Vagisil Anti-itch Medicated Creme Maximum Strength Cream
NDC Package 11509-4402-1

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 Creme Maximum Strength (benzocaine and resorcinol) cream is adults and children 12years and older          apply a fingertip amount (approximately 1-inch strip) to affected area not more than 3 to 4 times daily. This formulation utilizes a cream delivery system. Marketed by Combe Incorporated, this product is identified by NDC 11509-4402 and is authorized under FDA application M017.

Identification & Billing

NDC Package Code
11509-4402-1
Package Description
1 TUBE in 1 CARTON / 28 g in 1 TUBE
Product Code
11509-4402
11-Digit Billing Format
11509440201
Billing Unit
GM - Billing unit of "gram" is used when a product is measured by its weight.
Units Per Package
28 GM
RxNorm Crosswalk
  • RxCUI: 1247441 - Vagisil Maximum Strength 20 % / 3 % Vaginal Cream
  • RxCUI: 1247441 - benzocaine 200 MG/ML / resorcinol 30 MG/ML Vaginal Cream [Vagisil Original Formula]
  • RxCUI: 1247441 - Vagisil Maximum Strength (benzocaine 20 % / resorcinol 3 % ) Vaginal Cream
  • RxCUI: 1247441 - Vagisil, Maximum Strength, Anti-Itch Topical Cream
  • RxCUI: 637518 - benzocaine 20 % / resorcinol 3 % Vaginal Cream

Clinical Specifications

Proprietary Name
Vagisil Anti-itch Medicated Creme Maximum Strength
Non-Proprietary Name
Benzocaine And Resorcinol
Substance Name
Benzocaine; Resorcinol
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)
Pharmacologic Class
Usage Information
Adults and children 12years and older          apply a fingertip amount (approximately 1-inch strip) to affected area not more than 3 to 4 times daily. Clean nozzle of tube by wiping thoroughly before replacing cap. Keep cap tightly closed between uses. 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
03-01-1995
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 11509-4402-1 identifies a specific commercial package of 1 tube in 1 carton / 28 g in 1 tube of Vagisil Anti-itch Medicated Creme Maximum Strength, a human over the counter drug labeled by Combe Incorporated. This product is billed per "GM" gram and contains an estimated amount of 28 billable units per package. This cream is formulated for topical use and contains benzocaine; resorcinol 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 March 01, 1995. 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: 11509440201. Quantities are measured in per "gm or gram", products billed per gram are products measured by weight.. There are 28 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)
11509-4402-1
11-Digit CMS (5-4-2)
11509-4402-01

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