Home NDC 65517-0070 Povidone-Iodine Gel
Product NDC 65517-0070
11-digit product format 655170070
Labeler code 65517
Product ID 65517-0070_43f8fa10-9266-a4f3-e063-6394a90a9e93
Type HUMAN OTC DRUG
Nonproprietary name Povidone-Iodine
Dosage form GEL
Route TOPICAL
Labeler Dukal LLC
Application 505G(a)(3)
Marketing category OTC MONOGRAPH DRUG
Marketing start 2025-01-21
Substance POVIDONE-IODINE
Active strength 1 g/100mL
NDC exclude flag No
Listing certified through 2026-12-31
Current FDA listing Yes Additional Listing Data#
Finished product Yes
Brand name base Povidone-Iodine Gel
Listing expiration 2026-12-31 Active Ingredients# Ingredient, Strength table Ingredient Strength POVIDONE-IODINE 1 g/100mL
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 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 65517-0070-1 Povidone-Iodine Gel 29.5 mL in 1 POUCH GEL 29.5 2
DailyMed Dashboard NDC Coverage# NDC, Dashboard title, SPL version table NDC Dashboard title SPL version Validation Dashboard ZIP 65517-0070 POVIDONE-IODINE GEL (POVIDONE-IODINE) GEL [DUKAL LLC] 1 Current NDC, 1 package rows 20250122_2bebe082-59b6-17c1-e063-6294a90a9a52.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 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 65517-0070-1 65517007001 29.5 mL in 1 POUCH (65517-0070-1) 29.5 ml 2025-01-21 No No Current