Neorelief For Pain Gel
NDC Package 58368-005-01

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

Package Information

Neorelief For Pain (topical gel for pain) gel is adults and children 2 years of age and older, apply a thin layer of gel on clean skin to cover the affected area.For best results, allow gel to be absorbed into the skin;do not rub in.Apply at the onset of symptoms, not more than 6 times daily or every 15 minutes for the first hour.Do not use with other topical remedies or lotions. This formulation utilizes a gel delivery system. Marketed by Biolyte Laboratories, Llc, this product is identified by NDC 58368-005.

Identification & Billing

NDC Package Code
58368-005-01
Package Description
1 BOTTLE, PUMP in 1 CARTON / 56.7 g in 1 BOTTLE, PUMP
Product Code
58368-005
11-Digit Billing Format
58368000501

Clinical Specifications

Proprietary Name
Neorelief For Pain
Non-Proprietary Name
Topical Gel For Pain
Substance Name
Actaea Spicata Root; Althaea Officinalis Root; Arnica Montana; Atropa Belladonna Root; Bellis Perennis; Black Cohosh; Bryonia Alba Root; Calendula Officinalis Flowering Top; Caulophyllum Thalictroides Root; Causticum; Frangula Californica Bark; Guaiacum Officinale Resin; Horse Chestnut; Hypericum Perforatum; Ledum Palustre Twig; Lithium Carbonate; Potassium Carbonate; Rhododendron Aureum Leaf; Ruta Graveolens Flowering Top; Salicylic Acid; Stellaria Media; Toxicodendron Pubescens Leaf
Dosage Form
Gel - A semisolid3 dosage form that contains a gelling agent to provide stiffness to a solution or a colloidal dispersion.4 A gel may contain suspended particles.
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
Mood Stabilizer - [EPC] (Established Pharmacologic Class)
Usage Information
Adults and children 2 years of age and older, apply a thin layer of gel on clean skin to cover the affected area.For best results, allow gel to be absorbed into the skin;do not rub in.Apply at the onset of symptoms, not more than 6 times daily or every 15 minutes for the first hour.Do not use with other topical remedies or lotions.

Regulatory & Marketing

Labeler Name
Biolyte Laboratories, Llc
Product Type
Human Otc Drug
Marketing Category
UNAPPROVED HOMEOPATHIC - A category specifying that a product is marketed as unapproved homeopathic product.
Start Marketing Date
02-01-2017
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 58368-005-01 identifies a specific commercial package of 1 bottle, pump in 1 carton / 56.7 g in 1 bottle, pump of Neorelief For Pain, a human over the counter drug labeled by Biolyte Laboratories, Llc. This gel is formulated for topical use and contains actaea spicata root; althaea officinalis root; arnica montana; atropa belladonna root; bellis perennis; black cohosh; bryonia alba root; calendula officinalis flowering top; caulophyllum thalictroides root; causticum; frangula californica bark; guaiacum officinale resin; horse chestnut; hypericum perforatum; ledum palustre twig; lithium carbonate; potassium carbonate; rhododendron aureum leaf; ruta graveolens flowering top; salicylic acid; stellaria media; toxicodendron pubescens leaf 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 Biolyte Laboratories, Llc on February 01, 2017. The current certification is valid through December 31, 2027.

How is this Biolyte Laboratories, Llc product billed for insurance claims?

For medical billing and reimbursement, this package follows the 11-digit CMS format: 58368000501. 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)
58368-005-01
11-Digit CMS (5-4-2)
58368-0005-01

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