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  4. NDC Product Code: 10223-0201 Cetacaine Anesthetic

NDC 10223-0201 Cetacaine Anesthetic

Benzocaine,Butamben,And Tetracaine Hydrochloride Aerosol, Spray Topical - View Dosage, Usage, Ingredients, Routes, UNII

Table of Contents

  1. Product Information
  2. Product Packages
  3. Product Characteristics
  4. What is NDC 10223-0201?
  5. Cetacaine Anesthetic Uses
  6. Active Ingredients
  7. Active Ingredients UNII Codes
  8. Inactive Ingredients UNII Codes
  9. NDC to RxNorm Crosswalk
  10. Pharmacologic Classes

Product Information

NDC Product Code:
10223-0201
Proprietary Name:
Cetacaine Anesthetic
Non-Proprietary Name: [1]
Benzocaine, Butamben, And Tetracaine Hydrochloride
Substance Name: [2]
Benzocaine; Butamben; Tetracaine Hydrochloride
NDC Directory Status:
Human Prescription Drug
Product Type: [3]
ACTIVE PRODUCT INCLUDED in the NDC Directory
Dosage Form:
Aerosol, Spray - An aerosol product which utilizes a compressed gas as the propellant to provide the force necessary to expel the product as a wet spray; it is applicable to solutions of medicinal agents in aqueous 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 Name: [5]
    Cetylite Industries, Inc.
    Labeler Code:
    10223
    Product Label ID:
    af1773c5-5d5b-4278-b551-30ad2df6d5b5
    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]
    01-01-1958
    Listing Expiration Date: [11]
    12-31-2024
    Exclude Flag: [12]
    N
    Code Navigator:

    Product Characteristics

    Flavor(s):
    BANANA (C73364)

    Code Structure Chart

    Product Details

    What is NDC 10223-0201?

    The NDC code 10223-0201 is assigned by the FDA to the product Cetacaine Anesthetic which is a human prescription drug product labeled by Cetylite Industries, Inc.. The generic name of Cetacaine Anesthetic is benzocaine, butamben, and tetracaine hydrochloride. The product's dosage form is aerosol, spray and is administered via topical form. The product is distributed in 2 packages with assigned NDC codes 10223-0201-3 1 bottle, glass in 1 box / 20 g in 1 bottle, glass, 10223-0201-4 1 bottle, glass in 1 box / 5 g in 1 bottle, glass. 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 Cetacaine Anesthetic?

    Cetacaine is a topical anesthetic indicated for the production of anesthesiaof all accessible mucous membrane except the eyes. CetacaineSpray is indicated for use to control pain or gagging.Cetacaine in all forms is indicated to control pain and for use for surgicalor endoscopic or other procedures in the ear, nose, mouth, pharynx,larynx, trachea, bronchi, and esophagus. It may also be used forvaginal or rectal procedures when feasible.

    What are Cetacaine Anesthetic 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 Cetacaine Anesthetic UNII Codes?

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

    Which are Cetacaine Anesthetic 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:

    What is the NDC to RxNorm Crosswalk for Cetacaine Anesthetic?

    RxNorm is a normalized naming system for generic and branded drugs that assigns unique concept identifier(s) known as RxCUIs to NDC products.The NDC to RxNorm Crosswalk for this produdct indicates multiple concept unique identifiers (RXCUIs) are associated with this product:
    • RxCUI: 1722107 - Cetacaine 14 % / 2 % / 2 % Mucosal Spray
    • RxCUI: 1722107 - benzocaine 140 MG/ML / butamben 20 MG/ML / tetracaine 20 MG/ML Mucosal Spray [Cetacaine]
    • RxCUI: 999683 - benzocaine 14 % / butamben 2 % / tetracaine 2 % Mucosal Spray
    • RxCUI: 999683 - benzocaine 140 MG/ML / butamben 20 MG/ML / tetracaine 20 MG/ML Mucosal Spray

    Which are the Pharmacologic Classes for Cetacaine Anesthetic?

    A pharmacologic class is a group of drugs that share the same scientifically documented properties. The following is a list of the reported pharmacologic class(es) corresponding to the active ingredients of this product.

    * 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".