Ad Treat Diaper Rash Cream With Dimethicone And Zinc Oxide Cream
NDC Package 65197-402-16

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

Ad Treat Diaper Rash Cream With Dimethicone And Zinc Oxide cream is change wet and soiled diapers promptlycleanse the diaper area, and allow to dryapply cream liberally as often as necessary, with each diaper change, especially at bedtime or anytime when exposure to wet diapers may be prolonged . This formulation utilizes a cream delivery system. Marketed by Wellspring Pharmaceutical Corporation, this product is identified by NDC 65197-402 and is authorized under FDA application M016.

Identification & Billing

NDC Package Code
65197-402-16
Package Description
454 g in 1 JAR
Product Code
65197-402
11-Digit Billing Format
65197040216
RxNorm Crosswalk
  • RxCUI: 686403 - dimethicone 1 % / zinc oxide 10 % Topical Cream
  • RxCUI: 686403 - dimethicone 10 MG/ML / zinc oxide 100 MG/ML Topical Cream
  • RxCUI: 686403 - dimethicone 10 MG/ML / ZNO 100 MG/ML Topical Cream

Clinical Specifications

Proprietary Name
Ad Treat Diaper Rash Cream With Dimethicone And Zinc Oxide
Non-Proprietary Name
Ad Treat Diaper Rash Cream With Dimethicone And Zinc Oxide
Substance Name
Dimethicone; Zinc Oxide
Dosage Form
Cream - An emulsion, semisolid3 dosage form, usually containing > 20% water and volatiles5 and/or < 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.
Active Ingredient(s)
Pharmacologic Class
Skin Barrier Activity - [PE] (Physiologic Effect)
Usage Information
Change wet and soiled diapers promptlycleanse the diaper area, and allow to dryapply cream liberally as often as necessary, with each diaper change, especially at bedtime or anytime when exposure to wet diapers may be prolonged 

Regulatory & Marketing

Labeler Name
Wellspring Pharmaceutical Corporation
Product Type
Human Otc Drug
FDA Application #
M016
Marketing Category
OTC MONOGRAPH DRUG -
Start Marketing Date
09-19-2023
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 (65197-402). Click a package code to view its specific billing and regulatory data.

65197-402-00
1 TUBE in 1 BOX / 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 65197-402-16 identifies a specific commercial package of 454 g in 1 jar of Ad Treat Diaper Rash Cream With Dimethicone And Zinc Oxide, a human over the counter drug labeled by Wellspring Pharmaceutical Corporation. This cream is formulated for topical use and contains dimethicone; 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 Wellspring Pharmaceutical Corporation on September 19, 2023. The current certification is valid through December 31, 2026.

How is this Wellspring Pharmaceutical Corporation product billed for insurance claims?

For medical billing and reimbursement, this package follows the 11-digit CMS format: 65197040216. 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)
65197-402-16
11-Digit CMS (5-4-2)
65197-0402-16

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