Calamine Phenolated Topical Suspension
NDC Package 0395-9109-96

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

Package Information

This product is EXCLUDED from the official NDC directory because the listing data was inactivated by the FDA.

Calamine Phenolated Topical Suspension is adult and children 2 years of age and older: Cleanse the skin with soap and water and let dry before each use. Marketed by Humco Holding Group, Inc., this product is identified by NDC 0395-9109 and is authorized under FDA application part347.

Identification & Billing

NDC Package Code
0395-9109-96
Package Description
177 mL in 1 BOTTLE, PLASTIC
Product Code
0395-9109
11-Digit Billing Format
00395910996
RxNorm Crosswalk
  • RxCUI: 991369 - calamine 8 % / phenol 1 % / zinc oxide 8 % Topical Lotion
  • RxCUI: 991369 - calamine 80 MG/ML / phenol 10 MG/ML / zinc oxide 80 MG/ML Topical Lotion
  • RxCUI: 991369 - calamine 8 % / phenol 1 % / zinc oxide 8 % Topical Suspension
  • RxCUI: 991369 - Calamine 80 MG/ML / phenol 10 MG/ML / ZNO 80 MG/ML Topical Lotion

Clinical Specifications

Proprietary Name
Calamine Phenolated Topical Suspension
Dosage Form
-
Usage Information
Adult and children 2 years of age and older: Cleanse the skin with soap and water and let dry before each use. Apply product to the affected area using cotton or soft cloth, as often as needed for comfort. Children under 2 years of age: Consult a doctor before use.

Regulatory & Marketing

Labeler Name
Humco Holding Group, Inc.
FDA Application #
part347
Marketing Category
OTC MONOGRAPH FINAL - A product marketed pursuant to a final Over-the-Counter (OTC) Drug Monograph.
Start Marketing Date
01-01-2008
Listing Expiration
12-31-2022
Exclude Flag
I
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 0395-9109-96 identifies a specific commercial package of 177 ml in 1 bottle, plastic of Calamine Phenolated Topical Suspension, labeled by Humco Holding Group, Inc.. This is formulated for use and contains as the active substance.

Is this product currently listed with the FDA?

This product code is currently listed as inactive or excluded from the primary directory. It was introduced to the market by Humco Holding Group, Inc. on January 01, 2008. The current certification is valid through December 31, 2022.

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: 00395910996. 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)
0395-9109-96
11-Digit CMS (5-4-2)
00395-9109-96

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