Remedy Nails Lotion
NDC Package 72222-224-10

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

Package Information

Remedy Nails (undecylenic acid) lotions is wash and dry affected area. This formulation utilizes a lotion delivery system. Marketed by Adwill Labs Inc, this product is identified by NDC 72222-224 and is authorized under FDA application M005.

Identification & Billing

NDC Package Code
72222-224-10
Package Description
1 BOTTLE, DROPPER in 1 CARTON / 15 mL in 1 BOTTLE, DROPPER
Product Code
72222-224
11-Digit Billing Format
72222022410

Clinical Specifications

Proprietary Name
Remedy Nails
Non-Proprietary Name
Undecylenic Acid
Substance Name
Undecylenic Acid
Dosage Form
Lotion - An emulsion, liquid1 dosage form. This dosage form is generally for external application to the skin.2
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)
UNDECYLENIC ACID 85 mg/mL
Usage Information
Wash and dry affected area. Apply a thin layer over affected area twice daily or as directed by a doctor. Apply enough medication to cover the affected area and surrounding skin. Wash hands after use. For maximum results, use twice daily or as instructed. Discontinuing use of this medication may allow recurrence of infection. If condition persists, consult your doctor.

Regulatory & Marketing

Labeler Name
Adwill Labs Inc
Product Type
Human Otc Drug
FDA Application #
M005
Marketing Category
OTC MONOGRAPH DRUG -
Start Marketing Date
06-01-2018
Listing Expiration
12-31-2027
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 72222-224-10 identifies a specific commercial package of 1 bottle, dropper in 1 carton / 15 ml in 1 bottle, dropper of Remedy Nails, a human over the counter drug labeled by Adwill Labs Inc. This lotion is formulated for topical use and contains undecylenic acid 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 Adwill Labs Inc on June 01, 2018. The current certification is valid through December 31, 2027.

How is this Adwill Labs Inc product billed for insurance claims?

For medical billing and reimbursement, this package follows the 11-digit CMS format: 72222022410. 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)
72222-224-10
11-Digit CMS (5-4-2)
72222-0224-10

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