Home NDC 0536-1408 Rugby Polyvinyl Alcohol 1.4% Lubricating Eye Drops
Product NDC 0536-1408
11-digit product format 005361408
Labeler code 0536
Product ID 0536-1408_47353eb5-bb01-f7e5-e063-6394a90ab152
Type HUMAN OTC DRUG
Nonproprietary name Polyvinyl alcohol
Dosage form SOLUTION/ DROPS
Route OPHTHALMIC
Labeler Rugby Laboratories
Application M018
Marketing category OTC MONOGRAPH DRUG
Marketing start 2023-10-19
Substance POLYVINYL ALCOHOL, UNSPECIFIED
Active strength 1.4 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 Rugby Polyvinyl Alcohol 1.4% Lubricating Eye Drops
Listing expiration 2026-12-31 Active Ingredients# Ingredient, Strength table Ingredient Strength POLYVINYL ALCOHOL, UNSPECIFIED 1.4 g/100mL
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 Product Concepts# DailyMed Package Descriptions# Package NDC, Product, Description table Package NDC Product Description Form Quantity Strength SPL version 0536-1408-94 Rugby Polyvinyl Alcohol 1.4% Lubricating Eye Drops 15 mL in 1 BOTTLE, DROPPER SOLUTION/ DROPS 15 2 0536-1408-94 Rugby Polyvinyl Alcohol 1.4% Lubricating Eye Drops 1 in 1 BOX SOLUTION/ DROPS 1 2
DailyMed Dashboard NDC Coverage# NDC, Dashboard title, SPL version table NDC Dashboard title SPL version Validation Dashboard ZIP 0536-1408 RUGBY POLYVINYL ALCOHOL 1.4% LUBRICATING EYE DROPS (POLYVINYL ALCOHOL) SOLUTION/ DROPS [RUGBY LABORATORIES] 1 Current NDC, 2 package rows 20231020_081673b2-5c74-1200-e063-6394a90ae363.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 0536-1408-94 00536140894 1 BOTTLE, DROPPER in 1 BOX (0536-1408-94) / 15 mL in 1 BOTTLE, DROPPER 2023-10-19 No No Current