Home NDC 83465-421 I2Pure I2Rx
Product NDC 83465-421
11-digit product format 834650421
Labeler code 83465
Product ID 83465-421_5ca0fa08-564f-06c5-e063-6294a90a5593
Type HUMAN OTC DRUG
Nonproprietary name Antiseptic and Skin Protectant Gel
Dosage form GEL
Route TOPICAL
Labeler I2Pure Corp
Application M003
Marketing category OTC MONOGRAPH DRUG
Marketing start 2026-05-11
Substance GLYCERIN; IODINE
Active strength 25.9; 95 g/30mL; mg/30mL
Pharmacologic classes Allergens [CS], Cell-mediated Immunity [PE], Glycerol [CS], Increased Histamine Release [PE], Increased IgG Production [PE], Non-Standardized Chemical Allergen [EPC]
NDC exclude flag No
Listing certified through 2027-12-31
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 I2Pure I2Rx
Listing expiration 2027-12-31 Active Ingredients# Ingredient, Strength table Ingredient Strength GLYCERIN 25.9 g/30mL IODINE 95 mg/30mL
DailyMed Product Concepts# DailyMed Package Descriptions# Package NDC, Product, Description table Package NDC Product Description Form Quantity Strength SPL version 83465-421-30 I2Pure I2Rx 30 mL in 1 TUBE GEL 30 1
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 108 of 115 · 2,286 matching rows.
Brand, Generic, Manufacturer table Brand Generic Manufacturer SPL set ID Effective date Available safety fields Join White Petrolatum WHITE PETROLATUM Nantong Health & Beyond Hygienic Products Inc. 0f0d6ff0-ff30-aaf8-e063-6394a90a2716 2024-01-16 Warnings Exact identifier application number: M003 Thompson Hand Sanitizer ETHYL ALCOHOL Thompson deada606-8a82-9eeb-e053-2a95a90a9e6d 2024-01-16 Warnings Exact identifier application number: M003 MyMedic Arnica Gel ARNICA MONTANA Nantong Health & Beyond Hygienic Products Inc. 0ef8760d-27c0-7ece-e063-6294a90a6873 2024-01-15 Warnings Exact identifier application number: M003 American Safety First Aid Antispetic HYDROGEN PEROXIDE Orazen Inc ea2fbdfe-1932-9fb4-e053-2a95a90a3563 2024-01-15 Warnings Exact identifier application number: M003 First Aid Antispetic BENZALKONIUM CHLORIDE Orazen Inc ea2debcb-892c-339f-e053-2a95a90a4b18 2024-01-15 Warnings Exact identifier application number: M003 Ever Ready First Aid BENZALKONIUM CHLORIDE, LIDOCAINE HCI Ever Ready First Aid e53f3bf5-25c0-2b86-e053-2a95a90a010f 2024-01-15 Warnings Exact identifier application number: M003 FIRST SHIELD First Aid Antiseptic BENZALKONIUM CHLORIDE Ever Ready First Aid e013ef0a-ef3d-7af5-e053-2a95a90a54d3 2024-01-15 Warnings Exact identifier application number: M003 Latalia Hand Sanitizer 80 Alcohol Antiseptic ALCOHOL INTERNATIONAL CONSUMER PRODUCTS (PVT.) LTD ae55fab3-3177-383e-e053-2995a90a17a0 2024-01-10 Warnings Exact identifier application number: M003 Latalia Sanitizing Wipe ALCOHOL INTERNATIONAL CONSUMER PRODUCTS (PVT.) LTD ae564635-898e-fbf6-e053-2995a90a8119 2024-01-10 Warnings Exact identifier application number: M003 Latalia Sanitizing Wipes ALCOHOL INTERNATIONAL CONSUMER PRODUCTS (PVT) LTD af850b5e-c99f-3d4e-e053-2995a90a7948 2024-01-10 Warnings Exact identifier application number: M003 Latalia Alcohol Antiseptic 80 Sanitizing ALCOHOL INTERNATIONAL CONSUMER PRODUCTS (PVT) LTD ba4b8fb3-09db-fa29-e053-2995a90a8617 2024-01-10 Warnings Exact identifier application number: M003 Northside Hospital Amenity Kit--GI Dept ALCOHOL ASP Global, LLc c284eba4-0b92-4981-b3f8-d8d99b58bdfd 2024-01-10 Warnings Exact identifier application number: M003 Meijer 3 Hydrogen Peroxide Wipes HYDROGEN PEROXIDE Meijer, Inc. 33143d87-3e57-4a17-a96c-b699ad034b5b 2024-01-09 Warnings Exact identifier application number: M003 Meijer 70 Isopropyl Alcohol Wipes First Aid Antiseptic ISOPROPYL ALCOHOL Meijer, Inc 2046162f-cb70-416c-ae37-14999883a807 2024-01-09 Warnings Exact identifier application number: M003 Lightning X Antiseptic BENZALKONIUM CHLORIDE Nantong Health & Beyond Hygienic Products Inc. 0e6b10e7-6e84-6bfc-e063-6294a90a8537 2024-01-08 Warnings Exact identifier application number: M003 Hydrogen Peroxide HYDROGEN PEROXIDE 3.0% Trifecta Pharmaceuticals USA, LLC. e4e45f11-7cd4-e693-e053-2a95a90a4c34 2024-01-02 Warnings Exact identifier application number: M003 GLOBAL CARE GOLD ANTIBACTERIAL HAND BENZALKONIUM CHLORIDE NINGBO LIYUAN DAILY CHEMICAL PRODUCTS CO., LTD. 27ba0f30-e066-f240-e063-6394a90ae7cb 2024-01-01 Warnings Exact identifier application number: M003 Freskaro Decolorized Iodine ALCOHOL Pharma Nobis, LLC fbd222a2-1151-99b9-e053-6394a90a8bb8 2023-12-28 Warnings Exact identifier application number: M003 Alcohol Prep ISOPROPYL ALCOHOL Topco Associates 65270825-48b1-49e7-a14e-f73df9beb9dd 2023-12-27 Warnings Exact identifier application number: M003 Humco Hydrogen Peroxide HYDROGEN PEROXIDE 3% Pharma Nobis, LLC e42f876d-0477-c4d5-e053-2a95a90ae6d4 2023-12-26 Warnings Exact identifier application number: M003
Packages# Package NDC, 11-digit format, Description table Package NDC 11-digit format Description Units Marketing start Sample Exclude flag Status 83465-421-30 83465042130 30 mL in 1 TUBE (83465-421-30) 30 ml 2026-05-11 No No Current