Acetaminophen And Diphenhydramine Hydrochloride
NDC Package 59105-001-24

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

Package Information

This product is EXCLUDED from the official NDC directory because the listing data was inactivated by the FDA.

Acetaminophen And Diphenhydramine Hydrochloride is do not take more than recommended (see overdose warning) adults and children 12 years of age and over:take 2 caplets at bedtime or as directed by a doctordo not take more than 2 caplets in a 24 hour periodchildren under 12 years or age:do not use this adult product in children under 12 years of age. Marketed by J.p. Business Enterprise, this product is identified by NDC 59105-001 and is authorized under FDA application part343.

Identification & Billing

NDC Package Code
59105-001-24
Package Description
1 BOTTLE in 1 CARTON / 24 TABLET, FILM COATED in 1 BOTTLE
Product Code
59105-001
11-Digit Billing Format
59105000124
RxNorm Crosswalk
  • RxCUI: 1092189 - acetaminophen 500 MG / diphenhydrAMINE HCl 25 MG Oral Tablet
  • RxCUI: 1092189 - acetaminophen 500 MG / diphenhydramine hydrochloride 25 MG Oral Tablet
  • RxCUI: 1092189 - APAP 500 MG / diphenhydramine hydrochloride 25 MG Oral Tablet

Clinical Specifications

Proprietary Name
Acetaminophen And Diphenhydramine Hydrochloride
Dosage Form
-
Usage Information
Do not take more than recommended (see overdose warning) adults and children 12 years of age and over:take 2 caplets at bedtime or as directed by a doctordo not take more than 2 caplets in a 24 hour periodchildren under 12 years or age:do not use this adult product in children under 12 years of age. This will provide more than the recommended dose (overdose) and may cause liver damage

Regulatory & Marketing

Labeler Name
J.p. Business Enterprise
FDA Application #
part343
Marketing Category
OTC MONOGRAPH NOT FINAL - A product marketed pursuant to an Over-the-Counter (OTC) Drug Monograph that is not final.
Start Marketing Date
08-20-2013
Listing Expiration
12-31-2020
Exclude Flag
I
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 59105-001-24 identifies a specific commercial package of 1 bottle in 1 carton / 24 tablet, film coated in 1 bottle of Acetaminophen And Diphenhydramine Hydrochloride, labeled by J.p. Business Enterprise. This is formulated for use and contains as the active substance.

Is this product currently listed with the FDA?

This product code is currently listed as inactive or excluded from the primary directory. It was introduced to the market by J.p. Business Enterprise on August 20, 2013. The current certification is valid through December 31, 2020.

How is this J.p. Business Enterprise product billed for insurance claims?

For medical billing and reimbursement, this package follows the 11-digit CMS format: 59105000124. 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)
59105-001-24
11-Digit CMS (5-4-2)
59105-0001-24

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