Home NDC 10223-0225 Cetacaine Anesthetic
Product NDC 10223-0225
11-digit product format 102230225
Labeler code 10223
Product ID 10223-0225_66344c64-2439-4a34-8eb4-707e707c8ab1
Type HUMAN PRESCRIPTION DRUG
Nonproprietary name Benzocaine, Butamben, and Tetracaine Hydrochloride
Dosage form SOLUTION
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 Observed NDC auxiliary status history# This history shows the information present in each captured FDA auxiliary file. It is not a continuous regulatory timeline, and a missing record does not establish a status.
Historic NDC status page 1 of 1 · 2 matching rows.
View current auxiliary records. · View the auxiliary file history.
Captured / source date, Dataset, Scope table Captured / source date Dataset Scope Product NDC Package NDC Code Status Reporting period Archive Snapshot Source SHA-256 2025-01-11 03:41 UTC · source 2025-01-10 excluded product product 10223-0225 U Excluded because listing certification expired excluded / ndc_excluded.zip 0efc9e666f02…f202fb6c5f17…2025-01-11 03:41 UTC · source 2025-01-10 excluded package package 10223-0225 10223-0225-1 U Excluded because listing certification expired excluded / ndc_excluded.zip 0efc9e666f02…f202fb6c5f17…
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 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 543786 Internal RxNorm lookup 543789 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 10223-0225-1 Cetacaine Anesthetic 11 g in 1 BOTTLE, GLASS SOLUTION 11 9 10223-0225-1 Cetacaine Anesthetic 1 in 1 KIT SOLUTION 1 9
DailyMed Socrata Ingredients# Ingredient, Type, UNII table Ingredient Type UNII DailyMed label SPL version Uploaded Benzocaine ACTIVE INGREDIENT U3RSY48JW5 CETACAINE ANESTHETIC (BENZOCAINE, BUTAMBEN, AND TETRACAINE HYDROCHLORIDE) SOLUTION [CETYLITE INDUSTRIES, INC.] 4 Butamben ACTIVE INGREDIENT EFW857872Q CETACAINE ANESTHETIC (BENZOCAINE, BUTAMBEN, AND TETRACAINE HYDROCHLORIDE) SOLUTION [CETYLITE INDUSTRIES, INC.] 4 Tetracaine Hydrochloride ACTIVE INGREDIENT 5NF5D4OPCI CETACAINE ANESTHETIC (BENZOCAINE, BUTAMBEN, AND TETRACAINE HYDROCHLORIDE) SOLUTION [CETYLITE INDUSTRIES, INC.] 4 Benzocaine ACTIVE MOIETY U3RSY48JW5 CETACAINE ANESTHETIC (BENZOCAINE, BUTAMBEN, AND TETRACAINE HYDROCHLORIDE) SOLUTION [CETYLITE INDUSTRIES, INC.] 4 Butamben ACTIVE MOIETY EFW857872Q CETACAINE ANESTHETIC (BENZOCAINE, BUTAMBEN, AND TETRACAINE HYDROCHLORIDE) SOLUTION [CETYLITE INDUSTRIES, INC.] 4 Tetracaine ACTIVE MOIETY 0619F35CGV CETACAINE ANESTHETIC (BENZOCAINE, BUTAMBEN, AND TETRACAINE HYDROCHLORIDE) SOLUTION [CETYLITE INDUSTRIES, INC.] 4 Benzalkonium chloride INACTIVE INGREDIENT F5UM2KM3W7 CETACAINE ANESTHETIC (BENZOCAINE, BUTAMBEN, AND TETRACAINE HYDROCHLORIDE) SOLUTION [CETYLITE INDUSTRIES, INC.] 4 Dipropylene glycol INACTIVE INGREDIENT E107L85C40 CETACAINE ANESTHETIC (BENZOCAINE, BUTAMBEN, AND TETRACAINE HYDROCHLORIDE) SOLUTION [CETYLITE INDUSTRIES, INC.] 4 Mecetronium Bromide INACTIVE INGREDIENT 7ZNQ7FIO9K CETACAINE ANESTHETIC (BENZOCAINE, BUTAMBEN, AND TETRACAINE HYDROCHLORIDE) SOLUTION [CETYLITE INDUSTRIES, INC.] 4 Saccharin INACTIVE INGREDIENT FST467XS7D CETACAINE ANESTHETIC (BENZOCAINE, BUTAMBEN, AND TETRACAINE HYDROCHLORIDE) SOLUTION [CETYLITE INDUSTRIES, INC.] 4
DailyMed Dashboard NDC Coverage# NDC, Dashboard title, SPL version table NDC Dashboard title SPL version Validation Dashboard ZIP 10223-0225 CETACAINE ANESTHETIC (BENZOCAINE, BUTAMBEN, AND TETRACAINE HYDROCHLORIDE) SOLUTION [CETYLITE INDUSTRIES, INC.] 9 Current NDC, 2 package rows 20250116_89f262a4-a41b-41d7-806b-61b9b89542f0.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 Marketing start Sample Exclude flag Status 10223-0225-1 10223022501 1 BOTTLE, GLASS in 1 KIT (10223-0225-1) / 11 g in 1 BOTTLE, GLASS 1960-01-01 No No Current