NDC 82377-301 Disinfection-tablets

Hocl Solution Topical - View Dosage, Usage, Ingredients, Routes, UNII

Product Information

NDC Product Code:
82377-301
Proprietary Name:
Disinfection-tablets
Non-Proprietary Name: [1]
Hocl
Substance Name: [2]
Hypochlorous Acid
NDC Directory Status:
Human Otc Drug
Product Type: [3]
ACTIVE PRODUCT INCLUDED in the NDC Directory
Dosage Form:
Solution - A clear, homogeneous liquid1 dosage form that contains one or more chemical substances dissolved in a solvent or mixture of mutually miscible solvents.
Administration Route(s): [4]
  • Topical - Administration to a particular spot on the outer surface of the body. The E2B term TRANSMAMMARY is a subset of the term TOPICAL.
  • Labeler Code:
    82377
    Marketing Category: [8]
    UNAPPROVED DRUG OTHER - An unapproved drug product in a marketing category that is not reflected on a particular list.
    Start Marketing Date: [9]
    11-04-2021
    Listing Expiration Date: [11]
    12-31-2024
    Exclude Flag: [12]
    N
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    Product Details

    What is NDC 82377-301?

    The NDC code 82377-301 is assigned by the FDA to the product Disinfection-tablets which is a human over the counter drug product labeled by Jinhua Shuxin Pharmaceutical Biotechnology Co., Ltd.. The generic name of Disinfection-tablets is hocl. The product's dosage form is solution and is administered via topical form. The product is distributed in 10 packages with assigned NDC codes 82377-301-01 6 mg in 1 bottle , 82377-301-02 8 mg in 1 bottle , 82377-301-03 10 mg in 1 bottle , 82377-301-04 12 mg in 1 bottle , 82377-301-05 24 mg in 1 bottle , 82377-301-06 30 mg in 1 bottle , 82377-301-07 40 mg in 1 bottle , 82377-301-08 50 mg in 1 bottle , 82377-301-09 60 mg in 1 bottle , 82377-301-10 100 mg in 1 bottle . 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 Disinfection-tablets?

    Simply drop 1 tablet into 17 fl oz(500mL) of clean water. Let the tablet dissolve to form the sterilising solution. Spray on the skin 3-5 times each use. No rinsing reqiured.

    What are Disinfection-tablets 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.
    • HYPOCHLOROUS ACID .8 mg/mg - An oxyacid of chlorine (HClO) containing monovalent chlorine that acts as an oxidizing or reducing agent.

    * 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.

    [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.

    [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".