Home NDC 81351-004-01 Saninta 10% Povidone-Iodine
Product NDC 81351-004
Requested package NDC 81351-004-01
11-digit product format 813510004
Labeler code 81351
Product ID 81351-004_47446355-315f-6485-e063-6294a90a0377
Type HUMAN OTC DRUG
Nonproprietary name Povidone-Iodine Solution
Dosage form LIQUID
Route TOPICAL
Labeler LL Pharma
Application 505G(a)(3)
Marketing category OTC MONOGRAPH DRUG
Marketing start 2021-08-25
Marketing end 2029-09-30
Substance POVIDONE-IODINE
Active strength 100 mg/mL
NDC exclude flag No
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 Saninta 10% Povidone-Iodine 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 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 81351-004-01 Saninta 10% Povidone-Iodine 2.3 mL in 1 APPLICATOR LIQUID 2.3 6 81351-004-01 Saninta 10% Povidone-Iodine 3 in 1 POUCH LIQUID 3 6 81351-004-02 Saninta 10% Povidone-Iodine 22.5 mL in 1 PACKET LIQUID 22.5 6
DailyMed Dashboard NDC Coverage# NDC, Dashboard title, SPL version table NDC Dashboard title SPL version Validation Dashboard ZIP 81351-004 SANINTA 10% POVIDONE-IODINE (POVIDONE-IODINE SOLUTION) LIQUID [LL PHARMA] 5 Current NDC, Legacy NDC, 3 package rows 20231022_bd344007-895e-30d6-e053-2a95a90a019d.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 Marketing end Sample Exclude flag Status 81351-004-01 81351000401 3 APPLICATOR in 1 POUCH (81351-004-01) / 2.3 mL in 1 APPLICATOR 3 applicator 2021-08-25 2029-07-31 No No Current