Diphenhydramine Oral Liquid
NDC Package 53807-204-04

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

Package Information

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

Diphenhydramine Oral Liquid is take every 4-6 hoursDo not use more than 6 times in 24 hoursadults and children 12 years of age and over2 to 4 teaspoonfuls (25 to 50 mg)children 6 to under 12 years of age1 to 2 teaspoonfuls (12.5 to 25 mg)children under 6 yearsask a doctor. Marketed by Rij Pharmaceutical Corporation, this product is identified by NDC 53807-204 and is authorized under FDA application part341.

Identification & Billing

NDC Package Code
53807-204-04
Package Description
118 mL in 1 BOTTLE
Product Code
53807-204
11-Digit Billing Format
53807020404
Billing Unit
ML - Billing unit of "milliliter" is used when a product is measured by its liquid volume.
Units Per Package
118 ML
RxNorm Crosswalk
  • RxCUI: 1049906 - diphenhydrAMINE HCl 12.5 MG in 5 mL Oral Solution
  • RxCUI: 1049906 - diphenhydramine hydrochloride 2.5 MG/ML Oral Solution
  • RxCUI: 1049906 - diphenhydramine HCl 12.5 MG per 5 ML Oral Solution
  • RxCUI: 1049906 - diphenhydramine hydrochloride 25 MG per 10 ML Oral Solution
  • RxCUI: 1049906 - diphenhydramine hydrochloride 50 MG per 20 ML Oral Solution

Clinical Specifications

Proprietary Name
Diphenhydramine Oral Liquid
Dosage Form
-
Usage Information
Take every 4-6 hoursDo not use more than 6 times in 24 hoursadults and children 12 years of age and over2 to 4 teaspoonfuls (25 to 50 mg)children 6 to under 12 years of age1 to 2 teaspoonfuls (12.5 to 25 mg)children under 6 yearsask a doctor

Regulatory & Marketing

Labeler Name
Rij Pharmaceutical Corporation
FDA Application #
part341
Marketing Category
OTC MONOGRAPH FINAL - A product marketed pursuant to a final Over-the-Counter (OTC) Drug Monograph.
Start Marketing Date
03-16-1999
Listing Expiration
12-31-2019
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.

Other Available Packages

The following commercial packages are registered under the same Product NDC (53807-204). Click a package code to view its specific billing and regulatory data.

53807-204-08
236 mL in 1 BOTTLE
53807-204-16
473 mL in 1 BOTTLE

* 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 53807-204-04 identifies a specific commercial package of 118 ml in 1 bottle of Diphenhydramine Oral Liquid, labeled by Rij Pharmaceutical Corporation. This product is billed per "ML" milliliter and contains an estimated amount of 118 billable units per package. 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 Rij Pharmaceutical Corporation on March 16, 1999. The current certification is valid through December 31, 2019.

How is this Rij Pharmaceutical Corporation product billed for insurance claims?

For medical billing and reimbursement, this package follows the 11-digit CMS format: 53807020404. Quantities are measured in per "ml or milliliter", products billed per milliliter are usually products measured by liquid volume.. There are 118 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)
53807-204-04
11-Digit CMS (5-4-2)
53807-0204-04

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