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 109 of 115 · 2,286 matching rows.
Brand, Generic, Manufacturer table Brand Generic Manufacturer SPL set ID Effective date Available safety fields Join 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 Health Mart Iodides ALCOHOL Strategic Sourcing Services LLC 8d9f2112-c678-4559-b567-9d6d287c5fa3 2023-12-20 Warnings Exact identifier application number: M003 Health Mart Iodine Tincture Mild IODINE AND SODIUM IODIDE AND ALCOHOL Strategic Sourcing Services LLC 72eeb3e6-c0a1-4b18-87f1-8db06f9bd111 2023-12-20 Warnings Exact identifier application number: M003 Health Mart Hydrogen Peroxide 3 Percent HYDROGEN PEROXIDE Strategic Sourcing Services LLC cbe02fa1-c167-4b77-8f63-817362090e19 2023-12-20 Warnings Exact identifier application number: M003 Health Mart Isopropyl Alcohol 91 Percent ISOPROPYL ALCOHOL Strategic Sourcing Services LLC fbd2aa69-b1c7-4a28-9642-a436ae09faaf 2023-12-20 Warnings Exact identifier application number: M003 Quality Choice Povidone Iodine POVIDONE IODINE 10% Chain Drug Market Association 9fa49a3c-ad09-4d35-8cd9-e1a0f2da0d2d 2023-12-20 Warnings Exact identifier application number: M003 Quality Choice Iodine Tincture Mild IODINE AND SODIUM IODIDE AND ALCOHOL Chain Drug Market Association 55c970ed-13a9-4ea2-a8cb-aaf14d3a214d 2023-12-20 Warnings Exact identifier application number: M003 Quality Choice Iodides Tincture ETHYL ALCOHOL Chain Drug Market Association 71aedfd5-e81f-4b69-b163-527ff1ce30b1 2023-12-20 Warnings Exact identifier application number: M003 Quality Choice Merthiolate BENZALKONIUM CHLORIDE Chain Drug Market Association 5b7303b9-b8c4-4e7c-876f-70ed76443055 2023-12-20 Warnings Exact identifier application number: M003 Premier Value Povidone Iodine POVIDONE IODINE 10% Chain Drug Consortium 5cc9d782-5f7e-27d9-e053-2991aa0a2428 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