI identifiers# RxCUI identifiers page 1 of 1 · 1 matching rows.
Identifier, FDA.report destination table Identifier FDA.report destination 996209 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 53209-6001-1 Visine Red Eye Hydrating ComfortEye Drops 1 in 1 BLISTER PACK SOLUTION/ DROPS 1 1 53209-6001-1 Visine Red Eye Hydrating ComfortEye Drops 8 mL in 1 BOTTLE, DROPPER SOLUTION/ DROPS 8 1
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 Sample Exclude flag Status 53209-6001-1 53209600101 1 BOTTLE, DROPPER in 1 BLISTER PACK (53209-6001-1) / 8 mL in 1 BOTTLE, DROPPER 2025-06-16 No No Current