Home NDC 81280-003 Povidone-Iodine
Product NDC 81280-003
11-digit product format 812800003
Labeler code 81280
Product ID 81280-003_58d9f789-b981-422e-8042-16dfeea07447
Type HUMAN OTC DRUG
Nonproprietary name Povidone-Iodine
Dosage form SWAB
Route TOPICAL
Labeler Mazza Healthcare, LLC
Application M005
Marketing category OTC MONOGRAPH DRUG
Marketing start 2021-03-01
Substance POVIDONE-IODINE
Active strength .1 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 Povidone-Iodine
Listing expiration 2026-12-31 Active Ingredients# Ingredient, Strength table Ingredient Strength POVIDONE-IODINE .1 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 RxCUI identifiers# RxCUI identifiers page 1 of 1 · 1 matching rows.
Identifier, FDA.report destination table Identifier FDA.report destination 1037205 Internal RxNorm 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 81280-003-01 Povidone-Iodine 1 in 1 POUCH SWAB 1 2 81280-003-01 Povidone-Iodine 500 in 1 CARTON SWAB 500 2 81280-003-03 Povidone-Iodine 500 in 1 CARTON SWAB 500 2 81280-003-03 Povidone-Iodine 3 in 1 POUCH SWAB 3 2
DailyMed Dashboard NDC Coverage# NDC, Dashboard title, SPL version table NDC Dashboard title SPL version Validation Dashboard ZIP 81280-003 POVIDONE-IODINE SWAB [MAZZA HEALTHCARE, LLC] 2 Current NDC, Legacy NDC, 4 package rows 20241124_31df570a-35ae-41a2-b04a-fce65e9d596d.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 23 of 49 · 973 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 81280-003-01 81280000301 500 POUCH in 1 CARTON (81280-003-01) / 1 APPLICATOR in 1 POUCH / 2.5 mL in 1 APPLICATOR 500 pouch 2021-03-01 0000-00-00 No No Current 81280-003-03 81280000303 500 POUCH in 1 CARTON (81280-003-03) / 3 APPLICATOR in 1 POUCH / 4.5 mL in 1 APPLICATOR 500 pouch 2021-03-01 0000-00-00 No No Current