Diphenhydramine Hydrochloride Solution
NDC Package 31722-601-31

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

Package Information

Diphenhydramine Hydrochloride solution is diphenhydramine hydrochloride in the oral form is effective for the following indications: Antihistaminic For allergic conjunctivitis due to foods; mild, uncomplicated allergic skin manifestations of urticaria and angioedema; amelioration of allergic reactions to blood or plasma; dermatographism; as therapy for anaphylactic reactions adjunctiveto epinephrine and other standard measures after the acute manifestations have been controlled. This formulation utilizes a solution delivery system. Marketed by Camber Pharmaceuticals, Inc., this product is identified by NDC 31722-601 and is authorized under FDA application ANDA219470.

Identification & Billing

NDC Package Code
31722-601-31
Package Description
10 CARTON in 1 BOX / 10 CUP, UNIT-DOSE in 1 CARTON / 10 mL in 1 CUP, UNIT-DOSE
Product Code
31722-601
11-Digit Billing Format
31722060131

Clinical Specifications

Proprietary Name
Diphenhydramine Hydrochloride
Non-Proprietary Name
Diphenhydramine Hydrochloride
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
Diphenhydramine hydrochloride in the oral form is effective for the following indications: Antihistaminic For allergic conjunctivitis due to foods; mild, uncomplicated allergic skin manifestations of urticaria and angioedema; amelioration of allergic reactions to blood or plasma; dermatographism; as therapy for anaphylactic reactions adjunctiveto epinephrine and other standard measures after the acute manifestations have been controlled. Motion Sickness For active and prophylactic treatment of motion sickness. Antiparkinsonism For parkinsonism (including drug-induced) in the elderly unable to tolerate more potent agents; mild cases of parkinsonism (including drug-induced) in other age groups; in other cases of parkinsonism (including drug-induced) in combination with centrally acting anticholinergic agents. Nighttime Sleep-aid.

Regulatory & Marketing

Labeler Name
Camber Pharmaceuticals, Inc.
Product Type
Human Prescription Drug
FDA Application #
ANDA219470
Marketing Category
ANDA - A product marketed under an approved Abbreviated New Drug Application.
Start Marketing Date
06-17-2026
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 31722-601-31 identifies a specific commercial package of 10 carton in 1 box / 10 cup, unit-dose in 1 carton / 10 ml in 1 cup, unit-dose of Diphenhydramine Hydrochloride, a human prescription drug labeled by Camber 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 Camber Pharmaceuticals, Inc. on June 17, 2026. The current certification is valid through December 31, 2027.

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

For medical billing and reimbursement, this package follows the 11-digit CMS format: 31722060131. 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)
31722-601-31
11-Digit CMS (5-4-2)
31722-0601-31

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