Home NDC 67751-198-01 Visine Red Eye Hydrating Comfort
Product NDC 67751-198
Requested package NDC 67751-198-01
11-digit product format 677510198
Labeler code 67751
Product ID 67751-198_16275c74-32a1-25f4-e063-6394a90a6717
Type HUMAN OTC DRUG
Nonproprietary name TETRAHYDROZOLINE HYDROCHLORIDE and Polyethylene Glycol 400
Dosage form SOLUTION/ DROPS
Route OPHTHALMIC
Labeler Navajo Manufacturing Company Inc.
Application 505G(a)(3)
Marketing category OTC MONOGRAPH DRUG
Marketing start 2020-06-01
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 Observed NDC auxiliary status history# This history shows the information present in each captured FDA auxiliary file. It is not a continuous regulatory timeline, and a missing record does not establish a status.
Historic NDC status page 1 of 1 · 1 matching rows.
View current auxiliary records. · View the auxiliary file history.
Captured / source date, Dataset, Scope table Captured / source date Dataset Scope Product NDC Package NDC Code Status Reporting period Archive Snapshot Source SHA-256 2024-03-11 06:39 UTC · source 2024-03-08 excluded package package 67751-198 67751-198-01 I Inactivated by FDA excluded / ndc_excluded.zip 1332a3947898…d4bfe170f9cd…
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# FDA-Initiated Inactive NDC Indexing# DailyMed Package Descriptions# Package NDC, Product, Description table Package NDC Product Description Form Quantity Strength SPL version 67751-198-01 Visine Red Eye Hydrating ComfortEye Drops 1 in 1 BLISTER PACK SOLUTION/ DROPS 1 2 67751-198-01 Visine Red Eye Hydrating ComfortEye Drops 8 mL in 1 BOTTLE, DROPPER SOLUTION/ DROPS 8 2
DailyMed Dashboard NDC Coverage# NDC, Dashboard title, SPL version table NDC Dashboard title SPL version Validation Dashboard ZIP 67751-198 VISINE RED EYE HYDRATING COMFORT EYE DROPS (TETRAHYDROZOLINE HYDROCHLORIDE AND POLYETHYLENE GLYCOL 400) SOLUTION/ DROPS [NAVAJO MANUFACTURING COMPANY INC.] 2 Current NDC, Legacy NDC, 2 package rows 20240417_a70751ff-a313-49a7-e053-2a95a90a5447.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 1 of 1 · 1 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 67751-198-01 67751019801 1 BOTTLE, DROPPER in 1 BLISTER PACK (67751-198-01) / 8 mL in 1 BOTTLE, DROPPER 2020-06-01 0000-00-00 No No Current