Home NDC 69968-0356-2 Visine Red Eye Hydrating Comfort
Product NDC 69968-0356
Requested package NDC 69968-0356-2
11-digit product format 699680356
Labeler code 69968
Product ID 69968-0356_21d7a4ce-7eb1-1416-e063-6294a90a9a98
Type HUMAN OTC DRUG
Nonproprietary name TETRAHYDROZOLINE HYDROCHLORIDE and Polyethylene Glycol 400
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
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 69968-0356-1 Visine Red Eye Hydrating ComfortEye Drops 8 mL in 1 BOTTLE, DROPPER SOLUTION/ DROPS 8 4 69968-0356-1 Visine Red Eye Hydrating ComfortEye Drops 700 in 1 CONTAINER, FLEXIBLE INTERMEDIATE BULK SOLUTION/ DROPS 700 4 69968-0356-2 Visine Red Eye Hydrating ComfortEye Drops 1 in 1 CARTON SOLUTION/ DROPS 1 4 69968-0356-2 Visine Red Eye Hydrating ComfortEye Drops 15 mL in 1 BOTTLE, DROPPER SOLUTION/ DROPS 15 4 69968-0356-3 Visine Red Eye Hydrating ComfortEye Drops 8 mL in 1 BOTTLE, DROPPER SOLUTION/ DROPS 8 4 69968-0356-3 Visine Red Eye Hydrating ComfortEye Drops 1 in 1 CARTON SOLUTION/ DROPS 1 4 69968-0356-4 Visine Red Eye Hydrating ComfortEye Drops 8 mL in 1 BOTTLE, DROPPER SOLUTION/ DROPS 8 4 69968-0356-4 Visine Red Eye Hydrating ComfortEye Drops 1 in 1 BLISTER PACK SOLUTION/ DROPS 1 4
DailyMed Dashboard NDC Coverage# NDC, Dashboard title, SPL version table NDC Dashboard title SPL version Validation Dashboard ZIP 69968-0356 VISINE RED EYE HYDRATING COMFORT EYE DROPS (TETRAHYDROZOLINE HYDROCHLORIDE AND POLYETHYLENE GLYCOL 400) SOLUTION/ DROPS [KENVUE BRANDS LLC] 4 Current NDC, Legacy NDC, 8 package rows 20241115_a9a90de6-3172-4d34-984b-f4442f880e3d.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 25 of 25 · 486 matching rows.
Brand, Generic, Manufacturer table Brand Generic Manufacturer SPL set ID Effective date Available safety fields Join REFRESH TEARS CARBOXYMETHYLCELLULOSE SODIUM Allergan, Inc. 329d1fe0-4432-4565-b7b1-65666bd86526 2022-06-30 Warnings Exact identifier application number: M018 REFRESH Optive Mega-3 CARBOXYMETHYLCELLULOSE SODIUM, GLYCERIN AND POLYSORBATE 80 Allergan, Inc. c5f2b3f2-2071-45bd-a010-67f848bc0233 2022-06-30 Warnings Exact identifier application number: M018 REFRESH P.M. MINERAL OIL, PETROLATUM Allergan, Inc. 24365d64-cd94-41cc-a7e1-033102d98114 2022-06-30 Warnings Exact identifier application number: M018 REFRESH PLUS CARBOXYMETHYLCELLULOSE SODIUM Allergan, Inc. 0f6a4b4b-cde6-4518-84b5-ce997f1154a7 2022-06-28 Warnings Exact identifier application number: M018 CIRCLE K sterile eye drops TETRAHYDROZOLINE HCL Lil' Drug Store Products, Inc. 2c0e106c-16f6-ff4e-e063-6294a90a7dbb 2018-07-30 Warnings Exact identifier application number: M018 Lil Drug Store Sterile Eye Drops Redness Reliever TETRAHYDROZOLINE HCL Lil' Drug Store Products, Inc. 2c0ea35c-ac52-1043-e063-6394a90a061c 2018-04-30 Warnings Exact identifier application number: M018
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 69968-0356-2 69968035602 1 BOTTLE, DROPPER in 1 CARTON (69968-0356-2) / 15 mL in 1 BOTTLE, DROPPER 2020-04-27 0000-00-00 No No Current