M-dryl Liquid
NDC Package 58657-528-04

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

Package Information

M-dryl (diphenhydramine hydrochloride) liquids is take every 4 to 6 hoursuse an accurate measuring device to administer this Medicationchildren under 2 years do not usedo not usechildren 2 to 5 yearsask a doctorchildren 6 years to under 12 years5 mL (1 tsp) to 10 mL (2 tsp); not more than 60 mL (12 tsp) in 24 hoursadults and children 12 years and over 10 mL (2 tsp) to 20 mL (4 tsp); not more than 120 mL (24 tsp) in 24 hours. This formulation utilizes a liquid delivery system. Marketed by Method Pharmaceuticals, Llc, this product is identified by NDC 58657-528 and is authorized under FDA application M012.

Identification & Billing

NDC Package Code
58657-528-04
Package Description
120 mL in 1 BOTTLE
Product Code
58657-528
11-Digit Billing Format
58657052804
Billing Unit
ML - Billing unit of "milliliter" is used when a product is measured by its liquid volume.
Units Per Package
120 ML
RxNorm Crosswalk
  • RxCUI: 1049906 - diphenhydrAMINE HCl 12.5 MG in 5 mL Oral Solution
  • RxCUI: 1049906 - diphenhydramine hydrochloride 2.5 MG/ML Oral Solution
  • RxCUI: 1049906 - diphenhydramine HCl 12.5 MG per 5 ML Oral Solution
  • RxCUI: 1049906 - diphenhydramine hydrochloride 25 MG per 10 ML Oral Solution
  • RxCUI: 1049906 - diphenhydramine hydrochloride 50 MG per 20 ML Oral Solution

Clinical Specifications

Proprietary Name
M-dryl
Non-Proprietary Name
Diphenhydramine Hydrochloride
Substance Name
Diphenhydramine Hydrochloride
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)
DIPHENHYDRAMINE HYDROCHLORIDE 12.5 mg/5mL
Pharmacologic Class
Usage Information
Take every 4 to 6 hoursuse an accurate measuring device to administer this Medicationchildren under 2 years do not usedo not usechildren 2 to 5 yearsask a doctorchildren 6 years to under 12 years5 mL (1 tsp) to 10 mL (2 tsp); not more than 60 mL (12 tsp) in 24 hoursadults and children 12 years and over 10 mL (2 tsp) to 20 mL (4 tsp); not more than 120 mL (24 tsp) in 24 hours

Regulatory & Marketing

Labeler Name
Method Pharmaceuticals, Llc
Product Type
Human Otc Drug
FDA Application #
M012
Marketing Category
OTC MONOGRAPH DRUG -
Start Marketing Date
08-01-2019
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.

Other Available Packages

The following commercial packages are registered under the same Product NDC (58657-528). Click a package code to view its specific billing and regulatory data.

58657-528-16
473 mL in 1 BOTTLE

* 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 58657-528-04 identifies a specific commercial package of 120 ml in 1 bottle of M-dryl, a human over the counter drug labeled by Method Pharmaceuticals, Llc. This liquid is formulated for oral use and contains diphenhydramine hydrochloride 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 Method Pharmaceuticals, Llc on August 01, 2019. The current certification is valid through December 31, 2026.

How is this Method Pharmaceuticals, Llc product billed for insurance claims?

For medical billing and reimbursement, this package follows the 11-digit CMS format: 58657052804. Quantities are measured in per "ml or milliliter", products billed per milliliter are usually products measured by liquid volume.. There are 120 total billable units per package. 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)
58657-528-04
11-Digit CMS (5-4-2)
58657-0528-04

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