Home NDC 83455-213-01 Equaline Redness Relief Lubricant Eye Drops
Product NDC 83455-213
Requested package NDC 83455-213-01
11-digit product format 834550213
Labeler code 83455
Product ID 83455-213_31a36709-1b78-e0d7-e063-6294a90a0a28
Type HUMAN OTC DRUG
Nonproprietary name Glycerin, Naphazoline hydrochloride
Dosage form SOLUTION/ DROPS
Route OPHTHALMIC
Labeler United Natural Foods, Inc
Application M018
Marketing category OTC MONOGRAPH DRUG
Marketing start 2024-01-01
Substance GLYCERIN; NAPHAZOLINE HYDROCHLORIDE
Active strength .25; .012 g/100mL; g/100mL
Pharmacologic classes Allergens [CS], Cell-mediated Immunity [PE], Glycerol [CS], Increased Histamine Release [PE], Increased IgG Production [PE], Non-Standardized Chemical Allergen [EPC]
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 Redness Relief Lubricant Eye Drops
Listing expiration 2026-12-31 Active Ingredients# Ingredient, Strength table Ingredient Strength GLYCERIN .25 g/100mL NAPHAZOLINE HYDROCHLORIDE .012 g/100mL
Harmonized UNII identifiers# UNII identifiers page 1 of 1 · 2 matching rows.
Identifier, FDA.report destination table Identifier FDA.report destination PDC6A3C0OX Internal UNII lookup MZ1131787D Internal UNII lookup
Harmonized RxCUI identifiers# RxCUI identifiers page 1 of 1 · 1 matching rows.
Identifier, FDA.report destination table Identifier FDA.report destination 1046700 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 83455-213-01 Equaline Redness Relief Lubricant Eye Drops 1 in 1 BOX SOLUTION/ DROPS 1 2 83455-213-01 Equaline Redness Relief Lubricant Eye Drops 15 mL in 1 BOTTLE, DROPPER SOLUTION/ DROPS 15 2
DailyMed Dashboard NDC Coverage# NDC, Dashboard title, SPL version table NDC Dashboard title SPL version Validation Dashboard ZIP 83455-213 EQUALINE REDNESS RELIEF LUBRICANT EYE DROPS (GLYCERIN, NAPHAZOLINE HYDROCHLORIDE) SOLUTION/ DROPS [UNITED NATURAL FOODS, INC] 2 Current NDC, 2 package rows 20250402_31a30b00-9f4b-717a-e063-6394a90a8a87.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 Sample Exclude flag Status 83455-213-01 83455021301 1 BOTTLE, DROPPER in 1 BOX (83455-213-01) / 15 mL in 1 BOTTLE, DROPPER 2024-01-01 No No Current