NDC 10223-0201

Cetacaine Anesthetic

Benzocaine, Butamben, And Tetracaine Hydrochloride

Cetacaine Anesthetic is a Topical Aerosol, Spray in the Human Prescription Drug category. It is labeled and distributed by Cetylite Industries, Inc.. The primary component is Benzocaine; Butamben; Tetracaine Hydrochloride.

• Product ID: 10223-0201_54cdf552-81f5-49ad-a5c3-1987f6ea1990
• NDC: 10223-0201
• Product Type: Human Prescription Drug
• Proprietary Name: Cetacaine Anesthetic
• Generic Name: Benzocaine, Butamben, And Tetracaine Hydrochloride
• Dosage Form: Aerosol, Spray
• Route of Administration: TOPICAL
• Marketing Start Date: 1958-01-01
• Marketing Category: UNAPPROVED DRUG OTHER / UNAPPROVED DRUG OTHER
• Labeler Name: Cetylite Industries, Inc.
• Substance Name: BENZOCAINE; BUTAMBEN; TETRACAINE HYDROCHLORIDE
• Active Ingredient Strength: 0 g/.2g; g/.2g; g/.2g
• Pharm Classes: Standardized Chemical Allergen [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Allergens [CS],Esters [CS],Local Anesthesia [PE],Ester Local Anesthetic [EPC]
• NDC Exclude Flag: N
• Listing Certified Through: 2019-12-31

Packaging

NDC 10223-0201-3

1 BOTTLE, GLASS in 1 BOX (10223-0201-3) > 20 g in 1 BOTTLE, GLASS

• Marketing Start Date: 2016-01-01
• NDC Exclude Flag: N
• Sample Package?: N

NDC SPL Data Element Entries

NDC 10223-0201-3 [10223020103]

Cetacaine Anesthetic AEROSOL, SPRAY

• Marketing Category: UNAPPROVED DRUG OTHER
• Product Type: HUMAN PRESCRIPTION DRUG
• Billing Unit: GM
• Marketing Start Date: 2016-01-01

NDC 10223-0201-4 [10223020104]

Cetacaine Anesthetic AEROSOL, SPRAY

• Marketing Category: UNAPPROVED DRUG OTHER
• Product Type: HUMAN PRESCRIPTION DRUG
• Billing Unit: GM
• Marketing Start Date: 2017-11-01

NDC 10223-0201-1 [10223020101]

Cetacaine Anesthetic AEROSOL, SPRAY

• Marketing Category: UNAPPROVED DRUG OTHER
• Product Type: HUMAN PRESCRIPTION DRUG
• Billing Unit: GM
• Marketing Start Date: 1958-01-01
• Marketing End Date: 2018-01-31

Drug Details

Active Ingredients

Ingredient	Strength
BENZOCAINE	.028 g/.2g

OpenFDA Data

• SPL SET ID: af1773c5-5d5b-4278-b551-30ad2df6d5b5
• Manufacturer:
  • Cetylite Industries, Inc.
• UNII:
  • U3RSY48JW5
  • EFW857872Q
  • 5NF5D4OPCI
• RxNorm Concept Unique ID - RxCUI:
  • 1722107
  • 999683

Pharmacological Class

• Standardized Chemical Allergen [EPC]
• Increased Histamine Release [PE]
• Cell-mediated Immunity [PE]
• Allergens [CS]
• Esters [CS]
• Local Anesthesia [PE]
• Ester Local Anesthetic [EPC]

NDC Crossover Matching brand name "Cetacaine Anesthetic" or generic name "Benzocaine, Butamben, And Tetracaine Hydrochloride"

NDC	Brand Name	Generic Name
10223-0201	Cetacaine Anesthetic	Benzocaine, Butamben, and Tetracaine Hydrochloride
10223-0202	Cetacaine Anesthetic	Benzocaine, Butamben, and Tetracaine Hydrochloride
10223-0217	Cetacaine Topical Anesthetic	Benzocaine, Butamben, and Tetracaine Hydrochloride
10223-0221	Cetacaine Topical Anesthetic	Benzocaine, Butamben, and Tetracaine Hydrochloride