Local Anesthetic Anorectal Cream
NDC Package 84767-001-01

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

Package Information

This product is EXCLUDED from the official NDC directory because the listing data was inactivated by the FDA.

Local Anesthetic Anorectal Cream is stop use and ask a doctor ifrectal bleeding occurscondition worsens or does not improve within 7 dayscertain persons can develop allergic reactions to ingredients in this product. Marketed by Make Labs Llc, this product is identified by NDC 84767-001 and is authorized under FDA application M015.

Identification & Billing

NDC Package Code
84767-001-01
Package Description
170 g in 1 TUBE
Product Code
84767-001
11-Digit Billing Format
84767000101
RxNorm Crosswalk

Clinical Specifications

Proprietary Name
Local Anesthetic Anorectal Cream
Dosage Form
-
Usage Information
Stop use and ask a doctor ifrectal bleeding occurscondition worsens or does not improve within 7 dayscertain persons can develop allergic reactions to ingredients in this product. If the symptom being treated does not subside or if redness, irritation, swelling, pain, or other symptoms develop or increase, discontinue use and consult a doctor.

Regulatory & Marketing

Labeler Name
Make Labs Llc
FDA Application #
M015
Marketing Category
OTC MONOGRAPH DRUG -
Start Marketing Date
08-01-2024
Listing Expiration
12-31-2025
Exclude Flag
I
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 84767-001-01 identifies a specific commercial package of 170 g in 1 tube of Local Anesthetic Anorectal Cream, labeled by Make Labs Llc. This is formulated for use and contains as the active substance.

Is this product currently listed with the FDA?

This product code is currently listed as inactive or excluded from the primary directory. It was introduced to the market by Make Labs Llc on August 01, 2024. The current certification is valid through December 31, 2025.

How is this Make Labs Llc product billed for insurance claims?

For medical billing and reimbursement, this package follows the 11-digit CMS format: 84767000101. 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)
84767-001-01
11-Digit CMS (5-4-2)
84767-0001-01

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