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NDC 50580-460 Childrens Tylenol

Acetaminophen Kit - View Dosage, Usage, Ingredients, Routes, UNII

Table of Contents

  1. Product Information
  2. Product Packages
  3. Product Characteristics
  4. What is NDC 50580-460?
  5. Childrens Tylenol Uses
  6. Active Ingredients UNII Codes
  7. Inactive Ingredients UNII Codes
  8. NDC to RxNorm Crosswalk

Product Information

NDC Product Code:
50580-460
Proprietary Name:
Childrens Tylenol
Non-Proprietary Name: [1]
Acetaminophen
NDC Directory Status:
Human Otc Drug
Product Type: [3]
ACTIVE PRODUCT INCLUDED in the NDC Directory
Dosage Form:
Kit - A packaged collection of related material.
Labeler Name: [5]
Johnson & Johnson Consumer Inc.
Labeler Code:
50580
Product Label ID:
babcb210-6a47-46ef-b4ea-bdde80411cd3
FDA Application Number: [6]
M013
Marketing Category: [8]
OTC MONOGRAPH DRUG -
Start Marketing Date: [9]
05-07-2018
Listing Expiration Date: [11]
12-31-2025
Exclude Flag: [12]
N
Code Structure:
Code Navigator:

Product Characteristics

Color(s):
PURPLE (C48327)
Shape:
ROUND (C48348)
Size(s):
16 MM
Imprint(s):
TY;160;HALF;HALF
Score:
2
Flavor(s):
GRAPE (C73391)

Product Packages

NDC Code 50580-460-01

Package Description: 1 KIT in 1 PACKAGE * 1 BOTTLE in 1 CARTON (50580-522-24) / 24 TABLET, CHEWABLE in 1 BOTTLE * 1 BOTTLE in 1 CARTON (50580-612-01) / 120 mL in 1 BOTTLE

Product Details

What is NDC 50580-460?

The NDC code 50580-460 is assigned by the FDA to the product Childrens Tylenol which is a human over the counter drug product labeled by Johnson & Johnson Consumer Inc.. The generic name of Childrens Tylenol is acetaminophen. The product's dosage form is kit. The product is distributed in a single package with assigned NDC code 50580-460-01 1 kit in 1 package * 1 bottle in 1 carton (50580-522-24) / 24 tablet, chewable in 1 bottle * 1 bottle in 1 carton (50580-612-01) / 120 ml in 1 bottle. This page includes all the important details about this product, including active and inactive ingredients, pharmagologic classes, product uses and characteristics, UNII information and RxNorm crosswalk.

What are the uses for Childrens Tylenol?

This drug is used to treat mild to moderate pain (from headaches, menstrual periods, toothaches, backaches, osteoarthritis, or cold/flu aches and pains) and to reduce fever.

Which are Childrens Tylenol UNII Codes?

The UNII codes for the active ingredients in this product are:

Which are Childrens Tylenol Inactive Ingredients UNII Codes?

The inactive ingredients are all the component of a medicinal product OTHER than the active ingredient(s). The acronym "UNII" stands for “Unique Ingredient Identifier” and is used to identify each inactive ingredient present in a product. The UNII codes for the inactive ingredients in this product are:

What is the NDC to RxNorm Crosswalk for Childrens Tylenol?

RxNorm is a normalized naming system for generic and branded drugs that assigns unique concept identifier(s) known as RxCUIs to NDC products.The NDC to RxNorm Crosswalk for this produdct indicates multiple concept unique identifiers (RXCUIs) are associated with this product:

* Please review the disclaimer below.

Product Footnotes

[1] What is the Non-Proprietary Name? - The non-proprietary name is sometimes called the generic name. The generic name usually includes the active ingredient(s) of the product.

[3] What kind of product is this? - Indicates the type of product, such as Human Prescription Drug or Human Over the Counter Drug. This data element matches the “Document Type” field of the Structured Product Listing.

[5] What is the Labeler Name? - Name of Company corresponding to the labeler code segment of the Product NDC.

[6] What is the FDA Application Number? - This corresponds to the NDA, ANDA, or BLA number reported by the labeler for products which have the corresponding Marketing Category designated. If the designated Marketing Category is OTC Monograph Final or OTC Monograph Not Final, then the Application number will be the CFR citation corresponding to the appropriate Monograph (e.g. “part 341”). For unapproved drugs, this field will be null.

[8] What is the Marketing Category? - Product types are broken down into several potential Marketing Categories, such as NDA/ANDA/BLA, OTC Monograph, or Unapproved Drug. One and only one Marketing Category may be chosen for a product, not all marketing categories are available to all product types. Currently, only final marketed product categories are included. The complete list of codes and translations can be found at www.fda.gov/edrls under Structured Product Labeling Resources.

[9] What is the Start Marketing Date? - This is the date that the labeler indicates was the start of its marketing of the drug product.

[11] What is the Listing Expiration Date? - This is the date when the listing record will expire if not updated or certified by the product labeler.

[12] What is the NDC Exclude Flag? - This field indicates whether the product has been removed/excluded from the NDC Directory for failure to respond to FDA"s requests for correction to deficient or non-compliant submissions ("Y"), or because the listing certification is expired ("E"), or because the listing data was inactivated by FDA ("I"). Values = "Y", "N", "E", or "I".