Home NDC 63029-324 Stye
Product NDC 63029-324
11-digit product format 630290324
Labeler code 63029
Product ID 63029-324_30207af5-e43e-4ac0-a76c-4824f020e24c
Type HUMAN OTC DRUG
Nonproprietary name polyvinyl alcohol and povidone
Dosage form SOLUTION/ DROPS
Route OPHTHALMIC
Labeler Medtech Products Inc.
Application M018
Marketing category OTC MONOGRAPH DRUG
Marketing start 2021-12-01
Substance POLYVINYL ALCOHOL, UNSPECIFIED; POVIDONE
Active strength 5; 6 mg/mL; 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 Stye
Listing expiration 2027-12-31 Active Ingredients# Ingredient, Strength table Ingredient Strength POLYVINYL ALCOHOL, UNSPECIFIED 5 mg/mL POVIDONE 6 mg/mL
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 · 2 matching rows.
Identifier, FDA.report destination table Identifier FDA.report destination 598050 Internal RxNorm lookup 2586181 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 63029-324-15 Stye 1 in 1 BOTTLE SOLUTION/ DROPS 1 3 63029-324-15 Stye 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 63029-324 STYE (POLYVINYL ALCOHOL AND POVIDONE) SOLUTION/ DROPS [MEDTECH PRODUCTS INC.] 2 Current NDC, Legacy NDC, 2 package rows 20241101_60c11d3d-df20-4d1c-b425-49a84fecea30.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 Marketing end Sample Exclude flag Status 63029-324-15 63029032415 1 BOTTLE, DROPPER in 1 BOTTLE (63029-324-15) / 15 mL in 1 BOTTLE, DROPPER 2021-12-01 0000-00-00 No No Current