Skyline Herbals
NDC Package 80239-9138-6

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

Package Information

This product is EXCLUDED from the official NDC directory because the listing data was inactivated by the FDA.

Skyline Herbals is do not swallowSupervise children as necessary until capable of using without supervisionInstruct children under 12 years of age in good brushing and rinsing habits (to minimize swallowing)Adults and children 6 years of age and older: Brush teeth thoroughly, preferably after each meal or at least twice a day, or as directed by a dentist or physician Children under 6 years of age: Do not use unless directed by a dentist or physician. Marketed by Skyline Herbals Private Limited, this product is identified by NDC 80239-9138 and is authorized under FDA application part355.

Identification & Billing

NDC Package Code
80239-9138-6
Package Description
43 g in 1 TUBE
Product Code
80239-9138
11-Digit Billing Format
80239913806
RxNorm Crosswalk
  • RxCUI: 545626 - sodium monofluorophosphate 0.76 % Toothpaste
  • RxCUI: 545626 - sodium monofluorophosphate 0.0076 MG/MG Toothpaste
  • RxCUI: 545626 - sodium monofluorophosphate 0.76 % (fluoride ion 0.12 % )Toothpaste
  • RxCUI: 545626 - sodium monofluorophosphate 0.76 % (fluoride ion 0.13 % )Toothpaste
  • RxCUI: 545626 - sodium monofluorophosphate 0.76 % (fluoride ion 0.14 % )Toothpaste

Clinical Specifications

Proprietary Name
Skyline Herbals
Dosage Form
-
Usage Information
Do not swallowSupervise children as necessary until capable of using without supervisionInstruct children under 12 years of age in good brushing and rinsing habits (to minimize swallowing)Adults and children 6 years of age and older: Brush teeth thoroughly, preferably after each meal or at least twice a day, or as directed by a dentist or physician Children under 6 years of age: Do not use unless directed by a dentist or physician

Regulatory & Marketing

Labeler Name
Skyline Herbals Private Limited
FDA Application #
part355
Marketing Category
OTC MONOGRAPH FINAL - A product marketed pursuant to a final Over-the-Counter (OTC) Drug Monograph.
Start Marketing Date
07-23-2019
Listing Expiration
12-31-2021
Exclude Flag
I
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 80239-9138-6 identifies a specific commercial package of 43 g in 1 tube of Skyline Herbals, labeled by Skyline Herbals Private Limited. This is formulated for use and contains as the active substance.

Is this product currently listed with the FDA?

This product code is currently listed as inactive or excluded from the primary directory. It was introduced to the market by Skyline Herbals Private Limited on July 23, 2019. The current certification is valid through December 31, 2021.

How is this Skyline Herbals Private Limited product billed for insurance claims?

For medical billing and reimbursement, this package follows the 11-digit CMS format: 80239913806. 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 (5-4-1)
80239-9138-6
11-Digit CMS (5-4-2)
80239-9138-06

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