Tylenol Tablet, Film Coated
NDC Package 50580-475-10

11-digit billing NDC: 50580047510
Table of Contents
    1. Package Information
    2. Other Packages
    3. Frequently Asked Questions

Package Information

Tylenol (acetaminophen) tablets is ■ do not take more than directed (see overdose warning) adults and children 12 years and over ■ take 2 caplets every 4 to 6 hours while symptoms last ■ do not take more than 10 caplets in 24 hours, unless directed by a doctor ■ do not use for more than 10 days unless directed by a doctor children 6 years to under 12 years ■ take 1 caplet every 4 to 6 hours while symptoms last ■ do not take more than 5 caplets in 24 hours ■ do not use for more than 5 days unless directed by a doctor children under 6 years ask a doctor. This formulation utilizes a tablet, film coated delivery system. Marketed by Kenvue Brands Llc, this product is identified by NDC 50580-475 and is authorized under FDA application M013.

Identification & Billing

NDC Package Code
50580-475-10
Package Description
1 BOTTLE in 1 CARTON / 1000 TABLET, FILM COATED in 1 BOTTLE
Product Code
50580-475
11-Digit Billing Format
50580047510
RxNorm Crosswalk

Clinical Specifications

Proprietary Name
Tylenol Regular Strength
Non-Proprietary Name
Acetaminophen
Substance Name
Acetaminophen
Dosage Form
Tablet, Film Coated - A solid dosage form that contains medicinal substances with or without suitable diluents and is coated with a thin layer of a water-insoluble or water-soluble polymer.
Administration Route
Oral - Administration to or by way of the mouth.
Active Ingredient(s)
ACETAMINOPHEN 325 mg/1
Usage Information
■ do not take more than directed (see overdose warning) adults and children 12 years and over ■ take 2 caplets every 4 to 6 hours while symptoms last ■ do not take more than 10 caplets in 24 hours, unless directed by a doctor ■ do not use for more than 10 days unless directed by a doctor children 6 years to under 12 years ■ take 1 caplet every 4 to 6 hours while symptoms last ■ do not take more than 5 caplets in 24 hours ■ do not use for more than 5 days unless directed by a doctor children under 6 years ask a doctor

Regulatory & Marketing

Labeler Name
Kenvue Brands Llc
Product Type
Human Otc Drug
FDA Application #
M013
Marketing Category
OTC MONOGRAPH DRUG -
Start Marketing Date
08-30-2025
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 (50580-475). Click a package code to view its specific billing and regulatory data.

50580-475-11
10 BLISTER PACK in 1 CARTON / 10 TABLET, FILM COATED in 1 BLISTER PACK
50580-475-50
1 BOTTLE in 1 CARTON / 50 TABLET, FILM COATED 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 50580-475-10 identifies a specific commercial package of 1 bottle in 1 carton / 1000 tablet, film coated in 1 bottle of Tylenol Regular Strength, a human over the counter drug labeled by Kenvue Brands Llc. This tablet, film coated is formulated for oral use and contains acetaminophen 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 August 30, 2025. 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: 50580047510. 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)
50580-475-10
11-Digit CMS (5-4-2)
50580-0475-10

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