Americaine Aerosol, Spray
NDC Package 63736-378-02

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

Package Information

Americaine (benzocaine) aerosols is shake can well, hold 6" to 12" from affected area; spray liberally.adults and children 2 years of age and older: apply to affected area not more than 3 to 4 times dailychildren under 2 years of age: consult a physician. This formulation utilizes a aerosol, spray delivery system. Marketed by Insight Pharmaceuticals Llc, this product is identified by NDC 63736-378 and is authorized under FDA application M017.

Identification & Billing

NDC Package Code
63736-378-02
Package Description
57 g in 1 CAN
Product Code
63736-378
11-Digit Billing Format
63736037802
RxNorm Crosswalk

Clinical Specifications

Proprietary Name
Americaine
Non-Proprietary Name
Benzocaine
Substance Name
Benzocaine
Dosage Form
Aerosol, Spray - An aerosol product which utilizes a compressed gas as the propellant to provide the force necessary to expel the product as a wet spray; it is applicable to solutions of medicinal agents in aqueous solvents.
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 11.4 g/57g
Pharmacologic Class
Usage Information
Shake can well, hold 6" to 12" from affected area; spray liberally.adults and children 2 years of age and older: apply to affected area not more than 3 to 4 times dailychildren under 2 years of age: consult a physician

Regulatory & Marketing

Labeler Name
Insight Pharmaceuticals Llc
Product Type
Human Otc Drug
FDA Application #
M017
Marketing Category
OTC MONOGRAPH DRUG -
Start Marketing Date
07-14-2009
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 63736-378-02 identifies a specific commercial package of 57 g in 1 can of Americaine, a human over the counter drug labeled by Insight Pharmaceuticals Llc. This aerosol, spray 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 14, 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: 63736037802. 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)
63736-378-02
11-Digit CMS (5-4-2)
63736-0378-02

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