Acetaminophen Diphenhydramine Hcl Capsule
NDC Package 55315-988-24

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

Package Information

Acetaminophen Diphenhydramine Hcl capsules is ■ do not take more than directed (see overdose warning) adults and children 12 years and over ■ take 2 gelcaps at bedtime ■ do not take more than 2 gelcaps of this product in 24 hours children under 12 years do not use. This formulation utilizes a capsule delivery system. Marketed by Freds, Inc, this product is identified by NDC 55315-988 and is authorized under FDA application part343.

Identification & Billing

NDC Package Code
55315-988-24
Package Description
24 CAPSULE in 1 BOTTLE
Product Code
55315-988
11-Digit Billing Format
55315098824
RxNorm Crosswalk
  • RxCUI: 1117245 - acetaminophen 500 MG / diphenhydrAMINE HCl 25 MG Oral Capsule
  • RxCUI: 1117245 - acetaminophen 500 MG / diphenhydramine hydrochloride 25 MG Oral Capsule
  • RxCUI: 1117245 - APAP 500 MG / diphenhydramine hydrochloride 25 MG Oral Capsule

Clinical Specifications

Proprietary Name
Acetaminophen Diphenhydramine Hcl
Non-Proprietary Name
Acetaminophen Diphenhydramine Hcl
Substance Name
Acetaminophen; Diphenhydramine Hydrochloride
Dosage Form
Capsule - A solid oral dosage form consisting of a shell and a filling. The shell is composed of a single sealed enclosure, or two halves that fit together and which are sometimes sealed with a band. Capsule shells may be made from gelatin, starch, or cellulose, or other suitable materials, may be soft or hard, and are filled with solid or liquid ingredients that can be poured or squeezed.
Administration Route
Oral - Administration to or by way of the mouth.
Active Ingredient(s)
Pharmacologic Class
Usage Information
■ do not take more than directed (see overdose warning) adults and children 12 years and over ■ take 2 gelcaps at bedtime ■ do not take more than 2 gelcaps of this product in 24 hours children under 12 years do not use

Regulatory & Marketing

Labeler Name
Freds, Inc
Product Type
Human Otc Drug
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
08-17-2017
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.

Frequently Asked Questions

What is the distribution configuration for this product package?

The code 55315-988-24 identifies a specific commercial package of 24 capsule in 1 bottle of Acetaminophen Diphenhydramine Hcl, a human over the counter drug labeled by Freds, Inc. This capsule is formulated for oral use and contains acetaminophen; diphenhydramine hydrochloride 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 Freds, Inc on August 17, 2017. The current certification is valid through December 31, 2026.

How is this Freds, Inc product billed for insurance claims?

For medical billing and reimbursement, this package follows the 11-digit CMS format: 55315098824. 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)
55315-988-24
11-Digit CMS (5-4-2)
55315-0988-24

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