Home NDC 68356-601 Saninta 10% Povidone-Iodine
Product NDC 68356-601
11-digit product format 683560601
Labeler code 68356
Product ID 68356-601_26edf53b-4ba3-a69b-e063-6294a90a1769
Type HUMAN OTC DRUG
Nonproprietary name Povidone-Iodine Solution
Dosage form LIQUID
Route TOPICAL
Labeler Lernapharm
Application 505G(a)(3)
Marketing category OTC MONOGRAPH DRUG
Marketing start 2024-02-26
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 Saninta 10% Povidone-Iodine
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 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 68356-601-01 Saninta 10% Povidone-Iodine 2.3 mL in 1 APPLICATOR LIQUID 2.3 2 68356-601-01 Saninta 10% Povidone-Iodine 3 in 1 POUCH LIQUID 3 2 68356-601-02 Saninta 10% Povidone-Iodine 22.5 mL in 1 PACKET LIQUID 22.5 2 68356-601-03 Saninta 10% Povidone-Iodine 15 mL in 1 PACKET LIQUID 15 2
DailyMed Dashboard NDC Coverage# NDC, Dashboard title, SPL version table NDC Dashboard title SPL version Validation Dashboard ZIP 68356-601 SANINTA 10% POVIDONE-IODINE (POVIDONE-IODINE SOLUTION) LIQUID [LERNAPHARM] 2 Current NDC, 4 package rows 20241116_1275efa3-0602-2f17-e063-6394a90ac56e.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.
DailyMed RxNorm Mappings# Packages# Package NDC, 11-digit format, Description table Package NDC 11-digit format Description Units Marketing start Sample Exclude flag Status 68356-601-01 68356060101 3 APPLICATOR in 1 POUCH (68356-601-01) / 2.3 mL in 1 APPLICATOR 3 applicator 2024-02-26 No No Current 68356-601-02 68356060102 22.5 mL in 1 PACKET (68356-601-02) 22.5 ml 2024-02-26 No No Current 68356-601-03 68356060103 15 mL in 1 PACKET (68356-601-03) 15 ml 2024-11-14 No No Current