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  5. NDC Package Code: 81033-003-41 Diphenhydramine Hydrochloride

NDC Package 81033-003-41 Diphenhydramine Hydrochloride

Liquid Oral - View Billable Units, 11-Digit Format, RxNorm

Table of Contents

    1. Package Information
    2. Other Packages
    3. Frequently Asked Questions

Package Information

Find all the important details about this NDC Package code, including the 11-Digit NDC Billing number, billing units, wholesale price, RxNorm crosswalk, active ingredients, pharmacologic clasess, etc.

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
Proprietary Name:
Diphenhydramine Hydrochloride
Non-Proprietary Name:
Diphenhydramine Hydrochloride
Substance Name:
Diphenhydramine Hydrochloride
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.
11-Digit NDC Billing Format:
81033000341
NDC to 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
    • Product Type:
    Human Otc Drug
    Labeler Name:
    Kesin Pharma Corporation
    Dosage Form:
    Liquid - A dosage form consisting of a pure chemical in its liquid1 state. This dosage form term should not be applied to solutions.
    Administration Route(s):
  • Oral - Administration to or by way of the mouth.
    • Active Ingredient(s):
  • DIPHENHYDRAMINE HYDROCHLORIDE 2.5 mg/mL
    • Pharmacologic Class(es):
  • Histamine H1 Receptor Antagonists - [MoA] (Mechanism of Action)
  • Histamine-1 Receptor Antagonist - [EPC] (Established Pharmacologic Class)
    • Sample Package:
    No
    FDA Application Number:
    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 Date:
    12-31-2024
    Exclude Flag:
    N
    Code Structure:

    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 disclaimer below.

    Other Product Packages

    The following packages are also available for this product:

    NDC Package CodePackage Description
    81033-003-528 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 disclaimer below.

    Frequently Asked Questions

    What is NDC 81033-003-41?

    The NDC Packaged Code 81033-003-41 is assigned to a 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, a human over the counter drug labeled by Kesin Pharma Corporation. The product's dosage form is liquid and is administered via oral form.

    Is NDC 81033-003 included in the NDC Directory?

    Yes, Diphenhydramine Hydrochloride with product code 81033-003 is active and included in the NDC Directory. The product was first marketed by Kesin Pharma Corporation on September 16, 2021 and its listing in the NDC Directory is set to expire on December 31, 2024 if the product is not updated or renewed by the manufacturer.

    What is the 11-digit format for NDC 81033-003-41?

    The 11-digit format is 81033000341. The 11-digit billing format might be required by the Centers for Medicare & Medicaid Services (CMS) and other payers in billing claim forms.

    This package code is originally configured in a 5-3-2 segment 10-digit format and by adding a zero within the original NDC package code we can obtain the converted 11-digit format in a 5-4-2 segment configuration. The table below shows the 11-digit code conversion:

    10-Digit Format10-Digit Original Code11-Digit Format11-Digit Code
    5-3-281033-003-415-4-281033-0003-41