Dormmy-lon Tablet
NDC Package 83164-000-01

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

Package Information

Dormmy-lon (diphenhydramine hydrochloride) tablets is take only one dose per day (24 hours) Adults and children 12 years & over 2 pills or as directed by a doctor children under 12 years Do not use . This formulation utilizes a tablet delivery system. Marketed by Haendel Farma, S.a. De C.v., this product is identified by NDC 83164-000 and is authorized under FDA application M010.

Identification & Billing

NDC Package Code
83164-000-01
Package Description
1 BOTTLE in 1 BOX / 60 TABLET in 1 BOTTLE
Product Code
83164-000
11-Digit Billing Format
83164000001
RxNorm Crosswalk

Clinical Specifications

Proprietary Name
Dormmy-lon
Non-Proprietary Name
Diphenhydramine Hydrochloride
Substance Name
Diphenhydramine Hydrochloride
Dosage Form
Tablet - A solid dosage form containing medicinal substances with or without suitable diluents.
Administration Route
Oral - Administration to or by way of the mouth.
Active Ingredient(s)
DIPHENHYDRAMINE HYDROCHLORIDE 25 mg/1
Pharmacologic Class
Usage Information
Take only one dose per day (24 hours) Adults and children 12 years & over 2 pills or as directed by a doctor children under 12 years Do not use 

Regulatory & Marketing

Labeler Name
Haendel Farma, S.a. De C.v.
Product Type
Human Otc Drug
FDA Application #
M010
Marketing Category
OTC MONOGRAPH DRUG -
Start Marketing Date
01-04-2023
Listing Expiration
12-31-2027
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 83164-000-01 identifies a specific commercial package of 1 bottle in 1 box / 60 tablet in 1 bottle of Dormmy-lon, a human over the counter drug labeled by Haendel Farma, S.a. De C.v.. This tablet 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 Haendel Farma, S.a. De C.v. on January 04, 2023. The current certification is valid through December 31, 2027.

How is this Haendel Farma, S.a. De C.v. product billed for insurance claims?

For medical billing and reimbursement, this package follows the 11-digit CMS format: 83164000001. 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)
83164-000-01
11-Digit CMS (5-4-2)
83164-0000-01

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