Asperflex Hot Patch
NDC Package 71399-4439-6
Package Information
Asperflex Hot (camphor, menthol, methyl salicylate) patches is adults and children 12 years of age and over:clean and dry affected arearemove patch from filmapply to affected area not more than 3 to 4 times dailyremove patch from the skin after at most 8-hour applicationChildren under 12 years of age: consult a doctor. This formulation utilizes a patch delivery system. Marketed by Akron Pharma Inc., this product is identified by NDC 71399-4439 and is authorized under FDA application M017.
Identification & Billing
- RxCUI: 853136 - capsaicin 0.025 % / menthol 1.25 % Medicated Patch
- RxCUI: 853136 - capsaicin 0.00025 MG/MG / menthol 0.0125 MG/MG Medicated Patch
Clinical Specifications
- Percutaneous - Administration through the skin.
- Topical - Administration to a particular spot on the outer surface of the body. The E2B term TRANSMAMMARY is a subset of the term TOPICAL.
- Transdermal - Administration through the dermal layer of the skin to the systemic circulation by diffusion.
- Allergens - [CS]
- Cell-mediated Immunity - [PE] (Physiologic Effect)
- Dietary Proteins - [CS]
- Increased Histamine Release - [PE] (Physiologic Effect)
- Non-Standardized Food Allergenic Extract - [EPC] (Established Pharmacologic Class)
- Non-Standardized Plant Allergenic Extract - [EPC] (Established Pharmacologic Class)
- Plant Proteins - [CS]
- Vegetable Proteins - [CS]
Regulatory & Marketing
Hierarchy Structure
- 71399 - Akron Pharma Inc.
- 71399-4439 - Asperflex Hot
- 71399-4439-6 - 6 PATCH in 1 BOX / 7 g in 1 PATCH
- 71399-4439 - Asperflex Hot
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 71399-4439-6 identifies a specific commercial package of 6 patch in 1 box / 7 g in 1 patch of Asperflex Hot, a human over the counter drug labeled by Akron Pharma Inc.. This product is billed for "EA" each discreet unit and contains an estimated amount of 1 billable units per package. This patch is formulated for percutaneous; topical; transdermal use and contains capsicum; menthol 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 Akron Pharma Inc. on November 04, 2021. The current certification is valid through December 31, 2026.
How is this Akron Pharma Inc. product billed for insurance claims?
For medical billing and reimbursement, this package follows the 11-digit CMS format: 71399443906. Quantities are measured in per "each", products billed on a per each basis are usually products dispensed in discreet units.. There are 1 total billable units per package. 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:
Note: The zero is added to the Package segment to maintain the 5-4-2 structure.