Dexchlorpheniramine Maleate Powder
NDC Package 12294-0010-3

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

This product is an UNFINISHED DRUG part of the official NDC directory. Unfinished drugs include products like active ingredients some of which are used in bulk for further processing or compounding. The FDA requires a list of these drugs manufactured in a U.S. commercial distribution facility.

Dexchlorpheniramine Maleate powders is dexchlorpheniramine is an antihistamine used to relieve symptoms of allergy, hay fever, and the common cold. This formulation utilizes a powder delivery system. Marketed by Kongo Chemical Co., Ltd., this product is identified by NDC 12294-0010.

Identification & Billing

NDC Package Code
12294-0010-3
Package Description
5 kg in 1 DRUM
Product Code
12294-0010
11-Digit Billing Format
12294001003

Clinical Specifications

Proprietary Name
Dexchlorpheniramine Maleate
Non-Proprietary Name
Dexchlorpheniramine Maleate
Substance Name
Dexchlorpheniramine Maleate
Dosage Form
Powder - An intimate mixture of dry, finely divided drugs and/or chemicals that may be intended for internal or external use.
Active Ingredient(s)
DEXCHLORPHENIRAMINE MALEATE 1 kg/kg
Usage Information
Dexchlorpheniramine is an antihistamine used to relieve symptoms of allergy, hay fever, and the common cold. These symptoms may include rash, watery eyes, itchy eyes/nose/throat/skin, cough, runny nose, and sneezing. This medication works by blocking a certain natural substance (histamine) that your body makes during an allergic reaction. It also blocks another natural substance made by your body (acetylcholine). Blocking acetylcholine helps lessen symptoms such as watery eyes and runny nose. Cough-and-cold products have not been shown to be safe or effective in children younger than 6 years. Do not use this product to treat cold symptoms in children younger than 6 years unless specifically directed by the doctor. Some products (such as long-acting tablets/capsules) are not recommended for use in children younger than 12 years. Ask your doctor or pharmacist for more details about using your product safely. These products do not cure or shorten the length of the common cold and may cause serious side effects. To decrease the risk for serious side effects, carefully follow all dosage directions. Do not use this product to make a child sleepy. Do not give other cough-and-cold medications that contain the same or similar ingredients (see also Drug Interactions section). Ask the doctor or pharmacist about other ways to relieve cough and cold symptoms (such as drinking enough fluids, using a humidifier or saline nose drops/spray).

Regulatory & Marketing

Labeler Name
Kongo Chemical Co., Ltd.
Product Type
Bulk Ingredient
Marketing Category
BULK INGREDIENT - A category specifying that a product is marketed as a bulk ingredient.
Start Marketing Date
02-01-1977
Listing Expiration
12-31-2026
Exclude Flag
N
Unfinished Product
Yes
Sample Package
N/A

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 (12294-0010). Click a package code to view its specific billing and regulatory data.

12294-0010-4
25 kg in 1 DRUM
12294-0010-5
1 kg in 1 CANISTER

* 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 12294-0010-3 identifies a specific commercial package of 5 kg in 1 drum of Dexchlorpheniramine Maleate (UNFINISHED drug), a bulk ingredient labeled by Kongo Chemical Co., Ltd.. This powder is formulated for use and contains dexchlorpheniramine maleate 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 Kongo Chemical Co., Ltd. on February 01, 1977. The current certification is valid through December 31, 2026.

What are the primary indications for this medication?

Dexchlorpheniramine is an antihistamine used to relieve symptoms of allergy, hay fever, and the common cold. These symptoms may include rash, watery eyes, itchy eyes/nose/throat/skin, cough, runny nose, and sneezing. This medication works by blocking a certain natural substance (histamine) that your body makes during an allergic reaction. It also blocks another natural substance made by your body (acetylcholine). Blocking acetylcholine helps lessen symptoms such as watery eyes and runny nose. Cough-and-cold products have not been shown to be safe or effective in children younger than 6 years. Do not use this product to treat cold symptoms in children younger than 6 years unless specifically directed by the doctor. Some products (such as long-acting tablets/capsules) are not recommended for use in children younger than 12 years. Ask your doctor or pharmacist for more details about using your product safely. These products do not cure or shorten the length of the common cold and may cause serious side effects. To decrease the risk for serious side effects, carefully follow all dosage directions. Do not use this product to make a child sleepy. Do not give other cough-and-cold medications that contain the same or similar ingredients (see also Drug Interactions section). Ask the doctor or pharmacist about other ways to relieve cough and cold symptoms (such as drinking enough fluids, using a humidifier or saline nose drops/spray).

How is this Kongo Chemical Co., Ltd. product billed for insurance claims?

For medical billing and reimbursement, this package follows the 11-digit CMS format: 12294001003. 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)
12294-0010-3
11-Digit CMS (5-4-2)
12294-0010-03

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