FDA.reportPublic FDA data

Cetacaine Anesthetic

Product NDC
10223-0202
Requested package NDC
10223-0202-5
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

NDC auxiliary status#

These records are reproduced from FDA’s unfinished, excluded, and compounder listings. They describe what appeared in the source files; a missing record does not establish a regulatory status. View all current auxiliary records, including entries without an NDC. · View the auxiliary file history.

Current NDC status page 1 of 1 · 1 matching rows.

Dataset, Scope, Product NDC table
DatasetScopeProduct NDCPackage NDCCodeStatusReporting periodSource date
excluded packagepackage10223-020210223-0202-5DDiscontinued by firm2026-10-05

Observed NDC auxiliary status history#

This history shows the information present in each captured FDA auxiliary file. It is not a continuous regulatory timeline, and a missing record does not establish a status.

Historic NDC status page 1 of 1 · 8 matching rows.

View current auxiliary records. · View the auxiliary file history.

Captured / source date, Snapshot, Source SHA-256 table
Captured / source dateSnapshotSource SHA-256
2025-12-14 17:58 UTC · source 2025-12-05d630ba8d3edf…732f749b63fb…
2025-08-27 00:01 UTC · source 2025-08-26f5e01cc5f278…a2eaf40c39c3…
2025-04-01 02:39 UTC · source 2025-03-312ef7874e63bc…57b86245f4fa…
2025-03-28 20:22 UTC · source 2025-03-28a1b67e2a42f9…c4cf2c586c0d…
2025-03-22 03:12 UTC · source 2025-03-21cfe11265f3b6…090c488252e2…
2025-03-10 12:48 UTC · source 2025-03-10cdf11ea48f46…ba0047e9e063…
2025-02-02 03:52 UTC · source 2025-01-31302b2466d912…e7b80fea0513…
2025-01-20 13:05 UTC · source 2025-01-20ed331223b511…672a5bd82f5f…

Reported adverse events (FAERS/openFDA)#

Adverse event summaries are temporarily unavailable. Other product information remains available.

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 UNII identifiers#

UNII identifiers page 1 of 1 · 3 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
5NF5D4OPCIInternal UNII lookup
U3RSY48JW5Internal UNII lookup
EFW857872QInternal UNII lookup

Harmonized RxCUI identifiers#

RxCUI identifiers page 1 of 1 · 2 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
543786Internal RxNorm lookup
543789Internal RxNorm lookup

Harmonized SPL set identifiers#

SPL set identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
89f262a4-a41b-41d7-806b-61b9b89542f0Available on FDA.report

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

openFDA label cross-check#

OpenFDA label data provides additional search and identifier links. DailyMed’s Structured Product Label is the canonical label on FDA.report. Matching records are deduplicated before they are shown below.

Matched openFDA labels page 1 of 1 · 1 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Cetacaine AnestheticBENZOCAINE, BUTAMBEN, AND TETRACAINE HYDROCHLORIDECetylite Industries, Inc.89f262a4-a41b-41d7-806b-61b9b89542f02025-01-10WarningsExact identifier
ndc (package): 10223-0202-5
ndc (product): 10223-0202
ndc11 (package): 10223020205

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
10223-0202-5102230202051 BOTTLE, GLASS in 1 KIT (10223-0202-5) > 30 g in 1 BOTTLE, GLASS1960-01-010000-00-00NoNoCurrent