1. Home
  2. Labeler Index
  3. Spirit Pharmaceuticals Llc
  4. 68210-4099
  5. NDC Package Code: 68210-4099-1 Maximum Strength Sleep Aid

NDC Package 68210-4099-1 Maximum Strength Sleep Aid

Diphenhydramine Hcl Capsule, Gelatin 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:
68210-4099-1
Package Description:
100 CAPSULE, GELATIN COATED in 1 BOTTLE
Product Code:
68210-4099
Proprietary Name:
Maximum Strength 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:
68210409901
NDC to RxNorm Crosswalk:
  • RxCUI: 1020477 - diphenhydrAMINE HCl 50 MG Oral Capsule
  • RxCUI: 1020477 - diphenhydramine hydrochloride 50 MG Oral Capsule
  • RxCUI: 1020477 - diphenhydramine HCl 50 MG Oral Capsule
    • Product Type:
    Human Otc Drug
    Labeler Name:
    Spirit Pharmaceuticals Llc
    Dosage Form:
    Capsule, Gelatin Coated - A solid dosage form in which the drug is enclosed within either a hard or soft soluble container made from a suitable form of gelatin; through a banding process, the capsule is coated with additional layers of gelatin so as to form a complete seal.
    Administration Route(s):
  • Oral - Administration to or by way of the mouth.
    • Active Ingredient(s):
  • DIPHENHYDRAMINE HYDROCHLORIDE 50 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:
    M010
    Marketing Category:
    OTC MONOGRAPH DRUG -
    Start Marketing Date:
    07-02-2020
    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 68210-4099-1?

    The NDC Packaged Code 68210-4099-1 is assigned to a package of 100 capsule, gelatin coated in 1 bottle of Maximum Strength Sleep Aid, a human over the counter drug labeled by Spirit Pharmaceuticals Llc. The product's dosage form is capsule, gelatin coated and is administered via oral form.

    Is NDC 68210-4099 included in the NDC Directory?

    Yes, Maximum Strength Sleep Aid with product code 68210-4099 is active and included in the NDC Directory. The product was first marketed by Spirit Pharmaceuticals Llc on July 02, 2020 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 68210-4099-1?

    The 11-digit format is 68210409901. 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
    5-4-168210-4099-15-4-268210-4099-01