Diphenhydramine
NDC Package 61010-4409-2

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

This product is EXCLUDED from the official NDC directory because the listing data was inactivated by the FDA.

Diphenhydramine is take every 4 to 6 hours, or as directed by a doctor do not take more than 6 times in 24 hours adults and children 12 years and over 1 to 2 capsules children 6 to under 12 years 1 capsule children under 6 years do not use. Marketed by Safetec Of America, Inc., this product is identified by NDC 61010-4409 and is authorized under FDA application part341.

Identification & Billing

NDC Package Code
61010-4409-2
Package Description
100 POUCH in 1 BOX / 2 CAPSULE in 1 POUCH (61010-4409-0)
Product Code
61010-4409
11-Digit Billing Format
61010440902
RxNorm Crosswalk

Clinical Specifications

Proprietary Name
Diphenhydramine
Dosage Form
-
Usage Information
Take every 4 to 6 hours, or as directed by a doctor do not take more than 6 times in 24 hours adults and children 12 years and over 1 to 2 capsules children 6 to under 12 years 1 capsule children under 6 years do not use

Regulatory & Marketing

Labeler Name
Safetec Of America, Inc.
FDA Application #
part341
Marketing Category
OTC MONOGRAPH FINAL - A product marketed pursuant to a final Over-the-Counter (OTC) Drug Monograph.
Start Marketing Date
12-30-2019
Listing Expiration
12-31-2022
Exclude Flag
I
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 (61010-4409). Click a package code to view its specific billing and regulatory data.

61010-4409-0
2 CAPSULE in 1 POUCH
61010-4409-1
50 POUCH in 1 BOX / 2 CAPSULE in 1 POUCH (61010-4409-0)

* 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 61010-4409-2 identifies a specific commercial package of 100 pouch in 1 box / 2 capsule in 1 pouch (61010-4409-0) of Diphenhydramine, labeled by Safetec Of America, Inc.. This is formulated for use and contains as the active substance.

Is this product currently listed with the FDA?

This product code is currently listed as inactive or excluded from the primary directory. It was introduced to the market by Safetec Of America, Inc. on December 30, 2019. The current certification is valid through December 31, 2022.

How is this Safetec Of America, Inc. product billed for insurance claims?

For medical billing and reimbursement, this package follows the 11-digit CMS format: 61010440902. 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)
61010-4409-2
11-Digit CMS (5-4-2)
61010-4409-02

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