Povidone Iodine Liquid
NDC Package 0395-9128-98

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

Package Information

Povidone Iodine (povidone iodine gargle 0.5%) liquids is dO NOT SWALLOWAdults and children 12 years and older:Gargle with 10mL full strength for 30 seconds, then spit out.Use only with dosing cup provided.Use up to 4 times daily.Children under 12:Do not use. This formulation utilizes a liquid delivery system. Marketed by Humco Holding Group, Inc., this product is identified by NDC 0395-9128 and is authorized under FDA application M003.

Identification & Billing

NDC Package Code
0395-9128-98
Package Description
1 CONTAINER in 1 CARTON / 237 mL in 1 CONTAINER
Product Code
0395-9128
11-Digit Billing Format
00395912898
RxNorm Crosswalk

Clinical Specifications

Proprietary Name
Povidone Iodine
Non-Proprietary Name
Povidone Iodine Gargle 0.5%
Substance Name
Povidone-iodine
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)
POVIDONE-IODINE 5 mg/mL
Usage Information
DO NOT SWALLOWAdults and children 12 years and older:Gargle with 10mL full strength for 30 seconds, then spit out.Use only with dosing cup provided.Use up to 4 times daily.Children under 12:Do not use.

Regulatory & Marketing

Labeler Name
Humco Holding Group, Inc.
Product Type
Human Otc Drug
FDA Application #
M003
Marketing Category
OTC MONOGRAPH DRUG -
Start Marketing Date
06-10-2020
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.

Frequently Asked Questions

What is the distribution configuration for this product package?

The code 0395-9128-98 identifies a specific commercial package of 1 container in 1 carton / 237 ml in 1 container of Povidone Iodine, a human over the counter drug labeled by Humco Holding Group, Inc.. This liquid is formulated for topical use and contains povidone-iodine 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 June 10, 2020. 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: 00395912898. 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)
0395-9128-98
11-Digit CMS (5-4-2)
00395-9128-98

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