Acetaminophen And Diphenhydramine Hcl Tablet
NDC Package 21130-661-20

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 And 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 hours children under 12 years ■ do not use. This formulation utilizes a tablet delivery system. Marketed by Safeway, this product is identified by NDC 21130-661 and is authorized under FDA application M013.

Identification & Billing

NDC Package Code
21130-661-20
Package Description
200 TABLET in 1 BOTTLE
Product Code
21130-661
11-Digit Billing Format
21130066120
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 And Diphenhydramine Hcl
Non-Proprietary Name
Acetaminophen And 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 hours children under 12 years ■ do not use

Regulatory & Marketing

Labeler Name
Safeway
Product Type
Human Otc Drug
FDA Application #
M013
Marketing Category
OTC MONOGRAPH DRUG -
Start Marketing Date
06-30-2023
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 (21130-661). Click a package code to view its specific billing and regulatory data.

21130-661-10
100 TABLET in 1 BOTTLE
21130-661-24
24 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 21130-661-20 identifies a specific commercial package of 200 tablet in 1 bottle of Acetaminophen And Diphenhydramine Hcl, a human over the counter drug labeled by Safeway. 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 Safeway on June 30, 2023. The current certification is valid through December 31, 2026.

How is this Safeway product billed for insurance claims?

For medical billing and reimbursement, this package follows the 11-digit CMS format: 21130066120. 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)
21130-661-20
11-Digit CMS (5-4-2)
21130-0661-20

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