Home NDC 83465-421-30 I2Pure I2Rx
Product NDC 83465-421
Requested package NDC 83465-421-30
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 114 · 2,275 matching rows.
Brand, Generic, Manufacturer table Brand Generic Manufacturer SPL set ID Effective date Available safety fields Join 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 Ethyl Rubbing Alcohol 70 Percent ETHYL ALCOHOL Pharma Nobis, LLC e42fccc2-1b50-e7f3-e053-2a95a90aef39 2023-12-26 Warnings Exact identifier application number: M003 Isopropyl Alcohol 70 Percent With Wintergreen Oil ISOPROPYL ALCOHOL Pharma Nobis, LLC e42f6c6d-c4e1-02c6-e053-2995a90a3ace 2023-12-26 Warnings Exact identifier application number: M003 CVS Merthiolate BENZALKONIUM CHLORIDE CVS Pharmacy dd498ab1-8350-41aa-86fc-2db57005f3e2 2023-12-22 Warnings Exact identifier application number: M003 Povidone Iodine POVIDONE IODINE 10% Pharma Nobis, LLC e42eee1b-3539-fb17-e053-2995a90af61d 2023-12-22 Warnings Exact identifier application number: M003 Decolorized Iodine ETHYL ALCOHOL Pharma Nobis, LLC e21dd43b-3712-cb16-e053-2a95a90ac276 2023-12-22 Warnings Exact identifier application number: M003 Isopropyl Rubbing Alcohol 70 Percent ISOPROPYL ALCOHOL Pharma Nobis, LLC e42f727c-beb0-fe9d-e053-2995a90aafea 2023-12-22 Warnings Exact identifier application number: M003 Povidone Iodine POVIDONE IODINE GARGLE 0.5% Pharma Nobis, LLC e42ee827-b350-7b56-e053-2a95a90a69cf 2023-12-22 Warnings Exact identifier application number: M003 Merthiolate BENZALKONIUM CHLORIDE Pharma Nobis, LLC e42f727c-beaf-fe9d-e053-2995a90aafea 2023-12-22 Warnings Exact identifier application number: M003 Isopropyl Alcohol 91 Percent ISOPROPYL ALCOHOL Pharma Nobis, LLC e42f6c6d-c4e0-02c6-e053-2995a90a3ace 2023-12-22 Warnings Exact identifier application number: M003 RevitaDERM Wound Care BENZALKONIUM CHLORIDE Blaine Labs Inc. 9254dada-4e32-43a0-892b-c488d68e23e7 2023-12-21 Warnings Exact identifier application number: M003 NUMSTAT Antiseptic and Pain Relieving Prep Pad ALCOHOL, MENTHOL, AND BENZOCAINE PREP PAD Spectra Medical Devices, LLC 07d20040-9dd9-0aba-e063-6294a90ab7cf 2023-12-20 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