Diphenhydramine Hcl Oral Solution
NDC Package 84415-013-01

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

Package Information

Diphenhydramine Hcl Oral Solution (diphenhydramine hcl oral) solution is for the 5 mL Unit-Dose: • take every 4 to 6 hours, or as directed by a physician• do not take more than 6 doses in 24 hoursagedoseChildren under 2 years of ageDo not useChildren 2 to under 6 years of ageDo not use unless directed by a doctorChildren 6 to under 12 years of age5 mL (12.5 mg) to 10 mL (25 mg) For the 10 mL Unit-Dose:• take every 4 to 6 hours, or as directed by a physician • do not take more than 6 doses in 24 hours agedoseChildren under 6 years of age                   Do not useChildren 6 to under 12 years of age               10 mL (25 mg)Adults and children 12 years of age and over 10 mL (25 mg) to 20 mL (50 mg) . This formulation utilizes a solution delivery system. Marketed by Everpharm Llc, this product is identified by NDC 84415-013 and is authorized under FDA application M012.

Identification & Billing

NDC Package Code
84415-013-01
Package Description
100 CUP, UNIT-DOSE in 1 BOX, UNIT-DOSE / 10 mL in 1 CUP, UNIT-DOSE
Product Code
84415-013
11-Digit Billing Format
84415001301
Billing Unit
ML - Billing unit of "milliliter" is used when a product is measured by its liquid volume.
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
Diphenhydramine Hcl Oral Solution
Non-Proprietary Name
Diphenhydramine Hcl Oral
Substance Name
Diphenhydramine Hydrochloride
Dosage Form
Solution - A clear, homogeneous liquid1 dosage form that contains one or more chemical substances dissolved in a solvent or mixture of mutually miscible solvents.
Administration Route
Oral - Administration to or by way of the mouth.
Active Ingredient(s)
DIPHENHYDRAMINE HYDROCHLORIDE 25 mg/10mL
Pharmacologic Class
Usage Information
For the 5 mL Unit-Dose: • take every 4 to 6 hours, or as directed by a physician• do not take more than 6 doses in 24 hoursagedoseChildren under 2 years of ageDo not useChildren 2 to under 6 years of ageDo not use unless directed by a doctorChildren 6 to under 12 years of age5 mL (12.5 mg) to 10 mL (25 mg) For the 10 mL Unit-Dose:• take every 4 to 6 hours, or as directed by a physician • do not take more than 6 doses in 24 hours agedoseChildren under 6 years of age                   Do not useChildren 6 to under 12 years of age               10 mL (25 mg)Adults and children 12 years of age and over 10 mL (25 mg) to 20 mL (50 mg) 

Regulatory & Marketing

Labeler Name
Everpharm Llc
Product Type
Human Otc Drug
FDA Application #
M012
Marketing Category
OTC MONOGRAPH DRUG -
Start Marketing Date
01-16-2025
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 84415-013-01 identifies a specific commercial package of 100 cup, unit-dose in 1 box, unit-dose / 10 ml in 1 cup, unit-dose of Diphenhydramine Hcl Oral Solution, a human over the counter drug labeled by Everpharm Llc. This solution 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 Everpharm Llc on January 16, 2025. The current certification is valid through December 31, 2026.

How is this Everpharm Llc product billed for insurance claims?

For medical billing and reimbursement, this package follows the 11-digit CMS format: 84415001301. 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)
84415-013-01
11-Digit CMS (5-4-2)
84415-0013-01

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