FDA.reportPublic FDA data

Cetacaine Anesthetic

Product NDC
10223-0225
11-digit product format
102230225
Labeler code
10223
Product ID
10223-0225_66344c64-2439-4a34-8eb4-707e707c8ab1
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Benzocaine, Butamben, and Tetracaine Hydrochloride
Dosage form
SOLUTION
Route
TOPICAL
Labeler
Cetylite Industries, Inc.
Marketing category
UNAPPROVED DRUG OTHER
Marketing start
1960-01-01
Substance
BENZOCAINE; BUTAMBEN; TETRACAINE HYDROCHLORIDE
Active strength
.028; .004; .004 g/.2g; g/.2g; g/.2g
Pharmacologic classes
Allergens [CS], Cell-mediated Immunity [PE], Ester Local Anesthetic [EPC], Esters [CS], Increased Histamine Release [PE], Local Anesthesia [PE], Standardized Chemical Allergen [EPC]
NDC exclude flag
No
Listing certified through
2026-12-31
Current FDA listing
Yes

Additional Listing Data#

Finished product
Yes
Brand name base
Cetacaine Anesthetic
Listing expiration
2026-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
BENZOCAINE.028 g/.2g
BUTAMBEN.004 g/.2g
TETRACAINE HYDROCHLORIDE.004 g/.2g

Harmonized Identifiers#

Field, Values table
FieldValues
UniiU3RSY48JW5, EFW857872Q, 5NF5D4OPCI
Rxcui543786, 543789

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
a26f29b9-6919-4f09-a354-491df8d2b97dProduct name120251021
122d1fa8-7b9e-49b4-89ce-b062ffd1d947Product name120181030
a993dfc5-f219-4460-bde6-30dd724d9ef0Product name120160818
4d7ae718-ed00-bae8-2abe-9eaec1eef7ffProduct name120140508
9137811f-f279-8640-5aeb-99fa2145d64dProduct name120140508

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
10223-0225-1Cetacaine Anesthetic11 g in 1 BOTTLE, GLASSSOLUTION119
10223-0225-1Cetacaine Anesthetic1 in 1 KITSOLUTION19

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
BenzocaineACTIVE INGREDIENTU3RSY48JW5CETACAINE ANESTHETIC (BENZOCAINE, BUTAMBEN, AND TETRACAINE HYDROCHLORIDE) SOLUTION [CETYLITE INDUSTRIES, INC.]4
ButambenACTIVE INGREDIENTEFW857872QCETACAINE ANESTHETIC (BENZOCAINE, BUTAMBEN, AND TETRACAINE HYDROCHLORIDE) SOLUTION [CETYLITE INDUSTRIES, INC.]4
Tetracaine HydrochlorideACTIVE INGREDIENT5NF5D4OPCICETACAINE ANESTHETIC (BENZOCAINE, BUTAMBEN, AND TETRACAINE HYDROCHLORIDE) SOLUTION [CETYLITE INDUSTRIES, INC.]4
BenzocaineACTIVE MOIETYU3RSY48JW5CETACAINE ANESTHETIC (BENZOCAINE, BUTAMBEN, AND TETRACAINE HYDROCHLORIDE) SOLUTION [CETYLITE INDUSTRIES, INC.]4
ButambenACTIVE MOIETYEFW857872QCETACAINE ANESTHETIC (BENZOCAINE, BUTAMBEN, AND TETRACAINE HYDROCHLORIDE) SOLUTION [CETYLITE INDUSTRIES, INC.]4
TetracaineACTIVE MOIETY0619F35CGVCETACAINE ANESTHETIC (BENZOCAINE, BUTAMBEN, AND TETRACAINE HYDROCHLORIDE) SOLUTION [CETYLITE INDUSTRIES, INC.]4
Benzalkonium chlorideINACTIVE INGREDIENTF5UM2KM3W7CETACAINE ANESTHETIC (BENZOCAINE, BUTAMBEN, AND TETRACAINE HYDROCHLORIDE) SOLUTION [CETYLITE INDUSTRIES, INC.]4
Dipropylene glycolINACTIVE INGREDIENTE107L85C40CETACAINE ANESTHETIC (BENZOCAINE, BUTAMBEN, AND TETRACAINE HYDROCHLORIDE) SOLUTION [CETYLITE INDUSTRIES, INC.]4
Mecetronium BromideINACTIVE INGREDIENT7ZNQ7FIO9KCETACAINE ANESTHETIC (BENZOCAINE, BUTAMBEN, AND TETRACAINE HYDROCHLORIDE) SOLUTION [CETYLITE INDUSTRIES, INC.]4
SaccharinINACTIVE INGREDIENTFST467XS7DCETACAINE ANESTHETIC (BENZOCAINE, BUTAMBEN, AND TETRACAINE HYDROCHLORIDE) SOLUTION [CETYLITE INDUSTRIES, INC.]4

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
10223-0225CETACAINE ANESTHETIC (BENZOCAINE, BUTAMBEN, AND TETRACAINE HYDROCHLORIDE) SOLUTION [CETYLITE INDUSTRIES, INC.]9Current NDC, 2 package rows20250116_89f262a4-a41b-41d7-806b-61b9b89542f0.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
543786benzocaine 14 % / butamben 2 % / tetracaine HCl 2 % Mucous Membrane Topical SolutionPSN89f262a4-a41b-41d7-806b-61b9b89542f09
543789Cetacaine LIQUID 14 % / 2 % / 2 % Mucous Membrane Topical SolutionPSN89f262a4-a41b-41d7-806b-61b9b89542f09
543789benzocaine 140 MG/ML / butamben 20 MG/ML / tetracaine 20 MG/ML Mucous Membrane Topical Solution [Cetacaine]SBD89f262a4-a41b-41d7-806b-61b9b89542f09
543786benzocaine 140 MG/ML / butamben 20 MG/ML / tetracaine 20 MG/ML Mucous Membrane Topical SolutionSCD89f262a4-a41b-41d7-806b-61b9b89542f09
543786benzocaine 14 % / butamben 2 % / tetracaine HCl 2 % Mucous Membrane Topical SolutionSY89f262a4-a41b-41d7-806b-61b9b89542f09
543789Cetacaine (benzocaine 14 % / butamben 2 % / tetracaine 2 % ) Mucous Membrane Topical SolutionSY89f262a4-a41b-41d7-806b-61b9b89542f09
543789Cetacaine (benzocaine 140 MG/ML / butamben 20 MG/ML / tetracaine 20 MG/ML) Mucous Membrane Topical SolutionSY89f262a4-a41b-41d7-806b-61b9b89542f09

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionMarketing startSampleExclude flagStatus
10223-0225-1102230225011 BOTTLE, GLASS in 1 KIT (10223-0225-1) / 11 g in 1 BOTTLE, GLASS1960-01-01NoNoHistorical