Cetacaine Anesthetic

Product NDC
10223-0202
11-digit product format
102230202
Labeler code
10223
Product ID
10223-0202_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
UniiEFW857872Q, 5NF5D4OPCI, U3RSY48JW5
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
10223-0202-2Cetacaine Anesthetic1 in 1 BOXSOLUTION19
10223-0202-2Cetacaine Anesthetic14 g in 1 BOTTLE, GLASSSOLUTION149
10223-0202-4Cetacaine Anesthetic1 in 1 BOXSOLUTION19
10223-0202-4Cetacaine Anesthetic30 g in 1 BOTTLE, GLASSSOLUTION309
10223-0202-5Cetacaine Anesthetic30 g in 1 BOTTLE, GLASSSOLUTION309
10223-0202-5Cetacaine Anesthetic1 in 1 KITSOLUTION19
10223-0202-6Cetacaine Anesthetic1 in 1 KITSOLUTION19
10223-0202-6Cetacaine Anesthetic14 g in 1 BOTTLE, GLASSSOLUTION149
10223-0202-7Cetacaine Anesthetic11 g in 1 BOTTLE, GLASSSOLUTION119
10223-0202-7Cetacaine Anesthetic1 in 1 BOXSOLUTION19
10223-0202-8Cetacaine Anesthetic1 in 1 BOXSOLUTION19
10223-0202-8Cetacaine Anesthetic24 g in 1 BOTTLE, GLASSSOLUTION249

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
10223-0202-2GM - Gram10223-0202abdc1d13-bab9-406a-a562-617ef0a9398912012-07-24
10223-0202-3GM - Gram10223-02026fd1486d-070d-4c77-a1bb-09ca413b7d3312012-07-24
10223-0202-4GM - Gram10223-020230f907fc-0f89-47c1-ab73-070e492c7c6512012-07-24
10223-0202-5GM - Gram10223-0202f5bfe00b-444e-45a8-86ff-ac9f2eb9651c12019-08-06

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
10223-0202CETACAINE ANESTHETIC (BENZOCAINE, BUTAMBEN, AND TETRACAINE HYDROCHLORIDE) SOLUTION [CETYLITE INDUSTRIES, INC.]9Current NDC, Legacy NDC, 12 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 startMarketing endSampleExclude flagStatus
10223-0202-2102230202021 BOTTLE, GLASS in 1 BOX (10223-0202-2) / 14 g in 1 BOTTLE, GLASS1960-01-010000-00-00NoNoCurrent
10223-0202-4102230202041 BOTTLE, GLASS in 1 BOX (10223-0202-4) > 30 g in 1 BOTTLE, GLASS1960-01-010000-00-00NoNoCurrent
10223-0202-5102230202051 BOTTLE, GLASS in 1 KIT (10223-0202-5) > 30 g in 1 BOTTLE, GLASS1960-01-010000-00-00NoNoCurrent
10223-0202-6102230202061 BOTTLE, GLASS in 1 KIT (10223-0202-6) / 14 g in 1 BOTTLE, GLASS1960-01-010000-00-00NoNoCurrent
10223-0202-7102230202071 BOTTLE, GLASS in 1 BOX (10223-0202-7) / 11 g in 1 BOTTLE, GLASS1960-01-01NoNoHistorical
10223-0202-8102230202081 BOTTLE, GLASS in 1 BOX (10223-0202-8) / 24 g in 1 BOTTLE, GLASS1960-01-01NoNoHistorical