Home NDC 50268-678 Polyvinyl Alcohol
Product NDC 50268-678
11-digit product format 502680678
Labeler code 50268
Product ID 50268-678_5606ef6c-2a66-67dd-e063-6294a90a9934
Type HUMAN OTC DRUG
Nonproprietary name Polyvinyl Alcohol
Dosage form SOLUTION/ DROPS
Route OPHTHALMIC
Labeler AvPAK
Application M018
Marketing category OTC MONOGRAPH DRUG
Marketing start 2023-01-05
Substance POLYVINYL ALCOHOL
Active strength 14 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
Listing expiration 2027-12-31 Active Ingredients# Ingredient, Strength table Ingredient Strength POLYVINYL ALCOHOL 14 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 RxCUI identifiers# RxCUI identifiers page 1 of 1 · 1 matching rows.
Identifier, FDA.report destination table Identifier FDA.report destination 142004 Internal RxNorm 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 50268-678-15 Polyvinyl Alcohol 15 mL in 1 BOTTLE SOLUTION/ DROPS 15 5
DailyMed Dashboard NDC Coverage# NDC, Dashboard title, SPL version table NDC Dashboard title SPL version Validation Dashboard ZIP 50268-678 POLYVINYL ALCOHOL SOLUTION/ DROPS [AVPAK] 5 Current NDC, Legacy NDC, 1 package rows 20250423_f18b61da-4033-341a-e053-2a95a90a8ebf.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 Units Marketing start Marketing end Sample Exclude flag Status 50268-678-15 50268067815 15 mL in 1 BOTTLE (50268-678-15) 15 ml 2023-01-05 0000-00-00 No No Current