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 6 of 93 · 1,849 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
FRESH THEORY ANTIBACTERIAL HAND WIPES FRESH AND FRUITYBENZALKONIUM CHLORIDEQuest USA Corp57135b3f-884d-1a03-e063-6294a90ae3e92026-07-20WarningsExact identifier
unii: F5UM2KM3W7
FRESH THEORY ANTIBACTERIAL HAND WIPES - PEACH PROSECCOBENZALKONIUM CHLORIDEQuest USA Corp571709fb-ca50-f7b1-e063-6394a90a8d352026-07-20WarningsExact identifier
unii: F5UM2KM3W7
FRESH THEORY ANTIBACTERIAL HAND WIPES - TROPICAL ESCAPEBENZALKONIUM CHLORIDEQuest USA Corp57180e7a-1134-9ecd-e063-6294a90af5bf2026-07-20WarningsExact identifier
unii: F5UM2KM3W7
ALTA ANTIBACTERIAL HAND WIPESBENZALKONIUM CHLORIDEAlta Sales Inc9064a1b1-dd4a-4f74-99c4-5ea93b4be2102026-07-20WarningsExact identifier
unii: F5UM2KM3W7
Meijer Antibacterial Spring Rain HandBENZALKONIUM CHLORIDEMeijer, Inc.35bbdd67-6d15-26b6-e063-6394a90a3f962026-07-19WarningsExact identifier
unii: F5UM2KM3W7
Urgent First Aid BZK Antiseptic WipeBENZALKONIUM CHLORIDEChangzhou Maokang Medical Products Co., Ltd5701c813-4346-a727-e063-6294a90a8e052026-07-19WarningsExact identifier
unii: F5UM2KM3W7
Alcohol Free Hand SanitizerBENZALKONIUM CHLORIDENANTONG HAIYIWEI TEXTILE CO., LTD.56cd55ee-b8ba-ddb9-e063-6394a90a1edc2026-07-17WarningsExact identifier
unii: F5UM2KM3W7
FoamyiQ Non-Alcohol Hand SanitizerFOAMYIQ NON-ALCOHOL HAND SANITIZERSpartan Chemical Companyee8a2af2-0572-19b1-e053-2995a90a23ae2026-07-17WarningsExact identifier
unii: F5UM2KM3W7
endurance wipeBENZOCAINEAbsorption Pharmaceuticals, LLC303db1de-94fc-4543-e063-6294a90a01b92026-07-17WarningsExact identifier
unii: U3RSY48JW5
Touchpoint Biodegradable Sanitizing WipesBENZALKONIUM CHLORIDEInnocore Sales & Marketing Incd4e03834-d487-9f5d-e053-2a95a90a5e282026-07-17WarningsExact identifier
unii: F5UM2KM3W7
Sanitizing Wipes Alcohol Free Fragrance FreeBENZALKONIUM CHLORIDEGoodEarth Distribution Llcd4de3289-5a00-5df4-e053-2995a90a9f3f2026-07-17WarningsExact identifier
unii: F5UM2KM3W7
MaxSaver Sanitizing WipesBENZALKONIUM CHLORIDEERC ACQUISITION, INC.00cd6f41-c9a8-b384-e063-6394a90a85752026-07-17WarningsExact identifier
unii: F5UM2KM3W7
Fragrance Free Sanitizing WipesBENZALKONIUM CHLORIDEGoodEarth Distribution Llcb92744a3-32aa-4aab-ab65-eba9a90e4c572026-07-17WarningsExact identifier
unii: F5UM2KM3W7
MaxSaver Sanitizing WipesBENZALKONIUM CHLORIDEInnocore Sales & Marketing Inc00ccdb15-7db9-0102-e063-6294a90a3ee32026-07-17WarningsExact identifier
unii: F5UM2KM3W7
Touchpoint Hand Sanitizing Wipes Fragrance FreeBENZALKONIUM CHLORIDEInnocore Sales & Marketing Inc9886fa20-65c7-4deb-a1ae-0c3e52ba887e2026-07-17WarningsExact identifier
unii: F5UM2KM3W7
Touchpoint Wipes Fragrance Free Sanitizing WipesBENZALKONIUM CHLORIDEInnocore Sales & Marketing Ince805a12d-2bd8-4331-bd81-02c99d057acf2026-07-17WarningsExact identifier
unii: F5UM2KM3W7
Touchpoint Wipes Sanitizing WipesBENZALKONIUM CHLORIDEInnocore Sales & Marketing Inc0ed4dcb8-857d-4631-89c9-66052b1d46312026-07-17WarningsExact identifier
unii: F5UM2KM3W7
24 7 life by 7 Eleven Antibacterial HAND WIPESBENZALKONIUM CHLORIDE7-ELEVEN, INC.56b2c8e4-254f-11b6-e063-6294a90a5bbb2026-07-16WarningsExact identifier
unii: F5UM2KM3W7
Non -Alcohol Grape Scented Hand SanitizerBENZALKONIUM CHLORIDEShenzhen Lantern Scicence Co.,Ltd.56b5c19e-cce5-16f8-e063-6394a90a1cbd2026-07-16WarningsExact identifier
unii: F5UM2KM3W7
Non -Alcohol Cherry Scented Hand SanitizerBENZALKONIUM CHLORIDEShenzhen Lantern Scicence Co.,Ltd.56b643ec-9433-9f19-e063-6294a90a5f222026-07-16WarningsExact identifier
unii: F5UM2KM3W7

Reported adverse events (FAERS/openFDA)#

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