Diphenhydramine Hydrochloride Capsule
NDC Package 51662-1628-1

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

Package Information

Diphenhydramine Hydrochloride capsules is  take every 4 to 6 hours, or as directed by a doctor do not take more than 6 doses in 24 hoursadults and children 12 years of age and over 1 to 2 capsules children 6 to under 12 years of age 1 capsule children under 6 years of age do not use this product in children under 6 years of age. This formulation utilizes a capsule delivery system. Marketed by Hf Acquisition Co Llc, Dba Healthfirst, this product is identified by NDC 51662-1628 and is authorized under FDA application M012.

Identification & Billing

NDC Package Code
51662-1628-1
Package Description
2 CAPSULE in 1 CARTON
Product Code
51662-1628
11-Digit Billing Format
51662162801
RxNorm Crosswalk

Clinical Specifications

Proprietary Name
Diphenhydramine Hydrochloride
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
 take every 4 to 6 hours, or as directed by a doctor do not take more than 6 doses in 24 hoursadults and children 12 years of age and over 1 to 2 capsules children 6 to under 12 years of age 1 capsule children under 6 years of age do not use this product in children under 6 years of age

Regulatory & Marketing

Labeler Name
Hf Acquisition Co Llc, Dba Healthfirst
Product Type
Human Otc Drug
FDA Application #
M012
Marketing Category
OTC MONOGRAPH DRUG -
Start Marketing Date
04-14-2022
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 51662-1628-1 identifies a specific commercial package of 2 capsule in 1 carton of Diphenhydramine Hydrochloride, a human over the counter drug labeled by Hf Acquisition Co Llc, Dba Healthfirst. 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 Hf Acquisition Co Llc, Dba Healthfirst on April 14, 2022. The current certification is valid through December 31, 2026.

How is this Hf Acquisition Co Llc, Dba Healthfirst product billed for insurance claims?

For medical billing and reimbursement, this package follows the 11-digit CMS format: 51662162801. 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 (5-4-1)
51662-1628-1
11-Digit CMS (5-4-2)
51662-1628-01

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