Herbal Utaplas External Analgesic Plaster Patch
NDC Package 82198-0016-1

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

Package Information

Herbal Utaplas External Analgesic Plaster (menthol, methyl salicylate) patches is ● Adults and children 12 years of age and older: clean and dry affected area. This formulation utilizes a patch delivery system. Marketed by Big 5 Nutrition Llc, this product is identified by NDC 82198-0016 and is authorized under FDA application 505G(a)(3).

Identification & Billing

NDC Package Code
82198-0016-1
Package Description
10 PATCH in 1 BAG / 3.1 g in 1 PATCH
Product Code
82198-0016
11-Digit Billing Format
82198001601

Clinical Specifications

Proprietary Name
Herbal Utaplas External Analgesic Plaster
Non-Proprietary Name
Menthol, Methyl Salicylate
Substance Name
Menthol, Unspecified Form; Methyl Salicylate
Dosage Form
Patch - A drug delivery system that often contains an adhesive backing that is usually applied to an external site on the body. Its ingredients either passively diffuse from, or are actively transported from, some portion of the patch. Depending upon the patch, the ingredients are either delivered to the outer surface of the body or into the body. A patch is sometimes synonymous with the terms ‘extended release film’ and ‘system’.
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)
Usage Information
● Adults and children 12 years of age and older: clean and dry affected area. Remove plaster from the protective layer, apply to the affected area, rub the area with your hand to secure the patch. ● Plaster will remain effective for 8 hours. ● Avoid using the same patch on the same area for more than 2 days. ● Do not apply to area with excessive hair. Adhesive plaster may hurt skin upon removal. ● Wet patch with warm water before removing from skin ● Children under 12 years of age: Do not use or consult a doctor.

Regulatory & Marketing

Labeler Name
Big 5 Nutrition Llc
Product Type
Human Otc Drug
FDA Application #
505G(a)(3)
Marketing Category
OTC MONOGRAPH DRUG -
Start Marketing Date
01-01-2024
Listing Expiration
12-31-2026
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 82198-0016-1 identifies a specific commercial package of 10 patch in 1 bag / 3.1 g in 1 patch of Herbal Utaplas External Analgesic Plaster, a human over the counter drug labeled by Big 5 Nutrition Llc. This patch is formulated for topical use and contains menthol, unspecified form; methyl salicylate 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 Big 5 Nutrition Llc on January 01, 2024. The current certification is valid through December 31, 2026.

How is this Big 5 Nutrition Llc product billed for insurance claims?

For medical billing and reimbursement, this package follows the 11-digit CMS format: 82198001601. 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 (5-4-1)
82198-0016-1
11-Digit CMS (5-4-2)
82198-0016-01

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