Home NDC 10223-0221 Cetacaine Topical Anesthetic
Product NDC 10223-0221
11-digit product format 102230221
Labeler code 10223
Product ID 10223-0221_5e116134-85fa-4b04-9795-d55a361b07de
Type HUMAN PRESCRIPTION DRUG
Nonproprietary name Benzocaine, Butamben, and Tetracaine Hydrochloride
Dosage form GEL
Route TOPICAL
Labeler Cetylite Industries, Inc.
Marketing category UNAPPROVED DRUG OTHER
Marketing start 1960-01-01
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 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 Topical Anesthetic
Listing expiration 2026-12-31 Active Ingredients# Ingredient, Strength table Ingredient Strength 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 Identifier FDA.report destination 5NF5D4OPCI Internal UNII lookup U3RSY48JW5 Internal UNII lookup EFW857872Q Internal UNII lookup
Harmonized RxCUI identifiers# RxCUI identifiers page 1 of 1 · 2 matching rows.
Identifier, FDA.report destination table Identifier FDA.report destination 209970 Internal RxNorm lookup 308645 Internal RxNorm lookup
Harmonized SPL set identifiers# SPL set identifiers page 1 of 1 · 1 matching rows.
DailyMed Product Concepts# DailyMed Package Descriptions# Package NDC, Product, Description table Package NDC Product Description Form Quantity Strength SPL version 10223-0221-1 Cetacaine Topical Anesthetic 1 in 1 BOX GEL 1 6 10223-0221-1 Cetacaine Topical Anesthetic 32 g in 1 JAR GEL 32 6
DailyMed Socrata Ingredients# Ingredient, Type, UNII table Ingredient Type UNII DailyMed label SPL version Uploaded Benzocaine ACTIVE INGREDIENT U3RSY48JW5 CETACAINE TOPICAL ANESTHETIC (BENZOCAINE, BUTAMBEN, AND TETRACAINE HYDROCHLORIDE) GEL [CETYLITE INDUSTRIES, INC.] 2 Butamben ACTIVE INGREDIENT EFW857872Q CETACAINE TOPICAL ANESTHETIC (BENZOCAINE, BUTAMBEN, AND TETRACAINE HYDROCHLORIDE) GEL [CETYLITE INDUSTRIES, INC.] 2 Tetracaine Hydrochloride ACTIVE INGREDIENT 5NF5D4OPCI CETACAINE TOPICAL ANESTHETIC (BENZOCAINE, BUTAMBEN, AND TETRACAINE HYDROCHLORIDE) GEL [CETYLITE INDUSTRIES, INC.] 2 Benzocaine ACTIVE MOIETY U3RSY48JW5 CETACAINE TOPICAL ANESTHETIC (BENZOCAINE, BUTAMBEN, AND TETRACAINE HYDROCHLORIDE) GEL [CETYLITE INDUSTRIES, INC.] 2 Butamben ACTIVE MOIETY EFW857872Q CETACAINE TOPICAL ANESTHETIC (BENZOCAINE, BUTAMBEN, AND TETRACAINE HYDROCHLORIDE) GEL [CETYLITE INDUSTRIES, INC.] 2 Tetracaine ACTIVE MOIETY 0619F35CGV CETACAINE TOPICAL ANESTHETIC (BENZOCAINE, BUTAMBEN, AND TETRACAINE HYDROCHLORIDE) GEL [CETYLITE INDUSTRIES, INC.] 2 Benzalkonium chloride INACTIVE INGREDIENT F5UM2KM3W7 CETACAINE TOPICAL ANESTHETIC (BENZOCAINE, BUTAMBEN, AND TETRACAINE HYDROCHLORIDE) GEL [CETYLITE INDUSTRIES, INC.] 2 Mecetronium bromide INACTIVE INGREDIENT 7ZNQ7FIO9K CETACAINE TOPICAL ANESTHETIC (BENZOCAINE, BUTAMBEN, AND TETRACAINE HYDROCHLORIDE) GEL [CETYLITE INDUSTRIES, INC.] 2 Polyethylene Glycols INACTIVE INGREDIENT 3WJQ0SDW1A CETACAINE TOPICAL ANESTHETIC (BENZOCAINE, BUTAMBEN, AND TETRACAINE HYDROCHLORIDE) GEL [CETYLITE INDUSTRIES, INC.] 2 Saccharin INACTIVE INGREDIENT FST467XS7D CETACAINE TOPICAL ANESTHETIC (BENZOCAINE, BUTAMBEN, AND TETRACAINE HYDROCHLORIDE) GEL [CETYLITE INDUSTRIES, INC.] 2 Water INACTIVE INGREDIENT 059QF0KO0R CETACAINE TOPICAL ANESTHETIC (BENZOCAINE, BUTAMBEN, AND TETRACAINE HYDROCHLORIDE) GEL [CETYLITE INDUSTRIES, INC.] 2
DailyMed Dashboard NDC Coverage# NDC, Dashboard title, SPL version table NDC Dashboard title SPL version Validation Dashboard ZIP 10223-0221 CETACAINE TOPICAL ANESTHETIC (BENZOCAINE, BUTAMBEN, AND TETRACAINE HYDROCHLORIDE) GEL [CETYLITE INDUSTRIES, INC.] 6 Current NDC, Legacy NDC, 2 package rows 20220119_9777acbb-8166-4734-9932-dc66b05bfcb5.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.
DailyMed RxNorm Mappings# Packages# Package NDC, 11-digit format, Description table Package NDC 11-digit format Description Units Marketing start Marketing end Sample Exclude flag Status 10223-0221-1 10223022101 1 JAR in 1 BOX (10223-0221-1) / 32 g in 1 JAR 1 jar 1960-01-01 0000-00-00 No No Current