Home NDC 34645-5501 Povidone Iodine Prep
Product NDC 34645-5501
11-digit product format 346455501
Labeler code 34645
Product ID 34645-5501_085c75f1-c9c9-cbb2-e063-6294a90a07c2
Type HUMAN OTC DRUG
Nonproprietary name POVIDONE-IODINE
Dosage form SOLUTION
Route TOPICAL
Labeler Jianerkang Medical Co., Ltd
Application M003
Marketing category OTC MONOGRAPH DRUG
Marketing start 2017-01-30
Substance POVIDONE-IODINE
Active strength 7.5 g/100g
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 Povidone Iodine Prep
Listing expiration 2027-12-31 Active Ingredients# Ingredient, Strength table Ingredient Strength POVIDONE-IODINE 7.5 g/100g
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 34645-5501-0 Povidone Iodine Prep 25 in 1 BOX SOLUTION 25 4 34645-5501-0 Povidone Iodine Prep 10 in 1 CARTON SOLUTION 10 4
DailyMed Dashboard NDC Coverage# NDC, Dashboard title, SPL version table NDC Dashboard title SPL version Validation Dashboard ZIP 34645-5501 POVIDONE IODINE PREP (POVIDONE-IODINE) SOLUTION [JIANERKANG MEDICAL CO., LTD] 4 Current NDC, Legacy NDC, 2 package rows 20231023_47a504b8-b0af-030a-e054-00144ff88e88.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 86 of 115 · 2,286 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 34645-5501-0 34645550100 10 BOX in 1 CARTON (34645-5501-0) / 25 PATCH in 1 BOX / .045 g in 1 PATCH 10 box 2017-02-03 0000-00-00 No No Current