Dologesic Tablet
NDC Package 54859-010-01

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

Package Information

Dologesic (acetaminophen, dexbrompheniramine maleate) tablets is overdose Warning: Taking more than recommended dose (overdose), may cause liver damage. This formulation utilizes a tablet delivery system. Marketed by Llorens Pharmaceutical International Division, this product is identified by NDC 54859-010 and is authorized under FDA application M012.

Identification & Billing

NDC Package Code
54859-010-01
Package Description
100 TABLET in 1 BOTTLE
Product Code
54859-010
11-Digit Billing Format
54859001001
Billing Unit
EA - Billing unit of "each" is used when the product is dispensed in discreet units.
Units Per Package
100 EA
RxNorm Crosswalk
  • RxCUI: 1798453 - acetaminophen 500 MG / dexbrompheniramine maleate 1 MG Oral Tablet
  • RxCUI: 1798453 - APAP 500 MG / Dexbrompheniramine maleate 1 MG Oral Tablet

Clinical Specifications

Proprietary Name
Dologesic DF
Non-Proprietary Name
Acetaminophen, Dexbrompheniramine Maleate
Substance Name
Acetaminophen; Dexbrompheniramine 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)
Usage Information
Overdose Warning: Taking more than recommended dose (overdose), may cause liver damage. In case of accidental overdose, contact a physician or Poison Control Center right away. Prompt medical attention is critical for adults as well as for children even if you do not notice any signs or symptomsDo not exceed recommended dosage AgeDose adults and children 12 years of age and overTake 2 caplets every 4-6 hours. Do not take more than 8 caplets in 24 hours, or as directed by a doctor  children under 12 years of age Do not use in children under 12 years of age. This will provide more than the recommended dose (overdose) of acetaminphen and could cause liver damage

Regulatory & Marketing

Labeler Name
Llorens Pharmaceutical International Division
Product Type
Human Otc Drug
FDA Application #
M012
Marketing Category
OTC MONOGRAPH DRUG -
Start Marketing Date
04-01-2016
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 54859-010-01 identifies a specific commercial package of 100 tablet in 1 bottle of Dologesic DF, a human over the counter drug labeled by Llorens Pharmaceutical International Division. This tablet is formulated for oral use and contains acetaminophen; dexbrompheniramine 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 Llorens Pharmaceutical International Division on April 01, 2016. The current certification is valid through December 31, 2026.

How is this Llorens Pharmaceutical International Division product billed for insurance claims?

For medical billing and reimbursement, this package follows the 11-digit CMS format: 54859001001. Quantities are measured in per "each", products billed on a per each basis are usually products dispensed in discreet units.. There are 100 total billable units per package. 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)
54859-010-01
11-Digit CMS (5-4-2)
54859-0010-01

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