Xtra Antibacterial Hand Juicy Orange Gel
NDC Package 51628-0033-0

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

Package Information

Xtra Antibacterial Hand Juicy Orange (chloroxylenol) gel is apply palmful to wet hands. This formulation utilizes a gel delivery system. Marketed by My Imports Usa, Llc, this product is identified by NDC 51628-0033 and is authorized under FDA application 505G(a)(3).

Identification & Billing

NDC Package Code
51628-0033-0
Package Description
709 mL in 1 BOTTLE
Product Code
51628-0033
11-Digit Billing Format
51628003300
RxNorm Crosswalk

Clinical Specifications

Proprietary Name
Xtra Antibacterial Hand Juicy Orange
Non-Proprietary Name
Chloroxylenol
Substance Name
Chloroxylenol
Dosage Form
Gel - A semisolid3 dosage form that contains a gelling agent to provide stiffness to a solution or a colloidal dispersion.4 A gel may contain suspended particles.
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)
CHLOROXYLENOL 3 mg/mL
Usage Information
Apply palmful to wet hands. Scrub and rinse thoroughly.

Regulatory & Marketing

Labeler Name
My Imports Usa, Llc
Product Type
Human Otc Drug
FDA Application #
505G(a)(3)
Marketing Category
OTC MONOGRAPH DRUG -
Start Marketing Date
12-01-2023
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 51628-0033-0 identifies a specific commercial package of 709 ml in 1 bottle of Xtra Antibacterial Hand Juicy Orange, a human over the counter drug labeled by My Imports Usa, Llc. This gel is formulated for topical use and contains chloroxylenol 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 My Imports Usa, Llc on December 01, 2023. The current certification is valid through December 31, 2027.

How is this My Imports Usa, Llc product billed for insurance claims?

For medical billing and reimbursement, this package follows the 11-digit CMS format: 51628003300. 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)
51628-0033-0
11-Digit CMS (5-4-2)
51628-0033-00

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