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  4. NDC Product Code: 51879-400 Tecnu Ivy Complete Kit

NDC 51879-400 Tecnu Ivy Complete Kit

Ivy Treatment Kit Topical - View Dosage, Usage, Ingredients, Routes, UNII

Table of Contents

  1. Product Information
  2. Product Packages
  3. What is NDC 51879-400?
  4. Tecnu Ivy Complete Kit Uses
  5. Active Ingredients UNII Codes
  6. Inactive Ingredients UNII Codes
  7. NDC to RxNorm Crosswalk

Product Information

NDC Product Code:
51879-400
Proprietary Name:
Tecnu Ivy Complete Kit
Non-Proprietary Name: [1]
Ivy Treatment
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.
Administration Route(s): [4]
  • Topical - Administration to a particular spot on the outer surface of the body. The E2B term TRANSMAMMARY is a subset of the term TOPICAL.
    • Labeler Name: [5]
    Tec Laboratories Inc.
    Labeler Code:
    51879
    Product Label ID:
    f047af5d-45d8-11ae-e053-2a95a90a2a22
    FDA Application Number: [6]
    part348
    Marketing Category: [8]
    OTC MONOGRAPH NOT FINAL - A product marketed pursuant to an Over-the-Counter (OTC) Drug Monograph that is not final.
    Start Marketing Date: [9]
    01-16-2023
    Listing Expiration Date: [11]
    12-31-2024
    Exclude Flag: [12]
    N
    Code Navigator:

    Code Structure Chart

    Product Details

    What is NDC 51879-400?

    The NDC code 51879-400 is assigned by the FDA to the product Tecnu Ivy Complete Kit which is a human over the counter drug product labeled by Tec Laboratories Inc.. The generic name of Tecnu Ivy Complete Kit is ivy treatment. The product's dosage form is kit and is administered via topical form. The product is distributed in a single package with assigned NDC code 51879-400-04 1 kit in 1 carton * 113.4 g in 1 bottle (51879-410-04). 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 Tecnu Ivy Complete Kit?

    For the temporary relief of pain and itching associated with:•minor burns•sunburn•minor cuts•scrapes•insect bites•minor skin irritaitons•rashes due to poison ivy, poison oak and poison sumac

    Which are Tecnu Ivy Complete Kit UNII Codes?

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

    • DIPHENHYDRAMINE HYDROCHLORIDE (UNII: TC2D6JAD40)
    • DIPHENHYDRAMINE (UNII: 8GTS82S83M) (Active Moiety)

    Which are Tecnu Ivy Complete Kit 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 Tecnu Ivy Complete Kit?

    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.

    [4] What are the Administration Routes? - The translation of the route code submitted by the firm, indicating route of administration.

    [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".