1. Home
  2. Labeler Index
  3. Saje Natural Business Inc.
  4. NDC Product Code: 70983-016 Comfort And Ease

NDC 70983-016 Comfort And Ease

Menthol Kit - View Dosage, Usage, Ingredients, Routes, UNII

Table of Contents

  1. Product Information
  2. Product Packages
  3. Product Characteristics
  4. What is NDC 70983-016?
  5. Comfort And Ease Uses
  6. Active Ingredients UNII Codes
  7. Inactive Ingredients UNII Codes

Product Information

NDC Product Code:
70983-016
Proprietary Name:
Comfort And Ease
Non-Proprietary Name: [1]
Menthol
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.
Labeler Name: [5]
Saje Natural Business Inc.
Labeler Code:
70983
Product Label ID:
97640f0c-0e8d-48ad-80a2-d3988962ded2
FDA Application Number: [6]
part341
Marketing Category: [8]
OTC MONOGRAPH FINAL - A product marketed pursuant to a final Over-the-Counter (OTC) Drug Monograph.
Start Marketing Date: [9]
10-16-2016
Listing Expiration Date: [11]
12-31-2024
Exclude Flag: [12]
N
Code Navigator:

Product Characteristics

Color(s):
WHITE (C48325 - CLEAR)
Shape:
FREEFORM (C48340)

Code Structure Chart

Product Details

What is NDC 70983-016?

The NDC code 70983-016 is assigned by the FDA to the product Comfort And Ease which is a human over the counter drug product labeled by Saje Natural Business Inc.. The generic name of Comfort And Ease is menthol. The product's dosage form is kit. The product is distributed in a single package with assigned NDC code 70983-016-18 1 kit in 1 kit * 6 ml in 1 bottle, dropper * 6 ml in 1 bottle, dropper * 6 ml in 1 bottle, dropper. 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 Comfort And Ease?

See important warnings under 'When using this product'Adults and children 12 years or older: rub on throat and chest in a  thick layercover with warm cloth if desiredclothing should be loose about throat and chest to help vapors reach the nose and mouth See important warnings under 'When using this product'Adults and children 12 years and older: rub on the throat and chest in a thick layercover with a warm, dry cloth if desiredclothing should be loose about throat and chest to help vapors reach the nose and mouth

Which are Comfort And Ease UNII Codes?

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

Which are Comfort And Ease 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:

* 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.

[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".