Diphenhydramine Hcl 12.5 Mg Per 5 Ml Solution
NDC Package 82568-0016-4

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

Diphenhydramine Hcl 12.5 Mg Per 5 Ml solution is directionsdo not take more than 6 doses in any 24 hourstake every 4 to 6 hours, or as directed by a doctormL = milliliterkeep dosing cup with productfind the right dose on the chart below Age (yr) Dose (mL) children 6 to 11 years 5 mL to 10 mL children 2 to 5 years Do not use unless directed by a doctor children under 2 years Do not use. This formulation utilizes a solution delivery system. Marketed by Aarna Usa Inc., this product is identified by NDC 82568-0016 and is authorized under FDA application M012.

Identification & Billing

NDC Package Code
82568-0016-4
Package Description
118 mL in 1 BOTTLE
Product Code
82568-0016
11-Digit Billing Format
82568001604
Billing Unit
ML - Billing unit of "milliliter" is used when a product is measured by its liquid volume.
Units Per Package
118 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
Diphenhydramine Hcl 12.5 Mg Per 5 Ml
Non-Proprietary Name
Diphenhydramine Hcl 12.5 Mg Per 5 Ml
Substance Name
Diphenhydramine
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 12.5 mg/5mL
Pharmacologic Class
Usage Information
Directionsdo not take more than 6 doses in any 24 hourstake every 4 to 6 hours, or as directed by a doctormL = milliliterkeep dosing cup with productfind the right dose on the chart below Age (yr) Dose (mL) children 6 to 11 years 5 mL to 10 mL children 2 to 5 years Do not use unless directed by a doctor children under 2 years Do not use

Regulatory & Marketing

Labeler Name
Aarna Usa Inc.
Product Type
Human Otc Drug
FDA Application #
M012
Marketing Category
OTC MONOGRAPH DRUG -
Start Marketing Date
04-14-2025
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.

Other Available Packages

The following commercial packages are registered under the same Product NDC (82568-0016). Click a package code to view its specific billing and regulatory data.

82568-0016-6
473 mL in 1 BOTTLE
82568-0016-8
236 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 82568-0016-4 identifies a specific commercial package of 118 ml in 1 bottle of Diphenhydramine Hcl 12.5 Mg Per 5 Ml, a human over the counter drug labeled by Aarna Usa Inc.. This solution is formulated for oral use and contains diphenhydramine 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 Aarna Usa Inc. on April 14, 2025. The current certification is valid through December 31, 2026.

How is this Aarna Usa Inc. product billed for insurance claims?

For medical billing and reimbursement, this package follows the 11-digit CMS format: 82568001604. Quantities are measured in per "ml or milliliter", products billed per milliliter are usually products measured by liquid volume.. There are 118 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 (5-4-1)
82568-0016-4
11-Digit CMS (5-4-2)
82568-0016-04

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