Diphenhydramine
NDC Package 54868-0113-0

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.

Diphenhydramine is do not use more than directedadults and children 2 years of age and older: apply to affected area no more than 3 to 4 times dailychildren under 2 years of age: ask a doctor. Marketed by Physicians Total Care, Inc., this product is identified by NDC 54868-0113 and is authorized under FDA application part348.

Identification & Billing

NDC Package Code
54868-0113-0
Package Description
1 TUBE in 1 CARTON / 28 g in 1 TUBE
Product Code
54868-0113
11-Digit Billing Format
54868011300
RxNorm Crosswalk
  • RxCUI: 1087026 - diphenhydrAMINE HCl 2 % / zinc acetate 0.1 % Topical Cream
  • RxCUI: 1087026 - diphenhydramine hydrochloride 20 MG/ML / zinc acetate 1 MG/ML Topical Cream
  • RxCUI: 1087026 - diphenhydramine hydrochloride 2 % / zinc acetate 0.1 % Topical Cream

Clinical Specifications

Proprietary Name
Diphenhydramine
Dosage Form
-
Usage Information
Do not use more than directedadults and children 2 years of age and older: apply to affected area no more than 3 to 4 times dailychildren under 2 years of age: ask a doctor

Regulatory & Marketing

Labeler Name
Physicians Total Care, Inc.
FDA Application #
part348
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
04-23-2008
Listing Expiration
12-31-2017
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 54868-0113-0 identifies a specific commercial package of 1 tube in 1 carton / 28 g in 1 tube of Diphenhydramine, labeled by Physicians Total Care, Inc.. 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 Physicians Total Care, Inc. on April 23, 2008. The current certification is valid through December 31, 2017.

How is this Physicians Total Care, Inc. product billed for insurance claims?

For medical billing and reimbursement, this package follows the 11-digit CMS format: 54868011300. 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 (5-4-1)
54868-0113-0
11-Digit CMS (5-4-2)
54868-0113-00

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