Home NDC 57511-0611 Povi-One
Product NDC 57511-0611
11-digit product format 575110611
Labeler code 57511
Product ID 57511-0611_3f1914a6-3095-23c3-e063-6294a90ac03a
Type HUMAN OTC DRUG
Nonproprietary name Povidone-Iodine 10% Topical
Dosage form LIQUID
Route TOPICAL
Labeler Elevate Oral Care
Application M022
Marketing category OTC MONOGRAPH DRUG
Marketing start 2023-03-01
Substance POVIDONE-IODINE
Active strength 1 mg/10mL
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 Povi-One
Listing expiration 2027-12-31 Active Ingredients# Ingredient, Strength table Ingredient Strength POVIDONE-IODINE 1 mg/10mL
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 57511-0611-1 Povi-One 6 mL in 1 BOX, UNIT-DOSE LIQUID 6 6 57511-0611-2 Povi-One 8 mL in 1 BOTTLE, DISPENSING LIQUID 8 4
DailyMed Dashboard NDC Coverage# NDC, Dashboard title, SPL version table NDC Dashboard title SPL version Validation Dashboard ZIP 57511-0611 POVI-ONE (POVIDONE-IODINE 10% TOPICAL) LIQUID [ELEVATE ORAL CARE] 2 Current NDC, 1 package rows 20231031_f5252b4f-5e14-509e-e053-2995a90a6db8.zip 57511-0611 POVI-ONE (POVIDONE-IODINE 10% TOPICAL) LIQUID [ELEVATE ORAL CARE] 2 Current NDC, 1 package rows 20250507_27c29a33-d1cc-d72f-e063-6394a90a4d45.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 14 of 40 · 786 matching rows.
Packages# Package NDC, 11-digit format, Description table Package NDC 11-digit format Description Units Marketing start Sample Exclude flag Status 57511-0611-1 57511061101 6 mL in 1 BOX, UNIT-DOSE (57511-0611-1) 6 ml 2023-03-01 No No Current 57511-0611-2 57511061102 8 mL in 1 BOTTLE, DISPENSING (57511-0611-2) 8 ml 2024-12-18 No No Current