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 9 of 115 · 2,286 matching rows.
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