Dyclopro Solution
NDC Package 0362-3971-05

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

Package Information

Dyclopro (dyclonine hydrochloride) solution is dyclonine HCl Topical Solution, USP is indicated for anesthetizing accessible mucous membranes (e.g., the mouth, pharynx, larynx, trachea, esophagus, and urethra) prior to various endoscopic procedures.Dyclonine HCl Topical Solution, USP, 0.5% topical anesthetic may also be used to block the gag reflex, to relieve the pain of oral ulcers or stomatitis and to relieve pain associated with ano-genital lesions. This formulation utilizes a solution delivery system. Marketed by Septodont Inc, this product is identified by NDC 0362-3971 and is authorized under FDA application ANDA200480.

Identification & Billing

NDC Package Code
0362-3971-05
Package Description
1 BOTTLE in 1 BOTTLE / 30 mL in 1 BOTTLE
Product Code
0362-3971
11-Digit Billing Format
00362397105
Billing Unit
ML - Billing unit of "milliliter" is used when a product is measured by its liquid volume.
RxNorm Crosswalk
  • RxCUI: 1048281 - dyclonine HCl 0.5 % Mucous Membrane Topical Solution
  • RxCUI: 1048281 - dyclonine hydrochloride 5 MG/ML Mucous Membrane Topical Solution
  • RxCUI: 1048281 - dyclonine hydrochloride 0.5 % Mucous Membrane Topical Solution
  • RxCUI: 2199132 - DycloPro 0.5 % Mucous Membrane Topical Solution
  • RxCUI: 2199132 - dyclonine hydrochloride 5 MG/ML Mucous Membrane Topical Solution [Dyclopro]

Clinical Specifications

Proprietary Name
Dyclopro
Non-Proprietary Name
Dyclonine Hydrochloride
Substance Name
Dyclonine Hydrochloride
Dosage Form
Solution - A clear, homogeneous liquid1 dosage form that contains one or more chemical substances dissolved in a solvent or mixture of mutually miscible 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)
DYCLONINE HYDROCHLORIDE 5 mg/mL
Usage Information
Dyclonine HCl Topical Solution, USP is indicated for anesthetizing accessible mucous membranes (e.g., the mouth, pharynx, larynx, trachea, esophagus, and urethra) prior to various endoscopic procedures.Dyclonine HCl Topical Solution, USP, 0.5% topical anesthetic may also be used to block the gag reflex, to relieve the pain of oral ulcers or stomatitis and to relieve pain associated with ano-genital lesions.

Regulatory & Marketing

Labeler Name
Septodont Inc
Product Type
Human Prescription Drug
FDA Application #
ANDA200480
Marketing Category
ANDA - A product marketed under an approved Abbreviated New Drug Application.
Start Marketing Date
09-01-2019
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 0362-3971-05 identifies a specific commercial package of 1 bottle in 1 bottle / 30 ml in 1 bottle of Dyclopro, a human prescription drug labeled by Septodont Inc. This solution is formulated for topical use and contains dyclonine hydrochloride 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 Septodont Inc on September 01, 2019. The current certification is valid through December 31, 2026.

How is this Septodont Inc product billed for insurance claims?

For medical billing and reimbursement, this package follows the 11-digit CMS format: 00362397105. 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 (4-4-2)
0362-3971-05
11-Digit CMS (5-4-2)
00362-3971-05

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