Iodine Tincture Mild Liquid
NDC Package 0395-1213-91

View Billable Units, 11-Digit Conversion Format, and RxNorm mappings
Table of Contents
    1. Package Information
    2. Other Packages
    3. Frequently Asked Questions

Package Information

Iodine Tincture Mild (iodine and sodium iodide and alcohol) liquids is first aid to help prevent infection in minor cuts, scrapes and burns. This formulation utilizes a liquid delivery system. Marketed by Humco Holding Group, Inc., this product is identified by NDC 0395-1213 and is authorized under FDA application M003.

Identification & Billing

NDC Package Code
0395-1213-91
Package Description
30 mL in 1 BOTTLE
Product Code
0395-1213
11-Digit Billing Format
00395121391
Billing Unit
ML - Billing unit of "milliliter" is used when a product is measured by its liquid volume.
Units Per Package
30 ML

Clinical Specifications

Proprietary Name
Iodine Tincture Mild
Non-Proprietary Name
Iodine And Sodium Iodide And Alcohol
Substance Name
Alcohol; Iodine; Sodium Iodide
Dosage Form
Liquid - A dosage form consisting of a pure chemical in its liquid1 state. This dosage form term should not be applied to solutions.
Administration Route
Topical - Administration to a particular spot on the outer surface of the body. The E2B term TRANSMAMMARY is a subset of the term TOPICAL.
Active Ingredient(s)
Usage Information
First aid to help prevent infection in minor cuts, scrapes and burns

Regulatory & Marketing

Labeler Name
Humco Holding Group, Inc.
Product Type
Human Otc Drug
FDA Application #
M003
Marketing Category
OTC MONOGRAPH DRUG -
Start Marketing Date
01-01-1979
Listing Expiration
12-31-2026
Exclude Flag
N
Sample Package
No

Hierarchy Structure

Code Lineage

The NDC Directory contains ONLY information on final marketed drugs submitted to FDA electronically by labelers. A labeler might be a manufacturer, re-packager or re-labeler. The product information included in the NDC directory does not indicate that FDA has verified the information provided by the product labeler. Assigned NDC numbers are not in any way an indication of FDA approval of the product.

* Please review the full disclaimer at the bottom of this page.

Other Available Packages

The following commercial packages are registered under the same Product NDC (0395-1213). Click a package code to view its specific billing and regulatory data.

0395-1213-16
473 mL in 1 BOTTLE
0395-1213-55
208000 mL in 1 DRUM

* Please review the full disclaimer at the bottom of this page.

Frequently Asked Questions

What is the distribution configuration for this product package?

The code 0395-1213-91 identifies a specific commercial package of 30 ml in 1 bottle of Iodine Tincture Mild, a human over the counter drug labeled by Humco Holding Group, Inc.. This product is billed per "ML" milliliter and contains an estimated amount of 30 billable units per package. This liquid is formulated for topical use and contains alcohol; iodine; sodium iodide as the active substance.

Is this product currently listed with the FDA?

Yes, this product is active and verified within the NDC Directory. It was introduced to the market by Humco Holding Group, Inc. on January 01, 1979. The current certification is valid through December 31, 2026.

How is this Humco Holding Group, Inc. product billed for insurance claims?

For medical billing and reimbursement, this package follows the 11-digit CMS format: 00395121391. Quantities are measured in per "ml or milliliter", products billed per milliliter are usually products measured by liquid volume.. There are 30 total billable units per package. The table below illustrates the segment conversion from the 10-digit labeler code to the 11-digit provider format.

11-Digit Code Conversion

Billing payers usually require a 5-4-2 segment configuration. Below is the conversion from the 10-digit package format to the 11-digit billing format:

10-Digit Format (4-4-2)
0395-1213-91
11-Digit CMS (5-4-2)
00395-1213-91

Note: The zero is added to the Labeler segment to maintain the 5-4-2 structure.