Unisom Sleepmelts Nighttime Sleep-aid Tablet, Chewable
NDC Package 63868-393-24

View Billable Units, 11-Digit Conversion Format, and RxNorm mappings
Table of Contents
    1. Package Information
    2. Frequently Asked Questions

Package Information

Unisom Sleepmelts Nighttime Sleep-aid (diphenhydramine hydrochloride) tablets is •adults and children 12 years of age and over: 2 tablets (25 mg each) at bedtime if needed, or as directed by a doctor•place 2 tablets on tongue; tablets dissolve with or without water•allow tablets to dissolve in mouth or chew before swallowing. This formulation utilizes a tablet, chewable delivery system. Marketed by Quality Choice (chain Drug Marketing Association), this product is identified by NDC 63868-393 and is authorized under FDA application M010.

Identification & Billing

NDC Package Code
63868-393-24
Package Description
24 TABLET, CHEWABLE in 1 BLISTER PACK
Product Code
63868-393
11-Digit Billing Format
63868039324
RxNorm Crosswalk
  • RxCUI: 1093098 - diphenhydrAMINE HCl 25 MG Disintegrating Oral Tablet
  • RxCUI: 1093098 - diphenhydramine hydrochloride 25 MG Disintegrating Oral Tablet
  • RxCUI: 1093102 - Unisom SleepMelts 25 MG Disintegrating Oral Tablet
  • RxCUI: 1093102 - diphenhydramine hydrochloride 25 MG Disintegrating Oral Tablet [Unisom Sleep]
  • RxCUI: 1093102 - Unisom Sleep 25 MG Disintegrating Oral Tablet

Clinical Specifications

Proprietary Name
Unisom Sleepmelts Nighttime Sleep-aid
Non-Proprietary Name
Diphenhydramine Hydrochloride
Substance Name
Diphenhydramine Hydrochloride
Dosage Form
Tablet, Chewable - A solid dosage form containing medicinal substances with or without suitable diluents that is intended to be chewed, producing a pleasant tasting residue in the oral cavity that is easily swallowed and does not leave a bitter or unpleasant after-taste.
Administration Route
Oral - Administration to or by way of the mouth.
Active Ingredient(s)
DIPHENHYDRAMINE HYDROCHLORIDE 25 mg/1
Pharmacologic Class
Usage Information
•adults and children 12 years of age and over: 2 tablets (25 mg each) at bedtime if needed, or as directed by a doctor•place 2 tablets on tongue; tablets dissolve with or without water•allow tablets to dissolve in mouth or chew before swallowing

Regulatory & Marketing

Labeler Name
Quality Choice (chain Drug Marketing Association)
Product Type
Human Otc Drug
FDA Application #
M010
Marketing Category
OTC MONOGRAPH DRUG -
Start Marketing Date
01-07-2019
Listing Expiration
12-31-2026
Exclude Flag
N
Sample Package
No

Hierarchy Structure

Code Lineage

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 full disclaimer at the bottom of this page.

Frequently Asked Questions

What is the distribution configuration for this product package?

The code 63868-393-24 identifies a specific commercial package of 24 tablet, chewable in 1 blister pack of Unisom Sleepmelts Nighttime Sleep-aid, a human over the counter drug labeled by Quality Choice (chain Drug Marketing Association). This tablet, chewable is formulated for oral use and contains diphenhydramine hydrochloride as the active substance.

Is this product currently listed with the FDA?

Yes, this product is active and verified within the NDC Directory. It was introduced to the market by Quality Choice (chain Drug Marketing Association) on January 07, 2019. The current certification is valid through December 31, 2026.

How is this Quality Choice (chain Drug Marketing Association) product billed for insurance claims?

For medical billing and reimbursement, this package follows the 11-digit CMS format: 63868039324. The table below illustrates the segment conversion from the 10-digit labeler code to the 11-digit provider format.

11-Digit Code Conversion

Billing payers usually require a 5-4-2 segment configuration. Below is the conversion from the 10-digit package format to the 11-digit billing format:

10-Digit Format (5-3-2)
63868-393-24
11-Digit CMS (5-4-2)
63868-0393-24

Note: The zero is added to the Product segment to maintain the 5-4-2 structure.