Gynol Ii
NDC Package 34362-0302-5

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 EXCLUDED from the official NDC directory because the listing data was inactivated by the FDA.

Gynol Ii is for maximum protection against unwanted pregnancy, follow the enclosed directions exactly.Each applicatorful is effective immediately and up to one hour after application. Marketed by Caldwell Consumer Health Llc, this product is identified by NDC 34362-0302 and is authorized under FDA application part333A.

Identification & Billing

NDC Package Code
34362-0302-5
Package Description
1 BOTTLE, WITH APPLICATOR in 1 CARTON / 81 g in 1 BOTTLE, WITH APPLICATOR (34362-0302-1)
Product Code
34362-0302
11-Digit Billing Format
34362030205
RxNorm Crosswalk

Clinical Specifications

Proprietary Name
Gynol Ii Extra Strength
Dosage Form
-
Usage Information
For maximum protection against unwanted pregnancy, follow the enclosed directions exactly.Each applicatorful is effective immediately and up to one hour after application.

Regulatory & Marketing

Labeler Name
Caldwell Consumer Health Llc
FDA Application #
part333A
Marketing Category
OTC MONOGRAPH NOT FINAL - A product marketed pursuant to an Over-the-Counter (OTC) Drug Monograph that is not final.
Start Marketing Date
05-01-2011
Listing Expiration
12-31-2021
Exclude Flag
I
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 34362-0302-5 identifies a specific commercial package of 1 bottle, with applicator in 1 carton / 81 g in 1 bottle, with applicator (34362-0302-1) of Gynol Ii Extra Strength, labeled by Caldwell Consumer Health Llc. This is formulated for use and contains as the active substance.

Is this product currently listed with the FDA?

This product code is currently listed as inactive or excluded from the primary directory. It was introduced to the market by Caldwell Consumer Health Llc on May 01, 2011. The current certification is valid through December 31, 2021.

How is this Caldwell Consumer Health Llc product billed for insurance claims?

For medical billing and reimbursement, this package follows the 11-digit CMS format: 34362030205. 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 (5-4-1)
34362-0302-5
11-Digit CMS (5-4-2)
34362-0302-05

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