Acetaminophen Diphenhydramine Hcl Tablet
NDC Package 69848-014-15

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 andchildren 12 years and over■ take 2 caplets at bedtime do not use ■ do not take more than 2 caplets of this product in 24 hours children under 12 years■ do not use. This formulation utilizes a tablet delivery system. Marketed by Granules Usa, Inc., this product is identified by NDC 69848-014 and is authorized under FDA application M013.

Identification & Billing

NDC Package Code
69848-014-15
Package Description
150 TABLET in 1 BOTTLE
Product Code
69848-014
11-Digit Billing Format
69848001415
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 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)
Pharmacologic Class
Usage Information
■ do not take more than directed (see overdose warning)adults andchildren 12 years and over■ take 2 caplets at bedtime do not use ■ do not take more than 2 caplets of this product in 24 hours children under 12 years■ do not use

Regulatory & Marketing

Labeler Name
Granules Usa, Inc.
Product Type
Human Otc Drug
FDA Application #
M013
Marketing Category
OTC MONOGRAPH DRUG -
Start Marketing Date
07-01-2019
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 (69848-014). Click a package code to view its specific billing and regulatory data.

69848-014-02
20 TABLET in 1 BOTTLE
69848-014-05
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 69848-014-15 identifies a specific commercial package of 150 tablet in 1 bottle of Acetaminophen Diphenhydramine Hcl, a human over the counter drug labeled by Granules Usa, Inc.. This tablet is formulated for oral use and contains acetaminophen; 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 Granules Usa, Inc. on July 01, 2019. The current certification is valid through December 31, 2026.

How is this Granules Usa, Inc. product billed for insurance claims?

For medical billing and reimbursement, this package follows the 11-digit CMS format: 69848001415. 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)
69848-014-15
11-Digit CMS (5-4-2)
69848-0014-15

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