Caldesene Medicated Protecting Powder
NDC Package 63736-306-01

View Billable Units, 11-Digit Conversion Format, and RxNorm mappings
Table of Contents
    1. Package Information
    2. Frequently Asked Questions

Package Information

Caldesene Medicated Protecting (cornstarch and zinc oxide) powders is for diaper rashchange wet or soiled diapers promptlycleanse the diaper area and allow to dryapply powder liberally, as often as necessary, with each diaper change, especially at bedtime or anytime exposure to wet diapers may be prolongedapply powder close to the body away from child's facecarefully shake the powder into the diaper or into the hand and apply to diaper areaFor minor skin irritationssmooth on powder to protect irritated and chafed skin. This formulation utilizes a powder delivery system. Marketed by Insight Pharmaceuticals Llc, this product is identified by NDC 63736-306 and is authorized under FDA application M016.

Identification & Billing

NDC Package Code
63736-306-01
Package Description
142 g in 1 BOTTLE
Product Code
63736-306
11-Digit Billing Format
63736030601
RxNorm Crosswalk

Clinical Specifications

Proprietary Name
Caldesene Medicated Protecting
Non-Proprietary Name
Cornstarch And Zinc Oxide
Substance Name
Starch, Corn; Zinc Oxide
Dosage Form
Powder - An intimate mixture of dry, finely divided drugs and/or chemicals that may be intended for internal or external use.
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)
Usage Information
For diaper rashchange wet or soiled diapers promptlycleanse the diaper area and allow to dryapply powder liberally, as often as necessary, with each diaper change, especially at bedtime or anytime exposure to wet diapers may be prolongedapply powder close to the body away from child's facecarefully shake the powder into the diaper or into the hand and apply to diaper areaFor minor skin irritationssmooth on powder to protect irritated and chafed skin. Apply as needed

Regulatory & Marketing

Labeler Name
Insight Pharmaceuticals Llc
Product Type
Human Otc Drug
FDA Application #
M016
Marketing Category
OTC MONOGRAPH DRUG -
Start Marketing Date
07-15-2017
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.

Frequently Asked Questions

What is the distribution configuration for this product package?

The code 63736-306-01 identifies a specific commercial package of 142 g in 1 bottle of Caldesene Medicated Protecting, a human over the counter drug labeled by Insight Pharmaceuticals Llc. This powder is formulated for topical use and contains starch, corn; 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 Insight Pharmaceuticals Llc on July 15, 2017. The current certification is valid through December 31, 2027.

How is this Insight Pharmaceuticals Llc product billed for insurance claims?

For medical billing and reimbursement, this package follows the 11-digit CMS format: 63736030601. 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)
63736-306-01
11-Digit CMS (5-4-2)
63736-0306-01

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