Dentek Instant Pain Relief Maximum Strength Liquid
NDC Package 60630-078-01

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

Package Information

Dentek Instant Pain Relief Maximum Strength (benzocaine) liquids is dip applicator into liquid Adults and children 2 years and olderApply a small amount of product to the affected area. This formulation utilizes a liquid delivery system. Marketed by Dentek Oral Care, Inc., this product is identified by NDC 60630-078 and is authorized under FDA application M022.

Identification & Billing

NDC Package Code
60630-078-01
Package Description
1 VIAL, GLASS in 1 CARTON / 3.5 mL in 1 VIAL, GLASS
Product Code
60630-078
11-Digit Billing Format
60630007801
RxNorm Crosswalk
  • RxCUI: 308657 - benzocaine 20 % Mucous Membrane Topical Solution
  • RxCUI: 308657 - benzocaine 200 MG/ML Mucous Membrane Topical Solution

Clinical Specifications

Proprietary Name
Dentek Instant Pain Relief Maximum Strength
Non-Proprietary Name
Benzocaine
Substance Name
Benzocaine
Dosage Form
Liquid - A dosage form consisting of a pure chemical in its liquid1 state. This dosage form term should not be applied to solutions.
Administration Route
  • Dental - Administration to a tooth or teeth.
  • 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 200 mg/mL
Pharmacologic Class
Usage Information
Dip applicator into liquid Adults and children 2 years and olderApply a small amount of product to the affected area. Use up to 4 times daily or as directed by a dentist or doctor.Children between 2 and 12 years Should be supervised in the use of this product.Children under 2 years Do not use.      

Regulatory & Marketing

Labeler Name
Dentek Oral Care, Inc.
Product Type
Human Otc Drug
FDA Application #
M022
Marketing Category
OTC MONOGRAPH DRUG -
Start Marketing Date
07-31-2015
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 60630-078-01 identifies a specific commercial package of 1 vial, glass in 1 carton / 3.5 ml in 1 vial, glass of Dentek Instant Pain Relief Maximum Strength, a human over the counter drug labeled by Dentek Oral Care, Inc.. This liquid is formulated for dental; 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 Dentek Oral Care, Inc. on July 31, 2015. The current certification is valid through December 31, 2026.

How is this Dentek Oral Care, Inc. product billed for insurance claims?

For medical billing and reimbursement, this package follows the 11-digit CMS format: 60630007801. 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)
60630-078-01
11-Digit CMS (5-4-2)
60630-0078-01

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