Home NDC 16030-201 Polyvinyl Alcohol Eye Drops 1,4 % w/v
Product NDC 16030-201
11-digit product format 160300201
Labeler code 16030
Product ID 16030-201_47edd91f-7907-3a97-e063-6294a90ad9df
Type HUMAN OTC DRUG
Nonproprietary name Polyvinyl Alcohol Eye Drops 1,4 % w/v
Dosage form FOR SOLUTION
Route TOPICAL
Labeler Aurolab
Application M018
Marketing category OTC MONOGRAPH DRUG
Marketing start 2022-09-20
Substance POLYVINYL ALCOHOL, UNSPECIFIED
Active strength 5 mg/mL
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 Polyvinyl Alcohol Eye Drops 1,4 % w/v
Listing expiration 2027-12-31 Active Ingredients# Ingredient, Strength table Ingredient Strength POLYVINYL ALCOHOL, UNSPECIFIED 5 mg/mL
Harmonized UNII identifiers# UNII identifiers page 1 of 1 · 1 matching rows.
Identifier, FDA.report destination table Identifier FDA.report destination 532B59J990 Internal UNII lookup
Harmonized SPL set identifiers# SPL set identifiers page 1 of 1 · 1 matching rows.
DailyMed Package Descriptions# Package NDC, Product, Description table Package NDC Product Description Form Quantity Strength SPL version 16030-201-05 Polyvinyl Alcohol Eye Drops 1,4 % w/v 5 mL in 1 BOTTLE, DROPPER FOR SOLUTION 5 9 16030-201-10 Polyvinyl Alcohol Eye Drops 1,4 % w/v 10 mL in 1 BOTTLE, DROPPER FOR SOLUTION 10 4
DailyMed Dashboard NDC Coverage# NDC, Dashboard title, SPL version table NDC Dashboard title SPL version Validation Dashboard ZIP 16030-201 POLYVINYL ALCOHOL EYE DROPS 1,4 % W/V FOR SOLUTION [AUROLAB] 8 Current NDC, Legacy NDC, 1 package rows 20241224_e8e09719-6e06-612b-e053-2995a90a79fc.zip 16030-201 POLYVINYL ALCOHOL EYE DROPS 1,4 % W/V FOR SOLUTION [AUROLAB] 4 Current NDC, Legacy NDC, 1 package rows 20241224_ec5cf186-f141-4377-e053-2995a90a6b32.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.
Packages# Package NDC, 11-digit format, Description table Package NDC 11-digit format Description Units Marketing start Marketing end Sample Exclude flag Status 16030-201-05 16030020105 5 mL in 1 BOTTLE, DROPPER (16030-201-05) 5 ml 2025-12-01 0000-00-00 No No Current 16030-201-10 16030020110 10 mL in 1 BOTTLE, DROPPER (16030-201-10) 10 ml 2022-09-20 0000-00-00 No No Current