Wentworth Alcohol Free Mouthwash
NDC Package 11527-735-16

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

Package Information

Wentworth Alcohol Free (sodium fluoride) mouthwashes is a dental caries preventive, for weekly self-applied topical use. This formulation utilizes a mouthwash delivery system. Marketed by Sheffield Pharmaceuticals Llc, this product is identified by NDC 11527-735.

Identification & Billing

NDC Package Code
11527-735-16
Package Description
1 BOTTLE, PLASTIC in 1 CARTON / 473 mL in 1 BOTTLE, PLASTIC
Product Code
11527-735
11-Digit Billing Format
11527073516
Billing Unit
ML - Billing unit of "milliliter" is used when a product is measured by its liquid volume.
RxNorm Crosswalk

Clinical Specifications

Proprietary Name
Wentworth Alcohol Free
Non-Proprietary Name
Sodium Fluoride
Substance Name
Sodium Fluoride
Dosage Form
Mouthwash - An aqueous solution which is most often used for its deodorant, refreshing, or antiseptic effect.
Administration Route
Dental - Administration to a tooth or teeth.
Active Ingredient(s)
SODIUM FLUORIDE .9 mg/mL
Usage Information
A dental caries preventive, for weekly self-applied topical use. Weekly rinsing with a neutral 0.2% sodium fluoride solution protects against dental caries in adults and pediatric patients. Wentworth Sodium Fluoride Rinse provides a ready-to-use preparation for convenient administration and favorable compliance. May be used in areas where drinking water is fluoridated since topical fluoride cannot produce fluorosis. (See WARNINGS for exception.)

Regulatory & Marketing

Labeler Name
Sheffield Pharmaceuticals Llc
Product Type
Human Prescription Drug
Marketing Category
UNAPPROVED DRUG OTHER - An unapproved drug product in a marketing category that is not reflected on a particular list.
Start Marketing Date
04-15-2021
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.

Frequently Asked Questions

What is the distribution configuration for this product package?

The code 11527-735-16 identifies a specific commercial package of 1 bottle, plastic in 1 carton / 473 ml in 1 bottle, plastic of Wentworth Alcohol Free, a human prescription drug labeled by Sheffield Pharmaceuticals Llc. This mouthwash 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 Sheffield Pharmaceuticals Llc on April 15, 2021. The current certification is valid through December 31, 2026.

How is this Sheffield Pharmaceuticals Llc product billed for insurance claims?

For medical billing and reimbursement, this package follows the 11-digit CMS format: 11527073516. Quantities are measured in per "ml or milliliter", products billed per milliliter are usually products measured by liquid volume.. 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)
11527-735-16
11-Digit CMS (5-4-2)
11527-0735-16

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