Periomed Rinse
NDC Package 48878-3315-2

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

Package Information

Periomed (stannous fluoride) rinses is adults and children 6 years of age and older: do not use before mixing with water use immediately after preparing the rinse use as directed by a dental professional use once a day after brushing your teeth with a toothpaste or as directed by your dentist remove cap and seal and replace with pump rotate spout counter clockwise to extend depress pump until medicine comes to the tip of the pump put 1/8 oz. This formulation utilizes a rinse delivery system. Marketed by Solventum Us Llc, this product is identified by NDC 48878-3315 and is authorized under FDA application M021.

Identification & Billing

NDC Package Code
48878-3315-2
Package Description
1 BOTTLE, PLASTIC in 1 BOX / 85 g in 1 BOTTLE, PLASTIC
Product Code
48878-3315
11-Digit Billing Format
48878331502
Billing Unit
GM - Billing unit of "gram" is used when a product is measured by its weight.
Units Per Package
85 GM

Clinical Specifications

Proprietary Name
Periomed
Non-Proprietary Name
Stannous Fluoride
Substance Name
Stannous Fluoride
Dosage Form
Rinse - A liquid used to cleanse by flushing.
Administration Route
Oral - Administration to or by way of the mouth.
Active Ingredient(s)
STANNOUS FLUORIDE 1.53 mg/g
Usage Information
Adults and children 6 years of age and older: do not use before mixing with water use immediately after preparing the rinse use as directed by a dental professional use once a day after brushing your teeth with a toothpaste or as directed by your dentist remove cap and seal and replace with pump rotate spout counter clockwise to extend depress pump until medicine comes to the tip of the pump put 1/8 oz. (approx. 2 pump strokes) of concentrated PerioMed Rinse into the provided mixing vial add water to 1 oz. line on mixing vial tightly snap on the cap and shake well vigorously swish rinse between your teeth for 1 minute and then spit out do not swallow the rinse do not eat or drink for 30 minutes after rinsing instruct children in good rinsing habits (to minimize swallowing) supervise children as necessary until capable of using without supervision children under 6 years of age: consult a dentist or doctor

Regulatory & Marketing

Labeler Name
Solventum Us Llc
Product Type
Human Otc Drug
FDA Application #
M021
Marketing Category
OTC MONOGRAPH DRUG -
Start Marketing Date
07-01-1967
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.

Other Available Packages

The following commercial packages are registered under the same Product NDC (48878-3315). Click a package code to view its specific billing and regulatory data.

48878-3315-0
1 BOTTLE, PLASTIC in 1 BOX / 283.5 g in 1 BOTTLE, PLASTIC

* 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 48878-3315-2 identifies a specific commercial package of 1 bottle, plastic in 1 box / 85 g in 1 bottle, plastic of Periomed, a human over the counter drug labeled by Solventum Us Llc. This product is billed per "GM" gram and contains an estimated amount of 85 billable units per package. This rinse is formulated for oral 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 Solventum Us Llc on July 01, 1967. The current certification is valid through December 31, 2026.

How is this Solventum Us Llc product billed for insurance claims?

For medical billing and reimbursement, this package follows the 11-digit CMS format: 48878331502. Quantities are measured in per "gm or gram", products billed per gram are products measured by weight.. There are 85 total billable units per package. 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)
48878-3315-2
11-Digit CMS (5-4-2)
48878-3315-02

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