Home NDC 81963-101 Avenova Lubricant Eye Drops High Performance
Product NDC 81963-101
11-digit product format 819630101
Labeler code 81963
Product ID 81963-101_474940b5-b173-6e9c-e063-6394a90a8b01
Type HUMAN OTC DRUG
Nonproprietary name Polyethylene glycol 400, Propylene glycol
Dosage form SOLUTION/ DROPS
Route OPHTHALMIC
Labeler NovaBay Pharmaceuticals, Inc.
Application M018
Marketing category OTC MONOGRAPH DRUG
Marketing start 2021-09-28
Substance POLYETHYLENE GLYCOL 400; PROPYLENE GLYCOL
Active strength .4; .3 g/100mL; 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 Avenova Lubricant Eye Drops High Performance
Listing expiration 2026-12-31 Active Ingredients# Ingredient, Strength table Ingredient Strength POLYETHYLENE GLYCOL 400 .4 g/100mL PROPYLENE GLYCOL .3 g/100mL
Harmonized UNII identifiers# UNII identifiers page 1 of 1 · 2 matching rows.
Identifier, FDA.report destination table Identifier FDA.report destination B697894SGQ Internal UNII lookup 6DC9Q167V3 Internal UNII lookup
Harmonized RxCUI identifiers# RxCUI identifiers page 1 of 1 · 1 matching rows.
Identifier, FDA.report destination table Identifier FDA.report destination 477589 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 81963-101-10 Avenova Lubricant Eye Drops High Performance 2 in 1 BOX SOLUTION/ DROPS 2 3 81963-101-10 Avenova Lubricant Eye Drops High Performance 15 mL in 1 BOTTLE, DROPPER SOLUTION/ DROPS 15 3
DailyMed Dashboard NDC Coverage# NDC, Dashboard title, SPL version table NDC Dashboard title SPL version Validation Dashboard ZIP 81963-101 AVENOVA LUBRICANT EYE DROPS HIGH PERFORMANCE (POLYETHYLENE GLYCOL 400, PROPYLENE GLYCOL) SOLUTION/ DROPS [NOVABAY PHARMACEUTICALS, INC.] 2 Current NDC, Legacy NDC, 2 package rows 20231224_cd17f037-5aa5-0ef8-e053-2a95a90a39cb.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 · 499 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 81963-101-10 81963010110 2 BOTTLE, DROPPER in 1 BOX (81963-101-10) / 15 mL in 1 BOTTLE, DROPPER 2021-09-28 0000-00-00 No No Current