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 12 of 114 · 2,277 matching rows.
Brand, Generic, Manufacturer table Brand Generic Manufacturer SPL set ID Effective date Available safety fields Join Ashley Belle 1 oz., Moisturizing Hand Sanitizing, Pink Sugar ETHYL ALCOHOL 70% V/V Zhejiang Guoyao Jingyue Aerosol Co., Ltd. 55fd1844-bfeb-c0ef-e063-6294a90a4492 2026-07-06 Warnings Exact identifier application number: M003 Ashley Belle 1 oz., Moisturizing Hand Sanitizing Spray, Sugared Plum ETHYL ALCOHOL 70% V/V MY IMPORTS USA LLC 559a9300-964e-ea9a-e063-6394a90a4016 2026-07-02 Warnings Exact identifier application number: M003 Ashley Belle 1 oz., Moisturizing Hand Sanitizing, Sea Salt Air ETHYL ALCOHOL 70% V/V MY IMPORTS USA LLC 559a5f07-1557-c6d6-e063-6394a90a832f 2026-07-02 Warnings Exact identifier application number: M003 Ashley Belle 1 oz., Moisturizing Hand Sanitizing, Amber Glow ETHYL ALCOHOL 70% V/V Zhejiang Guoyao Jingyue Aerosol Co., Ltd. 55242d92-04af-0224-e063-6394a90aee98 2026-07-02 Warnings Exact identifier application number: M003 BAK 1 750 BENZALKONIUM CHLORIDE Medical Chemical Corporation d1f06aa6-2264-4ac1-a9a4-8ca9be1c9ca8 2026-07-02 Warnings Exact identifier application number: M003 HYDROGEN PEROXIDE HYDROGEN PEROXIDE Medical Chemical Corporation b1ce5858-36fe-70dc-e053-2995a90a5913 2026-07-02 Warnings Exact identifier application number: M003 HYDROGEN PEROXIDE HYDROGEN PEROXIDE Medical Chemical Corporation f6d677b8-fa89-4efb-984a-fd98e3e590e8 2026-07-02 Warnings Exact identifier application number: M003 American Red Cross IPA 50% 6oz AMERICAN RED CROSS IPA 50% 6OZ TSM BRANDS LLC 29195bac-b096-ab8d-e063-6394a90a424a 2026-07-01 Warnings Exact identifier application number: M003 American Red Cross 6oz, 50% Isopropyl Alcohol AMERICAN RED CROSS 6 OZ, 50% ISOPROPYL ALCOHOL SPRAY MY IMPORTS USA LLC 2929d580-cfff-e2b6-e063-6394a90a79aa 2026-07-01 Warnings Exact identifier application number: M003 Medi Fect Antiseptic Hand Wash ETHYL ALCOHOL Medical Chemical Corporation dc397d9c-9c12-41e5-ab7f-196fcad5bf97 2026-07-01 Warnings Exact identifier application number: M003 AloeSafe Antiseptic Hand Sanitizer ETHYL ALCOHOL Medical Chemical Corporation 950f012e-7908-523c-e053-2995a90afa6b 2026-07-01 Warnings Exact identifier application number: M003 Compound Benzoin Tincture TINCTURE OF BENZOIN Medical Chemical Corporation 243494ee-342d-4c32-9a86-f8c6c347bd8b 2026-07-01 Warnings Exact identifier application number: M003 Ashley Belle 1 oz., Moisturizing Hand Sanitizing, Beach Sandalwood ETHYL ALCOHOL 70% V/V MY IMPORTS USA LLC 55984504-188f-13bc-e063-6394a90a9150 2026-07-01 Warnings Exact identifier application number: M003 Ashley Belle 1 oz., Moisturizing Hand Sanitizing, Amber Glow ETHYL ALCOHOL 70% V/V MY IMPORTS USA LLC 5597ed5f-ed98-ebeb-e063-6294a90a2e8d 2026-07-01 Warnings Exact identifier application number: M003 Ashley Belle 1 oz., Moisturizing Hand Sanitizing, Berry Creme ETHYL ALCOHOL 70% V/V MY IMPORTS USA LLC 5598c831-3986-00a5-e063-6394a90a1e66 2026-07-01 Warnings Exact identifier application number: M003 Ashley Belle 1 oz., Moisturizing Hand Sanitizing, Apple Splash ETHYL ALCOHOL 70% V/V MY IMPORTS USA LLC 55982f73-7baa-26a7-e063-6394a90ab74b 2026-07-01 Warnings Exact identifier application number: M003 Ashley Belle 1 oz., Moisturizing Hand Sanitizing, Autumn Berry Crumble ETHYL ALCOHOL 70% V/V MY IMPORTS USA LLC 55981d2a-d4de-af08-e063-6294a90a4b7c 2026-07-01 Warnings Exact identifier application number: M003 Ashley Belle 1 oz., Moisturizing Hand Sanitizing, Confetti Cupcake ETHYL ALCOHOL 70% V/V MY IMPORTS USA LLC 5597ff1f-b134-0beb-e063-6394a90a39a1 2026-07-01 Warnings Exact identifier application number: M003 Ashley Belle 1 oz., Moisturizing Hand Sanitizing, Gingerbread Cake ETHYL ALCOHOL 70% V/V MY IMPORTS USA LLC 5598d6ca-39f6-ca2a-e063-6394a90abc0e 2026-07-01 Warnings Exact identifier application number: M003 Ashley Belle 1 oz., Moisturizing Hand Sanitizing, Matcha Mist ETHYL ALCOHOL 70% V/V MY IMPORTS USA LLC 559832ca-df92-0c2d-e063-6294a90ab66f 2026-07-01 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