Giltuss Bucalsep Spray
NDC Package 65852-015-01

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

Package Information

Giltuss Bucalsep (benzocaine, menthol, zinc chloride) sprays is directions:Adults and children 2 years of age and olderapply to affected areagargle, swish around in the mouth, or allow to remain in place at least 1 minute and then spit outuse 4 times daily or as directed by dentist or doctorchildren under 12 years of age should be supervised in the use of the productChildren under 2 years of age: do not use. This formulation utilizes a spray delivery system. Marketed by Dextrum Laboratories Inc., this product is identified by NDC 65852-015 and is authorized under FDA application M022.

Identification & Billing

NDC Package Code
65852-015-01
Package Description
1 BOTTLE, PLASTIC in 1 CARTON / 30 mL in 1 BOTTLE, PLASTIC
Product Code
65852-015
11-Digit Billing Format
65852001501

Clinical Specifications

Proprietary Name
Giltuss Bucalsep
Non-Proprietary Name
Benzocaine, Menthol, Zinc Chloride
Substance Name
Benzocaine; Menthol; Zinc Cation
Dosage Form
Spray - A liquid minutely divided as by a jet of air or steam.
Administration Route
  • Oral - Administration to or by way of the mouth.
  • 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)
Pharmacologic Class
Usage Information
Directions:Adults and children 2 years of age and olderapply to affected areagargle, swish around in the mouth, or allow to remain in place at least 1 minute and then spit outuse 4 times daily or as directed by dentist or doctorchildren under 12 years of age should be supervised in the use of the productChildren under 2 years of age: do not use

Regulatory & Marketing

Labeler Name
Dextrum Laboratories Inc.
Product Type
Human Otc Drug
FDA Application #
M022
Marketing Category
OTC MONOGRAPH DRUG -
Start Marketing Date
07-26-2018
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 65852-015-01 identifies a specific commercial package of 1 bottle, plastic in 1 carton / 30 ml in 1 bottle, plastic of Giltuss Bucalsep, a human over the counter drug labeled by Dextrum Laboratories Inc.. This spray is formulated for oral; topical use and contains benzocaine; menthol; zinc cation 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 Dextrum Laboratories Inc. on July 26, 2018. The current certification is valid through December 31, 2026.

How is this Dextrum Laboratories Inc. product billed for insurance claims?

For medical billing and reimbursement, this package follows the 11-digit CMS format: 65852001501. 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)
65852-015-01
11-Digit CMS (5-4-2)
65852-0015-01

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