FDA.reportPublic FDA data

Cetacaine Topical Anesthetic

Product NDC
10223-0217
11-digit product format
102230217
Labeler code
10223
Product ID
10223-0217_5e116134-85fa-4b04-9795-d55a361b07de
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Benzocaine, Butamben, and Tetracaine Hydrochloride
Dosage form
GEL
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 Topical 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
Rxcui209970, 308645

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
10223-0217-3Cetacaine Topical Anesthetic32 g in 1 JARGEL326
10223-0217-3Cetacaine Topical Anesthetic1 in 1 BOXGEL16

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
10223-0217-3GM - Gram10223-02170fb37a32-b5e8-4dac-9dea-6e5d0b054cff12021-07-15

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
BenzocaineACTIVE INGREDIENTU3RSY48JW5CETACAINE TOPICAL ANESTHETIC (BENZOCAINE, BUTAMBEN, AND TETRACAINE HYDROCHLORIDE) GEL [CETYLITE INDUSTRIES, INC.]2
ButambenACTIVE INGREDIENTEFW857872QCETACAINE TOPICAL ANESTHETIC (BENZOCAINE, BUTAMBEN, AND TETRACAINE HYDROCHLORIDE) GEL [CETYLITE INDUSTRIES, INC.]2
Tetracaine HydrochlorideACTIVE INGREDIENT5NF5D4OPCICETACAINE TOPICAL ANESTHETIC (BENZOCAINE, BUTAMBEN, AND TETRACAINE HYDROCHLORIDE) GEL [CETYLITE INDUSTRIES, INC.]2
BenzocaineACTIVE MOIETYU3RSY48JW5CETACAINE TOPICAL ANESTHETIC (BENZOCAINE, BUTAMBEN, AND TETRACAINE HYDROCHLORIDE) GEL [CETYLITE INDUSTRIES, INC.]2
ButambenACTIVE MOIETYEFW857872QCETACAINE TOPICAL ANESTHETIC (BENZOCAINE, BUTAMBEN, AND TETRACAINE HYDROCHLORIDE) GEL [CETYLITE INDUSTRIES, INC.]2
TetracaineACTIVE MOIETY0619F35CGVCETACAINE TOPICAL ANESTHETIC (BENZOCAINE, BUTAMBEN, AND TETRACAINE HYDROCHLORIDE) GEL [CETYLITE INDUSTRIES, INC.]2
Benzalkonium chlorideINACTIVE INGREDIENTF5UM2KM3W7CETACAINE TOPICAL ANESTHETIC (BENZOCAINE, BUTAMBEN, AND TETRACAINE HYDROCHLORIDE) GEL [CETYLITE INDUSTRIES, INC.]2
Mecetronium bromideINACTIVE INGREDIENT7ZNQ7FIO9KCETACAINE TOPICAL ANESTHETIC (BENZOCAINE, BUTAMBEN, AND TETRACAINE HYDROCHLORIDE) GEL [CETYLITE INDUSTRIES, INC.]2
Polyethylene GlycolsINACTIVE INGREDIENT3WJQ0SDW1ACETACAINE TOPICAL ANESTHETIC (BENZOCAINE, BUTAMBEN, AND TETRACAINE HYDROCHLORIDE) GEL [CETYLITE INDUSTRIES, INC.]2
SaccharinINACTIVE INGREDIENTFST467XS7DCETACAINE TOPICAL ANESTHETIC (BENZOCAINE, BUTAMBEN, AND TETRACAINE HYDROCHLORIDE) GEL [CETYLITE INDUSTRIES, INC.]2
WaterINACTIVE INGREDIENT059QF0KO0RCETACAINE TOPICAL ANESTHETIC (BENZOCAINE, BUTAMBEN, AND TETRACAINE HYDROCHLORIDE) GEL [CETYLITE INDUSTRIES, INC.]2

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
10223-0217CETACAINE TOPICAL ANESTHETIC (BENZOCAINE, BUTAMBEN, AND TETRACAINE HYDROCHLORIDE) GEL [CETYLITE INDUSTRIES, INC.]6Current NDC, Legacy NDC, 2 package rows20220119_9777acbb-8166-4734-9932-dc66b05bfcb5.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
308645benzocaine 14 % / butamben 2 % / tetracaine 2 % Topical GelPSN9777acbb-8166-4734-9932-dc66b05bfcb56
209970Cetacaine 14 % / 2 % / 2 % Topical GelPSN9777acbb-8166-4734-9932-dc66b05bfcb56
209970benzocaine 0.14 MG/MG / butamben 0.02 MG/MG / tetracaine 0.02 MG/MG Topical Gel [Cetacaine]SBD9777acbb-8166-4734-9932-dc66b05bfcb56
308645benzocaine 0.14 MG/MG / butamben 0.02 MG/MG / tetracaine 0.02 MG/MG Topical GelSCD9777acbb-8166-4734-9932-dc66b05bfcb56
308645benzocaine 14 % / butamben 2 % / tetracaine 2 % Topical GelSY9777acbb-8166-4734-9932-dc66b05bfcb56
209970Cetacaine (benzocaine 14 % / butamben 2 % / tetracaine 2 % ) Topical GelSY9777acbb-8166-4734-9932-dc66b05bfcb56

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
10223-0217-3102230217031 JAR in 1 BOX (10223-0217-3) / 32 g in 1 JAR1 jar1960-01-010000-00-00NoNoCurrent