Terramed Just Think Comfort Gynocare Bv Guard Intimate Wash Liquid
NDC Package 83004-040-01

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

Package Information

Terramed Just Think Comfort Gynocare Bv Guard Intimate Wash (pramoxine hydrochloride) liquids is for adult women 18 years and older: • Wet external vaginal area with warm water. This formulation utilizes a liquid delivery system. Marketed by Rida Llc, this product is identified by NDC 83004-040 and is authorized under FDA application M017.

Identification & Billing

NDC Package Code
83004-040-01
Package Description
150 mL in 1 BOTTLE
Product Code
83004-040
11-Digit Billing Format
83004004001

Clinical Specifications

Proprietary Name
Terramed Just Think Comfort Gynocare Bv Guard Intimate Wash
Non-Proprietary Name
Pramoxine Hydrochloride
Substance Name
Pramoxine Hydrochloride
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
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)
PRAMOXINE HYDROCHLORIDE 1 g/100mL
Usage Information
For adult women 18 years and older: • Wet external vaginal area with warm water. • Dispense a small amount of wash into your hands or onto a clean washcloth. • Gently cleanse the external vaginal area only. • Allow wash to remain on skin for 30–60 seconds. • Rinse thoroughly with warm water. • Pat dry. • Use once or twice daily.

Regulatory & Marketing

Labeler Name
Rida Llc
Product Type
Human Otc Drug
FDA Application #
M017
Marketing Category
OTC MONOGRAPH DRUG -
Start Marketing Date
12-12-2024
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 83004-040-01 identifies a specific commercial package of 150 ml in 1 bottle of Terramed Just Think Comfort Gynocare Bv Guard Intimate Wash, a human over the counter drug labeled by Rida Llc. This liquid is formulated for topical use and contains pramoxine hydrochloride 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 Rida Llc on December 12, 2024. The current certification is valid through December 31, 2027.

How is this Rida Llc product billed for insurance claims?

For medical billing and reimbursement, this package follows the 11-digit CMS format: 83004004001. 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)
83004-040-01
11-Digit CMS (5-4-2)
83004-0040-01

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