1. Home
  2. Labeler Index
  3. Rugby Laboratories
  4. 0536-1214
  5. NDC Package Code: 0536-1214-29 Diphenhydramine Hcl

NDC Package 0536-1214-29 Diphenhydramine Hcl

Tablet, Film Coated 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:
0536-1214-29
Package Description:
100 TABLET, FILM COATED in 1 BOTTLE, PLASTIC
Product Code:
0536-1214
Proprietary Name:
Diphenhydramine Hcl
Non-Proprietary Name:
Diphenhydramine Hcl
Substance Name:
Diphenhydramine Hydrochloride
Usage Information:
Diphenhydramine injection is an antihistamine used to treat life-threatening allergic reactions (anaphylaxis) along with epinephrine and other treatments. It is also used to relieve symptoms of household allergies, hay fever and the common cold when medication cannot be given by mouth. Common allergy symptoms relieved by antihistamines include rash, itching, watery eyes, itchy eyes/nose/throat, cough, runny nose and sneezing. It is also used to treat nausea, vomiting and dizziness caused by motion sickness when medication cannot be given by mouth. Diphenhydramine works by blocking a certain natural substance (histamine) that your body makes during an allergic reaction. Its drying effects on such symptoms as watery eyes and runny nose are caused by blocking another natural substance made by your body (acetylcholine). Diphenhydramine should not be used in newborns or premature infants because of an increased risk of side effects. It should not be used for common cold symptoms in children less than 6 years of age due to the risk of serious side effects, such as slow/shallow breathing. Cough-and-cold products have not been shown to be safe or effective in children younger than 6.
11-Digit NDC Billing Format:
00536121429
Billing Unit:
EA - Billing unit of "each" is used when the product is dispensed in discreet units.
NDC to RxNorm Crosswalk:
100 EA
NDC to RxNorm Crosswalk:
  • RxCUI: 1049630 - diphenhydrAMINE HCl 25 MG Oral Tablet
  • RxCUI: 1049630 - diphenhydramine hydrochloride 25 MG Oral Tablet
    • Product Type:
    Human Otc Drug
    Labeler Name:
    Rugby Laboratories
    Dosage Form:
    Tablet, Film Coated - A solid dosage form that contains medicinal substances with or without suitable diluents and is coated with a thin layer of a water-insoluble or water-soluble polymer.
    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:
    03-28-2019
    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.

    Frequently Asked Questions

    What is NDC 0536-1214-29?

    The NDC Packaged Code 0536-1214-29 is assigned to a package of 100 tablet, film coated in 1 bottle, plastic of Diphenhydramine Hcl, a human over the counter drug labeled by Rugby Laboratories. The product's dosage form is tablet, film coated and is administered via oral form.

    Is NDC 0536-1214 included in the NDC Directory?

    Yes, Diphenhydramine Hcl with product code 0536-1214 is active and included in the NDC Directory. The product was first marketed by Rugby Laboratories on March 28, 2019 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 NDC billing unit for package 0536-1214-29?

    The contents of this package are billed per "each", products billed on a per each basis are usually products dispensed in discreet units. The calculated billable units for this package is 100.

    What is the 11-digit format for NDC 0536-1214-29?

    The 11-digit format is 00536121429. 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 4-4-2 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
    4-4-20536-1214-295-4-200536-1214-29