Sprinsol Tablet
NDC Package 51467-101-01

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

Sprinsol (chlorpheniramine maleate) tablets is chlorpheniramine is an antihistamine used to relieve symptoms of allergy, hay fever, and the common cold. This formulation utilizes a tablet delivery system. Marketed by Fortune Pharmacal Company Limited, this product is identified by NDC 51467-101 and is authorized under FDA application M012.

Identification & Billing

NDC Package Code
51467-101-01
Package Description
2 BLISTER PACK in 1 BOX / 12 TABLET in 1 BLISTER PACK
Product Code
51467-101
11-Digit Billing Format
51467010101
RxNorm Crosswalk
RxCUI: 1363309 - chlorpheniramine maleate 4 MG Oral Tablet

Clinical Specifications

Proprietary Name
Sprinsol
Non-Proprietary Name
Chlorpheniramine Maleate
Substance Name
Chlorpheniramine Maleate
Dosage Form
Tablet - A solid dosage form containing medicinal substances with or without suitable diluents.
Administration Route
Oral - Administration to or by way of the mouth.
Active Ingredient(s)
CHLORPHENIRAMINE MALEATE 4 mg/1
Pharmacologic Class
Usage Information
Chlorpheniramine is an antihistamine used to relieve symptoms of allergy, hay fever, and the common cold. These symptoms 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. By blocking another natural substance made by your body (acetylcholine), it helps dry up some body fluids to relieve 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. Therefore, 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 medication that might 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
Fortune Pharmacal Company Limited
Product Type
Human Otc Drug
FDA Application #
M012
Marketing Category
OTC MONOGRAPH DRUG -
Start Marketing Date
09-22-2017
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 (51467-101). Click a package code to view its specific billing and regulatory data.

51467-101-02
3 BLISTER PACK in 1 BOX / 12 TABLET in 1 BLISTER PACK

* 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 51467-101-01 identifies a specific commercial package of 2 blister pack in 1 box / 12 tablet in 1 blister pack of Sprinsol, a human over the counter drug labeled by Fortune Pharmacal Company Limited. This tablet is formulated for oral use and contains chlorpheniramine 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 Fortune Pharmacal Company Limited on September 22, 2017. The current certification is valid through December 31, 2026.

What are the primary indications for this medication?

Chlorpheniramine is an antihistamine used to relieve symptoms of allergy, hay fever, and the common cold. These symptoms 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. By blocking another natural substance made by your body (acetylcholine), it helps dry up some body fluids to relieve 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. Therefore, 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 medication that might 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 Fortune Pharmacal Company Limited product billed for insurance claims?

For medical billing and reimbursement, this package follows the 11-digit CMS format: 51467010101. 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)
51467-101-01
11-Digit CMS (5-4-2)
51467-0101-01

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