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  5. NDC Package Code: 35916-0435-1 Diphenhydramine Hydrochloride

NDC Package 35916-0435-1 Diphenhydramine Hydrochloride

Capsule, Liquid Filled 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:
35916-0435-1
Package Description:
3 CAPSULE, LIQUID FILLED in 1 CARTON
Product Code:
35916-0435
Proprietary Name:
Diphenhydramine Hydrochloride
Non-Proprietary Name:
Diphenhydramine Hydrochloride
Substance Name:
Diphenhydramine Hydrochloride
Usage Information:
Take every 4 to 6 hours do not take more than 6 doses in 24 hours adults and children 12 years and over1 to 2 capsuleschildren 6 to under 12 years1 capsulechildren under 6 yearsdo not use this product in children under 6 years of age
11-Digit NDC Billing Format:
35916043501
NDC to RxNorm Crosswalk:
  • RxCUI: 1049909 - diphenhydrAMINE HCl 25 MG Oral Capsule
  • RxCUI: 1049909 - diphenhydramine hydrochloride 25 MG Oral Capsule
    • Product Type:
    Human Otc Drug
    Labeler Name:
    Softgel Healthcare Private Limited
    Dosage Form:
    Capsule, Liquid Filled - A solid dosage form in which the drug is enclosed within a soluble, gelatin shell which is plasticized by the addition of a polyol, such as sorbitol or glycerin, and is therefore of a somewhat thicker consistency than that of a hard shell capsule; typically, the active ingredients are dissolved or suspended in a liquid vehicle.
    Administration Route(s):
  • Oral - Administration to or by way of the mouth.
    • Active Ingredient(s):
  • DIPHENHYDRAMINE HYDROCHLORIDE 25 mg/1
    • 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:
    M012
    Marketing Category:
    OTC MONOGRAPH DRUG -
    Start Marketing Date:
    08-07-2023
    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 35916-0435-1?

    The NDC Packaged Code 35916-0435-1 is assigned to a package of 3 capsule, liquid filled in 1 carton of Diphenhydramine Hydrochloride, a human over the counter drug labeled by Softgel Healthcare Private Limited. The product's dosage form is capsule, liquid filled and is administered via oral form.

    Is NDC 35916-0435 included in the NDC Directory?

    Yes, Diphenhydramine Hydrochloride with product code 35916-0435 is active and included in the NDC Directory. The product was first marketed by Softgel Healthcare Private Limited on August 07, 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 11-digit format for NDC 35916-0435-1?

    The 11-digit format is 35916043501. 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 5-4-1 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
    5-4-135916-0435-15-4-235916-0435-01