NDC 76357-285 Smartmouth Mouthwash Clinical Dds Formula

Cetylpyridinium Chloride Kit - View Dosage, Usage, Ingredients, Routes, UNII

Product Information

NDC Product Code:
76357-285
Proprietary Name:
Smartmouth Mouthwash Clinical Dds Formula
Non-Proprietary Name: [1]
Cetylpyridinium Chloride
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]
Triumph Pharmaceuticals Inc.
Labeler Code:
76357
FDA Application Number: [6]
part356
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]
10-01-2018
Listing Expiration Date: [11]
12-31-2024
Exclude Flag: [12]
N
Code Structure:
Code Navigator:

Product Characteristics

Color(s):
WHITE (C48325 - CLEAR WATER)
GREEN (C48329)
Flavor(s):
MINT (C73404 - MINT VANILLA)

Product Packages

NDC Code 76357-285-01

Package Description: 1 KIT in 1 CELLO PACK * 480 mL in 1 BOTTLE, PLASTIC * 480 mL in 1 BOTTLE, PLASTIC

Product Details

What is NDC 76357-285?

The NDC code 76357-285 is assigned by the FDA to the product Smartmouth Mouthwash Clinical Dds Formula which is a human over the counter drug product labeled by Triumph Pharmaceuticals Inc.. The generic name of Smartmouth Mouthwash Clinical Dds Formula is cetylpyridinium chloride. The product's dosage form is kit. The product is distributed in a single package with assigned NDC code 76357-285-01 1 kit in 1 cello pack * 480 ml in 1 bottle, plastic * 480 ml in 1 bottle, plastic. 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 Smartmouth Mouthwash Clinical Dds Formula?

Adults and children 12 years of age and older: vigorously swish 20 milliliters of rinse (5 pumps from each bottle) twice a day for 30 seconds and then spit out. Do not swallow.Children 6 years to under 12 years of age: supervise use.Children under 6 years of age: do not use.

Which are Smartmouth Mouthwash Clinical Dds Formula UNII Codes?

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

Which are Smartmouth Mouthwash Clinical Dds Formula 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.

[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".