Planeaire Hands Gel
NDC Package 80335-112-02

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

Package Information

Planeaire Hands (ethanol hand sanitizer) gel is wet hands thoroughly with product, rub hands, and allow to dry without wiping.For children under 6 years of age, use only under adult supervision to avoid swallowingnot recommended for infants Wet hands thoroughly with product, rub hands, and allow to dry without wiping.For children under 6 years of age, use only under adult supervision to avoid swallowingnot recommended for infants. This formulation utilizes a gel delivery system. Marketed by Everywhereaire Llc, this product is identified by NDC 80335-112 and is authorized under FDA application M003.

Identification & Billing

NDC Package Code
80335-112-02
Package Description
60 mL in 1 BOTTLE, PUMP
Product Code
80335-112
11-Digit Billing Format
80335011202
RxNorm Crosswalk

Clinical Specifications

Proprietary Name
Planeaire Hands
Non-Proprietary Name
Ethanol Hand Sanitizer
Substance Name
Alcohol
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)
ALCOHOL 70 mL/100mL
Usage Information
Wet hands thoroughly with product, rub hands, and allow to dry without wiping.For children under 6 years of age, use only under adult supervision to avoid swallowingnot recommended for infants Wet hands thoroughly with product, rub hands, and allow to dry without wiping.For children under 6 years of age, use only under adult supervision to avoid swallowingnot recommended for infants

Regulatory & Marketing

Labeler Name
Everywhereaire Llc
Product Type
Human Otc Drug
FDA Application #
M003
Marketing Category
OTC MONOGRAPH DRUG -
Start Marketing Date
01-11-2021
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 80335-112-02 identifies a specific commercial package of 60 ml in 1 bottle, pump of Planeaire Hands, a human over the counter drug labeled by Everywhereaire Llc. This gel is formulated for topical use and contains alcohol 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 Everywhereaire Llc on January 11, 2021. The current certification is valid through December 31, 2026.

How is this Everywhereaire Llc product billed for insurance claims?

For medical billing and reimbursement, this package follows the 11-digit CMS format: 80335011202. 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)
80335-112-02
11-Digit CMS (5-4-2)
80335-0112-02

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