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  4. NDC Product Code: 42669-231 Medicated Cornstarch Baby Powder

NDC 42669-231 Medicated Cornstarch Baby Powder

Active Corn Starch Powder Topical - View Dosage, Usage, Ingredients, Routes, UNII

Table of Contents

  1. Product Information
  2. Product Packages
  3. What is NDC 42669-231?
  4. Medicated Cornstarch Baby Powder Uses
  5. Active Ingredients
  6. Active Ingredients UNII Codes
  7. Inactive Ingredients UNII Codes
  8. NDC to RxNorm Crosswalk

Product Information

NDC Product Code:
42669-231
Proprietary Name:
Medicated Cornstarch Baby Powder
Non-Proprietary Name: [1]
Active Corn Starch
Substance Name: [2]
Kaolin; Starch, Corn; Zinc Oxide
NDC Directory Status:
Human Otc Drug
Product Type: [3]
ACTIVE PRODUCT INCLUDED in the NDC Directory
Dosage Form:
Powder - An intimate mixture of dry, finely divided drugs and/or chemicals that may be intended for internal or external use.
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]
    Davion, Inc.
    Labeler Code:
    42669
    Product Label ID:
    e39032d1-c8cd-4a41-af10-126970b8ad38
    FDA Application Number: [6]
    M016
    Marketing Category: [8]
    OTC MONOGRAPH DRUG -
    Start Marketing Date: [9]
    09-01-2016
    Listing Expiration Date: [11]
    12-31-2025
    Exclude Flag: [12]
    N
    Code Structure:
    Code Navigator:

    Product Packages

    NDC Code 42669-231-04

    Package Description: 113 g in 1 BOX

    Product Details

    What is NDC 42669-231?

    The NDC code 42669-231 is assigned by the FDA to the product Medicated Cornstarch Baby Powder which is a human over the counter drug product labeled by Davion, Inc.. The generic name of Medicated Cornstarch Baby Powder is active corn starch. The product's dosage form is powder and is administered via topical form. The product is distributed in a single package with assigned NDC code 42669-231-04 113 g in 1 box . 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 Medicated Cornstarch Baby Powder?

    Babies: Change wet and soiled diaper promptly, cleanse the diaper area and allow to dry.  Apply powder liberally as often as necessary, with each diaper change, especially at bedtime, or anytime when exposure to wet diapers may be prolonged.  Apply powder close to the body away from child's face.  Carefully shake the powder into the diaper or into the hand and apply to diaper area.  Adults and children 2 years and older: apply freely up to 3 or 4 times daily.  For best results, dry skin thoroughly before applying.

    What are Medicated Cornstarch Baby Powder Active Ingredients?

    An active ingredient is the substance responsible for the medicinal effects of a product specified by the substance's molecular structure or if the molecular structure is not known, defined by an unambiguous definition that identifies the substance. Each active ingredient name is the preferred term of the UNII code submitted.
    • KAOLIN 4.52 g/113g - The most common mineral of a group of hydrated aluminum silicates, approximately H2Al2Si2O8-H2O. It is prepared for pharmaceutical and medicinal purposes by levigating with water to remove sand, etc. (From Merck Index, 11th ed) The name is derived from Kao-ling (Chinese: "high ridge"), the original site. (From Grant & Hackh's Chemical Dictionary, 5th ed)
    • STARCH, CORN 89.27 g/113g
    • ZINC OXIDE 16.95 g/113g - A mild astringent and topical protectant with some antiseptic action. It is also used in bandages, pastes, ointments, dental cements, and as a sunblock.

    Which are Medicated Cornstarch Baby Powder UNII Codes?

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

    Which are Medicated Cornstarch Baby Powder 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 Medicated Cornstarch Baby Powder?

    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:
    • RxCUI: 1361201 - cornstarch 79 % / kaolin 4 % / zinc oxide 15 % Topical Powder
    • RxCUI: 1361201 - corn starch 0.79 MG/MG / kaolin 0.04 MG/MG / zinc oxide 0.15 MG/MG Topical Powder
    • RxCUI: 1361201 - corn starch 0.79 MG/MG / Kaolin 0.04 MG/MG / ZNO 0.15 MG/MG Topical Powder

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    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.

    [2] What is the Substance Name? - An active ingredient is the substance responsible for the medicinal effects of a product specified by the substance's molecular structure or if the molecular structure is not known, defined by an unambiguous definition that identifies the substance. Each active ingredient name is the preferred term of the UNII code submitted.

    [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".