The Humble Co Tablet, Chewable
NDC Package 84411-555-12

11-digit billing NDC: 84411055512
Table of Contents
    1. Package Information
    2. Other Packages
    3. Frequently Asked Questions

Package Information

The Humble Co (fluoride fresh mint toothpaste tablets) tablets is adults: Wet your toothbrush and crush the tab between your teeth. This formulation utilizes a tablet, chewable delivery system. Marketed by Productos De Bio Oxidacion Energetica Sapi De Cv, this product is identified by NDC 84411-555 and is authorized under FDA application M021.

Identification & Billing

NDC Package Code
84411-555-12
Package Description
180 TABLET, CHEWABLE in 1 PACKAGE
Product Code
84411-555
11-Digit Billing Format
84411055512

Clinical Specifications

Proprietary Name
The Humble Co
Non-Proprietary Name
Fluoride Fresh Mint Toothpaste Tablets
Substance Name
Sodium Fluoride
Dosage Form
Tablet, Chewable - A solid dosage form containing medicinal substances with or without suitable diluents that is intended to be chewed, producing a pleasant tasting residue in the oral cavity that is easily swallowed and does not leave a bitter or unpleasant after-taste.
Administration Route
Dental - Administration to a tooth or teeth.
Active Ingredient(s)
SODIUM FLUORIDE .32 mg/1
Usage Information
Adults: Wet your toothbrush and crush the tab between your teeth. Brush like normal. Rinse after using. Brush teeth thoroughly preferably after each meal or at least twice a day or as directed by a dentist or physician. Do not swallow.

Regulatory & Marketing

Labeler Name
Productos De Bio Oxidacion Energetica Sapi De Cv
Product Type
Human Otc Drug
FDA Application #
M021
Marketing Category
OTC MONOGRAPH DRUG -
Start Marketing Date
09-16-2026
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 (84411-555). Click a package code to view its specific billing and regulatory data.

84411-555-11
60 TABLET, CHEWABLE in 1 PACKAGE
84411-555-13
360 TABLET, CHEWABLE in 1 PACKAGE

* 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 84411-555-12 identifies a specific commercial package of 180 tablet, chewable in 1 package of The Humble Co, a human over the counter drug labeled by Productos De Bio Oxidacion Energetica Sapi De Cv. This tablet, chewable is formulated for dental use and contains sodium fluoride 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 Productos De Bio Oxidacion Energetica Sapi De Cv on September 16, 2026. The current certification is valid through December 31, 2027.

How is this Productos De Bio Oxidacion Energetica Sapi De Cv product billed for insurance claims?

For medical billing and reimbursement, this package follows the 11-digit CMS format: 84411055512. 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)
84411-555-12
11-Digit CMS (5-4-2)
84411-0555-12

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