Flanders Buttocks Ointment
NDC Package 54323-215-03

View Billable Units, 11-Digit Conversion Format, and RxNorm mappings

Package Information

Flanders Buttocks (white petrolatum, zinc oxide) ointment is change wet and soiled diapers promptly, cleanse the diaper area, allow to dryapply ointment liberally as necessary, with each diaper change, especailly at bedtime or anytime prolonged exposure to wet diapers may be prolonged. This formulation utilizes a ointment delivery system. Marketed by Flanders Inc, this product is identified by NDC 54323-215 and is authorized under FDA application M016.

Identification & Billing

NDC Package Code
54323-215-03
Package Description
5 g in 1 PACKET
Product Code
11-Digit Billing Format
54323021503
RxNorm Crosswalk

Clinical Specifications

Proprietary Name
Flanders Buttocks
Non-Proprietary Name
White Petrolatum, Zinc Oxide
Substance Name
Petrolatum; Zinc Oxide
Dosage Form
Ointment - A semisolid3 dosage form, usually containing <20% water and volatiles5 and >50% hydrocarbons, waxes, or polyols as the vehicle. This dosage form is generally for external application to the skin or mucous membranes.
Administration Route
Topical - Administration to a particular spot on the outer surface of the body. The E2B term TRANSMAMMARY is a subset of the term TOPICAL.
Usage Information
Change wet and soiled diapers promptly, cleanse the diaper area, allow to dryapply ointment liberally as necessary, with each diaper change, especailly at bedtime or anytime prolonged exposure to wet diapers may be prolonged

Regulatory & Marketing

Labeler Name
Flanders Inc
Product Type
Human Otc Drug
FDA Application #
M016
Marketing Category
OTC MONOGRAPH DRUG -
Start Marketing Date
10-16-1986
Listing Expiration
12-31-2027
Exclude Flag
N
Sample Package
Yes

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 (54323-215). Click a package code to view its specific billing and regulatory data.

113 g in 1 TUBE

* 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 54323-215-03 identifies a specific commercial package of 5 g in 1 packet of Flanders Buttocks, a human over the counter drug labeled by Flanders Inc. This ointment is formulated for topical use and contains petrolatum; zinc oxide 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 Flanders Inc on October 16, 1986. The current certification is valid through December 31, 2027.

How is this Flanders Inc product billed for insurance claims?

For medical billing and reimbursement, this package follows the 11-digit CMS format: 54323021503. 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)
54323-215-03
11-Digit CMS (5-4-2)
54323-0215-03

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