FDA.reportPublic FDA data

Cetacaine Anesthetic

Product NDC
10223-0201
11-digit product format
102230201
Labeler code
10223
Product ID
10223-0201_ac4f8056-7c1b-461f-86c3-f5e44cbe4249
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Benzocaine, Butamben, and Tetracaine Hydrochloride
Dosage form
AEROSOL, SPRAY
Route
TOPICAL
Labeler
Cetylite Industries, Inc.
Marketing category
UNAPPROVED DRUG OTHER
Marketing start
1958-01-01
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
Rxcui999683, 1722107

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
10223-0201-1Cetacaine Anesthetic56 g in 1 BOTTLE, GLASSAEROSOL, SPRAY566
10223-0201-1Cetacaine Anesthetic1 in 1 BOXAEROSOL, SPRAY16
10223-0201-3Cetacaine Anesthetic1 in 1 BOXAEROSOL, SPRAY16
10223-0201-3Cetacaine Anesthetic20 g in 1 BOTTLE, GLASSAEROSOL, SPRAY206
10223-0201-4Cetacaine Anesthetic1 in 1 BOXAEROSOL, SPRAY16
10223-0201-4Cetacaine Anesthetic5 g in 1 BOTTLE, GLASSAEROSOL, SPRAY56

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
10223-0201-1GM - Gram10223-0201e09b6893-5527-46a4-8562-de76cfc80f4212012-07-24
10223-0201-3GM - Gram10223-02018404d8fd-9940-45b1-a507-15511e03836612015-12-02
10223-0201-4GM - Gram10223-0201b43368f6-da33-45b0-b497-288346c20b3412017-11-06

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
BenzocaineACTIVE INGREDIENTU3RSY48JW5CETACAINE ANESTHETIC (BENZOCAINE, BUTAMBEN, AND TETRACAINE HYDROCHLORIDE) AEROSOL, SPRAY [CETYLITE INDUSTRIES, INC.]3
ButambenACTIVE INGREDIENTEFW857872QCETACAINE ANESTHETIC (BENZOCAINE, BUTAMBEN, AND TETRACAINE HYDROCHLORIDE) AEROSOL, SPRAY [CETYLITE INDUSTRIES, INC.]3
Tetracaine HydrochlorideACTIVE INGREDIENT5NF5D4OPCICETACAINE ANESTHETIC (BENZOCAINE, BUTAMBEN, AND TETRACAINE HYDROCHLORIDE) AEROSOL, SPRAY [CETYLITE INDUSTRIES, INC.]3
BenzocaineACTIVE MOIETYU3RSY48JW5CETACAINE ANESTHETIC (BENZOCAINE, BUTAMBEN, AND TETRACAINE HYDROCHLORIDE) AEROSOL, SPRAY [CETYLITE INDUSTRIES, INC.]3
ButambenACTIVE MOIETYEFW857872QCETACAINE ANESTHETIC (BENZOCAINE, BUTAMBEN, AND TETRACAINE HYDROCHLORIDE) AEROSOL, SPRAY [CETYLITE INDUSTRIES, INC.]3
TetracaineACTIVE MOIETY0619F35CGVCETACAINE ANESTHETIC (BENZOCAINE, BUTAMBEN, AND TETRACAINE HYDROCHLORIDE) AEROSOL, SPRAY [CETYLITE INDUSTRIES, INC.]3
Benzalkonium chlorideINACTIVE INGREDIENTF5UM2KM3W7CETACAINE ANESTHETIC (BENZOCAINE, BUTAMBEN, AND TETRACAINE HYDROCHLORIDE) AEROSOL, SPRAY [CETYLITE INDUSTRIES, INC.]3
Dipropylene glycolINACTIVE INGREDIENTE107L85C40CETACAINE ANESTHETIC (BENZOCAINE, BUTAMBEN, AND TETRACAINE HYDROCHLORIDE) AEROSOL, SPRAY [CETYLITE INDUSTRIES, INC.]3
Mecetronium bromideINACTIVE INGREDIENT7ZNQ7FIO9KCETACAINE ANESTHETIC (BENZOCAINE, BUTAMBEN, AND TETRACAINE HYDROCHLORIDE) AEROSOL, SPRAY [CETYLITE INDUSTRIES, INC.]3
SaccharinINACTIVE INGREDIENTFST467XS7DCETACAINE ANESTHETIC (BENZOCAINE, BUTAMBEN, AND TETRACAINE HYDROCHLORIDE) AEROSOL, SPRAY [CETYLITE INDUSTRIES, INC.]3

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
10223-0201CETACAINE ANESTHETIC (BENZOCAINE, BUTAMBEN, AND TETRACAINE HYDROCHLORIDE) AEROSOL, SPRAY [CETYLITE INDUSTRIES, INC.]6Current NDC, Legacy NDC, 6 package rows20220119_af1773c5-5d5b-4278-b551-30ad2df6d5b5.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
999683benzocaine 14 % / butamben 2 % / tetracaine 2 % Mucosal SprayPSNaf1773c5-5d5b-4278-b551-30ad2df6d5b56
1722107Cetacaine 14 % / 2 % / 2 % Mucosal SprayPSNaf1773c5-5d5b-4278-b551-30ad2df6d5b56
1722107benzocaine 140 MG/ML / butamben 20 MG/ML / tetracaine 20 MG/ML Mucosal Spray [Cetacaine]SBDaf1773c5-5d5b-4278-b551-30ad2df6d5b56
999683benzocaine 140 MG/ML / butamben 20 MG/ML / tetracaine 20 MG/ML Mucosal SpraySCDaf1773c5-5d5b-4278-b551-30ad2df6d5b56
999683benzocaine 14 % / butamben 2 % / tetracaine 2 % Mucosal SpraySYaf1773c5-5d5b-4278-b551-30ad2df6d5b56
1722107Cetacaine 14 % / 2 % / 2 % Mucosal SpraySYaf1773c5-5d5b-4278-b551-30ad2df6d5b56

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
10223-0201-11022302010156 g in 1 BOTTLE, GLASS56 gHistorical
10223-0201-3102230201031 BOTTLE, GLASS in 1 BOX (10223-0201-3) / 20 g in 1 BOTTLE, GLASS2016-01-010000-00-00NoNoCurrent
10223-0201-4102230201041 BOTTLE, GLASS in 1 BOX (10223-0201-4) / 5 g in 1 BOTTLE, GLASS2017-11-010000-00-00NoNoCurrent