Diphenhydramine Hydrochloride
NDC Package 81033-003-41

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 Hydrochloride is adults and children 12 years of age and over: oral dosage is 25 to 50 milligrams every 4 to 6 hours, not to exceed 300 milligrams in 24 hours, or as directed by a doctor.Children 6 to under 12 years of age: oral dosage is 12.5 to 25 milligrams every 4 to 6 hours, not to exceed 150 milligrams in 24 hours, or as directed by a doctor. Marketed by Kesin Pharma Corporation, this product is identified by NDC 81033-003 and is authorized under FDA application part341.

Identification & Billing

NDC Package Code
81033-003-41
Package Description
8 CARTON in 1 CASE / 40 CUP, UNIT-DOSE in 1 CARTON (81033-003-40) / 10 mL in 1 CUP, UNIT-DOSE (81033-003-10)
Product Code
81033-003
11-Digit Billing Format
81033000341
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 Hydrochloride
Dosage Form
-
Usage Information
Adults and children 12 years of age and over: oral dosage is 25 to 50 milligrams every 4 to 6 hours, not to exceed 300 milligrams in 24 hours, or as directed by a doctor.Children 6 to under 12 years of age: oral dosage is 12.5 to 25 milligrams every 4 to 6 hours, not to exceed 150 milligrams in 24 hours, or as directed by a doctor. Children under 6 years of age: consult a doctor.

Regulatory & Marketing

Labeler Name
Kesin Pharma 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
09-16-2021
Listing Expiration
12-31-2024
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 (81033-003). Click a package code to view its specific billing and regulatory data.

81033-003-52
8 CARTON in 1 CASE / 50 CUP, UNIT-DOSE in 1 CARTON (81033-003-50) / 5 mL in 1 CUP, UNIT-DOSE (81033-003-05)

* 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 81033-003-41 identifies a specific commercial package of 8 carton in 1 case / 40 cup, unit-dose in 1 carton (81033-003-40) / 10 ml in 1 cup, unit-dose (81033-003-10) of Diphenhydramine Hydrochloride, labeled by Kesin Pharma Corporation. 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 Kesin Pharma Corporation on September 16, 2021. The current certification is valid through December 31, 2024.

How is this Kesin Pharma Corporation product billed for insurance claims?

For medical billing and reimbursement, this package follows the 11-digit CMS format: 81033000341. 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)
81033-003-41
11-Digit CMS (5-4-2)
81033-0003-41

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