Acetaminophen Diphenhydramine Hcl Tablet
NDC Package 68016-654-10

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

Acetaminophen Diphenhydramine Hcl tablets is ■ do not take more than directed (see overdose warning)adults and children 12 years and over- take 2 caplets at bedtime- do not take more than 2 caplets of this product in 24 hourschildren under 12 years- do not use this product in children under 12 years of age; this will provide more than the recommended dose (overdose) and may cause liver damage. This formulation utilizes a tablet delivery system. Marketed by Chain Drug Consortium,llc, this product is identified by NDC 68016-654 and is authorized under FDA application part343.

Identification & Billing

NDC Package Code
68016-654-10
Package Description
100 TABLET in 1 BOTTLE
Product Code
68016-654
11-Digit Billing Format
68016065410
Billing Unit
EA - Billing unit of "each" is used when the product is dispensed in discreet units.
Units Per Package
100 EA
RxNorm Crosswalk
  • RxCUI: 1092189 - acetaminophen 500 MG / diphenhydrAMINE HCl 25 MG Oral Tablet
  • RxCUI: 1092189 - acetaminophen 500 MG / diphenhydramine hydrochloride 25 MG Oral Tablet
  • RxCUI: 1092189 - APAP 500 MG / diphenhydramine hydrochloride 25 MG Oral Tablet

Clinical Specifications

Proprietary Name
Acetaminophen Diphenhydramine Hcl
Non-Proprietary Name
Acetaminophen Diphenhydramine Hcl
Substance Name
Acetaminophen; Diphenhydramine
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)
Pharmacologic Class
Usage Information
■ do not take more than directed (see overdose warning)adults and children 12 years and over- take 2 caplets at bedtime- do not take more than 2 caplets of this product in 24 hourschildren under 12 years- do not use this product in children under 12 years of age; this will provide more than the recommended dose (overdose) and may cause liver damage.

Regulatory & Marketing

Labeler Name
Chain Drug Consortium,llc
Product Type
Human Otc Drug
FDA Application #
part343
Marketing Category
OTC MONOGRAPH NOT FINAL - A product marketed pursuant to an Over-the-Counter (OTC) Drug Monograph that is not final.
Start Marketing Date
02-25-2016
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 (68016-654). Click a package code to view its specific billing and regulatory data.

68016-654-05
50 TABLET in 1 BOTTLE

* 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 68016-654-10 identifies a specific commercial package of 100 tablet in 1 bottle of Acetaminophen Diphenhydramine Hcl, a human over the counter drug labeled by Chain Drug Consortium,llc. This product is billed for "EA" each discreet unit and contains an estimated amount of 100 billable units per package. This tablet is formulated for oral use and contains acetaminophen; diphenhydramine 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 Chain Drug Consortium,llc on February 25, 2016. The current certification is valid through December 31, 2026.

How is this Chain Drug Consortium,llc product billed for insurance claims?

For medical billing and reimbursement, this package follows the 11-digit CMS format: 68016065410. Quantities are measured in per "each", products billed on a per each basis are usually products dispensed in discreet units.. There are 100 total billable units per package. 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)
68016-654-10
11-Digit CMS (5-4-2)
68016-0654-10

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