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  4. NDC Product Code: 71042-005 Olive Extract, Calendula, Melaleuca

NDC 71042-005 Olive Extract, Calendula, Melaleuca

Ointment - View Dosage, Usage, Ingredients, Routes, UNII

Table of Contents

  1. Product Information
  2. Product Packages
  3. What is NDC 71042-005?
  4. Olive Extract, Calendula, Melaleuca Uses
  5. Active Ingredients
  6. Active Ingredients UNII Codes
  7. Inactive Ingredients UNII Codes

Product Information

This product is an UNFINISHED DRUG part of the official NDC directory. Unfinished drugs include products like active ingredients some of which are used in bulk for further processing or compounding. The FDA requires a list of these drugs manufactured in a U.S. commercial distribution facility.
NDC Product Code:
71042-005
Proprietary Name:
Olive Extract, Calendula, Melaleuca
Non-Proprietary Name: [1]
Olive Extract, Calendula, Melaleuca
Substance Name: [2]
Calendula Officinalis Flowering Top; Melaleuca Cajuputi Leaf Oil; Olea Europaea Fruit Volatile Oil
NDC Directory Status:
Human Otc Drug
Product Type: [3]
UNFINISHED PRODUCT INCLUDED in the NDC Directory
Dosage Form:
Ointment - A semisolid3 dosage form, usually containing <20% water and volatiles5 and >50% hydrocarbons, waxes, or polyols as the vehicle. This dosage form is generally for external application to the skin or mucous membranes.
Labeler Name: [5]
Organicare Nature's Science, Llc
Labeler Code:
71042
Product Label ID:
60cccf41-3534-3cfb-e053-2991aa0a1e04
Marketing Category: [8]
DRUG FOR FURTHER PROCESSING - A drug (other than the bulk ingredient API) that is in an interim stage of manufacture, processing, preparation, or packaging, and not ready for human or animal use.
Start Marketing Date: [9]
12-20-2017
Listing Expiration Date: [11]
12-31-2024
Exclude Flag: [12]
N
Unfinished Product: [13]
Yes
Code Structure:
Code Navigator:

Product Packages

NDC Code 71042-005-14

Package Description: 14 g in 1 TUBE

Product Details

What is NDC 71042-005?

The NDC code 71042-005 is assigned by the FDA to the UNFINISHED product Olive Extract, Calendula, Melaleuca which is a human over the counter drug product labeled by Organicare Nature's Science, Llc. The generic name of Olive Extract, Calendula, Melaleuca is olive extract, calendula, melaleuca. The product's dosage form is ointment. The product is distributed in a single package with assigned NDC code 71042-005-14 14 g in 1 tube . 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 Olive Extract, Calendula, Melaleuca?

UsesSee your doctor if this is the first time you have vaginal itching and discomfort to find out if you have a vaginal yeast infection.Treats repeat vaginal yeast infectionsTo relieve external itching and irritation due to a repeat vaginal yeast infection

What are Olive Extract, Calendula, Melaleuca 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 Olive Extract, Calendula, Melaleuca UNII Codes?

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

  • MELALEUCA CAJUPUTI LEAF OIL (UNII: 5O59RMR6DU)
  • MELALEUCA CAJUPUTI LEAF OIL (UNII: 5O59RMR6DU) (Active Moiety)
  • OLEA EUROPAEA FRUIT VOLATILE OIL (UNII: 8E7358CX1J)
  • OLEA EUROPAEA FRUIT VOLATILE OIL (UNII: 8E7358CX1J) (Active Moiety)
  • CALENDULA OFFICINALIS FLOWERING TOP (UNII: 18E7415PXQ)
  • CALENDULA OFFICINALIS FLOWERING TOP (UNII: 18E7415PXQ) (Active Moiety)

Which are Olive Extract, Calendula, Melaleuca 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:

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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.

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

[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".

[13] What is an Unfinished Product? - This field indicates if the product is an unfinished drug. An unfinished drug is an active pharmaceutical ingredient either alone or with other ingredients that is not a finished drug product. Unfinished drugs are used to process other drugs or for drug compounding.