Bum Ease
NDC Package 76330-100-10

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.

Bum Ease is • Shake Well Before Use• Hold bottle 2-3 inches from baby’s bottom while spraying• Press down on the pump to spray• Change wet and solid diapers promptly• Cleanse the diaper area, and allow to dry• Apply spray liberally as often as necessary, with each diaper change, especially atbedtime or anytime when exposeure to wet diapers may be prolonged. Marketed by Wake Innovation, Llc, this product is identified by NDC 76330-100 and is authorized under FDA application part347.

Identification & Billing

NDC Package Code
76330-100-10
Package Description
1 BOTTLE, PUMP in 1 BOX / 100 mL in 1 BOTTLE, PUMP
Product Code
76330-100
11-Digit Billing Format
76330010010
RxNorm Crosswalk

Clinical Specifications

Proprietary Name
Bum Ease
Dosage Form
-
Usage Information
• Shake Well Before Use• Hold bottle 2-3 inches from baby’s bottom while spraying• Press down on the pump to spray• Change wet and solid diapers promptly• Cleanse the diaper area, and allow to dry• Apply spray liberally as often as necessary, with each diaper change, especially atbedtime or anytime when exposeure to wet diapers may be prolonged

Regulatory & Marketing

Labeler Name
Wake Innovation, Llc
FDA Application #
part347
Marketing Category
OTC MONOGRAPH FINAL - A product marketed pursuant to a final Over-the-Counter (OTC) Drug Monograph.
Start Marketing Date
07-01-2011
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 76330-100-10 identifies a specific commercial package of 1 bottle, pump in 1 box / 100 ml in 1 bottle, pump of Bum Ease, labeled by Wake Innovation, 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 Wake Innovation, Llc on July 01, 2011. The current certification is valid through December 31, 2017.

How is this Wake Innovation, Llc product billed for insurance claims?

For medical billing and reimbursement, this package follows the 11-digit CMS format: 76330010010. 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)
76330-100-10
11-Digit CMS (5-4-2)
76330-0100-10

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