Giltuss Bucalsep Spray
NDC Package 58552-135-01

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 usesfor the temporary relief of occasional minor irritations, pain, sore mouth, sore throat, pain associated with canker sores, pain due to minor irritation or injury of the mouth and gums, pain due to dental procedures, pain due to minor irritations caused by dentures or orthodontic appliances, sore gums. This formulation utilizes a spray delivery system. Marketed by Gil Pharmaceutical Corp, this product is identified by NDC 58552-135 and is authorized under FDA application M022.

Identification & Billing

NDC Package Code
58552-135-01
Package Description
1 BOTTLE, SPRAY in 1 CARTON / 30 mL in 1 BOTTLE, SPRAY
Product Code
58552-135
11-Digit Billing Format
58552013501
Billing Unit
ML - Billing unit of "milliliter" is used when a product is measured by its liquid volume.
RxNorm Crosswalk
  • RxCUI: 2170427 - benzocaine 6.5 % / menthol 0.1 % / zinc chloride 0.12 % Mucosal Spray
  • RxCUI: 2170427 - benzocaine 65 MG/ML / menthol 1 MG/ML / zinc chloride 1.2 MG/ML Mucosal Spray

Clinical Specifications

Proprietary Name
Giltuss Bucalsep
Non-Proprietary Name
Benzocaine, Menthol, Zinc Chloride
Substance Name
Benzocaine; Menthol; Zinc Chloride
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
Usesfor the temporary relief of occasional minor irritations, pain, sore mouth, sore throat, pain associated with canker sores, pain due to minor irritation or injury of the mouth and gums, pain due to dental procedures, pain due to minor irritations caused by dentures or orthodontic appliances, sore gums

Regulatory & Marketing

Labeler Name
Gil Pharmaceutical Corp
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 58552-135-01 identifies a specific commercial package of 1 bottle, spray in 1 carton / 30 ml in 1 bottle, spray of Giltuss Bucalsep, a human over the counter drug labeled by Gil Pharmaceutical Corp. This spray is formulated for oral; topical use and contains benzocaine; menthol; zinc chloride 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 Gil Pharmaceutical Corp on July 26, 2018. The current certification is valid through December 31, 2026.

How is this Gil Pharmaceutical Corp product billed for insurance claims?

For medical billing and reimbursement, this package follows the 11-digit CMS format: 58552013501. Quantities are measured in per "ml or milliliter", products billed per milliliter are usually products measured by liquid volume.. 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)
58552-135-01
11-Digit CMS (5-4-2)
58552-0135-01

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