Cool Comfort Swab
NDC Package 71453-211-00

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

Package Information

Cool Comfort (organic witch hazel) swabs is adult: cleanse the area by gently wiping, patting or blotting. This formulation utilizes a swab delivery system. Marketed by Naticura Inc, this product is identified by NDC 71453-211 and is authorized under FDA application M016.

Identification & Billing

NDC Package Code
71453-211-00
Package Description
100 PACKET in 1 PACKAGE / 2.9 g in 1 PACKET
Product Code
71453-211
11-Digit Billing Format
71453021100
RxNorm Crosswalk

Clinical Specifications

Proprietary Name
Cool Comfort
Non-Proprietary Name
Organic Witch Hazel
Substance Name
Witch Hazel
Dosage Form
Swab - A small piece of relatively flat absorbent material that contains a drug. A swab may also be attached to one end of a small stick. A swab 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)
WITCH HAZEL 60 g/100g
Usage Information
Adult: cleanse the area by gently wiping, patting or blotting. If necessary, repeat until all matter is removed from the area.use up to 6 times daily or after each bowel movement and before applying hemorrhoidal treatments, and then discardDispose of pad in trash after use.Do not flushchildren under 12 years of age: consult a doctor

Regulatory & Marketing

Labeler Name
Naticura Inc
Product Type
Human Otc Drug
FDA Application #
M016
Marketing Category
OTC MONOGRAPH DRUG -
Start Marketing Date
11-29-2017
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.

Frequently Asked Questions

What is the distribution configuration for this product package?

The code 71453-211-00 identifies a specific commercial package of 100 packet in 1 package / 2.9 g in 1 packet of Cool Comfort, a human over the counter drug labeled by Naticura Inc. This swab is formulated for topical use and contains witch hazel 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 Naticura Inc on November 29, 2017. The current certification is valid through December 31, 2026.

How is this Naticura Inc product billed for insurance claims?

For medical billing and reimbursement, this package follows the 11-digit CMS format: 71453021100. 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)
71453-211-00
11-Digit CMS (5-4-2)
71453-0211-00

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