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  5. NDC Package Code: 57237-318-11 Diphenhydramine Hcl Oral Solution

NDC Package 57237-318-11 Diphenhydramine Hcl Oral Solution

Diphenhydramine Hcl Oral Solution Oral - View Billable Units, 11-Digit Format, RxNorm

Table of Contents

    1. Package Information
    2. 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:
57237-318-11
Package Description:
100 CUP, UNIT-DOSE in 1 BOX, UNIT-DOSE / 10 mL in 1 CUP, UNIT-DOSE (57237-318-01)
Product Code:
57237-318
Proprietary Name:
Diphenhydramine Hcl Oral Solution
Non-Proprietary Name:
Diphenhydramine Hcl Oral
Substance Name:
Diphenhydramine Hydrochloride
Usage Information:
• take every 4 to 6 hours, or as directed by a physician• do not take more than 6 doses in 24 hoursagedoseAdults and children over 12 years of age10 mL (25 mg) to 20 mL (50 mg)Children 6 to under 12 years of age10 mL (25 mg)Children under 6 years of ageDo not use
11-Digit NDC Billing Format:
57237031811
Billing Unit:
ML - Billing unit of "milliliter" is used when a product is measured by its liquid volume.
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:
    Rising Pharma Holdings, Inc.
    Dosage Form:
    Solution - A clear, homogeneous liquid1 dosage form that contains one or more chemical substances dissolved in a solvent or mixture of mutually miscible solvents.
    Administration Route(s):
  • Oral - Administration to or by way of the mouth.
    • Active Ingredient(s):
  • DIPHENHYDRAMINE HYDROCHLORIDE 25 mg/10mL
    • 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:
    M
    Marketing Category:
    OTC MONOGRAPH DRUG -
    Start Marketing Date:
    12-15-2023
    Listing Expiration Date:
    12-31-2025
    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.

    Frequently Asked Questions

    What is NDC 57237-318-11?

    The NDC Packaged Code 57237-318-11 is assigned to a package of 100 cup, unit-dose in 1 box, unit-dose / 10 ml in 1 cup, unit-dose (57237-318-01) of Diphenhydramine Hcl Oral Solution, a human over the counter drug labeled by Rising Pharma Holdings, Inc.. The product's dosage form is solution and is administered via oral form.

    Is NDC 57237-318 included in the NDC Directory?

    Yes, Diphenhydramine Hcl Oral Solution with product code 57237-318 is active and included in the NDC Directory. The product was first marketed by Rising Pharma Holdings, Inc. on December 15, 2023 and its listing in the NDC Directory is set to expire on December 31, 2025 if the product is not updated or renewed by the manufacturer.

    What is the NDC billing unit for package 57237-318-11?

    The contents of this package are billed per "ml or milliliter", products billed per milliliter are usually products measured by liquid volume.

    What is the 11-digit format for NDC 57237-318-11?

    The 11-digit format is 57237031811. 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
    5-3-257237-318-115-4-257237-0318-11