Vagisil Anti-itch Creme Maximum Strength Sensitive Skin Formula Cream
NDC Package 11509-5101-1
Package Information
Vagisil Anti-itch Creme Maximum Strength Sensitive Skin Formula (hydrocortisone acetate) cream is a medication used to treat hemorrhoids and itching/swelling in the rectum and anus. This formulation utilizes a cream delivery system. Marketed by Combe Incorporated, this product is identified by NDC 11509-5101 and is authorized under FDA application M017.
Identification & Billing
- RxCUI: 1039349 - hydrocortisone acetate 1 % Vaginal Cream
- RxCUI: 1039349 - hydrocortisone acetate 10 MG/ML Vaginal Cream
- RxCUI: 1039353 - Vagisil Satin 1 % Vaginal Cream
- RxCUI: 1039353 - hydrocortisone acetate 10 MG/ML Vaginal Cream [Vagisil Satin]
- RxCUI: 1039353 - Vagisil Satin 10 MG/ML Vaginal Cream
Clinical Specifications
Regulatory & Marketing
Hierarchy Structure
- 11509 - Combe Incorporated
- 11509-5101 - Vagisil Anti-itch Creme Maximum Strength Sensitive Skin Formula
- 11509-5101-1 - 28 g in 1 CARTON
- 11509-5101 - Vagisil Anti-itch Creme Maximum Strength Sensitive Skin Formula
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 11509-5101-1 identifies a specific commercial package of 28 g in 1 carton of Vagisil Anti-itch Creme Maximum Strength Sensitive Skin Formula, 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 hydrocortisone acetate 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 January 30, 2016. The current certification is valid through December 31, 2026.
What are the primary indications for this medication?
This medication is used to treat hemorrhoids and itching/swelling in the rectum and anus. It is also used with other medications to treat certain intestinal problems (such as ulcerative colitis of the rectum and other rectal/anal inflammatory conditions). Hydrocortisone suppositories help to relieve rectal pain, itching, bloody diarrhea, and bleeding by reducing swelling (inflammation) directly in the rectum and anus. Hydrocortisone belongs to a class of drugs called corticosteroids.
How is this Combe Incorporated product billed for insurance claims?
For medical billing and reimbursement, this package follows the 11-digit CMS format: 11509510101. 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:
Note: The zero is added to the Package segment to maintain the 5-4-2 structure.
