Vagisil Anti-itch Medicated Wipes Maximum Strength Cloth
NDC Package 11509-5035-1

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

Package Information

Vagisil Anti-itch Medicated Wipes Maximum Strength (pramoxine hydrochloride) cloths is adults and children12 years and older                           Unfold towelette and gently pat or wipe external vaginal area from front to back. This formulation utilizes a cloth delivery system. Marketed by Combe Incorporated, this product is identified by NDC 11509-5035 and is authorized under FDA application M017.

Identification & Billing

NDC Package Code
11509-5035-1
Package Description
12 PACKET in 1 CARTON / 4.5 g in 1 PACKET
Product Code
11509-5035
11-Digit Billing Format
11509503501
Billing Unit
EA - Billing unit of "each" is used when the product is dispensed in discreet units.
Units Per Package
1 EA
RxNorm Crosswalk

Clinical Specifications

Proprietary Name
Vagisil Anti-itch Medicated Wipes Maximum Strength
Non-Proprietary Name
Pramoxine Hydrochloride
Substance Name
Pramoxine Hydrochloride
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)
PRAMOXINE HYDROCHLORIDE 10 mg/g
Usage Information
Adults and children12 years and older                           Unfold towelette and gently pat or wipe external vaginal area from front to back. Use each towelette only once and then throw away. Apply to affected area not more than 3 to 4 times daily.children under 12 yearsconsult a doctor adults and children12 years and older          Unfold towelette and gently pat or wipe external vaginal area from front to back. Use each towelette only once and then throw away. Apply to affected area not more than 3 to 4 times daily.children under 12 yearsconsult a doctor

Regulatory & Marketing

Labeler Name
Combe Incorporated
Product Type
Human Otc Drug
FDA Application #
M017
Marketing Category
OTC MONOGRAPH DRUG -
Start Marketing Date
06-28-2005
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 11509-5035-1 identifies a specific commercial package of 12 packet in 1 carton / 4.5 g in 1 packet of Vagisil Anti-itch Medicated Wipes Maximum Strength, a human over the counter drug labeled by Combe Incorporated. This product is billed for "EA" each discreet unit and contains an estimated amount of 1 billable units per package. This cloth is formulated for topical use and contains pramoxine hydrochloride 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 Combe Incorporated on June 28, 2005. The current certification is valid through December 31, 2026.

How is this Combe Incorporated product billed for insurance claims?

For medical billing and reimbursement, this package follows the 11-digit CMS format: 11509503501. Quantities are measured in per "each", products billed on a per each basis are usually products dispensed in discreet units.. There are 1 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 (5-4-1)
11509-5035-1
11-Digit CMS (5-4-2)
11509-5035-01

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