Ahhh Bite Relief Gel
NDC Package 78271-041-01

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

Package Information

Ahhh Bite Relief (sodium bicarbonate) gel is use cap to puncture seal.Adults and children 2 years and older, apply to affedtec areas as needed. This formulation utilizes a gel delivery system. Marketed by 78271, this product is identified by NDC 78271-041 and is authorized under FDA application M016.

Identification & Billing

NDC Package Code
78271-041-01
Package Description
1 TUBE in 1 BOX / 25 g in 1 TUBE
Product Code
78271-041
11-Digit Billing Format
78271004101

Clinical Specifications

Proprietary Name
Ahhh Bite Relief
Non-Proprietary Name
Sodium Bicarbonate
Substance Name
Sodium Bicarbonate
Dosage Form
Gel - A semisolid3 dosage form that contains a gelling agent to provide stiffness to a solution or a colloidal dispersion.4 A gel may contain suspended particles.
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)
SODIUM BICARBONATE 5 g/25g
Pharmacologic Class
Usage Information
Use cap to puncture seal.Adults and children 2 years and older, apply to affedtec areas as needed. Children under 2 years, ask a doctor.

Regulatory & Marketing

Labeler Name
78271
Product Type
Human Otc Drug
FDA Application #
M016
Marketing Category
OTC MONOGRAPH DRUG -
Start Marketing Date
10-29-2024
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 78271-041-01 identifies a specific commercial package of 1 tube in 1 box / 25 g in 1 tube of Ahhh Bite Relief, a human over the counter drug labeled by 78271. This gel is formulated for topical use and contains sodium bicarbonate 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 78271 on October 29, 2024. The current certification is valid through December 31, 2026.

How is this 78271 product billed for insurance claims?

For medical billing and reimbursement, this package follows the 11-digit CMS format: 78271004101. 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)
78271-041-01
11-Digit CMS (5-4-2)
78271-0041-01

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