Tome Clearing Treatment Kit
NDC Package 87609-104-03

11-digit billing NDC: 87609010403
Table of Contents
    1. Package Information
    2. Other Packages
    3. Frequently Asked Questions

Package Information

Tome Clearing Treatment (0.5% salicylic acid wipe with bioneedle mask) kits is • For the treatment of acne • Reduces the number of acne blemishes and allows skin to heal • Helps prevent the development of new acne blemishes. This formulation utilizes a kit delivery system. Marketed by Dermata Therapeutics, Inc., this product is identified by NDC 87609-104 and is authorized under FDA application M006.

Identification & Billing

NDC Package Code
87609-104-03
Package Description
4 BOX in 1 BOX / 1 CUP in 1 BOX / 1 KIT in 1 CUP * 3 mL in 1 TUBE * 3.66 g in 1 PACKET * 1 g in 1 CUP
Product Code
87609-104
11-Digit Billing Format
87609010403

Clinical Specifications

Proprietary Name
Tome Clearing Treatment
Non-Proprietary Name
0.5% Salicylic Acid Wipe With Bioneedle Mask
Dosage Form
Kit - A packaged collection of related material.
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.
Usage Information
• For the treatment of acne • Reduces the number of acne blemishes and allows skin to heal • Helps prevent the development of new acne blemishes

Regulatory & Marketing

Labeler Name
Dermata Therapeutics, Inc.
Product Type
Human Otc Drug
FDA Application #
M006
Marketing Category
OTC MONOGRAPH DRUG -
Start Marketing Date
09-10-2026
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.

Other Available Packages

The following commercial packages are registered under the same Product NDC (87609-104). Click a package code to view its specific billing and regulatory data.

87609-104-01
4 BOX in 1 BOX / 1 PACKET in 1 BOX / 1 KIT in 1 PACKET * 3 mL in 1 TUBE * 3.66 g in 1 PACKET * 1 g in 1 CUP
87609-104-02
4 BOX in 1 BOX / 1 TUBE in 1 BOX / 1 KIT in 1 TUBE * 3 mL in 1 TUBE * 3.66 g in 1 PACKET * 1 g in 1 CUP

* 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 87609-104-03 identifies a specific commercial package of 4 box in 1 box / 1 cup in 1 box / 1 kit in 1 cup * 3 ml in 1 tube * 3.66 g in 1 packet * 1 g in 1 cup of Tome Clearing Treatment, a human over the counter drug labeled by Dermata Therapeutics, Inc.. This kit is formulated for topical use and contains 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 Dermata Therapeutics, Inc. on September 10, 2026. The current certification is valid through December 31, 2027.

How is this Dermata Therapeutics, Inc. product billed for insurance claims?

For medical billing and reimbursement, this package follows the 11-digit CMS format: 87609010403. 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)
87609-104-03
11-Digit CMS (5-4-2)
87609-0104-03

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