Smarth
NDC Package 60927-116-11

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.

Smarth 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 doctorChildren under 6 years of age: Do not use unless directed by a doctor or dentist. Marketed by Carib Sales, Llc, this product is identified by NDC 60927-116 and is authorized under FDA application part355.

Identification & Billing

NDC Package Code
60927-116-11
Package Description
1 TUBE in 1 CARTON / 181 g in 1 TUBE
Product Code
60927-116
11-Digit Billing Format
60927011611
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
Smarth Extra Strength Minty Fresh
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 doctorChildren under 6 years of age: Do not use unless directed by a doctor or dentist

Regulatory & Marketing

Labeler Name
Carib Sales, Llc
FDA Application #
part355
Marketing Category
OTC MONOGRAPH FINAL - A product marketed pursuant to a final Over-the-Counter (OTC) Drug Monograph.
Start Marketing Date
12-01-2013
Listing Expiration
12-31-2017
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 60927-116-11 identifies a specific commercial package of 1 tube in 1 carton / 181 g in 1 tube of Smarth Extra Strength Minty Fresh, labeled by Carib Sales, Llc. 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 Carib Sales, Llc on December 01, 2013. The current certification is valid through December 31, 2017.

How is this Carib Sales, Llc product billed for insurance claims?

For medical billing and reimbursement, this package follows the 11-digit CMS format: 60927011611. 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)
60927-116-11
11-Digit CMS (5-4-2)
60927-0116-11

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