Safetussin Non Drowsy Tablet
NDC Package 55505-231-24

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

Package Information

Safetussin Non Drowsy (dextromethorphan hydrobromide, and guaifenesin) tablets is adults and children 12 years and over: take 1-2 caplets every 4 hours as needed. This formulation utilizes a tablet delivery system. Marketed by Kramer Laboratories, this product is identified by NDC 55505-231 and is authorized under FDA application M012.

Identification & Billing

NDC Package Code
55505-231-24
Package Description
24 TABLET in 1 CARTON
Product Code
55505-231
11-Digit Billing Format
55505023124
RxNorm Crosswalk
  • RxCUI: 2173726 - dextromethorphan HBr 10 MG / guaiFENesin 200 MG Oral Tablet
  • RxCUI: 2173726 - dextromethorphan hydrobromide 10 MG / guaifenesin 200 MG Oral Tablet

Clinical Specifications

Proprietary Name
Safetussin Non Drowsy Cough Plus Chest Congestion
Non-Proprietary Name
Dextromethorphan Hydrobromide, And Guaifenesin
Substance Name
Dextromethorphan Hydrobromide; Guaifenesin
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)
Pharmacologic Class
Usage Information
Adults and children 12 years and over: take 1-2 caplets every 4 hours as needed. Children under 12 years:do not use Do not take more than 12 caplets in any 24-hour period.

Regulatory & Marketing

Labeler Name
Kramer Laboratories
Product Type
Human Otc Drug
FDA Application #
M012
Marketing Category
OTC MONOGRAPH DRUG -
Start Marketing Date
05-17-2024
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.

Frequently Asked Questions

What is the distribution configuration for this product package?

The code 55505-231-24 identifies a specific commercial package of 24 tablet in 1 carton of Safetussin Non Drowsy Cough Plus Chest Congestion, a human over the counter drug labeled by Kramer Laboratories. This tablet is formulated for oral use and contains dextromethorphan hydrobromide; guaifenesin 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 Kramer Laboratories on May 17, 2024. The current certification is valid through December 31, 2026.

How is this Kramer Laboratories product billed for insurance claims?

For medical billing and reimbursement, this package follows the 11-digit CMS format: 55505023124. 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)
55505-231-24
11-Digit CMS (5-4-2)
55505-0231-24

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