Diphenhydramine Oral Solution
NDC Package 73564-814-16

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

Package Information

Diphenhydramine Oral Solution (diphenhydramine hcl12.5mg/5ml) solution is take every 4 hours, as needed, or as directed by a doctorDo not take more than 6 doses in 24 hoursadults and children 12 years and over: 10 to 20 ml 2 to 4 teaspoonsfulChildren under 12 years: consult a doctor. This formulation utilizes a solution delivery system. Marketed by Aldama Pharmaceuticals, Inc, this product is identified by NDC 73564-814 and is authorized under FDA application M012.

Identification & Billing

NDC Package Code
73564-814-16
Package Description
1 BOTTLE in 1 BOX / 473 mL in 1 BOTTLE
Product Code
73564-814
11-Digit Billing Format
73564081416
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 Oral Solution
Non-Proprietary Name
Diphenhydramine Hcl12.5mg/5ml
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 12.5 mg/5mL
Pharmacologic Class
Usage Information
Take every 4 hours, as needed, or as directed by a doctorDo not take more than 6 doses in 24 hoursadults and children 12 years and over: 10 to 20 ml 2 to 4 teaspoonsfulChildren under 12 years: consult a doctor

Regulatory & Marketing

Labeler Name
Aldama Pharmaceuticals, Inc
Product Type
Human Otc Drug
FDA Application #
M012
Marketing Category
OTC MONOGRAPH DRUG -
Start Marketing Date
06-01-2026
Listing Expiration
12-31-2027
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 73564-814-16 identifies a specific commercial package of 1 bottle in 1 box / 473 ml in 1 bottle of Diphenhydramine Oral Solution, a human over the counter drug labeled by Aldama Pharmaceuticals, Inc. 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 Aldama Pharmaceuticals, Inc on June 01, 2026. The current certification is valid through December 31, 2027.

How is this Aldama Pharmaceuticals, Inc product billed for insurance claims?

For medical billing and reimbursement, this package follows the 11-digit CMS format: 73564081416. 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)
73564-814-16
11-Digit CMS (5-4-2)
73564-0814-16

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