China-gel Cream
NDC Package 76305-402-01

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

China-gel (menthol and camohor (synthetic)) cream is adults or children 2 years or olderCleanse area-apply liberally over affected area as neededMassage into skin until absorbedRepeat up to 4 times a day. This formulation utilizes a cream delivery system. Marketed by China-gel, Inc., this product is identified by NDC 76305-402 and is authorized under FDA application M017.

Identification & Billing

NDC Package Code
76305-402-01
Package Description
113.5 g in 1 JAR
Product Code
76305-402
11-Digit Billing Format
76305040201
RxNorm Crosswalk

Clinical Specifications

Proprietary Name
China-gel
Non-Proprietary Name
Menthol And Camohor (synthetic)
Substance Name
Camphor (synthetic); Menthol
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)
Usage Information
Adults or children 2 years or olderCleanse area-apply liberally over affected area as neededMassage into skin until absorbedRepeat up to 4 times a day

Regulatory & Marketing

Labeler Name
China-gel, Inc.
Product Type
Human Otc Drug
FDA Application #
M017
Marketing Category
OTC MONOGRAPH DRUG -
Start Marketing Date
02-11-2022
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 (76305-402). Click a package code to view its specific billing and regulatory data.

76305-402-02
453.6 g in 1 JAR
76305-402-03
170 g in 1 TUBE

* 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 76305-402-01 identifies a specific commercial package of 113.5 g in 1 jar of China-gel, a human over the counter drug labeled by China-gel, Inc.. This cream is formulated for topical use and contains camphor (synthetic); menthol 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 China-gel, Inc. on February 11, 2022. The current certification is valid through December 31, 2026.

How is this China-gel, Inc. product billed for insurance claims?

For medical billing and reimbursement, this package follows the 11-digit CMS format: 76305040201. 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)
76305-402-01
11-Digit CMS (5-4-2)
76305-0402-01

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