Cetacaine Anesthetic Aerosol, Spray
NDC 10223-0201

View dosage, usage, ingredients, routes, and UNII mappings.
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

Cetacaine Anesthetic (benzocaine, butamben, and tetracaine hydrochloride) is a UNAPPROVED DRUG OTHER-approved product labeled by Cetylite Industries, Inc.. This medication is typically used as a allergens [cs]. It is supplied as a aerosol, spray for topical administration. This product entry covers the primary NDC 10223-0201 and 3 associated package configurations. This profile includes active and inactive ingredient UNII references and FDA labeling data.

Primary Identification

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
Code Navigator:

Clinical Specifications

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 & Regulatory Data

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.

Marketing Timeline

Start Marketing Date: [9]
01-01-1958
Listing Expiration Date: [11]
12-31-2026
Exclude Flag: [12]
N

Product Characteristics

Flavor(s):

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. It is commonly known by its generic name, benzocaine, butamben, and tetracaine hydrochloride. This pharmaceutical product is labeled by Cetylite Industries, Inc. and is currently categorized as listed product. The medication is a aerosol, spray administered via topical route. In terms of distribution, this product is available in 3 different package configurations. The associated package NDC(s) include: 10223-0201-1, 10223-0201-3, 10223-0201-4. Beyond standard identification, this entry provides technical data including pharmacologic classes, UNII ingredient references, and RxNorm cross-referencing for healthcare systems.

What are the uses of this product?

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 Active Ingredients of this product?

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 the associated UNII Codes?

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

Which are the Inactive Ingredients associated 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 this product?

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 of this product?

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.

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Product & Regulatory Definitions
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.
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.
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.
What are the Administration Routes? The translation of the route code submitted by the firm, indicating route of administration.
What is the Labeler Name? Name of Company corresponding to the labeler code segment of the Product NDC.
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.
What is the Start Marketing Date? This is the date that the labeler indicates was the start of its marketing of the drug product.
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.
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, or because the listing certification is expired, or because the listing data was inactivated by FDA, or because it was discontinued by the labeler. Possible values in this field are: "D", "E", "I", "N", "U".