Studio 35 External Analgesic Medicated Body Powder
NDC Package 0363-0552-38

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

Package Information

Studio 35 External Analgesic Medicated Body (menthol and zinc oxide) powders is adults and children 2 years of age and older: apply to affected area no more than 3 to 4 times dailychildren under 2 years of age: consult a doctorfor best results, dry area thoroughly before applying. This formulation utilizes a powder delivery system. Marketed by Walgreen Co, this product is identified by NDC 0363-0552 and is authorized under FDA application part348.

Identification & Billing

NDC Package Code
0363-0552-38
Package Description
283 g in 1 BOTTLE
Product Code
0363-0552
11-Digit Billing Format
00363055238
RxNorm Crosswalk
  • RxCUI: 577232 - menthol 0.15 % / zinc oxide 1 % Topical Powder
  • RxCUI: 577232 - menthol 0.0015 MG/MG / zinc oxide 0.01 MG/MG Topical Powder
  • RxCUI: 577232 - Menthol 0.0015 MG/MG / ZNO 0.01 MG/MG Topical Powder

Clinical Specifications

Proprietary Name
Studio 35 External Analgesic Medicated Body
Non-Proprietary Name
Menthol And Zinc Oxide
Substance Name
Menthol; Zinc Oxide
Dosage Form
Powder - An intimate mixture of dry, finely divided drugs and/or chemicals that may be intended for internal or external use.
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
Usage Information
Adults and children 2 years of age and older: apply to affected area no more than 3 to 4 times dailychildren under 2 years of age: consult a doctorfor best results, dry area thoroughly before applying

Regulatory & Marketing

Labeler Name
Walgreen Co
Product Type
Human Otc Drug
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
02-07-2017
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 0363-0552-38 identifies a specific commercial package of 283 g in 1 bottle of Studio 35 External Analgesic Medicated Body, a human over the counter drug labeled by Walgreen Co. This powder is formulated for topical use and contains menthol; 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 Walgreen Co on February 07, 2017. The current certification is valid through December 31, 2026.

How is this Walgreen Co product billed for insurance claims?

For medical billing and reimbursement, this package follows the 11-digit CMS format: 00363055238. 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 (4-4-2)
0363-0552-38
11-Digit CMS (5-4-2)
00363-0552-38

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