Earache Relief Solution
NDC Package 53799-277-11

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

Package Information

Earache Relief (chamomilla and mercurius solubilis and sulphur) solution is fOR USE IN THE EAR ONLY.• Remove tamper-evident seal from neck of bottle.• Twist cap off bottle.• Tilt head sideways.• DON'T squeeze bottle, squeeze plastic tip to release 3 to 5 drops into ear (Tip of applicator should not enter ear canal).• Keep drops in ear for 3 to 5 minutes by keeping head tilted or placing cotton in ear. This formulation utilizes a solution delivery system. Marketed by Similasan Ag, this product is identified by NDC 53799-277.

Identification & Billing

NDC Package Code
53799-277-11
Package Description
10 mL in 1 BOTTLE, GLASS
Product Code
53799-277
11-Digit Billing Format
53799027711

Clinical Specifications

Proprietary Name
Earache Relief
Non-Proprietary Name
Chamomilla And Mercurius Solubilis And Sulphur
Substance Name
Chamomile; Mercurius Solubilis; Sulfur
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)
Usage Information
FOR USE IN THE EAR ONLY.• Remove tamper-evident seal from neck of bottle.• Twist cap off bottle.• Tilt head sideways.• DON'T squeeze bottle, squeeze plastic tip to release 3 to 5 drops into ear (Tip of applicator should not enter ear canal).• Keep drops in ear for 3 to 5 minutes by keeping head tilted or placing cotton in ear. Any excess drops can be wiped away from outer ear.• Use up to 4 times daily for no more than 48 hours, or as directed by a doctor.• Children under 12 years of age consult a doctor.

Regulatory & Marketing

Labeler Name
Similasan Ag
Product Type
Human Otc Drug
Marketing Category
UNAPPROVED HOMEOPATHIC - A category specifying that a product is marketed as unapproved homeopathic product.
Start Marketing Date
07-02-2013
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 53799-277-11 identifies a specific commercial package of 10 ml in 1 bottle, glass of Earache Relief, a human over the counter drug labeled by Similasan Ag. This solution is formulated for auricular (otic) use and contains chamomile; mercurius solubilis; sulfur 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 Similasan Ag on July 02, 2013. The current certification is valid through December 31, 2026.

How is this Similasan Ag product billed for insurance claims?

For medical billing and reimbursement, this package follows the 11-digit CMS format: 53799027711. 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)
53799-277-11
11-Digit CMS (5-4-2)
53799-0277-11

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