Hylands Naturals Earache Drops Liquid
NDC Package 54973-4124-1

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

Package Information

Hylands Naturals Earache Drops (belladonna leaf, calcium carbonate, chamomile, lycopodium clavatum spore, anemone patens whole, sulfur) liquids is adults and children ages 4 years and over: ■ Tilt head sideways and apply 3-4 drops into involved ear (tip of applicator should not enter ear canal). This formulation utilizes a liquid delivery system. Marketed by Hyland's Inc., this product is identified by NDC 54973-4124.

Identification & Billing

NDC Package Code
54973-4124-1
Package Description
1 BOTTLE, DROPPER in 1 CARTON / 10 mL in 1 BOTTLE, DROPPER
Product Code
54973-4124
11-Digit Billing Format
54973412401

Clinical Specifications

Proprietary Name
Hylands Naturals Earache Drops
Non-Proprietary Name
Belladonna Leaf, Calcium Carbonate, Chamomile, Lycopodium Clavatum Spore, Anemone Patens Whole, Sulfur
Substance Name
Belladonna Leaf; Calcium Carbonate; Chamomile; Lycopodium Clavatum Spore; Pulsatilla Patens Whole; Sulfur
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
Auricular (otic) - Administration to or by way of the ear.
Active Ingredient(s)
Pharmacologic Class
Usage Information
Adults and children ages 4 years and over: ■ Tilt head sideways and apply 3-4 drops into involved ear (tip of applicator should not enter ear canal). ■ Keep head tilted for at least 2 minutes to keep drops in ear. ■ Repeat until relieved, up to 4 times per day. ■ Use as directed. ■ Do not refrigerate. ■ Shake well before using.

Regulatory & Marketing

Labeler Name
Hyland's Inc.
Product Type
Human Otc Drug
Marketing Category
UNAPPROVED HOMEOPATHIC - A category specifying that a product is marketed as unapproved homeopathic product.
Start Marketing Date
07-27-2023
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 54973-4124-1 identifies a specific commercial package of 1 bottle, dropper in 1 carton / 10 ml in 1 bottle, dropper of Hylands Naturals Earache Drops, a human over the counter drug labeled by Hyland's Inc.. This liquid is formulated for auricular (otic) use and contains belladonna leaf; calcium carbonate; chamomile; lycopodium clavatum spore; pulsatilla patens whole; 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 Hyland's Inc. on July 27, 2023. The current certification is valid through December 31, 2027.

How is this Hyland's Inc. product billed for insurance claims?

For medical billing and reimbursement, this package follows the 11-digit CMS format: 54973412401. 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)
54973-4124-1
11-Digit CMS (5-4-2)
54973-4124-01

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