Home NDC 0395-1213 Iodine Tincture Mild
Product NDC 0395-1213
11-digit product format 003951213
Labeler code 0395
Product ID 0395-1213_450f5c66-e5f3-d151-e063-6294a90a6714
Type HUMAN OTC DRUG
Nonproprietary name Iodine and Sodium Iodide and Alcohol
Dosage form LIQUID
Route TOPICAL
Labeler Humco Holding Group, Inc.
Application M003
Marketing category OTC MONOGRAPH DRUG
Marketing start 1979-01-01
Substance IODINE; SODIUM IODIDE; ALCOHOL
Active strength 20; 20.4; 470 mg/mL; mg/mL; mg/mL
NDC exclude flag No
Listing certified through 2026-12-31
Current FDA listing Yes
Observed NDC auxiliary status history# This history shows the information present in each captured FDA auxiliary file. It is not a continuous regulatory timeline, and a missing record does not establish a status.
Historic NDC status page 1 of 1 · 12 matching rows.
View current auxiliary records. · View the auxiliary file history.
Captured / source date, Snapshot, Source SHA-256 table Captured / source date Snapshot Source SHA-256 2025-12-14 17:58 UTC · source 2025-12-05 d630ba8d3edf…732f749b63fb…2025-08-27 00:01 UTC · source 2025-08-26 f5e01cc5f278…a2eaf40c39c3…2025-04-01 02:39 UTC · source 2025-03-31 2ef7874e63bc…57b86245f4fa…2025-03-28 20:22 UTC · source 2025-03-28 a1b67e2a42f9…c4cf2c586c0d…2025-03-22 03:12 UTC · source 2025-03-21 cfe11265f3b6…090c488252e2…2025-03-10 12:48 UTC · source 2025-03-10 cdf11ea48f46…ba0047e9e063…2025-02-02 03:52 UTC · source 2025-01-31 302b2466d912…e7b80fea0513…2025-01-20 13:05 UTC · source 2025-01-20 ed331223b511…672a5bd82f5f…2025-01-11 03:41 UTC · source 2025-01-10 0efc9e666f02…f202fb6c5f17…2024-11-09 02:27 UTC · source 2024-11-08 ad56d346431e…cc804d4bbf1e…2024-10-04 04:10 UTC · source 2024-10-03 367a005e9d99…383a685ebd0f…2024-07-10 04:00 UTC · source 2024-07-09 557ba5c1ecfa…9c80585c8c6e…
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 Iodine Tincture Mild
Listing expiration 2026-12-31 Active Ingredients# Ingredient, Strength table Ingredient Strength IODINE 20 mg/mL SODIUM IODIDE 20.4 mg/mL ALCOHOL 470 mg/mL
Harmonized UNII identifiers# UNII identifiers page 1 of 1 · 3 matching rows.
Identifier, FDA.report destination table Identifier FDA.report destination 9679TC07X4 Internal UNII lookup F5WR8N145C Internal UNII lookup 3K9958V90M 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 0395-1213-16 Iodine Tincture Mild 473 mL in 1 BOTTLE LIQUID 473 8 0395-1213-55 Iodine Tincture Mild 208000 mL in 1 DRUM LIQUID 208000 8 0395-1213-91 Iodine Tincture Mild 30 mL in 1 BOTTLE LIQUID 30 8
DailyMed Socrata Ingredients# DailyMed Dashboard NDC Coverage# NDC, Dashboard title, SPL version table NDC Dashboard title SPL version Validation Dashboard ZIP 0395-1213 IODINE TINCTURE MILD (IODINE AND SODIUM IODIDE AND ALCOHOL) LIQUID [HUMCO HOLDING GROUP, INC.] 7 Current NDC, Legacy NDC, 3 package rows 20231216_41c0927e-df40-4f83-8fd4-284ec0c02b60.zip
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 39 of 114 · 2,270 matching rows.
Brand, Generic, Manufacturer table Brand Generic Manufacturer SPL set ID Effective date Available safety fields Join 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 CVS Hydrogen Peroxide Wipes HYDROGEN PEROXIDE CVS Pharmacy d2c22ab0-9647-4025-8282-6b492209b04c 2026-01-20 Warnings Exact identifier application number: M003
Packages# Package NDC, 11-digit format, Description table Package NDC 11-digit format Description Units Marketing start Marketing end Sample Exclude flag Status 0395-1213-16 00395121316 473 mL in 1 BOTTLE (0395-1213-16) 473 ml 2017-11-14 0000-00-00 No No Current 0395-1213-55 00395121355 208000 mL in 1 DRUM 208000 ml Historical 0395-1213-91 00395121391 30 mL in 1 BOTTLE (0395-1213-91) 30 ml 2017-11-14 0000-00-00 No No Current