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

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 packagepackage10223-020110223-0201-1DDiscontinued 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 · 12 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…
2025-01-11 03:41 UTC · source 2025-01-100efc9e666f02…f202fb6c5f17…
2024-11-09 02:27 UTC · source 2024-11-08ad56d346431e…cc804d4bbf1e…
2024-10-04 04:10 UTC · source 2024-10-03367a005e9d99…383a685ebd0f…
2024-07-10 04:00 UTC · source 2024-07-09557ba5c1ecfa…9c80585c8c6e…

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
U3RSY48JW5Internal UNII lookup
EFW857872QInternal UNII lookup
5NF5D4OPCIInternal UNII lookup

Harmonized RxCUI identifiers#

RxCUI identifiers page 1 of 1 · 2 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
999683Internal RxNorm lookup
1722107Internal RxNorm lookup

Harmonized SPL set identifiers#

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

Identifier, FDA.report destination table
IdentifierFDA.report destination
af1773c5-5d5b-4278-b551-30ad2df6d5b5Available 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
10223-0201-1Cetacaine 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

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.af1773c5-5d5b-4278-b551-30ad2df6d5b52022-01-17WarningsExact identifier
ndc (product): 10223-0201

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