Zihua Embrocation
NDC Package 49980-003-01

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.

Zihua Embrocation is ■ Adults and children 12 years of age and older apply to affected area not more than 3 to 4 time daily■ Apply liberally and gently rub into affected area■ Children under 12 years of age, consult a doctor before using■ Do not use otherwise than as directed. Marketed by Hong Kong Zihua Pharmaceutical Ltd., this product is identified by NDC 49980-003 and is authorized under FDA application part348.

Identification & Billing

NDC Package Code
49980-003-01
Package Description
1 BOTTLE, GLASS in 1 BOX / 26 mL in 1 BOTTLE, GLASS (49980-003-26)
Product Code
49980-003
11-Digit Billing Format
49980000301
RxNorm Crosswalk
  • RxCUI: 1495457 - camphor 11 % / menthol 15 % / methyl salicylate 15 % Topical Oil
  • RxCUI: 1495457 - camphor 0.11 MG/MG / menthol 0.15 MG/MG / methyl salicylate 0.15 MG/MG Topical Oil

Clinical Specifications

Proprietary Name
Zihua Embrocation Cooling Pain Relief
Dosage Form
-
Usage Information
■ Adults and children 12 years of age and older apply to affected area not more than 3 to 4 time daily■ Apply liberally and gently rub into affected area■ Children under 12 years of age, consult a doctor before using■ Do not use otherwise than as directed

Regulatory & Marketing

Labeler Name
Hong Kong Zihua Pharmaceutical Ltd.
FDA Application #
part348
Marketing Category
OTC MONOGRAPH NOT FINAL - A product marketed pursuant to an Over-the-Counter (OTC) Drug Monograph that is not final.
Start Marketing Date
04-15-2014
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 49980-003-01 identifies a specific commercial package of 1 bottle, glass in 1 box / 26 ml in 1 bottle, glass (49980-003-26) of Zihua Embrocation Cooling Pain Relief, labeled by Hong Kong Zihua Pharmaceutical 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 Hong Kong Zihua Pharmaceutical Ltd. on April 15, 2014. The current certification is valid through December 31, 2017.

How is this Hong Kong Zihua Pharmaceutical Ltd. product billed for insurance claims?

For medical billing and reimbursement, this package follows the 11-digit CMS format: 49980000301. 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)
49980-003-01
11-Digit CMS (5-4-2)
49980-0003-01

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