4rlf Topical Analgesic
NDC Package 76849-201-11

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.

4rlf Topical Analgesic is ■ Adults and children 2 years of age or older: Apply to the desired area and gently rub into the skin, not more than 3 to 4 times daily. Marketed by Rinati Skin, Llc, this product is identified by NDC 76849-201 and is authorized under FDA application part348.

Identification & Billing

NDC Package Code
76849-201-11
Package Description
1 BLISTER PACK in 1 CARTON / 10 VIAL in 1 BLISTER PACK / 1 mL in 1 VIAL
Product Code
76849-201
11-Digit Billing Format
76849020111

Clinical Specifications

Proprietary Name
4rlf Topical Analgesic
Dosage Form
-
Usage Information
■ Adults and children 2 years of age or older: Apply to the desired area and gently rub into the skin, not more than 3 to 4 times daily. ■ Children under the age of 2: Consult a physician.

Regulatory & Marketing

Labeler Name
Rinati Skin, Llc
FDA Application #
part348
Marketing Category
OTC MONOGRAPH NOT FINAL - A product marketed pursuant to an Over-the-Counter (OTC) Drug Monograph that is not final.
Start Marketing Date
08-23-2021
Listing Expiration
12-31-2023
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 76849-201-11 identifies a specific commercial package of 1 blister pack in 1 carton / 10 vial in 1 blister pack / 1 ml in 1 vial of 4rlf Topical Analgesic, labeled by Rinati Skin, 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 Rinati Skin, Llc on August 23, 2021. The current certification is valid through December 31, 2023.

How is this Rinati Skin, Llc product billed for insurance claims?

For medical billing and reimbursement, this package follows the 11-digit CMS format: 76849020111. 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)
76849-201-11
11-Digit CMS (5-4-2)
76849-0201-11

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