Olu Pain Management Patch
NDC Package 84991-0208-5

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

Package Information

Olu Pain Management (lidocaine and camphor) patches is adults and Children 12 Years of Age and Older:-Clean and dry the affected area-Apply gel pad directly onto skin for up to 12 hours-Wash hands immediately after use-Gel pad can be cut into pieces and used on up to 2 body parts at a time-One application per day is recommended. This formulation utilizes a patch delivery system. Marketed by Olakino Therapeutics Llc, this product is identified by NDC 84991-0208 and is authorized under FDA application M017.

Identification & Billing

NDC Package Code
84991-0208-5
Package Description
5 PATCH in 1 POUCH / 8.5 g in 1 PATCH
Product Code
84991-0208
11-Digit Billing Format
84991020805
RxNorm Crosswalk

Clinical Specifications

Proprietary Name
Olu Pain Management
Non-Proprietary Name
Lidocaine And Camphor
Substance Name
Camphor (natural); Lidocaine
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
Cutaneous - Administration to the skin.
Active Ingredient(s)
Pharmacologic Class
Usage Information
Adults and Children 12 Years of Age and Older:-Clean and dry the affected area-Apply gel pad directly onto skin for up to 12 hours-Wash hands immediately after use-Gel pad can be cut into pieces and used on up to 2 body parts at a time-One application per day is recommended

Regulatory & Marketing

Labeler Name
Olakino Therapeutics Llc
Product Type
Human Otc Drug
FDA Application #
M017
Marketing Category
OTC MONOGRAPH DRUG -
Start Marketing Date
12-24-2024
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.

Other Available Packages

The following commercial packages are registered under the same Product NDC (84991-0208). Click a package code to view its specific billing and regulatory data.

84991-0208-1
3 POUCH in 1 BOX / 5 PATCH in 1 POUCH / 8.5 g in 1 PATCH

* 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 84991-0208-5 identifies a specific commercial package of 5 patch in 1 pouch / 8.5 g in 1 patch of Olu Pain Management, a human over the counter drug labeled by Olakino Therapeutics Llc. This patch is formulated for cutaneous use and contains camphor (natural); lidocaine 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 Olakino Therapeutics Llc on December 24, 2024. The current certification is valid through December 31, 2026.

How is this Olakino Therapeutics Llc product billed for insurance claims?

For medical billing and reimbursement, this package follows the 11-digit CMS format: 84991020805. 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)
84991-0208-5
11-Digit CMS (5-4-2)
84991-0208-05

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