Karl And Hans Botanic Double Mint Paste, Dentifrice
NDC Package 78151-040-02

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

Package Information

Karl And Hans Botanic Double Mint (sodium monofluorophosphate) pastes is ■ Brushing the teeth with a suitable amount. This formulation utilizes a paste, dentifrice delivery system. Marketed by Pigeon Corporation, this product is identified by NDC 78151-040 and is authorized under FDA application M021.

Identification & Billing

NDC Package Code
78151-040-02
Package Description
1 TUBE in 1 CARTON / 120 g in 1 TUBE (78151-040-01)
Product Code
78151-040
11-Digit Billing Format
78151004002
RxNorm Crosswalk

Clinical Specifications

Proprietary Name
Karl And Hans Botanic Double Mint
Non-Proprietary Name
Sodium Monofluorophosphate
Substance Name
Sodium Monofluorophosphate
Dosage Form
Paste, Dentifrice - A paste formulation intended to clean and/or polish the teeth, and which may contain certain additional agents.
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)
SODIUM MONOFLUOROPHOSPHATE .74 g/100g
Usage Information
■ Brushing the teeth with a suitable amount

Regulatory & Marketing

Labeler Name
Pigeon Corporation
Product Type
Human Otc Drug
FDA Application #
M021
Marketing Category
OTC MONOGRAPH DRUG -
Start Marketing Date
07-01-2024
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 78151-040-02 identifies a specific commercial package of 1 tube in 1 carton / 120 g in 1 tube (78151-040-01) of Karl And Hans Botanic Double Mint, a human over the counter drug labeled by Pigeon Corporation. This paste, dentifrice is formulated for topical use and contains sodium monofluorophosphate 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 Pigeon Corporation on July 01, 2024. The current certification is valid through December 31, 2026.

How is this Pigeon Corporation product billed for insurance claims?

For medical billing and reimbursement, this package follows the 11-digit CMS format: 78151004002. 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)
78151-040-02
11-Digit CMS (5-4-2)
78151-0040-02

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