Oido Sana Solution
NDC Package 58988-1100-1

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

Package Information

Oido Sana (isopropyl alcohol) solution is remove safety seal from bottle, apply 4 to 5 drops in each affected ear. This formulation utilizes a solution delivery system. Marketed by Promex Llc, this product is identified by NDC 58988-1100 and is authorized under FDA application M014.

Identification & Billing

NDC Package Code
58988-1100-1
Package Description
1 BOTTLE, PLASTIC in 1 CARTON / 30 mL in 1 BOTTLE, PLASTIC
Product Code
58988-1100
11-Digit Billing Format
58988110001
RxNorm Crosswalk

Clinical Specifications

Proprietary Name
Oido Sana
Non-Proprietary Name
Isopropyl Alcohol
Substance Name
Isopropyl Alcohol
Dosage Form
Solution - A clear, homogeneous liquid1 dosage form that contains one or more chemical substances dissolved in a solvent or mixture of mutually miscible solvents.
Administration Route
Auricular (otic) - Administration to or by way of the ear.
Active Ingredient(s)
ISOPROPYL ALCOHOL .95 g/mL
Usage Information
Remove safety seal from bottle, apply 4 to 5 drops in each affected ear.

Regulatory & Marketing

Labeler Name
Promex Llc
Product Type
Human Otc Drug
FDA Application #
M014
Marketing Category
OTC MONOGRAPH DRUG -
Start Marketing Date
05-31-2006
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 58988-1100-1 identifies a specific commercial package of 1 bottle, plastic in 1 carton / 30 ml in 1 bottle, plastic of Oido Sana, a human over the counter drug labeled by Promex Llc. This solution is formulated for auricular (otic) use and contains isopropyl 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 Promex Llc on May 31, 2006. The current certification is valid through December 31, 2026.

How is this Promex Llc product billed for insurance claims?

For medical billing and reimbursement, this package follows the 11-digit CMS format: 58988110001. 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)
58988-1100-1
11-Digit CMS (5-4-2)
58988-1100-01

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