Home NDC 82667-013 FRESHKOTE PRESERVATIVE FREE LUBRICANT EYE DROPS
Product NDC 82667-013
11-digit product format 826670013
Labeler code 82667
Product ID 82667-013_5ab03f28-5724-8d7c-e063-6394a90af62c
Type HUMAN OTC DRUG
Nonproprietary name povidone, polyvinyl alcohol solution
Dosage form SOLUTION/ DROPS
Route OPHTHALMIC
Labeler Harrow Eye, LLC
Application M018
Marketing category OTC MONOGRAPH DRUG
Marketing start 2023-09-15
Substance POLYVINYL ALCOHOL, UNSPECIFIED; POVIDONE
Active strength 27; 20 g/1000mL; g/1000mL
NDC exclude flag No
Listing certified through 2027-12-31
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 FRESHKOTE PRESERVATIVE FREE LUBRICANT EYE DROPS
Listing expiration 2027-12-31 Active Ingredients# Ingredient, Strength table Ingredient Strength POLYVINYL ALCOHOL, UNSPECIFIED 27 g/1000mL POVIDONE 20 g/1000mL
Harmonized UNII identifiers# UNII identifiers page 1 of 1 · 2 matching rows.
Identifier, FDA.report destination table Identifier FDA.report destination 532B59J990 Internal UNII lookup FZ989GH94E Internal UNII lookup
Harmonized RxCUI identifiers# RxCUI identifiers page 1 of 1 · 1 matching rows.
Identifier, FDA.report destination table Identifier FDA.report destination 630977 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 82667-013-10 FRESHKOTE PRESERVATIVE FREE LUBRICANT EYE DROPS 10 mL in 1 BOTTLE, DROPPER SOLUTION/ DROPS 10 3 82667-013-10 FRESHKOTE PRESERVATIVE FREE LUBRICANT EYE DROPS 1 in 1 BOX SOLUTION/ DROPS 1 3
DailyMed Dashboard NDC Coverage# NDC, Dashboard title, SPL version table NDC Dashboard title SPL version Validation Dashboard ZIP 82667-013 FRESHKOTE PRESERVATIVE FREE LUBRICANT EYE DROPS (POVIDONE, POLYVINYL ALCOHOL SOLUTION) SOLUTION/ DROPS [HARROW EYE, LLC] 2 Current NDC, 2 package rows 20241218_049e9cc9-0663-53bc-e063-6294a90a2c4f.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 82667-013-10 82667001310 1 BOTTLE, DROPPER in 1 BOX (82667-013-10) / 10 mL in 1 BOTTLE, DROPPER 2023-09-15 No No Current