Home NDC 53329-938-08 Povidone-Iodine
Product NDC 53329-938
Requested package NDC 53329-938-08
11-digit product format 533290938
Labeler code 53329
Product ID 53329-938_41c65656-ff98-67e5-e063-6394a90a6079
Type HUMAN OTC DRUG
Nonproprietary name Povidone-Iodine
Dosage form SOLUTION
Route TOPICAL
Labeler Medline Industries, LP
Application 505G(a)(3)
Marketing category OTC MONOGRAPH DRUG
Marketing start 2007-01-01
Substance POVIDONE-IODINE
Active strength .75 g/100mL
NDC exclude flag No
Listing certified through 2026-12-31
Current FDA listing Yes Observed NDC auxiliary status history# This history shows the information present in each captured FDA auxiliary file. It is not a continuous regulatory timeline, and a missing record does not establish a status.
Historic NDC status page 1 of 1 · 12 matching rows.
View current auxiliary records. · View the auxiliary file history.
Captured / source date, Snapshot, Source SHA-256 table Captured / source date Snapshot Source SHA-256 2025-12-14 17:58 UTC · source 2025-12-05 d630ba8d3edf…732f749b63fb…2025-08-27 00:01 UTC · source 2025-08-26 f5e01cc5f278…a2eaf40c39c3…2025-04-01 02:39 UTC · source 2025-03-31 2ef7874e63bc…57b86245f4fa…2025-03-28 20:22 UTC · source 2025-03-28 a1b67e2a42f9…c4cf2c586c0d…2025-03-22 03:12 UTC · source 2025-03-21 cfe11265f3b6…090c488252e2…2025-03-10 12:48 UTC · source 2025-03-10 cdf11ea48f46…ba0047e9e063…2025-02-02 03:52 UTC · source 2025-01-31 302b2466d912…e7b80fea0513…2025-01-20 13:05 UTC · source 2025-01-20 ed331223b511…672a5bd82f5f…2025-01-11 03:41 UTC · source 2025-01-10 0efc9e666f02…f202fb6c5f17…2024-11-09 02:27 UTC · source 2024-11-08 ad56d346431e…cc804d4bbf1e…2024-10-04 04:10 UTC · source 2024-10-03 367a005e9d99…383a685ebd0f…2024-07-10 04:00 UTC · source 2024-07-09 557ba5c1ecfa…9c80585c8c6e…
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 .75 g/100mL
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 211747 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 53329-938-04 Povidone-Iodine 118 mL in 1 BOTTLE SOLUTION 118 8 53329-938-06 Povidone-Iodine 473 mL in 1 BOTTLE SOLUTION 473 8 53329-938-08 Povidone-Iodine 237 mL in 1 BOTTLE SOLUTION 237 8 53329-938-23 Povidone-Iodine 946 mL in 1 BOTTLE SOLUTION 946 8 53329-938-25 Povidone-Iodine 3785 mL in 1 BOTTLE SOLUTION 3785 8
DailyMed Dashboard NDC Coverage# NDC, Dashboard title, SPL version table NDC Dashboard title SPL version Validation Dashboard ZIP 53329-938 POVIDONE-IODINE SOLUTION [MEDLINE INDUSTRIES, LP] 7 Current NDC, Legacy NDC, 5 package rows 20241212_2b95078e-2caf-7005-e054-00144ff88e88.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 53329-938-08 53329093808 237 mL in 1 BOTTLE (53329-938-08) 237 ml 2017-04-06 0000-00-00 No No Current