Home NDC 83465-421 I2Pure I2Rx
Product NDC 83465-421
11-digit product format 834650421
Labeler code 83465
Product ID 83465-421_51941ac4-b20f-4da2-e063-6394a90aa7ee
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
Harmonized UNII identifiers# UNII identifiers page 1 of 1 · 2 matching rows.
Identifier, FDA.report destination table Identifier FDA.report destination PDC6A3C0OX Internal UNII lookup 9679TC07X4 Internal UNII 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 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 40 of 117 · 2,333 matching rows.
Brand, Generic, Manufacturer table Brand Generic Manufacturer SPL set ID Effective date Available safety fields Join EVERLIT SURVIVAL IODINE PREP PADS POVIDONE-IODINE EVERLIT GLOBAL INC. 3a03fc8d-2653-9183-e063-6294a90ad76e 2026-01-23 Warnings Exact identifier application number: M003 EVERLIT SURVIVAL PREP PAD ISOPROPYL ALCOHOL EVERLIT GLOBAL INC. 3a03ed81-5b1d-172e-e063-6394a90ac59c 2026-01-23 Warnings Exact identifier application number: M003 Everlit Survival Antiseptic Wipe ANTISEPTIC WIPE EVERLIT GLOBAL INC. 3a03f7e6-cc74-22a2-e063-6394a90a5f9f 2026-01-23 Warnings Exact identifier application number: M003 Rite Aid Isopropyl Alcohol Wipes ISOPROPYL ALCOHOL Rite Aid bca837b0-5044-4e97-e053-2a95a90a13af 2026-01-22 Warnings Exact identifier application number: M003 Drs. Pharmacy Triple Antibiotic AND BURN RELIEF BACITRACIN ZINC, NEOMYCIN SULFATE, POLYMYXIN B SULFATE OL PHARMA TECH, LLC Drs PHARMACY 4928d9dd-542b-fe8b-e063-6294a90a9252 2026-01-22 Warnings Exact identifier application number: M003 DOP Ethyl Alcohol 70% ETHYL ALCOHOL Omega & Delta Co., Inc. b96d85f8-739c-4b96-9dd5-8119ebf66c9f 2026-01-21 Warnings Exact identifier application number: M003 AshleyBelle Moisturizing Hand Sanitizer Rose Lychee ETHYL ALCOHOL Zhejiang Guoyao Jingyue Aerosol Co., Ltd. 48dfcbe1-8e0c-1715-e063-6394a90a733f 2026-01-21 Warnings Exact identifier application number: M003 Lights Povindone Iodine Swabstick POVIDONE-IODINE Lights Medical Manufacture Co., Ltd. 977b6077-bf47-4e02-bde4-c752e73d7628 2026-01-21 Warnings Exact identifier application number: M003 Lights Povindone Iodine Scrub POVIDONE-IODINE Lights Medical Manufacture Co., Ltd. 000bf57b-1805-4746-bf1c-32856241213a 2026-01-21 Warnings Exact identifier application number: M003 Lights Povidone Iodine Solution POVIDONE-IODINE Lights Medical Manufacture Co., Ltd. 6946eb98-6870-4b21-9dda-b01a8adab84b 2026-01-21 Warnings Exact identifier application number: M003 Lights Povidone Iodine Prep Pad POVIDONE-IODINE Lights Medical Manufacture Co., Ltd. e561332d-e419-43db-a68e-0c0d49b01c9a 2026-01-21 Warnings Exact identifier application number: M003 Lights Povindone Iodine Swabstick POVIDONE-IODINE Lights Medical Manufacture Co., Ltd. 2610fde4-4572-4d15-a970-f6d3beb734fe 2026-01-21 Warnings Exact identifier application number: M003 Lights Povidone Iodine Solution POVIDONE-IODINE Lights Medical Manufacture Co., Ltd. 7d4a92be-0601-4256-bc5b-bc1b07d97bb7 2026-01-21 Warnings Exact identifier application number: M003 AshleyBelle Moisturizing Hand Sanitizer Blueberry Freesia ETHYL ALCOHOL MY IMPORTS USA LLC 48f0a73a-66b5-e7d0-e063-6394a90a2333 2026-01-21 Warnings Exact identifier application number: M003 AshleyBelle Moisturizing Hand Sanitizer Lemon Sugar Blossom ETHYL ALCOHOL MY IMPORTS USA LLC 48f127be-8259-5aaa-e063-6294a90a3f1a 2026-01-21 Warnings Exact identifier application number: M003 AshleyBelle Moisturizing Hand Sanitizer Rose Lychee ETHYL ALCOHOL MY IMPORTS USA LLC 48f2433f-b924-ade1-e063-6394a90a2c9a 2026-01-21 Warnings Exact identifier application number: M003 AshleyBelle Moisturizing Hand Sanitizer Pineapple Soleil ETHYL ALCOHOL MY IMPORTS USA LLC 48f2527c-a83e-f709-e063-6394a90aa030 2026-01-21 Warnings Exact identifier application number: M003 DOP Hydrogen Peroxide 3% HYDROGEN PEROXIDE Omega & Delta Co. Inc. 73edab95-74ff-4f45-a941-634c83a52188 2026-01-21 Warnings Exact identifier application number: M003 DOP Isopropyl Rubbing Alcohol 70% ISOPROPYL ALCOHOL Omega & Delta Co., Inc. c779a35b-1118-4560-8d77-6878edb4c267 2026-01-21 Warnings Exact identifier application number: M003 Betadine Solution POVIDONE-IODINE Atlantis Consumer Healthcare, Inc. 1b1e224c-8c00-46ea-9bdd-020a9b45321d 2026-01-21 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