Oral7 Dry Mouth Moisturizing
NDC Package 81175-000-02

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.

Oral7 Dry Mouth Moisturizing is adults and Children 2 years of age and olderUse 2-3 times a day, 7 days a week.Brush teeth thoroughly, preferably after each meal or at least twice a day, or as directed by a doctor or dentist.Instruct children under 6 years of age in good brushing and rinsing habits (to minimize swallowing). Marketed by Oral7 Usa Operations Inc, this product is identified by NDC 81175-000 and is authorized under FDA application part355.

Identification & Billing

NDC Package Code
81175-000-02
Package Description
75 mL in 1 TUBE
Product Code
81175-000
11-Digit Billing Format
81175000002
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
Oral7 Dry Mouth Moisturizing
Dosage Form
-
Usage Information
Adults and Children 2 years of age and olderUse 2-3 times a day, 7 days a week.Brush teeth thoroughly, preferably after each meal or at least twice a day, or as directed by a doctor or dentist.Instruct children under 6 years of age in good brushing and rinsing habits (to minimize swallowing). Supervise children as necessary until capable of using without supervision. Children under 2 years of age: Consult a dentist or doctor.

Regulatory & Marketing

Labeler Name
Oral7 Usa Operations Inc
FDA Application #
part355
Marketing Category
OTC MONOGRAPH FINAL - A product marketed pursuant to a final Over-the-Counter (OTC) Drug Monograph.
Start Marketing Date
06-01-2019
Listing Expiration
12-31-2023
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 81175-000-02 identifies a specific commercial package of 75 ml in 1 tube of Oral7 Dry Mouth Moisturizing, labeled by Oral7 Usa Operations Inc. 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 Oral7 Usa Operations Inc on June 01, 2019. The current certification is valid through December 31, 2023.

How is this Oral7 Usa Operations Inc product billed for insurance claims?

For medical billing and reimbursement, this package follows the 11-digit CMS format: 81175000002. 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)
81175-000-02
11-Digit CMS (5-4-2)
81175-0000-02

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