Guardian Douche
NDC Package 68915-280-02

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

Package Information

Guardian (benzalkonium chloride) douches is insert the gel into the vagina when cleansing is desired, one unit (5.5ml) each time. This formulation utilizes a douche delivery system. Marketed by Eastern Century Pharmaceuticals, this product is identified by NDC 68915-280 and is authorized under FDA application M003.

Identification & Billing

NDC Package Code
68915-280-02
Package Description
1 BOTTLE in 1 BOX / 5.5 mL in 1 BOTTLE (68915-280-01)
Product Code
68915-280
11-Digit Billing Format
68915028002
RxNorm Crosswalk

Clinical Specifications

Proprietary Name
Guardian Vaginal
Non-Proprietary Name
Benzalkonium Chloride
Substance Name
Benzalkonium Chloride
Dosage Form
Douche - A liquid preparation, intended for the irrigative cleansing of the vagina, that is prepared from powders, liquid solutions, or liquid concentrates and contains one or more chemical substances dissolved in a suitable solvent or mutually miscible solvents.
Administration Route
Vaginal - Administration into the vagina.
Active Ingredient(s)
BENZALKONIUM CHLORIDE 1 mg/mL
Usage Information
Insert the gel into the vagina when cleansing is desired, one unit (5.5ml) each time. Please read the following instructions carefully before use. 1. Take off any plastic around the tube. 2. Remove the small plastic tip from the top of the applicator. 3. Gently insert the small end of the applicator deep into the vagina. While in this position, squeeze the entire contents of the applicator to release the gel. Remove the applicator and discard it in a waste container. Do not use this product if the package seal is broken.Children under 12 years of age: ask doctor.

Regulatory & Marketing

Labeler Name
Eastern Century Pharmaceuticals
Product Type
Human Otc Drug
FDA Application #
M003
Marketing Category
OTC MONOGRAPH DRUG -
Start Marketing Date
05-23-2011
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 68915-280-02 identifies a specific commercial package of 1 bottle in 1 box / 5.5 ml in 1 bottle (68915-280-01) of Guardian Vaginal, a human over the counter drug labeled by Eastern Century Pharmaceuticals. This douche is formulated for vaginal use and contains benzalkonium chloride 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 Eastern Century Pharmaceuticals on May 23, 2011. The current certification is valid through December 31, 2026.

How is this Eastern Century Pharmaceuticals product billed for insurance claims?

For medical billing and reimbursement, this package follows the 11-digit CMS format: 68915028002. 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)
68915-280-02
11-Digit CMS (5-4-2)
68915-0280-02

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