Benzocaine 20% Solution
NDC Package 0121-1077-25

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

Package Information

Benzocaine 20% solution is read Directions on side panel for how to useadults and children 2 years of age and older apply to the affected area, Gargle, swish around in the mouth, or allow to remain in place for at least 15 seconds and them spit out.  Use up to 4 times daily or as directed by a dentist or doctor. children under 12 years of age should be supervised in the use of the product children under 2 years of age do not use. This formulation utilizes a solution delivery system. Marketed by Pai Holdings, Llc Dba Pai Pharma, this product is identified by NDC 0121-1077 and is authorized under FDA application M022.

Identification & Billing

NDC Package Code
0121-1077-25
Package Description
25 POUCH in 1 CARTON / 1 APPLICATOR in 1 POUCH (0121-1077-01) / .5 mL in 1 APPLICATOR
Product Code
0121-1077
11-Digit Billing Format
00121107725
Billing Unit
EA - Billing unit of "each" is used when the product is dispensed in discreet units.
Units Per Package
1 EA
RxNorm Crosswalk
  • RxCUI: 308657 - benzocaine 20 % Mucous Membrane Topical Solution
  • RxCUI: 308657 - benzocaine 200 MG/ML Mucous Membrane Topical Solution

Clinical Specifications

Proprietary Name
Benzocaine 20%
Non-Proprietary Name
Benzocaine 20%
Substance Name
Benzocaine
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)
BENZOCAINE 200 mg/mL
Pharmacologic Class
Usage Information
Read Directions on side panel for how to useadults and children 2 years of age and older apply to the affected area, Gargle, swish around in the mouth, or allow to remain in place for at least 15 seconds and them spit out.  Use up to 4 times daily or as directed by a dentist or doctor. children under 12 years of age should be supervised in the use of the product children under 2 years of age do not use

Regulatory & Marketing

Labeler Name
Pai Holdings, Llc Dba Pai Pharma
Product Type
Human Otc Drug
FDA Application #
M022
Marketing Category
OTC MONOGRAPH DRUG -
Start Marketing Date
03-20-2026
Listing Expiration
12-31-2027
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 0121-1077-25 identifies a specific commercial package of 25 pouch in 1 carton / 1 applicator in 1 pouch (0121-1077-01) / .5 ml in 1 applicator of Benzocaine 20%, a human over the counter drug labeled by Pai Holdings, Llc Dba Pai Pharma. This product is billed for "EA" each discreet unit and contains an estimated amount of 1 billable units per package. This solution 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 Pai Holdings, Llc Dba Pai Pharma on March 20, 2026. The current certification is valid through December 31, 2027.

How is this Pai Holdings, Llc Dba Pai Pharma product billed for insurance claims?

For medical billing and reimbursement, this package follows the 11-digit CMS format: 00121107725. Quantities are measured in per "each", products billed on a per each basis are usually products dispensed in discreet units.. There are 1 total billable units per package. 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)
0121-1077-25
11-Digit CMS (5-4-2)
00121-1077-25

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