Home NDC 52380-4801-8 Aplicare Povidone-Iodine
Product NDC 52380-4801
Requested package NDC 52380-4801-8
11-digit product format 523804801
Labeler code 52380
Product ID 52380-4801_3dd65ceb-91c2-da2e-e063-6394a90a62cc
Type HUMAN OTC DRUG
Nonproprietary name Povidone-Iodine
Dosage form SOLUTION
Route TOPICAL
Labeler Aplicare Products, LLC
Application 505G(a)(3)
Marketing category OTC MONOGRAPH DRUG
Marketing start 1998-01-01
Substance POVIDONE-IODINE
Active strength 10 mg/mL
NDC exclude flag No
Listing certified through 2026-12-31
Current FDA listing Yes Additional Listing Data#
Finished product Yes
Brand name base Aplicare Povidone-Iodine
Listing expiration 2026-12-31 Active Ingredients# Ingredient, Strength table Ingredient Strength POVIDONE-IODINE 10 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 312564 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 52380-4801-8 Aplicare Povidone-Iodine 118 mL in 1 BOTTLE, PLASTIC SOLUTION 118 8
DailyMed Socrata Ingredients# Ingredient, Type, UNII table Ingredient Type UNII DailyMed label SPL version Uploaded POVIDONE-IODINE ACTIVE INGREDIENT 85H0HZU99M APLICARE POVIDONE-IODINE (POVIDONE-IODINE) SOLUTION [APLICARE, INC.] 2 IODINE ACTIVE MOIETY 9679TC07X4 APLICARE POVIDONE-IODINE (POVIDONE-IODINE) SOLUTION [APLICARE, INC.] 2 CITRIC ACID MONOHYDRATE INACTIVE INGREDIENT 2968PHW8QP APLICARE POVIDONE-IODINE (POVIDONE-IODINE) SOLUTION [APLICARE, INC.] 2 NONOXYNOL-9 INACTIVE INGREDIENT 48Q180SH9T APLICARE POVIDONE-IODINE (POVIDONE-IODINE) SOLUTION [APLICARE, INC.] 2 SODIUM HYDROXIDE INACTIVE INGREDIENT 55X04QC32I APLICARE POVIDONE-IODINE (POVIDONE-IODINE) SOLUTION [APLICARE, INC.] 2 SODIUM PHOSPHATE, DIBASIC INACTIVE INGREDIENT GR686LBA74 APLICARE POVIDONE-IODINE (POVIDONE-IODINE) SOLUTION [APLICARE, INC.] 2 WATER INACTIVE INGREDIENT 059QF0KO0R APLICARE POVIDONE-IODINE (POVIDONE-IODINE) SOLUTION [APLICARE, INC.] 2
DailyMed Dashboard NDC Coverage# NDC, Dashboard title, SPL version table NDC Dashboard title SPL version Validation Dashboard ZIP 52380-4801 APLICARE POVIDONE-IODINE (POVIDONE-IODINE) SOLUTION [APLICARE PRODUCTS, LLC] 7 Current NDC, Legacy NDC, 1 package rows 20240110_91aef86d-ce8b-45be-bce9-74450292e0cd.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 Marketing end Sample Exclude flag Status 52380-4801-8 52380480108 118 mL in 1 BOTTLE, PLASTIC (52380-4801-8) 118 ml 1998-01-01 0000-00-00 No No Current