Childrens Benadryl Chewables Tablet, Chewable
NDC Package 50580-232-01

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

Package Information

Childrens Benadryl Chewables (diphenhydramine hydrochloride) tablets is find right dose on chart belowtake every 4 to 6 hours, or as directed by a doctordo not take more than 6 times in 24 hoursAge (yr)Dose (chewable tablets)children under 2 yearsdo not usechildren 2 to 5 yearsdo not use unless directed by a doctorchildren 6 to 11 years1 to 2 chewable tablets (12.5 mg to 25 mg)adults and children 12 years and over2 to 4 chewable tablets (25 mg to 50 mg). This formulation utilizes a tablet, chewable delivery system. Marketed by Kenvue Brands Llc, this product is identified by NDC 50580-232 and is authorized under FDA application M012.

Identification & Billing

NDC Package Code
50580-232-01
Package Description
2 BLISTER PACK in 1 CARTON / 10 TABLET, CHEWABLE in 1 BLISTER PACK
Product Code
50580-232
11-Digit Billing Format
50580023201
Billing Unit
EA - Billing unit of "each" is used when the product is dispensed in discreet units.
Units Per Package
2 EA
RxNorm Crosswalk

Clinical Specifications

Proprietary Name
Childrens Benadryl Chewables
Non-Proprietary Name
Diphenhydramine Hydrochloride
Substance Name
Diphenhydramine Hydrochloride
Dosage Form
Tablet, Chewable - A solid dosage form containing medicinal substances with or without suitable diluents that is intended to be chewed, producing a pleasant tasting residue in the oral cavity that is easily swallowed and does not leave a bitter or unpleasant after-taste.
Administration Route
Oral - Administration to or by way of the mouth.
Active Ingredient(s)
DIPHENHYDRAMINE HYDROCHLORIDE 12.5 mg/1
Pharmacologic Class
Usage Information
Find right dose on chart belowtake every 4 to 6 hours, or as directed by a doctordo not take more than 6 times in 24 hoursAge (yr)Dose (chewable tablets)children under 2 yearsdo not usechildren 2 to 5 yearsdo not use unless directed by a doctorchildren 6 to 11 years1 to 2 chewable tablets (12.5 mg to 25 mg)adults and children 12 years and over2 to 4 chewable tablets (25 mg to 50 mg)

Regulatory & Marketing

Labeler Name
Kenvue Brands Llc
Product Type
Human Otc Drug
FDA Application #
M012
Marketing Category
OTC MONOGRAPH DRUG -
Start Marketing Date
07-11-2016
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.

Frequently Asked Questions

What is the distribution configuration for this product package?

The code 50580-232-01 identifies a specific commercial package of 2 blister pack in 1 carton / 10 tablet, chewable in 1 blister pack of Childrens Benadryl Chewables, a human over the counter drug labeled by Kenvue Brands Llc. This product is billed for "EA" each discreet unit and contains an estimated amount of 2 billable units per package. This tablet, chewable is formulated for oral use and contains 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 Kenvue Brands Llc on July 11, 2016. The current certification is valid through December 31, 2026.

How is this Kenvue Brands Llc product billed for insurance claims?

For medical billing and reimbursement, this package follows the 11-digit CMS format: 50580023201. Quantities are measured in per "each", products billed on a per each basis are usually products dispensed in discreet units.. There are 2 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)
50580-232-01
11-Digit CMS (5-4-2)
50580-0232-01

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