Acetaminophen, Diphenhydramine Hydrochloride, And Phenylephrine Hydrochloride Tablet, Film Coated
NDC Package 83586-004-00

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

Package Information

Acetaminophen, Diphenhydramine Hydrochloride, And Phenylephrine Hydrochloride tablets is do not use more than directedadults and children 12 years and over: take 2 caplets every 4 hoursdo not take more than 10 caplets in 24 hourschildren under 12 years: ask a doctor. This formulation utilizes a tablet, film coated delivery system. Marketed by Hhh Pharmaceuticals, this product is identified by NDC 83586-004 and is authorized under FDA application M012.

Identification & Billing

NDC Package Code
83586-004-00
Package Description
32000 TABLET, FILM COATED in 1 BOTTLE
Product Code
83586-004
11-Digit Billing Format
83586000400

Clinical Specifications

Proprietary Name
Acetaminophen, Diphenhydramine Hydrochloride, And Phenylephrine Hydrochloride
Non-Proprietary Name
Acetaminophen, Diphenhydramine Hydrochloride, And Phenylephrine Hydrochloride
Substance Name
Acetaminophen; Diphenhydramine Hydrochloride; Phenylephrine Hydrochloride
Dosage Form
Tablet, Film Coated - A solid dosage form that contains medicinal substances with or without suitable diluents and is coated with a thin layer of a water-insoluble or water-soluble polymer.
Administration Route
Oral - Administration to or by way of the mouth.
Active Ingredient(s)
Pharmacologic Class
Usage Information
Do not use more than directedadults and children 12 years and over: take 2 caplets every 4 hoursdo not take more than 10 caplets in 24 hourschildren under 12 years: ask a doctor

Regulatory & Marketing

Labeler Name
Hhh Pharmaceuticals
Product Type
Human Otc Drug
FDA Application #
M012
Marketing Category
OTC MONOGRAPH DRUG -
Start Marketing Date
06-27-2026
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 83586-004-00 identifies a specific commercial package of 32000 tablet, film coated in 1 bottle of Acetaminophen, Diphenhydramine Hydrochloride, And Phenylephrine Hydrochloride, a human over the counter drug labeled by Hhh Pharmaceuticals. This tablet, film coated is formulated for oral use and contains acetaminophen; diphenhydramine hydrochloride; phenylephrine 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 Hhh Pharmaceuticals on June 27, 2026. The current certification is valid through December 31, 2027.

How is this Hhh Pharmaceuticals product billed for insurance claims?

For medical billing and reimbursement, this package follows the 11-digit CMS format: 83586000400. 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)
83586-004-00
11-Digit CMS (5-4-2)
83586-0004-00

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