Pain Relieving Cream
NDC Package 84338-001-92

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

Pain Relieving Cream (camphor and menthol) cream is adults and children 12 years of age and older: apply to affected area not more than 3 to 4 times daily children under 12 years of age: do not use, consult a physician wash hands after use with cool water. This formulation utilizes a cream delivery system. Marketed by Pain Wizard Limited Liability Company, this product is identified by NDC 84338-001 and is authorized under FDA application M017.

Identification & Billing

NDC Package Code
84338-001-92
Package Description
118.29 mL in 1 TUBE
Product Code
84338-001
11-Digit Billing Format
84338000192

Clinical Specifications

Proprietary Name
Pain Relieving Cream
Non-Proprietary Name
Camphor And Menthol
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.
  • 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 and children 12 years of age and older: apply to affected area not more than 3 to 4 times daily children under 12 years of age: do not use, consult a physician wash hands after use with cool water

Regulatory & Marketing

Labeler Name
Pain Wizard Limited Liability Company
Product Type
Human Otc Drug
FDA Application #
M017
Marketing Category
OTC MONOGRAPH DRUG -
Start Marketing Date
12-02-2004
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 (84338-001). Click a package code to view its specific billing and regulatory data.

84338-001-09
88.7 mL in 1 BOTTLE, WITH APPLICATOR
84338-001-16
236 mL in 1 TUBE
84338-001-23
473.17 mL in 1 BOTTLE, PUMP
84338-001-30
59.14 mL 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 84338-001-92 identifies a specific commercial package of 118.29 ml in 1 tube of Pain Relieving Cream, a human over the counter drug labeled by Pain Wizard Limited Liability Company. 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 Pain Wizard Limited Liability Company on December 02, 2004. The current certification is valid through December 31, 2026.

How is this Pain Wizard Limited Liability Company product billed for insurance claims?

For medical billing and reimbursement, this package follows the 11-digit CMS format: 84338000192. 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)
84338-001-92
11-Digit CMS (5-4-2)
84338-0001-92

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