Home NDC 10819-3801 PVP-I Prep Pad
Product NDC 10819-3801
11-digit product format 108193801
Labeler code 10819
Product ID 10819-3801_57b02ea2-7b36-0b77-e063-6394a90acff5
Type HUMAN OTC DRUG
Nonproprietary name Povidone-Iodine
Dosage form SWAB
Route TOPICAL
Labeler Professional Disposables International, Inc.
Application 505G(a)(3)
Marketing category OTC MONOGRAPH DRUG
Marketing start 2026-06-22
Substance POVIDONE-IODINE
Active strength 10 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 PVP-I Prep Pad
Listing expiration 2027-12-31 Active Ingredients# Ingredient, Strength table Ingredient Strength POVIDONE-IODINE 10 mg/mL
Harmonized UNII identifiers# UNII identifiers page 1 of 1 · 1 matching rows.
Identifier, FDA.report destination table Identifier FDA.report destination 85H0HZU99M Internal UNII lookup
Harmonized RxCUI identifiers# RxCUI identifiers page 1 of 1 · 1 matching rows.
Identifier, FDA.report destination table Identifier FDA.report destination 797730 Internal RxNorm lookup
Harmonized SPL set identifiers# SPL set identifiers page 1 of 1 · 1 matching rows.
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 1 of 1 · 1 matching rows.
Packages# Package NDC, 11-digit format, Description table Package NDC 11-digit format Description Units Marketing start Sample Exclude flag Status 10819-3801-2 10819380102 100 PACKET in 1 BOX (10819-3801-2) / .485 mL in 1 PACKET (10819-3801-1) 100 packet 2026-06-22 No No Current