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 7 of 93 · 1,856 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Non -Alcohol Blueberry scented Hand sanitizerBENZALKONIUM CHLORIDEShenzhen Lantern Scicence Co.,Ltd.56b67ff4-5785-106e-e063-6294a90af4ec2026-07-16WarningsExact identifier
unii: F5UM2KM3W7
DoveMEN CARE ANTIBACTERIAL CARE MOISTURIZING CREAM BARConopco d/b/a Unilever56bd6fcb-c762-4e5a-e063-6394a90a34382026-07-16WarningsExact identifier
unii: F5UM2KM3W7
BENZALKONIUM CHLORIDEBENZALKONIUM CHLORIDEH E B56a72ebb-6037-12e4-e063-6294a90a34dc2026-07-15Warnings, Adverse reactionsExact identifier
unii: F5UM2KM3W7
BENZALKONIUM CHLORIDEBENZALKONIUM CHLORIDEH E B56a7ea90-51d6-f366-e063-6294a90a8bbd2026-07-15Warnings, Adverse reactionsExact identifier
unii: F5UM2KM3W7
Benzalkonium ChlorideBENZALKONIUM CHLORIDEH E B56a8570f-caf4-627a-e063-6294a90a996f2026-07-15Warnings, Adverse reactionsExact identifier
unii: F5UM2KM3W7
Benzalkonium ChlorideBENZALKONIUM CHLORIDEH E B56a90a3e-1831-29f8-e063-6294a90a08742026-07-15Warnings, Adverse reactionsExact identifier
unii: F5UM2KM3W7
Benzalkonium ChlorideBENZALKONIUM CHLORIDEH E B56a94b9d-8b38-6bd9-e063-6294a90ad14a2026-07-15Warnings, Adverse reactionsExact identifier
unii: F5UM2KM3W7
Benzalkonium ChlorideBENZALKONIUM CHLORIDEH E B56aa852a-2945-3ec8-e063-6394a90a45152026-07-15Warnings, Adverse reactionsExact identifier
unii: F5UM2KM3W7
Benzalkonium ChlorideBENZALKONIUM CHLORIDEH E B56aad930-26cf-7f09-e063-6394a90a2a492026-07-15Warnings, Adverse reactionsExact identifier
unii: F5UM2KM3W7
Benzalkonium ChlorideBENZALKONIUM CHLORIDEH E B56ab500f-83fe-f3d7-e063-6394a90a14b12026-07-15Warnings, Adverse reactionsExact identifier
unii: F5UM2KM3W7
Benzalkonium ChlorideBENZALKONIUM CHLORIDEH E B56ab94e1-ef63-238a-e063-6394a90a5fdb2026-07-15Warnings, Adverse reactionsExact identifier
unii: F5UM2KM3W7
Non -Alcohol Peach Scented Hand SanitizerBENZALKONIUM CHLORIDEShenzhen Lantern Scicence Co.,Ltd.56b26868-833c-3d72-e063-6394a90aea4f2026-07-15WarningsExact identifier
unii: F5UM2KM3W7
Benzalkonium ChlorideBENZALKONIUM CHLORIDEH E B56426ecd-e3e7-46df-e063-6394a90ab5cd2026-07-10Warnings, Adverse reactionsExact identifier
unii: F5UM2KM3W7
GOJO Antibacterial Plum Foam HandwashBENZALKONIUM CHLORIDEGOJO Industries, LLCa485a02f-0f6a-45b2-af5b-f690e02637ec2026-07-10WarningsExact identifier
unii: F5UM2KM3W7
Antibacterial Hand Wipes Lil Drug StoreBENZALKONIUM CHLORIDELil' Drug Store Products, Inc.6ab0488c-02f3-4aa6-b6b3-d4f0d582b1672026-07-10WarningsExact identifier
unii: F5UM2KM3W7
PURELL HEALTHY SP 0.5pct BAK Antimicrobial FoamBENZALKONIUM CHLORIDEGOJO Industries, LLC97b7d732-3b33-4c60-b6d9-0f1d28dda4bf2026-07-09WarningsExact identifier
unii: F5UM2KM3W7
Amazon Basics Citrus Scent Antibacterial Hand WipesBENZALKONIUM CHLORIDEAmazon.com Services LLC52e5b1a4-3a84-c4cb-e063-6394a90a822c2026-07-07WarningsExact identifier
unii: F5UM2KM3W7
Amazon Basics Fresh Scent Antibacterial Hand WipesBENZALKONIUM CHLORIDEAmazon.com Services LLC5256f38a-74b6-0d18-e063-6294a90a5b462026-07-07WarningsExact identifier
unii: F5UM2KM3W7
Dr. Drop NMN Vital Balance (Drop No.1 Cream 90g)NMN (NICOTINAMIDE MONONUCLEOTIDE), ECTOIN (ECTOINE)Reedfresh Co., LTD55d703ca-ff9d-0dbc-e063-6294a90ab6b12026-07-05WarningsExact identifier
unii: 059QF0KO0R
Tetracaine HydrochlorideTETRACAINE HYDROCHLORIDESportpharm LLC90ffa320-652b-442f-97fa-6d618439db792026-07-03Warnings, Adverse reactionsExact identifier
unii: 5NF5D4OPCI

Reported adverse events (FAERS/openFDA)#

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