Home NDC 34645-4021 Povidone Iodine Surgical Scrub
Product NDC 34645-4021
11-digit product format 346454021
Labeler code 34645
Product ID 34645-4021_beac24d4-f9f1-7f26-e053-2995a90a96f2
Type HUMAN OTC DRUG
Nonproprietary name Povidone Iodine
Dosage form SPONGE
Route TOPICAL
Labeler Jianerkang Medical Co., Ltd
Application part333C
Marketing category OTC MONOGRAPH FINAL
Marketing start 2010-01-01
Marketing end 0000-00-00
Substance POVIDONE-IODINE
Active strength 100 mg/mL
NDC exclude flag No
Listing certified through 2022-12-31
Current FDA listing Historical FDA.report record NDC auxiliary status# Explicit status records from FDA unfinished, excluded, and compounder auxiliary files. Absence of a row is not itself a regulatory status.
Dataset, Scope, Product NDC table Dataset Scope Product NDC Package NDC Code Status Reporting period Source date excluded product product 34645-4021 I Inactivated by FDA 2026-07-31 excluded package package 34645-4021 34645-4021-7 I Inactivated by FDA 2026-07-31
openFDA label cross-check# Cross-check layer: openFDA label JSON enriches search and identifies hydration gaps. The DailyMed Structured Product Label remains the canonical label presentation on FDA.report.
Warnings cross-check# openFDA text is shown for search and cross-checking; DailyMed SPL is canonical.
warnings Warnings For external use only Flammable: Keep away from fire or flame. Do not use on children under 2 years of age unless directed by a doctor. If pregnant or breastfeeding ask a health professional before use. When using this product avoid contact with the eyes. Stop use and ask a doctor if irritation occurs. there is no improvement within 4 weeks. Keep out of reach of children. If swallowed, get medical help or contact a poison control center right away.
DailyMed Product Concepts# FDA-Initiated Inactive NDC Indexing# DailyMed Package Descriptions# Package NDC, Product, Description table Package NDC Product Description Form Quantity Strength SPL version 34645-4021-7 Povidone Iodine Surgical Scrub 20 mL in 1 POUCH SPONGE 20 6
DailyMed Socrata Ingredients# DailyMed Dashboard NDC Coverage# NDC, Dashboard title, SPL version table NDC Dashboard title SPL version Validation Dashboard ZIP 34645-4021 POVIDONE IODINE SURGICAL SCRUB (POVIDONE IODINE) SPONGE [JIANERKANG MEDICAL CO., LTD] 6 Legacy NDC, 1 package rows 20210330_9377d7e8-e7b5-40e1-ba91-decb476c0752.zip
Packages# Package NDC, 11-digit format, Description table Package NDC 11-digit format Description Units Marketing start Marketing end Sample Exclude flag Status 34645-4021-7 34645402107 20 mL in 1 POUCH (34645-4021-7) 20 ml 2010-01-01 0000-00-00 No No Current