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 9 of 93 · 1,856 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
GingiCaine GelGINGICAINE GEL BANANA FLAVORGingi-Pak a Division of the Belport62857d06-a829-4efa-e053-2991aa0a6d152026-06-25WarningsExact identifier
unii: U3RSY48JW5
GingiCaine Gel, Cotton Candy FlavorGINGICAINE GEL, COTTON CANDY FLAVORGingi-Pak a Division of the Belport628515a5-175f-ac2c-e053-2991aa0a19ce2026-06-25WarningsExact identifier
unii: U3RSY48JW5
MOUTAIN DEW HAND SANITIZING WIPESHAND SANITIZING WIPESZhejiang Bright Care Co., Ltd54fbbdde-ef7b-0a8b-e063-6294a90ad9e42026-06-24WarningsExact identifier
unii: F5UM2KM3W7
BAJA BLAST HAND SANITIZING WIPESHAND SANITIZING WIPESZhejiang Bright Care Co., Ltd54fc7e91-53f7-70b4-e063-6294a90ac0852026-06-24WarningsExact identifier
unii: F5UM2KM3W7
MISTIFY SEA SALT CARAMEL HAND SANITIZING WIPESHAND SANITIZING WIPESZhejiang Bright Care Co., Ltd54fce390-6b53-f9f7-e063-6294a90aa44f2026-06-24WarningsExact identifier
unii: F5UM2KM3W7
MISTIFY CHERRY CRUSH HAND SANITIZING WIPESHAND SANITIZING WIPESZhejiang Bright Care Co., Ltd54fd0c49-bf20-c2e3-e063-6294a90a56402026-06-24WarningsExact identifier
unii: F5UM2KM3W7
MISTIFY VANILLA CUPCAKE HAND SANITIZING WIPESHAND SANITIZING WIPESZhejiang Bright Care Co., Ltd54fd0885-0d8c-614d-e063-6394a90acef92026-06-24WarningsExact identifier
unii: F5UM2KM3W7
Fendall 2000 Pure FlowPURIFIED WATERHoneywell Safety Products USA, Inc.37dead3e-60cb-88ae-e063-6294a90a8f702026-06-24WarningsExact identifier
unii: 059QF0KO0R
MISTIFY SWEET STRAWBERRY HAND SANITIZING WIPESHAND SANITIZING WIPESZhejiang Bright Care Co., Ltd55042fdb-ce19-2396-e063-6394a90a99862026-06-24WarningsExact identifier
unii: F5UM2KM3W7
VANILL HAND SANITIZING WIPESHAND SANITIZING WIPESZhejiang Bright Care Co., Ltd54e9d23b-45e5-5e53-e063-6394a90a60662026-06-23WarningsExact identifier
unii: F5UM2KM3W7
Antibacterial Hand WipeANTIBACTERIAL HAND WIPEFujian Yifa Healthcare Products Co., Ltd.3ca0168d-8945-907a-e063-6294a90a9deb2026-06-23WarningsExact identifier
unii: F5UM2KM3W7
Bacteriostatic WaterBACTERIOSTATIC WATERFujian Genohope Biotech Ltd.54f66b82-c9e5-a2bc-e063-6394a90adbbc2026-06-23Exact identifier
unii: 059QF0KO0R
Anbesol Maximum StrengthBENZOCAINEFoundation Consumer Brands8c6ac499-9bd2-4ea5-9f26-df7947bff4a62026-06-22WarningsExact identifier
unii: U3RSY48JW5
Anbesol Maximum StrengthBENZOCAINEFoundation Consumer Brandsdcc37403-0192-4658-bb7a-059273ce00472026-06-22WarningsExact identifier
unii: U3RSY48JW5
Biopure Antibacterial Hand WipeANTIBACTERIAL HAND WIPEFujian Yifa Healthcare Products Co., Ltd.54def395-2f22-20a4-e063-6294a90a61962026-06-22WarningsExact identifier
unii: F5UM2KM3W7
Pain Relieving cleansing sparyBENZALKONIUM CHLORIDE AND LIDOCAINE HCITrifecta Pharmaceuticals USA, LLC.48edbb8d-0c35-91d8-e063-6394a90a71b82026-06-19WarningsExact identifier
unii: F5UM2KM3W7
DoveANTIBACTERIAL CARE BEAUTY BARConopco d/b/a Unilever547472cf-4902-584e-e063-6294a90a28ac2026-06-17WarningsExact identifier
unii: F5UM2KM3W7
HumalogINSULIN LISPROEli Lilly and Companyc8ecbd7a-0e22-4fc7-a503-faa58c1b6f3f2026-06-16Warnings, Adverse reactionsExact identifier
unii: 059QF0KO0R
AntisepticBENZALKONIUM CHLORIDE, BENZOCAINEWildman Business Group1fd15b91-6b81-d0bd-e063-6294a90a4d272026-06-15WarningsExact identifier
unii: U3RSY48JW5
unii: F5UM2KM3W7
TideFresh MOUTH SORE AND TOOTHACHEBENZOCAINE 20% MOUTH SORE AND TOOTHACHEWenzhou Yuyuan Pharmaceutical Co., Ltd.541e1814-c00e-efdf-e063-6394a90a41a12026-06-13WarningsExact identifier
unii: U3RSY48JW5

Reported adverse events (FAERS/openFDA)#

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