NDC 54111-165 Josie Maran Intensive Daily Repair Body Butter -vanilla And Shea
Colloidal Oatmeal 0.8% Cream Topical

Table of Contents

    1. Product Information
    2. Product Packages
    3. What is NDC 54111-165?
    4. Josie Maran Intensive Daily Repair Body Butter -vanilla And Shea Uses
    5. Active Ingredients
    6. Active Ingredients UNII Codes
    7. Inactive Ingredients UNII Codes
    8. NDC to RxNorm Crosswalk
    9. Pharmacologic Classes

Product Information

NDC Product Code54111-165
Proprietary Name 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.		Josie Maran Intensive Daily Repair Body Butter -vanilla And Shea
Non-Proprietary Name 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.		Colloidal Oatmeal 0.8%
Substance Name 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.		Oatmeal
Product Type 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.		Human Otc Drug
NDC Directory StatusACTIVE PRODUCT INCLUDED in the NDC Directory
Dosage FormCream - An emulsion, semisolid3 dosage form, usually containing > 20% water and volatiles5 and/or < 50% hydrocarbons, waxes, or polyols as the vehicle. This dosage form is generally for external application to the skin or mucous membranes.
Administration Route(s) What are the Administration Route(s)?
The translation of the route code submitted by the firm, indicating route of administration.
  • Topical - Administration to a particular spot on the outer surface of the body. The E2B term TRANSMAMMARY is a subset of the term TOPICAL.
Product Labeler Information What is the Labeler Name?
Name of Company corresponding to the labeler code segment of the Product NDC.		Bentley Laboratories, Llc
Labeler Code54111
SPL SET ID:0071a8c3-74df-443a-9d22-d4f6a86c9271
FDA Application Number 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.		part347
Marketing Category 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.		OTC MONOGRAPH FINAL - A product marketed pursuant to a final Over-the-Counter (OTC) Drug Monograph.
Start Marketing Date What is the Start Marketing Date?
This is the date that the labeler indicates was the start of its marketing of the drug product.		07-08-2022
Listing Expiration Date 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.		12-31-2023
Exclude Flag 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". 		N
NDC Code Structure

Product Packages

NDC Code 54111-165-50

Package Description: 1 JAR in 1 CARTON / 170 g in 1 JAR

Product Details

What is NDC 54111-165?

The NDC code 54111-165 is assigned by the FDA to the product Josie Maran Intensive Daily Repair Body Butter -vanilla And Shea which is a human over the counter drug product labeled by Bentley Laboratories, Llc. The generic name of Josie Maran Intensive Daily Repair Body Butter -vanilla And Shea is colloidal oatmeal 0.8%. The product's dosage form is cream and is administered via topical form. The product is distributed in a single package with assigned NDC code 54111-165-50 1 jar in 1 carton / 170 g in 1 jar. 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 Josie Maran Intensive Daily Repair Body Butter -vanilla And Shea?

Uses• temporarily protects and helps relieve minor skin irritation and itching due to eczema

What are Josie Maran Intensive Daily Repair Body Butter -vanilla And Shea 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.

Which are Josie Maran Intensive Daily Repair Body Butter -vanilla And Shea UNII Codes?

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

Which are Josie Maran Intensive Daily Repair Body Butter -vanilla And Shea 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 Josie Maran Intensive Daily Repair Body Butter -vanilla And Shea?

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:

Which are the Pharmacologic Classes for Josie Maran Intensive Daily Repair Body Butter -vanilla And Shea?

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