Home NDC 83455-210 Equaline Sterile Eye Drops
Product NDC 83455-210
11-digit product format 834550210
Labeler code 83455
Product ID 83455-210_31a25f09-2524-067d-e063-6294a90a24d8
Type HUMAN OTC DRUG
Nonproprietary name Tetrahydrozoline HCl
Dosage form SOLUTION/ DROPS
Route OPHTHALMIC
Labeler United Natural Foods, Inc.
Application M018
Marketing category OTC MONOGRAPH DRUG
Marketing start 2024-01-01
Substance TETRAHYDROZOLINE HYDROCHLORIDE
Active strength .05 g/100mL
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 Equaline Sterile Eye Drops
Listing expiration 2026-12-31 Active Ingredients# Ingredient, Strength table Ingredient Strength TETRAHYDROZOLINE HYDROCHLORIDE .05 g/100mL
Harmonized UNII identifiers# UNII identifiers page 1 of 1 · 1 matching rows.
Identifier, FDA.report destination table Identifier FDA.report destination 0YZT43HS7D Internal UNII lookup
Harmonized RxCUI identifiers# RxCUI identifiers page 1 of 1 · 1 matching rows.
Identifier, FDA.report destination table Identifier FDA.report destination 1052943 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 83455-210-01 Equaline Sterile Eye Drops 1 in 1 BOX SOLUTION/ DROPS 1 1 83455-210-01 Equaline Sterile Eye Drops 15 mL in 1 BOTTLE, DROPPER SOLUTION/ DROPS 15 1
DailyMed Dashboard NDC Coverage# NDC, Dashboard title, SPL version table NDC Dashboard title SPL version Validation Dashboard ZIP 83455-210 EQUALINE STERILE EYE DROPS (TETRAHYDROZOLINE HCL) SOLUTION/ DROPS [UNITED NATURAL FOODS, INC.] 1 Current NDC, 2 package rows 20250402_31a25efb-a627-1a13-e063-6394a90a2ca3.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 Sample Exclude flag Status 83455-210-01 83455021001 1 BOTTLE, DROPPER in 1 BOX (83455-210-01) / 15 mL in 1 BOTTLE, DROPPER 2024-01-01 No No Current