Aquafresh Paste
NDC Package 0135-0604-01

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

Package Information

Aquafresh (sodium fluoride) pastes is •adults and children 2 years of age and older:•apply toothpaste onto a toothbrush•brush teeth thoroughly, preferably after each meal or at least twice a day, and not more than 3 times a day, or as directed by a dentist or doctor. This formulation utilizes a paste delivery system. Marketed by Haleon Us Holdings Llc, this product is identified by NDC 0135-0604 and is authorized under FDA application M022.

Identification & Billing

NDC Package Code
0135-0604-01
Package Description
1 TUBE in 1 CARTON / 158.8 g in 1 TUBE
Product Code
0135-0604
11-Digit Billing Format
00135060401
RxNorm Crosswalk

Clinical Specifications

Proprietary Name
Aquafresh Extreme Clean Pure Breath Action
Non-Proprietary Name
Sodium Fluoride
Substance Name
Sodium Fluoride
Dosage Form
Paste - A semisolid3 dosage form, containing a large proportion (20 – 50%) of solids finely dispersed in a fatty vehicle. This dosage form is generally for external application to the skin or mucous membranes.
Administration Route
Dental - Administration to a tooth or teeth.
Active Ingredient(s)
SODIUM FLUORIDE 1.15 mg/g
Usage Information
•adults and children 2 years of age and older:•apply toothpaste onto a toothbrush•brush teeth thoroughly, preferably after each meal or at least twice a day, and not more than 3 times a day, or as directed by a dentist or doctor. Minimize swallowing. Spit out after brushing.•to minimize swallowing for children under 6 years of age, use a pea-sized amount and supervise brushing and rinsing until good habits are established.•children under 2 years of age: consult a dentist or doctor.

Regulatory & Marketing

Labeler Name
Haleon Us Holdings Llc
Product Type
Human Otc Drug
FDA Application #
M022
Marketing Category
OTC MONOGRAPH DRUG -
Start Marketing Date
06-01-2016
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 0135-0604-01 identifies a specific commercial package of 1 tube in 1 carton / 158.8 g in 1 tube of Aquafresh Extreme Clean Pure Breath Action, a human over the counter drug labeled by Haleon Us Holdings Llc. This paste is formulated for dental use and contains sodium fluoride 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 Haleon Us Holdings Llc on June 01, 2016. The current certification is valid through December 31, 2026.

How is this Haleon Us Holdings Llc product billed for insurance claims?

For medical billing and reimbursement, this package follows the 11-digit CMS format: 00135060401. 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)
0135-0604-01
11-Digit CMS (5-4-2)
00135-0604-01

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