NDC 74084-0011-2 Dr.libeaute Thermal Spring Water

Allantoin

  1. Labeler Index
  2. Ongoong Co Ltd
  3. 74084-0011
  4. NDC Code: 74084-0011-2 Dr.libeaute Thermal Spring Water

NDC Package Code 74084-0011-2

The NDC Code 74084-0011-2 is assigned to a package of 100 ml in 1 bottle of Dr.libeaute Thermal Spring Water, a human over the counter drug labeled by Ongoong Co Ltd. The product's dosage form is liquid and is administered via topical form.

Field Name Field Value
NDC Code 74084-0011-2
Package Description 100 mL in 1 BOTTLE
Proprietary Name Dr.libeaute Thermal Spring Water What is the Proprietary Name?
The proprietary name also known as the trade name is the name of the product chosen by the medication labeler for marketing purposes.
Non-Proprietary Name Allantoin 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.
11-Digit NDC Billing Format 74084001102 NDC Format for Billing
For insurance billing purposes the Centers for Medicare & Medicaid Services (CMS) created an 11 digit NDC derivative identifier. If the NDC Package code is less than 11 digits the code must be padded with leading zeros. The leading zeros must be added to the appropriate segment to create a 5-4-2 configuration.
Product Type Human Otc Drug 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.
Labeler Name Ongoong Co Ltd
Dosage Form Liquid - A dosage form consisting of a pure chemical in its liquid1 state. This dosage form term should not be applied to solutions.
Administration Route(s)
  • Topical - Administration to a particular spot on the outer surface of the body. The E2B term TRANSMAMMARY is a subset of the term TOPICAL.
Active Ingredient(s)
  • ALLANTOIN .5 g/100mL
Sample Package No Sample Package?
This field Indicates whether this package is a sample packaging or not.
Marketing Category UNAPPROVED DRUG OTHER - 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.
Start Marketing Date 01-30-2021 What is the Start Marketing Date?
This is the date that the labeler indicates was the start of its marketing of the drug product.
Listing Expiration Date 12-31-2022 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.
Exclude Flag N 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. Values = ‘Y’ or ‘N’.

NDC Code Structure

  • 74084 - Ongoong Co Ltd
    • 74084-0011 - Dr.libeaute Thermal Spring Water
      • 74084-0011-2 - 100 mL in 1 BOTTLE

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.

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Other Product Packages

The following packages are also available for Dr.libeaute Thermal Spring Water with product NDC 74084-0011.

NDC Package CodePackage Description
74084-0011-1500 mL in 1 BOTTLE

* Please review the disclaimer below.