Crest Pro-health Paste, Dentifrice
NDC Package 84126-613-45

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

Package Information

Crest Pro-health (stannous fluoride) pastes is • adults and children 12 yrs. This formulation utilizes a paste, dentifrice delivery system. Marketed by The Procter & Gamble Manufacturing Company, this product is identified by NDC 84126-613 and is authorized under FDA application M021.

Identification & Billing

NDC Package Code
84126-613-45
Package Description
1 TUBE in 1 CARTON / 127 g in 1 TUBE
Product Code
84126-613
11-Digit Billing Format
84126061345
RxNorm Crosswalk
  • RxCUI: 416784 - stannous fluoride 0.454 % (fluoride ion 0.16 % ) Toothpaste
  • RxCUI: 416784 - stannous fluoride 0.00454 MG/MG Toothpaste
  • RxCUI: 416784 - stannous fluoride 0.454 % (fluoride ion 0.14 % ) Toothpaste
  • RxCUI: 416784 - stannous fluoride 0.454 % (fluoride ion 0.15 % ) Toothpaste

Clinical Specifications

Proprietary Name
Crest Pro-health Gum Detoxify Plus
Non-Proprietary Name
Stannous Fluoride
Substance Name
Stannous 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
Dental - Administration to a tooth or teeth.
Active Ingredient(s)
STANNOUS FLUORIDE 1.5 mg/g
Usage Information
• adults and children 12 yrs. & older: apply at least a 1-inch strip of the product onto a soft bristle toothbrush. Brush teeth thoroughly for at least 1 minute twice a day (morning and evening) or as recommended by a dentist. Make sure to brush all sensitive areas of the teeth. • do not swallow • children under 12 yrs. of age: ask a dentist

Regulatory & Marketing

Labeler Name
The Procter & Gamble Manufacturing Company
Product Type
Human Otc Drug
FDA Application #
M021
Marketing Category
OTC MONOGRAPH DRUG -
Start Marketing Date
06-03-2024
Listing Expiration
12-31-2027
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 84126-613-45 identifies a specific commercial package of 1 tube in 1 carton / 127 g in 1 tube of Crest Pro-health Gum Detoxify Plus, a human over the counter drug labeled by The Procter & Gamble Manufacturing Company. This paste, dentifrice is formulated for dental use and contains stannous 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 The Procter & Gamble Manufacturing Company on June 03, 2024. The current certification is valid through December 31, 2027.

How is this The Procter & Gamble Manufacturing Company product billed for insurance claims?

For medical billing and reimbursement, this package follows the 11-digit CMS format: 84126061345. 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)
84126-613-45
11-Digit CMS (5-4-2)
84126-0613-45

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