Maximum Strength Diaper Rash Paste
NDC Package 83650-107-01

11-digit billing NDC: 83650010701
Table of Contents
    1. Package Information
    2. Other Packages
    3. Frequently Asked Questions

Package Information

Maximum Strength Diaper Rash (zinc oxide) pastes is change wet and soiled diapers promptlycleanse the diaper areaallow to dryapply paste 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 paste delivery system. Marketed by Savvy Care And Cosmetics Pvt Ltd, this product is identified by NDC 83650-107 and is authorized under FDA application M016.

Identification & Billing

NDC Package Code
83650-107-01
Package Description
28 g in 1 TUBE
Product Code
83650-107
11-Digit Billing Format
83650010701

Clinical Specifications

Proprietary Name
Maximum Strength Diaper Rash
Non-Proprietary Name
Zinc Oxide
Substance Name
Zinc Oxide
Dosage Form
Paste - A semisolid3 dosage form, containing a large proportion (20 – 50%) of solids finely dispersed in a fatty 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)
ZINC OXIDE 400 mg/g
Usage Information
Change wet and soiled diapers promptlycleanse the diaper areaallow to dryapply paste 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
Savvy Care And Cosmetics Pvt Ltd
Product Type
Human Otc Drug
FDA Application #
M016
Marketing Category
OTC MONOGRAPH DRUG -
Start Marketing Date
11-16-2015
Listing Expiration
12-31-2027
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 (83650-107). Click a package code to view its specific billing and regulatory data.

83650-107-02
57 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 83650-107-01 identifies a specific commercial package of 28 g in 1 tube of Maximum Strength Diaper Rash, a human over the counter drug labeled by Savvy Care And Cosmetics Pvt Ltd. This paste 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 Savvy Care And Cosmetics Pvt Ltd on November 16, 2015. The current certification is valid through December 31, 2027.

How is this Savvy Care And Cosmetics Pvt Ltd product billed for insurance claims?

For medical billing and reimbursement, this package follows the 11-digit CMS format: 83650010701. 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)
83650-107-01
11-Digit CMS (5-4-2)
83650-0107-01

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