Premier Value Ear Relief Ear Drops Solution/ Drops
NDC Package 68016-377-00

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

Package Information

Premier Value Ear Relief Ear Drops (chamomile, mercurius solubilis, sulfur) solution/ dropses is fOR USE IN THE EAR ONLY.Remove tamper-evident seal from neck of bottle.Twist cap off bottle.Tilt head sideways.Apply 4 to 5 drops in each affected ear (applicator should not enter ear canal).Keep drops in ear by keeping head tilted or placing cotton in ear.Use up to 4 times daily for no more than 48 hours, or as direted by a doctor. Children under 12 years of age  consult a doctor. This formulation utilizes a solution/ drops delivery system. Marketed by Chain Drug Consortium, Llc, this product is identified by NDC 68016-377.

Identification & Billing

NDC Package Code
68016-377-00
Package Description
1 BOTTLE in 1 BOX / 12 mL in 1 BOTTLE
Product Code
68016-377
11-Digit Billing Format
68016037700
Billing Unit
ML - Billing unit of "milliliter" is used when a product is measured by its liquid volume.

Clinical Specifications

Proprietary Name
Premier Value Ear Relief Ear Drops
Non-Proprietary Name
Chamomile, Mercurius Solubilis, Sulfur
Substance Name
Chamomile; Mercurius Solubilis; Sulfur
Dosage Form
Solution/ Drops - A solution which is usually administered in a drop-wise fashion.
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.Apply 4 to 5 drops in each affected ear (applicator should not enter ear canal).Keep drops in ear by keeping head tilted or placing cotton in ear.Use up to 4 times daily for no more than 48 hours, or as direted by a doctor. Children under 12 years of age  consult a doctor.

Regulatory & Marketing

Labeler Name
Chain Drug Consortium, Llc
Product Type
Human Otc Drug
Marketing Category
UNAPPROVED HOMEOPATHIC - A category specifying that a product is marketed as unapproved homeopathic product.
Start Marketing Date
10-01-2005
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 68016-377-00 identifies a specific commercial package of 1 bottle in 1 box / 12 ml in 1 bottle of Premier Value Ear Relief Ear Drops, a human over the counter drug labeled by Chain Drug Consortium, Llc. This solution/ drops 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 Chain Drug Consortium, Llc on October 01, 2005. The current certification is valid through December 31, 2026.

How is this Chain Drug Consortium, Llc product billed for insurance claims?

For medical billing and reimbursement, this package follows the 11-digit CMS format: 68016037700. Quantities are measured in per "ml or milliliter", products billed per milliliter are usually products measured by liquid volume.. 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)
68016-377-00
11-Digit CMS (5-4-2)
68016-0377-00

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