Au Kah Chuen Fugical Cream
NDC Package 69070-306-01

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

Package Information

Au Kah Chuen Fugical (calamine and diphenhydramine hydrochlorid) cream is classified as a

administered via topical route. This formulation utilizes a cream delivery system. Marketed by Zhejiang Dingtai Pharmaceutical Co., Ltd, this product is identified by NDC 69070-306 and is authorized under FDA application M016.

Identification & Billing

NDC Package Code
69070-306-01
Package Description
1 TUBE in 1 BOX / 15 g in 1 TUBE
Product Code
69070-306
11-Digit Billing Format
69070030601
RxNorm Crosswalk
  • RxCUI: 2727332 - calamine 10 % / diphenhydrAMINE hydrochloride 2 % Topical Cream
  • RxCUI: 2727332 - calamine 100 MG/ML / diphenhydramine hydrochloride 20 MG/ML Topical Cream
  • RxCUI: 2727332 - calamine 10 % / diphenhydramine hydrochloride 2 % Topical Cream

Clinical Specifications

Proprietary Name
Au Kah Chuen Fugical
Non-Proprietary Name
Calamine And Diphenhydramine Hydrochlorid
Substance Name
Diphenhydramine Hydrochloride; Ferric Oxide Red; Zinc Oxide
Dosage Form
Cream - An emulsion, semisolid3 dosage form, usually containing > 20% water and volatiles5 and/or < 50% hydrocarbons, waxes, or polyols as the vehicle. This dosage form is generally for external application to the skin or mucous membranes.
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)
Pharmacologic Class

Regulatory & Marketing

Labeler Name
Zhejiang Dingtai Pharmaceutical Co., Ltd
Product Type
Human Otc Drug
FDA Application #
M016
Marketing Category
OTC MONOGRAPH DRUG -
Start Marketing Date
06-10-2019
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 69070-306-01 identifies a specific commercial package of 1 tube in 1 box / 15 g in 1 tube of Au Kah Chuen Fugical, a human over the counter drug labeled by Zhejiang Dingtai Pharmaceutical Co., Ltd. This cream is formulated for topical use and contains diphenhydramine hydrochloride; ferric oxide red; zinc oxide 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 Zhejiang Dingtai Pharmaceutical Co., Ltd on June 10, 2019. The current certification is valid through December 31, 2026.

How is this Zhejiang Dingtai Pharmaceutical Co., Ltd product billed for insurance claims?

For medical billing and reimbursement, this package follows the 11-digit CMS format: 69070030601. 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)
69070-306-01
11-Digit CMS (5-4-2)
69070-0306-01

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