Hello Wild Strawberry Mouthwash
NDC Package 35000-685-10

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

Package Information

This product is approaching its end of marketing date. An upcoming end of marketing date means the product has been delisted but will remain in the NDC database until the end of marketing date is reached. In most cases, the FDA advises firms to use the expiration date of the last lot produced as the end marketing date, reflecting the possibility that the product may still be available even after manufacturing has stopped.

Hello Wild Strawberry (sodium fluoride) mouthwashes is adults and children 6 years of age and older:use once a day after brushing your teeth with a toothpastevigorously swish 10 mL (2 teaspoonfuls) of rinse between your teeth for 1 minute and then spit outdo not swallow the rinsedo not eat or drink for 30 minutes after rinsinginstruct children under 12 years of age in good rinsing habits (to minimize swallowing)supervise children as necessary until capable of using without supervision Children under 6 years of age: consult a dentist or doctor. This formulation utilizes a mouthwash delivery system. Marketed by Colgate-palmolive Company, this product is identified by NDC 35000-685 and is authorized under FDA application M021.

Identification & Billing

NDC Package Code
35000-685-10
Package Description
473 mL in 1 BOTTLE
Product Code
35000-685
11-Digit Billing Format
35000068510
RxNorm Crosswalk

Clinical Specifications

Proprietary Name
Hello Wild Strawberry
Non-Proprietary Name
Sodium Fluoride
Substance Name
Sodium Fluoride
Dosage Form
Mouthwash - An aqueous solution which is most often used for its deodorant, refreshing, or antiseptic effect.
Administration Route
Dental - Administration to a tooth or teeth.
Active Ingredient(s)
SODIUM FLUORIDE .02 g/100mL
Usage Information
Adults and children 6 years of age and older:use once a day after brushing your teeth with a toothpastevigorously swish 10 mL (2 teaspoonfuls) of rinse between your teeth for 1 minute and then spit outdo not swallow the rinsedo not eat or drink for 30 minutes after rinsinginstruct children under 12 years of age in good rinsing habits (to minimize swallowing)supervise children as necessary until capable of using without supervision Children under 6 years of age: consult a dentist or doctor

Regulatory & Marketing

Labeler Name
Colgate-palmolive Company
Product Type
Human Otc Drug
FDA Application #
M021
Marketing Category
OTC MONOGRAPH DRUG -
Start Marketing Date
07-01-2023
End Marketing Date
09-30-2026
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 35000-685-10 identifies a specific commercial package of 473 ml in 1 bottle of Hello Wild Strawberry, a human over the counter drug labeled by Colgate-palmolive Company. This mouthwash 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 Colgate-palmolive Company on July 01, 2023.

How is this Colgate-palmolive Company product billed for insurance claims?

For medical billing and reimbursement, this package follows the 11-digit CMS format: 35000068510. 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)
35000-685-10
11-Digit CMS (5-4-2)
35000-0685-10

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