Americaine Ointment
NDC Package 63736-375-01

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

Package Information

Americaine (benzocaine) ointment is adultswhen practical, cleanse affected area with mild soap and warm water and rinse thoroughly. This formulation utilizes a ointment delivery system. Marketed by Insight Pharmaceuticals Llc, this product is identified by NDC 63736-375 and is authorized under FDA application M015.

Identification & Billing

NDC Package Code
63736-375-01
Package Description
1 TUBE in 1 BOX / 28 g in 1 TUBE
Product Code
63736-375
11-Digit Billing Format
63736037501
Billing Unit
GM - Billing unit of "gram" is used when a product is measured by its weight.
Units Per Package
28 GM
RxNorm Crosswalk

Clinical Specifications

Proprietary Name
Americaine
Non-Proprietary Name
Benzocaine
Substance Name
Benzocaine
Dosage Form
Ointment - A semisolid3 dosage form, usually containing <20% water and volatiles5 and >50% hydrocarbons, waxes, or polyols as the vehicle. This dosage form is generally for external application to the skin or mucous membranes.
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)
BENZOCAINE 5.6 g/28g
Pharmacologic Class
Usage Information
Adultswhen practical, cleanse affected area with mild soap and warm water and rinse thoroughly. Gently dry by patting or blotting with toilet tissue or soft cloth before application of this product.apply externally to the affected area up to 6 times dailyChildren under 12 years: ask a doctor

Regulatory & Marketing

Labeler Name
Insight Pharmaceuticals Llc
Product Type
Human Otc Drug
FDA Application #
M015
Marketing Category
OTC MONOGRAPH DRUG -
Start Marketing Date
07-10-2009
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 63736-375-01 identifies a specific commercial package of 1 tube in 1 box / 28 g in 1 tube of Americaine, a human over the counter drug labeled by Insight Pharmaceuticals Llc. This product is billed per "GM" gram and contains an estimated amount of 28 billable units per package. This ointment is formulated for topical use and contains benzocaine 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 Insight Pharmaceuticals Llc on July 10, 2009. The current certification is valid through December 31, 2026.

How is this Insight Pharmaceuticals Llc product billed for insurance claims?

For medical billing and reimbursement, this package follows the 11-digit CMS format: 63736037501. Quantities are measured in per "gm or gram", products billed per gram are products measured by weight.. There are 28 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:

10-Digit Format (5-3-2)
63736-375-01
11-Digit CMS (5-4-2)
63736-0375-01

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