Secura Dimethicone Protectant Cream
NDC Package 69740-322-00

11-digit billing NDC: 69740032200 · Billing unit: GM · 114 GM per package
Table of Contents
    1. Package Information
    2. Other Packages
    3. Frequently Asked Questions

Package Information

Secura Dimethicone Protectant (dimethicone) cream is apply as neededChange wet and soiled diapers, garments, and linens promptlyCleanse the affected area and allow to dryApply cream liberally as often as necessary with each diaper, garment or linen change; especially at bedtime or anytime when exposure to soiled diapers, garments, linens, feces, or urine may be prolonged. This formulation utilizes a cream delivery system. Marketed by Smith & Nephew Medical Ltd, this product is identified by NDC 69740-322 and is authorized under FDA application M016.

Identification & Billing

NDC Package Code
69740-322-00
Package Description
114 g in 1 TUBE
Product Code
69740-322
11-Digit Billing Format
69740032200
Billing Unit
GM - Billing unit of "gram" is used when a product is measured by its weight.
Units Per Package
114 GM
RxNorm Crosswalk

Clinical Specifications

Proprietary Name
Secura Dimethicone Protectant
Non-Proprietary Name
Dimethicone
Substance Name
Dimethicone
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)
DIMETHICONE 50 mg/g
Pharmacologic Class
Skin Barrier Activity - [PE] (Physiologic Effect)
Usage Information
Apply as neededChange wet and soiled diapers, garments, and linens promptlyCleanse the affected area and allow to dryApply cream liberally as often as necessary with each diaper, garment or linen change; especially at bedtime or anytime when exposure to soiled diapers, garments, linens, feces, or urine may be prolonged

Regulatory & Marketing

Labeler Name
Smith & Nephew Medical Ltd
Product Type
Human Otc Drug
FDA Application #
M016
Marketing Category
OTC MONOGRAPH DRUG -
Start Marketing Date
08-01-2005
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 (69740-322). Click a package code to view its specific billing and regulatory data.

69740-322-01
3.5 g in 1 PACKET

* 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 69740-322-00 identifies a specific commercial package of 114 g in 1 tube of Secura Dimethicone Protectant, a human over the counter drug labeled by Smith & Nephew Medical Ltd. This product is billed per "GM" gram and contains an estimated amount of 114 billable units per package. This cream is formulated for topical use and contains dimethicone 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 Smith & Nephew Medical Ltd on August 01, 2005. The current certification is valid through December 31, 2027.

How is this Smith & Nephew Medical Ltd product billed for insurance claims?

For medical billing and reimbursement, this package follows the 11-digit CMS format: 69740032200. Quantities are measured in per "gm or gram", products billed per gram are products measured by weight.. There are 114 total billable units per package. 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)
69740-322-00
11-Digit CMS (5-4-2)
69740-0322-00

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