Dg Health Miconazole Cream
NDC Package 55910-698-29

11-digit billing NDC: 55910069829
Table of Contents
    1. Package Information
    2. Frequently Asked Questions

Package Information

Dg Health Miconazole (miconazole nitrate) cream is •before using this product read the enclosed consumer information leaflet for complete directions and information•adults and children 12 years of age and over:•applicators: insert 1 applicatorful into the vagina at bedtime for 7 nights in a row. This formulation utilizes a cream delivery system. Marketed by Dolgencorp Inc, this product is identified by NDC 55910-698 and is authorized under FDA application ANDA074760.

Identification & Billing

NDC Package Code
55910-698-29
Package Description
1 TUBE in 1 CARTON / 45 g in 1 TUBE
Product Code
55910-698
11-Digit Billing Format
55910069829
RxNorm Crosswalk

Clinical Specifications

Proprietary Name
Dg Health Miconazole
Non-Proprietary Name
Miconazole Nitrate
Substance Name
Miconazole Nitrate
Dosage Form
Cream - An emulsion, semisolid3 dosage form, usually containing > 20% water and volatiles5 and/or < 50% hydrocarbons, waxes, or polyols as the vehicle. This dosage form is generally for external application to the skin or mucous membranes.
Administration Route
Vaginal - Administration into the vagina.
Active Ingredient(s)
MICONAZOLE NITRATE 2 g/100g
Pharmacologic Class
Usage Information
•before using this product read the enclosed consumer information leaflet for complete directions and information•adults and children 12 years of age and over:•applicators: insert 1 applicatorful into the vagina at bedtime for 7 nights in a row. Throw applicator away after use.•use the same tube of cream if you have itching and irritation on the skin outside the vagina. Squeeze a small amount of cream onto your fingertip. Apply to itchy, irritated skin outside the vagina. Use 2 times daily for up to 7 days, as needed.•children under 12 years of age: ask a doctor

Regulatory & Marketing

Labeler Name
Dolgencorp Inc
Product Type
Human Otc Drug
FDA Application #
ANDA074760
Marketing Category
ANDA - A product marketed under an approved Abbreviated New Drug Application.
Start Marketing Date
03-18-2020
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 55910-698-29 identifies a specific commercial package of 1 tube in 1 carton / 45 g in 1 tube of Dg Health Miconazole, a human over the counter drug labeled by Dolgencorp Inc. This cream is formulated for vaginal use and contains miconazole nitrate 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 Dolgencorp Inc on March 18, 2020. The current certification is valid through December 31, 2027.

How is this Dolgencorp Inc product billed for insurance claims?

For medical billing and reimbursement, this package follows the 11-digit CMS format: 55910069829. 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)
55910-698-29
11-Digit CMS (5-4-2)
55910-0698-29

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