NDC 37000-962 Oral B Mouth Sore Special Care Rinse

Sodium Fluoride Rinse Oral - View Dosage, Usage, Ingredients, Routes, UNII

Product Information

NDC Product Code:
37000-962
Proprietary Name:
Oral B Mouth Sore Special Care Rinse
Non-Proprietary Name: [1]
Sodium Fluoride
Substance Name: [2]
Hydrogen Peroxide
NDC Directory Status:
Human Otc Drug
Product Type: [3]
ACTIVE PRODUCT INCLUDED in the NDC Directory
Dosage Form:
Rinse - A liquid used to cleanse by flushing.
Administration Route(s): [4]
  • Oral - Administration to or by way of the mouth.
  • Labeler Name: [5]
    The Procter & Gamble Manufacturing Company
    Labeler Code:
    37000
    FDA Application Number: [6]
    M021
    Marketing Category: [8]
    OTC MONOGRAPH DRUG -
    Start Marketing Date: [9]
    01-02-2020
    Listing Expiration Date: [11]
    12-31-2024
    Exclude Flag: [12]
    N
    Code Navigator:

    Product Characteristics

    Flavor(s):
    MINT (C73404)

    Product Packages

    NDC Code 37000-962-08

    Package Description: 237 mL in 1 BOTTLE, PLASTIC

    NDC Code 37000-962-16

    Package Description: 475 mL in 1 BOTTLE, PLASTIC

    Product Details

    What is NDC 37000-962?

    The NDC code 37000-962 is assigned by the FDA to the product Oral B Mouth Sore Special Care Rinse which is a human over the counter drug product labeled by The Procter & Gamble Manufacturing Company. The generic name of Oral B Mouth Sore Special Care Rinse is sodium fluoride. The product's dosage form is rinse and is administered via oral form. The product is distributed in 2 packages with assigned NDC codes 37000-962-08 237 ml in 1 bottle, plastic , 37000-962-16 475 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 Oral B Mouth Sore Special Care Rinse?

    • adults and children 6 yrs. & older:Rinse with 20 mLSwish around in the mouth over the affected area for at least 1 minute and then spit out.Use up to four times daily after meals and at bedtime or as directed by a dentist or doctor.do not swallowchildren 6 years to under 12 years of age:supervise usechildren under 6 years of age:do not use

    What are Oral B Mouth Sore Special Care Rinse 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.
    • HYDROGEN PEROXIDE .03 mL/20mL - A strong oxidizing agent used in aqueous solution as a ripening agent, bleach, and topical anti-infective. It is relatively unstable and solutions deteriorate over time unless stabilized by the addition of acetanilide or similar organic materials.

    Which are Oral B Mouth Sore Special Care Rinse UNII Codes?

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

    Which are Oral B Mouth Sore Special Care Rinse 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.

    [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".