Ear Care Earache Drops Liquid
NDC Package 11822-3644-3

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

Package Information

Ear Care Earache Drops (atropa belladonna, anemone pulsatilla, lycopodium clavatum spore, matricaria chamomilla, and sulfur) liquids is suitable for adults and children over the age of 2.• For use in the ears only• Remove any hearing aids• Use 3-5 drops twice per day or as needed. This formulation utilizes a liquid delivery system. Marketed by Rite Aid Corporation, this product is identified by NDC 11822-3644.

Identification & Billing

NDC Package Code
11822-3644-3
Package Description
1 BOTTLE, DROPPER in 1 CARTON / 10 mL in 1 BOTTLE, DROPPER
Product Code
11822-3644
11-Digit Billing Format
11822364403

Clinical Specifications

Proprietary Name
Ear Care Earache Drops
Non-Proprietary Name
Atropa Belladonna, Anemone Pulsatilla, Lycopodium Clavatum Spore, Matricaria Chamomilla, And Sulfur
Substance Name
Anemone Pulsatilla; Atropa Belladonna; Lycopodium Clavatum Spore; Matricaria Chamomilla; Oyster Shell Calcium Carbonate, Crude; 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)
Usage Information
Suitable for adults and children over the age of 2.• For use in the ears only• Remove any hearing aids• Use 3-5 drops twice per day or as needed. Warm contents to body temperature by holding bottle in your hands. Tilt ear upward for at least 2 minutes after application or gently place cotton in ear to keep drops in. Tilt your head to the side and let solution drip into the ear. Never put the tip in the ear canal. Keep drops in your ear by tilting your head for 1-2 minutes or gently place cotton in the ear to keep drops in.

Regulatory & Marketing

Labeler Name
Rite Aid Corporation
Product Type
Human Otc Drug
Marketing Category
UNAPPROVED HOMEOPATHIC - A category specifying that a product is marketed as unapproved homeopathic product.
Start Marketing Date
08-03-2017
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 11822-3644-3 identifies a specific commercial package of 1 bottle, dropper in 1 carton / 10 ml in 1 bottle, dropper of Ear Care Earache Drops, a human over the counter drug labeled by Rite Aid Corporation. This liquid is formulated for auricular (otic) use and contains anemone pulsatilla; atropa belladonna; lycopodium clavatum spore; matricaria chamomilla; oyster shell calcium carbonate, crude; 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 Rite Aid Corporation on August 03, 2017. The current certification is valid through December 31, 2026.

How is this Rite Aid Corporation product billed for insurance claims?

For medical billing and reimbursement, this package follows the 11-digit CMS format: 11822364403. 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)
11822-3644-3
11-Digit CMS (5-4-2)
11822-3644-03

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