Remedy Barrier Cream Cloths Cloth
NDC Package 53329-074-76

11-digit billing NDC: 53329007476
Table of Contents
    1. Package Information
    2. Frequently Asked Questions

Package Information

Remedy Barrier Cream Cloths (dimethicone) cloths is open package as designatedRemove fresh cloths and thoroughly cleanse soiled area as neededDispose of cloths in waste receptacle, do not flush in toiletSingle Patient Use only. This formulation utilizes a cloth delivery system. Marketed by Medline Industries, Lp, this product is identified by NDC 53329-074 and is authorized under FDA application M016.

Identification & Billing

NDC Package Code
53329-074-76
Package Description
8 APPLICATOR in 1 PACKAGE / 17 mL in 1 APPLICATOR
Product Code
53329-074
11-Digit Billing Format
53329007476
RxNorm Crosswalk

Clinical Specifications

Proprietary Name
Remedy Barrier Cream Cloths Fragrance Free
Non-Proprietary Name
Dimethicone
Substance Name
Dimethicone
Dosage Form
Cloth - A large piece of relatively flat, absorbent material that contains a drug. It is typically used for applying medication or for cleansing.
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 3.6 g/100mL
Pharmacologic Class
Skin Barrier Activity - [PE] (Physiologic Effect)
Usage Information
Open package as designatedRemove fresh cloths and thoroughly cleanse soiled area as neededDispose of cloths in waste receptacle, do not flush in toiletSingle Patient Use only

Regulatory & Marketing

Labeler Name
Medline Industries, Lp
Product Type
Human Otc Drug
FDA Application #
M016
Marketing Category
OTC MONOGRAPH DRUG -
Start Marketing Date
08-31-2016
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 53329-074-76 identifies a specific commercial package of 8 applicator in 1 package / 17 ml in 1 applicator of Remedy Barrier Cream Cloths Fragrance Free, a human over the counter drug labeled by Medline Industries, Lp. This cloth 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 Medline Industries, Lp on August 31, 2016. The current certification is valid through December 31, 2027.

How is this Medline Industries, Lp product billed for insurance claims?

For medical billing and reimbursement, this package follows the 11-digit CMS format: 53329007476. 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)
53329-074-76
11-Digit CMS (5-4-2)
53329-0074-76

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