Home NDC 39892-0809 Povidone-Iodine Prep
Product NDC 39892-0809
11-digit product format 398920809
Labeler code 39892
Product ID 39892-0809_40b3cd7d-5f77-2f44-e063-6294a90a46e0
Type HUMAN OTC DRUG
Nonproprietary name POVIDONE-IODINE
Dosage form SOLUTION
Route TOPICAL
Labeler O&M HALYARD, INC.
Application M005
Marketing category OTC MONOGRAPH DRUG
Marketing start 2019-03-01
Substance POVIDONE-IODINE
Active strength 100 mg/mL
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 Povidone-Iodine Prep
Listing expiration 2026-12-31 Active Ingredients# Ingredient, Strength table Ingredient Strength POVIDONE-IODINE 100 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 312564 Internal RxNorm lookup
Harmonized SPL set identifiers# SPL set identifiers page 1 of 1 · 1 matching rows.
DailyMed Product Concepts# FDA-Initiated Inactive NDC Indexing# DailyMed Package Descriptions# Package NDC, Product, Description table Package NDC Product Description Form Quantity Strength SPL version 39892-0809-1 Povidone-Iodine Prep 1.5 mL in 1 PACKET SOLUTION 1.5 7
DailyMed Dashboard NDC Coverage# NDC, Dashboard title, SPL version table NDC Dashboard title SPL version Validation Dashboard ZIP 39892-0809 POVIDONE-IODINE PREP (POVIDONE-IODINE) SOLUTION [OWENS & MINOR DISTRIBUTION, INC.] 6 Current NDC, Legacy NDC, 1 package rows 20231210_f3e0af11-39b6-44a0-8f84-a4b36631e8f0.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 8 of 51 · 1,004 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 39892-0809-1 39892080901 1.5 mL in 1 PACKET (39892-0809-1) 1.5 ml 2019-03-01 0000-00-00 No No Current