Otitis Media Drops Liquid
NDC Package 63083-2153-2

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

Package Information

Otitis Media Drops liquids is for the temporary relief of minor earache or ringing in the ears.*. This formulation utilizes a liquid delivery system. Marketed by Professional Complementary Health Formulas, this product is identified by NDC 63083-2153.

Identification & Billing

NDC Package Code
63083-2153-2
Package Description
59 mL in 1 BOTTLE, DROPPER
Product Code
63083-2153
11-Digit Billing Format
63083215302

Clinical Specifications

Proprietary Name
Otitis Media Drops 2153
Non-Proprietary Name
Otitis Media Drops
Substance Name
Oyster Shell Calcium Carbonate, Crude; Pulsatilla Montana Whole; Aconitum Napellus Whole; Sus Scrofa Ear; Amaryllis Belladonna Whole; Tellurium; Ferrosoferric Phosphate; Gelsemium Sempervirens Root; Mercury; Streptococcus Pneumoniae; Haemophilus Influenzae
Dosage Form
Liquid - A dosage form consisting of a pure chemical in its liquid1 state. This dosage form term should not be applied to solutions.
Administration Route
Oral - Administration to or by way of the mouth.
Active Ingredient(s)
Usage Information
For the temporary relief of minor earache or ringing in the ears.*

Regulatory & Marketing

Labeler Name
Professional Complementary Health Formulas
Product Type
Human Otc Drug
Marketing Category
UNAPPROVED HOMEOPATHIC - A category specifying that a product is marketed as unapproved homeopathic product.
Start Marketing Date
08-15-1984
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 63083-2153-2 identifies a specific commercial package of 59 ml in 1 bottle, dropper of Otitis Media Drops 2153, a human over the counter drug labeled by Professional Complementary Health Formulas. This liquid is formulated for oral use and contains oyster shell calcium carbonate, crude; pulsatilla montana whole; aconitum napellus whole; sus scrofa ear; amaryllis belladonna whole; tellurium; ferrosoferric phosphate; gelsemium sempervirens root; mercury; streptococcus pneumoniae; haemophilus influenzae 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 Professional Complementary Health Formulas on August 15, 1984. The current certification is valid through December 31, 2027.

How is this Professional Complementary Health Formulas product billed for insurance claims?

For medical billing and reimbursement, this package follows the 11-digit CMS format: 63083215302. 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)
63083-2153-2
11-Digit CMS (5-4-2)
63083-2153-02

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