Dormin Capsule
NDC Package 52412-100-32

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

Package Information

Dormin (diphenhydramine hydrochloride) capsules is adult and children 12 years and over: Take 2 capsules (50 mg) at bedtime if needed or as directed by a doctorChildren under 12 years of age: Do not give this product to children under 12 years of age. This formulation utilizes a capsule delivery system. Marketed by Randob Labs,ltd., this product is identified by NDC 52412-100 and is authorized under FDA application part338.

Identification & Billing

NDC Package Code
52412-100-32
Package Description
32 CAPSULE in 1 BOTTLE, PLASTIC
Product Code
52412-100
11-Digit Billing Format
52412010032
RxNorm Crosswalk

Clinical Specifications

Proprietary Name
Dormin
Non-Proprietary Name
Diphenhydramine Hydrochloride
Substance Name
Diphenhydramine Hydrochloride
Dosage Form
Capsule - A solid oral dosage form consisting of a shell and a filling. The shell is composed of a single sealed enclosure, or two halves that fit together and which are sometimes sealed with a band. Capsule shells may be made from gelatin, starch, or cellulose, or other suitable materials, may be soft or hard, and are filled with solid or liquid ingredients that can be poured or squeezed.
Administration Route
Oral - Administration to or by way of the mouth.
Active Ingredient(s)
DIPHENHYDRAMINE HYDROCHLORIDE 25 mg/1
Pharmacologic Class
Usage Information
Adult and children 12 years and over: Take 2 capsules (50 mg) at bedtime if needed or as directed by a doctorChildren under 12 years of age: Do not give this product to children under 12 years of age

Regulatory & Marketing

Labeler Name
Randob Labs,ltd.
Product Type
Human Otc Drug
FDA Application #
part338
Marketing Category
OTC MONOGRAPH FINAL - A product marketed pursuant to a final Over-the-Counter (OTC) Drug Monograph.
Start Marketing Date
01-01-1992
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.

Other Available Packages

The following commercial packages are registered under the same Product NDC (52412-100). Click a package code to view its specific billing and regulatory data.

52412-100-02
2 CAPSULE in 1 POUCH
52412-100-72
72 CAPSULE in 1 BOTTLE, PLASTIC

* 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 52412-100-32 identifies a specific commercial package of 32 capsule in 1 bottle, plastic of Dormin, a human over the counter drug labeled by Randob Labs,ltd.. This capsule 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 Randob Labs,ltd. on January 01, 1992. The current certification is valid through December 31, 2026.

How is this Randob Labs,ltd. product billed for insurance claims?

For medical billing and reimbursement, this package follows the 11-digit CMS format: 52412010032. 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)
52412-100-32
11-Digit CMS (5-4-2)
52412-0100-32

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