Dr. Blue Painzaway Pain Relieving Roll-on Lotion
NDC Package 10578-136-03

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

Package Information

Dr. Blue Painzaway Pain Relieving Roll-on (menthol) lotions is ■ See the important warnings under "when using this product"■ Adults and children 2 years of age and older: apply to affected area not more than 3 to 4 times daily.■ Children under 2 years of age: Consult a physician. This formulation utilizes a lotion delivery system. Marketed by Indiana Botanic Gardens, this product is identified by NDC 10578-136 and is authorized under FDA application M017.

Identification & Billing

NDC Package Code
10578-136-03
Package Description
85 g in 1 CYLINDER
Product Code
10578-136
11-Digit Billing Format
10578013603
RxNorm Crosswalk

Clinical Specifications

Proprietary Name
Dr. Blue Painzaway Pain Relieving Roll-on
Non-Proprietary Name
Menthol
Substance Name
Menthol
Dosage Form
Lotion - An emulsion, liquid1 dosage form. This dosage form is generally for external application to the skin.2
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)
MENTHOL 4.6 g/100g
Usage Information
■ See the important warnings under "when using this product"■ Adults and children 2 years of age and older: apply to affected area not more than 3 to 4 times daily.■ Children under 2 years of age: Consult a physician.

Regulatory & Marketing

Labeler Name
Indiana Botanic Gardens
Product Type
Human Otc Drug
FDA Application #
M017
Marketing Category
OTC MONOGRAPH DRUG -
Start Marketing Date
04-06-2026
Listing Expiration
12-31-2027
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 10578-136-03 identifies a specific commercial package of 85 g in 1 cylinder of Dr. Blue Painzaway Pain Relieving Roll-on, a human over the counter drug labeled by Indiana Botanic Gardens. This lotion is formulated for topical use and contains 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 Indiana Botanic Gardens on April 06, 2026. The current certification is valid through December 31, 2027.

How is this Indiana Botanic Gardens product billed for insurance claims?

For medical billing and reimbursement, this package follows the 11-digit CMS format: 10578013603. 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)
10578-136-03
11-Digit CMS (5-4-2)
10578-0136-03

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