Bebe Bottoms Spray
NDC Package 51672-5318-3

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

Bebe Bottoms (zinc oxide) sprays is a medication used to treat and prevent diaper rash and other minor skin irritations (e.g., burns, cuts, scrapes). This formulation utilizes a spray delivery system. Marketed by Taro Pharmaceuticals U.s.a., Inc., this product is identified by NDC 51672-5318 and is authorized under FDA application M016.

Identification & Billing

NDC Package Code
51672-5318-3
Package Description
1 BOTTLE, SPRAY in 1 CARTON / 50 mL in 1 BOTTLE, SPRAY
Product Code
51672-5318
11-Digit Billing Format
51672531803
Billing Unit
ML - Billing unit of "milliliter" is used when a product is measured by its liquid volume.
RxNorm Crosswalk

Clinical Specifications

Proprietary Name
Bebe Bottoms
Non-Proprietary Name
Zinc Oxide
Substance Name
Zinc Oxide
Dosage Form
Spray - A liquid minutely divided as by a jet of air or steam.
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.
Active Ingredient(s)
ZINC OXIDE 100 mg/mL
Usage Information
This medication is used to treat and prevent diaper rash and other minor skin irritations (e.g., burns, cuts, scrapes). It works by forming a barrier on the skin to protect it from irritants/moisture.

Regulatory & Marketing

Labeler Name
Taro Pharmaceuticals U.s.a., Inc.
Product Type
Human Otc Drug
FDA Application #
M016
Marketing Category
OTC MONOGRAPH DRUG -
Start Marketing Date
12-01-2023
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 (51672-5318). Click a package code to view its specific billing and regulatory data.

51672-5318-7
1 BOTTLE, SPRAY in 1 CARTON / 100 mL in 1 BOTTLE, SPRAY

* 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 51672-5318-3 identifies a specific commercial package of 1 bottle, spray in 1 carton / 50 ml in 1 bottle, spray of Bebe Bottoms, a human over the counter drug labeled by Taro Pharmaceuticals U.s.a., Inc.. This spray is formulated for topical use and contains 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 Taro Pharmaceuticals U.s.a., Inc. on December 01, 2023. The current certification is valid through December 31, 2026.

What are the primary indications for this medication?

This medication is used to treat and prevent diaper rash and other minor skin irritations (e.g., burns, cuts, scrapes). It works by forming a barrier on the skin to protect it from irritants/moisture.

How is this Taro Pharmaceuticals U.s.a., Inc. product billed for insurance claims?

For medical billing and reimbursement, this package follows the 11-digit CMS format: 51672531803. 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 (5-4-1)
51672-5318-3
11-Digit CMS (5-4-2)
51672-5318-03

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