Assured Acne Cream
NDC Package 35038-200-01

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.

Assured Acne Cream is cleanse the skin thoroughly before applying medication. Marketed by Hangzhou Mino Daily Chemicals Co.ltd., this product is identified by NDC 35038-200 and is authorized under FDA application part333D.

Identification & Billing

NDC Package Code
35038-200-01
Package Description
44 mL in 1 TUBE
Product Code
35038-200
11-Digit Billing Format
35038020001
RxNorm Crosswalk

Clinical Specifications

Proprietary Name
Assured Acne Cream
Dosage Form
-
Usage Information
Cleanse the skin thoroughly before applying medication. Apply cream directly on acne pimples. Because excessive drying of the skin may occur, start with one application daily, then gradually increase to two or three times daily if needed or as directed by a doctor. If bothersome occurs, reduce application to once a day.

Regulatory & Marketing

Labeler Name
Hangzhou Mino Daily Chemicals Co.ltd.
FDA Application #
part333D
Marketing Category
OTC MONOGRAPH FINAL - A product marketed pursuant to a final Over-the-Counter (OTC) Drug Monograph.
Start Marketing Date
06-01-2010
Listing Expiration
12-31-2017
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 35038-200-01 identifies a specific commercial package of 44 ml in 1 tube of Assured Acne Cream, labeled by Hangzhou Mino Daily Chemicals Co.ltd.. 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 Hangzhou Mino Daily Chemicals Co.ltd. on June 01, 2010. The current certification is valid through December 31, 2017.

How is this Hangzhou Mino Daily Chemicals Co.ltd. product billed for insurance claims?

For medical billing and reimbursement, this package follows the 11-digit CMS format: 35038020001. 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 (5-3-2)
35038-200-01
11-Digit CMS (5-4-2)
35038-0200-01

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