Kaylaan Tablet, Chewable
NDC Package 82091-113-10

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

Package Information

Kaylaan (zero waste refill for toothpaste) tablets is a human otc drug administered via dental route. This formulation utilizes a tablet, chewable delivery system. Marketed by Kaylaan Llc, this product is identified by NDC 82091-113 and is authorized under FDA application M022.

Identification & Billing

NDC Package Code
82091-113-10
Package Description
74.3 mg in 1 BOTTLE, UNIT-DOSE
Product Code
82091-113
11-Digit Billing Format
82091011310

Clinical Specifications

Proprietary Name
Kaylaan
Non-Proprietary Name
Zero Waste Refill For Toothpaste
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 .37 mg/440mg

Regulatory & Marketing

Labeler Name
Kaylaan Llc
Product Type
Human Otc Drug
FDA Application #
M022
Marketing Category
OTC MONOGRAPH DRUG -
Start Marketing Date
09-01-2021
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.

Other Available Packages

The following commercial packages are registered under the same Product NDC (82091-113). Click a package code to view its specific billing and regulatory data.

82091-113-01
74.3 mg in 1 BOTTLE, UNIT-DOSE

* 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 82091-113-10 identifies a specific commercial package of 74.3 mg in 1 bottle, unit-dose of Kaylaan, a human over the counter drug labeled by Kaylaan Llc. 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 Kaylaan Llc on September 01, 2021. The current certification is valid through December 31, 2026.

How is this Kaylaan Llc product billed for insurance claims?

For medical billing and reimbursement, this package follows the 11-digit CMS format: 82091011310. 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)
82091-113-10
11-Digit CMS (5-4-2)
82091-0113-10

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