NDC Package 69168-431-96 Sleep Aid

Diphenhydramine Hcl Capsule, Liquid Filled Oral - View Billable Units, 11-Digit Format, RxNorm

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:
69168-431-96
Package Description:
96 CAPSULE, LIQUID FILLED in 1 BOTTLE
Product Code:
Proprietary Name:
Sleep Aid
Non-Proprietary Name:
Diphenhydramine Hcl
Substance Name:
Diphenhydramine Hydrochloride
Usage Information:
Diphenhydramine is an antihistamine used to relieve symptoms of allergy, hay fever, and the common cold. These symptoms include rash, itching, watery eyes, itchy eyes/nose/throat, cough, runny nose, and sneezing. It is also used to prevent and treat nausea, vomiting and dizziness caused by motion sickness. Diphenhydramine can also be used to help you relax and fall asleep. This medication 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). Cough-and-cold products have not been shown to be safe or effective in children younger than 6 years. Therefore, do not use this product to treat cold symptoms in children younger than 6 years unless specifically directed by the doctor. Some products (such as long-acting tablets/capsules) are not recommended for use in children younger than 12 years. Ask your doctor or pharmacist for more details about using your product safely. These products do not cure or shorten the length of the common cold and may cause serious side effects. To decrease the risk for serious side effects, carefully follow all dosage directions. Do not use this product to make a child sleepy. Do not give other cough-and-cold medication that might contain the same or similar ingredients (see also Drug Interactions section). Ask the doctor or pharmacist about other ways to relieve cough and cold symptoms (such as drinking enough fluids, using a humidifier or saline nose drops/spray).
11-Digit NDC Billing Format:
69168043196
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:
    Allegiant Health
    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.
  • Sample Package:
    No
    FDA Application Number:
    M011
    Marketing Category:
    OTC MONOGRAPH DRUG -
    Start Marketing Date:
    09-21-2021
    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
    69168-431-03250 CAPSULE, LIQUID FILLED in 1 BOTTLE
    69168-431-861 BLISTER PACK in 1 CARTON / 12 CAPSULE, LIQUID FILLED in 1 BLISTER PACK

    * Please review the disclaimer below.

    Frequently Asked Questions

    What is NDC 69168-431-96?

    The NDC Packaged Code 69168-431-96 is assigned to a package of 96 capsule, liquid filled in 1 bottle of Sleep Aid, a human over the counter drug labeled by Allegiant Health. The product's dosage form is capsule, liquid filled and is administered via oral form.

    Is NDC 69168-431 included in the NDC Directory?

    Yes, Sleep Aid with product code 69168-431 is active and included in the NDC Directory. The product was first marketed by Allegiant Health on September 21, 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 69168-431-96?

    The 11-digit format is 69168043196. 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
    5-3-269168-431-965-4-269168-0431-96