Dr. Jen Superpaste Nano-hydroxyapatite Paste, Dentifrice
NDC Package 84181-357-05

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

Package Information

Dr. Jen Superpaste Nano-hydroxyapatite (sodium fluoride) pastes is use: Aids in the prevention of dental cavities. This formulation utilizes a paste, dentifrice delivery system. Marketed by Dr Jen Natural, Llc, this product is identified by NDC 84181-357 and is authorized under FDA application M021.

Identification & Billing

NDC Package Code
84181-357-05
Package Description
1 TUBE in 1 BOX / 100 mL in 1 TUBE
Product Code
84181-357
11-Digit Billing Format
84181035705
RxNorm Crosswalk

Clinical Specifications

Proprietary Name
Dr. Jen Superpaste Nano-hydroxyapatite
Non-Proprietary Name
Sodium Fluoride
Substance Name
Sodium Fluoride
Dosage Form
Paste, Dentifrice - A paste formulation intended to clean and/or polish the teeth, and which may contain certain additional agents.
Administration Route
Oral - Administration to or by way of the mouth.
Active Ingredient(s)
SODIUM FLUORIDE .22 g/100mL
Usage Information
Use: Aids in the prevention of dental cavities

Regulatory & Marketing

Labeler Name
Dr Jen Natural, Llc
Product Type
Human Otc Drug
FDA Application #
M021
Marketing Category
OTC MONOGRAPH DRUG -
Start Marketing Date
03-13-2024
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 84181-357-05 identifies a specific commercial package of 1 tube in 1 box / 100 ml in 1 tube of Dr. Jen Superpaste Nano-hydroxyapatite, a human over the counter drug labeled by Dr Jen Natural, Llc. This paste, dentifrice is formulated for oral 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 Dr Jen Natural, Llc on March 13, 2024. The current certification is valid through December 31, 2026.

How is this Dr Jen Natural, Llc product billed for insurance claims?

For medical billing and reimbursement, this package follows the 11-digit CMS format: 84181035705. 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)
84181-357-05
11-Digit CMS (5-4-2)
84181-0357-05

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