FDA.reportPublic FDA data

NDC 10223-0221-01 - Cetacaine Topical Anesthetic

This NDC is not currently matched to an FDA NDC product listing in FDA.report, but it is a valid NDC-form code. FDA.report is showing the available DailyMed label context for the product root.

Product NDC
10223-0221
Requested NDC
10223-0221-01
Package NDCs from labels
10223-0221-1, 10223-0221-01
Manufacturer
Cetylite Industries, Inc.
Effective date
2022-01-17
Current FDA listing
Not matched in FDA.report NDC product tables

DailyMed Labels#

Label, Manufacturer, Effective date table
LabelManufacturerEffective dateType
Cetacaine ® Topical Anesthetic GELCetylite Industries, Inc.2022-01-17HUMAN PRESCRIPTION DRUG LABEL

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
10223-0221-1Cetacaine Topical Anesthetic1 in 1 BOXGEL16
10223-0221-1Cetacaine Topical Anesthetic32 g in 1 JARGEL326

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
10223-0221CETACAINE 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 Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
10223-0221-1GM - Gram10223-02213b217164-98fc-403f-aeb1-9d98c3e3d05012022-01-06

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

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 5 of 93 · 1,856 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
KeepGoing Non Sting Cleaning WipeBENZALKONIUM CHLORIDEJ&A Digital Inc.1a6303ce-8df7-4e8b-93f2-e162fdd2540c2026-07-22WarningsExact identifier
unii: F5UM2KM3W7
Germfree24 Hand SanitizerBENZALKONIUM CHLORIDEEnviro Specialty Chemicals Incfb43545b-6ddc-49fb-86dd-17cd1a925a782026-07-22WarningsExact identifier
unii: F5UM2KM3W7
Pharma-Care Skin Preparation ClothsBENZALKONIUM CHLORIDEEnviro Specialty Chemicals Inc324ec648-59f9-46c2-ab7a-7ec6ba42dd422026-07-22WarningsExact identifier
unii: F5UM2KM3W7
My-Shield Hand SanitizerBENZALKONIUM CHLORIDEEnviro Specialty Chemicals Inc0c73f042-47e5-4eba-ba59-52aabf8f45312026-07-22WarningsExact identifier
unii: F5UM2KM3W7
DOCTOR INK TOPICAL ANTISEPTIC WITH PAIN RELIEFBENZALKONIUM CHLORIDE, LIDOCAINEEnviro Specialty Chemicals Incf7abe66c-dc2d-4ef7-9b11-5b87157fd3022026-07-21WarningsExact identifier
unii: F5UM2KM3W7
MY-SHIELD SANITIZINGBENZALKONIUM CHLORIDEEnviro Specialty Chemicals Inc91655320-7d8e-4024-b8f3-511d33d059f92026-07-21WarningsExact identifier
unii: F5UM2KM3W7
Germ-Free 24 SanitizingBENZALKONIUM CHLORIDEEnviro Specialty Chemicals Inc1ef9c150-f885-4b0e-8b69-82c4832fab912026-07-21WarningsExact identifier
unii: F5UM2KM3W7
DOCTOR INKS TOPICAL ANTISEPTICBENZALKONIUM CHLORIDEEnviro Specialty Chemicals Incd503a2db-e326-4a31-bc6a-5034ad74bf0b2026-07-21WarningsExact identifier
unii: F5UM2KM3W7
MY-SHIELD TOPICAL ANTISEPTICBENZALKONIUM CHLORIDEEnviro Specialty Chemicals Incc2c1f5d9-cd6e-4314-9dfc-961ed877c2932026-07-21WarningsExact identifier
unii: F5UM2KM3W7
DOCTOR INKS HAND SANITIZERBENZALKONIUM CHLORIDEEnviro Specialty Chemicals Ince174f231-73df-464b-bd92-23222659df242026-07-21WarningsExact identifier
unii: F5UM2KM3W7
My-Shield Sanitizing Hand WipesBENZALKONIUM CHLORIDEENVIRO SPECIALTY CHEMICALS INCea99c72e-1881-498a-a653-29bac1dab97b2026-07-21WarningsExact identifier
unii: F5UM2KM3W7
Softsoap Antibacterial with Moisturizers Crisp Clean LHSBENZALKONIUM CHLORIDEColgate-Palmolive Company7e978e04-9b1a-44ef-b082-429a6a7520282026-07-21WarningsExact identifier
unii: F5UM2KM3W7
Germ Free Topical AntisepticBENZALKONIUM CHLORIDEEnviro Specialty Chemicals Inc5e004412-1797-4cbf-83e3-7001286ad1572026-07-21WarningsExact identifier
unii: F5UM2KM3W7
SoftSoap Antibacterial with moisturizers White Tea and Berry FusionBENZALKONIUM CHLORIDEColgate-Palmolive Company804d6674-bd6c-4533-89c2-8c82de92a0772026-07-21WarningsExact identifier
unii: F5UM2KM3W7
SoftSoap Antibacterial with moisturizers Fresh CitrusBENZALKONIUM CHLORIDEColgate-Palmolive Companyb1352731-9050-4e1b-a292-ab921c22160f2026-07-21WarningsExact identifier
unii: F5UM2KM3W7
Sterile WaterWATERCardinal Health 107, LLC9655cd02-82b5-4a75-813b-854b195514812026-07-21Warnings, Adverse reactionsExact identifier
unii: 059QF0KO0R
Germ Free 24 Hand SanitizerBENZALKONIUM CHLORIDEEnviro Specialty Chemicals Incfa0cb8a1-d58a-4c7a-928e-2b071d9dd3ee2026-07-21WarningsExact identifier
unii: F5UM2KM3W7
SoftSoap Antibacterial with moisturizers Crisp CleanBENZALKONIUM CHLORIDEColgate-Palmolive Company65d4de78-fa6f-4838-8217-0e3599cc09a02026-07-21WarningsExact identifier
unii: F5UM2KM3W7
DOCTOR INKS SANITIZINGBENZALKONIUM CHLORIDEEnviro Specialty Chemicals Incd56dc7a8-bee3-4eca-95cf-f1b0a6e2aad22026-07-21WarningsExact identifier
unii: F5UM2KM3W7
DrugStore Antibacterial Hand WipesBENZALKONIUM CHLORIDELil' Drug Store Products, Inc.56b621f2-eeaf-6ff1-e063-6394a90a88292026-07-20WarningsExact identifier
unii: F5UM2KM3W7

Reported adverse events (FAERS/openFDA)#

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