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Cetacaine Topical Anesthetic Benzocaine, Butamben, and Tetracaine Hydrochloride .028 g/.2g; .004 g/.2g; .004 g/.2g Gel — NDC 10223-0221-01 package photo

Cetacaine Topical Anesthetic Benzocaine, Butamben, and Tetracaine Hydrochloride .028 g/.2g; .004 g/.2g; .004 g/.2g Gel

by Cetylite Industries, Inc. · 1 JAR in 1 BOX (10223-0221-1) / 32 g in 1 JAR
NDC 10223-0221-01
🏷️ FDA NDC (as labeled) 10223-0221-1 billing pads the package segment with a zero
Rx only On market Non-controlled
🗂️ Data synced Sep 10, 2026 · sources: openFDA · FDA label (DailyMed) · FDA Orange & Purple Book · First Databank · CMS NADAC, ASP, Medicare & Medicaid · RxNorm
📋 All sources & update times →

This page is curated, coded, and maintained by

Compiled from public FDA, CMS, DailyMed, NADAC, and related drug data sources. Editorial policy

🆔 Identity & classification

FDA NDC (as labeled) 10223-0221-1
Product NDC 10223-0221
11-digit billing NDC 10223022101
NCPDP billing unit GM — per gram (weight)
RxCUI 209970, 308645
UNII U3RSY48JW5, 5NF5D4OPCI, EFW857872Q
SPL Set ID 9777acbb-8166-4734-9932-dc66b05bfcb5
Established class (EPC) Standardized Chemical Allergen
Physiologic effect Increased Histamine Release; Cell-mediated Immunity
Chemical class Allergens
DEA schedule Non-controlled
Marketing category UNAPPROVED DRUG OTHER
Marketing status On market
FDA listing status Listed (active directory)
Marketing start 1960-01-01
Route TOPICAL
Dosage form GEL
Substance BENZOCAINE; BUTAMBEN; TETRACAINE HYDROCHLORIDE
GPI-14 90859903404020
GPI class Cetacaine
Why two NDCs? The FDA registers this code as 10223-0221-1 — a 5-4-1 layout, and that's what's printed on the package and shown on DailyMed. For insurance claims, every NDC is standardized to a uniform 11-digit 5-4-2 format by adding a zero to the package segment → 10223-0221-01. Same drug, same package — only the format differs.
Where does this data come from?
Identifiers from the FDA openFDA NDC Directory and Structured Product Labeling; RxCUI from RxNorm (NLM); GPI from Medi-Span; GCN / HIC / AHFS / legend from First Databank.

🏷️ RxNorm drug class

This medicine belongs to the Ester Local Anesthetic class.

Pharmacologic class Ester Local Anesthetic
Drug family (ATC) Local anesthetics, Anesthetics for topical use, Esters of aminobenzoic acid
Where does this data come from?
Therapeutic classes from RxNorm RxClass (U.S. National Library of Medicine) — Established Pharmacologic Class (FDA), ATC drug family (WHO) and mechanism of action, matched by this product’s RxCUI.

🏭 Manufacturer & labeler

LabelerCetylite Industries, Inc.
Labeler code10223
First marketedJan 1960
Product typeHuman Prescription Drug
Portfolio6 products on file
The labeler markets the product; the application holder owns the FDA approval. They’re often the same company but can differ (e.g. a repackager or an authorized generic). A mailing address / phone appears here when the manufacturer includes it in the product’s FDA label (not all do).
Where does this data come from?
Labeler, application holder and registered establishment from the FDA openFDA NDC Directory and Drugs@FDA; address/contact from the product’s FDA label.

🩺 Clinical

🧪 What is this product?

Cetacaine is a topical gel containing three local anesthetic ingredients: benzocaine, butamben, and tetracaine hydrochloride. These agents are typically used to numb the skin and mucous membranes on contact, reducing pain and discomfort during minor procedures or exams. This product is marketed without an approved FDA application.

Supplement & herbal interactions

🌿 Drug–supplement interaction checker →
Where does this data come from?
Plain-language summary from MedlinePlus (U.S. National Library of Medicine); supplement & herbal interactions and nutrient depletion data from the Natural Medicines database; our full guide is HelloPharmacist editorial content.

🧪 Inactive Ingredients / Excipients

Inactive ingredients, also called excipients, are components of the drug product other than the active ingredient. They may include fillers, dyes, coatings, preservatives, flavors, or other formulation ingredients.

💡 Tap an ingredient (hover on desktop) to see what it is and why it’s used.

  • UNII F5UM2KM3W7
    Benzalkonium chloride is a chemical compound that works as a preservative and antimicrobial agent in medications. It prevents bacterial and fungal growth in liquid formulations to keep the product safe during storage and use.
  • UNII 7ZNQ7FIO9K
    Mecetronium bromide is a synthetic antimicrobial agent used as a preservative in liquid medicines and topical products. It helps prevent bacterial and fungal growth to maintain product safety and shelf life.
  • UNII 3WJQ0SDW1A
    Polyethylene glycol is a synthetic liquid or solid polymer used in medicines as a solvent, lubricant, and humectant. It helps dissolve active ingredients, reduces friction during manufacturing, and retains moisture in the final product.
  • UNII FST467XS7D
    Saccharin is an artificial sweetener derived from benzoic sulfinilanide. It's added to medicines to improve taste and make them easier to take, especially in liquid or chewable formulations.
  • UNII 059QF0KO0R
    Water is a liquid solvent that dissolves and mixes ingredients together in liquid medicines, syrups, and injections. It helps distribute the active drug evenly throughout the product.

5 inactive ingredients listed in the exact product block matched to this NDC.

Where does this data come from?
Data sourced from official FDA Structured Product Labeling (SPL) via DailyMed — ingredient classCode="IACT" elements from the exact product block matched by this NDC. Label-section narrative from DailyMed / the openFDA label index is shown separately when available.

Inactive ingredient FAQ

Are inactive ingredients the same for every manufacturer?
No. Inactive ingredients can differ by manufacturer, dosage form, strength, and package / product version.
Why might an inactive ingredient be missing?
Some SPLs do not provide a complete structured inactive-ingredient list, and older or unusual labels may only include the information in narrative text.
Can inactive ingredients matter?
Yes. They can matter for allergies, intolerances, dyes, gluten / lactose concerns, preservatives, and formulation differences — but confirm with a pharmacist or the manufacturer when it’s clinically important.

💲 Pricing

A drug doesn't have one price. Each row is a different public payment system, and none is what you'd pay at the counter — that depends on your insurance. The ⓘ on each row explains what it measures.

Price systemPer gPer package
Retail pharmacies payNADAC · weekly Not in the retail survey — common for institutional, discontinued, or low-volume packs.
Medicaid paysCMS SDUD · 12 mo No recent Medicaid claims on file for this NDC — rare and low-volume NDCs are suppressed in the public data.
Medicare drug plans payPart D · quarterly No Part D plan price is available for this NDC in our data.
ℹ️
No price is published for this exact package yet. CMS surveys NADAC per package size, so a different pack of the same drug often has one.
Where does this data come from?
NADAC (National Average Drug Acquisition Cost) is the CMS weekly pharmacy-acquisition-cost survey — what pharmacies pay. ASP (Average Sales Price) is the CMS Medicare Part B drug-payment file, published quarterly. Medicaid pays is computed by us from CMS State Drug Utilization Data (total reimbursed ÷ units, trailing 12 months) — gross of rebates and inclusive of dispensing fees, so it reflects what Medicaid paid, not an acquisition cost. Medicare drug plans pay is the median negotiated point-of-sale unit cost across plans listing this NDC in the CMS quarterly Prescription Drug Plan pricing files, before rebates. The VA pays is the federal contract price (FSS, and the statutory Big 4 ceiling where listed) from the VA National Acquisition Center pharmaceutical price file. All are free public government data; each measures a different payer, so the figures are not directly comparable.

🔁 Therapeutic equivalents

ProductLabelerPackNADAC/unitTEStatusPrice vs. this
Cetacaine Topical Anesthetic .028 g/.2g; .004 g/.2g; .004 g/.2g 10223-0217-03 Cetylite 1 jar — — FDA listed —
Cetacaine Topical Anesthetic .028 g/.2g; .004 g/.2g; .004 g/.2gthis 10223-0221-01 Cetylite 1 jar — — FDA listed —
About this product: other versions of the same ingredient, strength and form are listed above, least expensive first, with FDA equivalence ratings where available.
Where does this data come from?
Equivalents are other NDCs of the same ingredient, form and route from the openFDA NDC Directory, ranked least-expensive-first by NADAC. Therapeutic-equivalence (AB) ratings come from the FDA Orange Book; biologics use the FDA Purple Book for biosimilar & interchangeable status.

⏳ Availability & generic status

🏛️
1960
On the market since
Jan 1960
📍
2026
Currently FDA-listed
66 years listed
🔒
·
No generic listed yet
brand only
ℹ️No FDA-approved generic found

We did not find an FDA-approved generic match for this exact strength, form and route.

Where does this data come from?
Patents and exclusivity from the FDA Orange Book (small-molecule drugs), refreshed from public FDA data. Generic launch timing is an estimate, not a guarantee.

📦 Packaging — all sizes for this product

Package NDCDescription Marketing startStatus
10223-0221-01 You're viewing this 1 JAR in 1 BOX (10223-0221-1) / 32 g in 1 JAR 1960-01-01 Active

🧭 About this NDC listing & data coverage

Finished prescription product Marketed without an FDA application

Listed without an FDA application

This product's marketing category indicates it is marketed without an approved FDA application (no NDA, ANDA, or BLA on file). Having an NDC does not by itself establish FDA approval — the NDC Directory is a listing system, not an approval decision. Approval-linked data such as Orange Book therapeutic-equivalence ratings therefore does not apply.

What data is (and isn’t) available for this NDC — tap to expand
NDC identity (package / product / labeler codes) ✓ Available
Labeler ✓ Available
Product & package description ✓ Available
Marketing category & status ✓ Available
Active ingredient / dosage form / route ✓ Available
FDA label (SPL via DailyMed) ✓ Available
Package photos ✓ Available
Inactive ingredients (structured) ✓ Available
NADAC pharmacy acquisition price (CMS) — Not published for this NDC CMS publishes NADAC only for NDCs reported in its retail-pharmacy survey.
Orange Book / therapeutic-equivalence data — Not published for this NDC Applies only to products approved under an NDA/ANDA; many listings are out of scope.
HCPCS J-code billing crosswalk — Not published for this NDC Most self-administered / retail products have no J-code — that is normal.
Medicaid utilization (CMS SDUD) — Not published for this NDC CMS reports utilization only for NDCs with Medicaid claims above its privacy threshold.
“Not published” reflects what the public FDA / CMS / NLM sources provide for this exact package code — it is a property of the data feeds, not a judgment about the product.

Questions about this listing

Is this NDC FDA-approved?
An NDC listing does not by itself establish FDA approval — the NDC Directory records that a product is listed with FDA, not that it was reviewed and approved. This listing's marketing category is "Unapproved Drug Other". Products approved under an application carry an NDA, ANDA, or BLA number.
Why is there no price listed?
The pricing shown on our NDC pages comes from CMS NADAC, a voluntary survey of retail community pharmacy invoices. CMS does not publish a NADAC for every NDC — packages outside the retail survey (institutional and hospital products, bulk packages, discontinued items, and many OTC items) may never receive one. A missing price reflects the survey's scope, not this product's actual cost, and does not mean the product is free or unavailable.
Is the NDC printed on the package the same as the 11-digit billing NDC?
Yes, they identify this exact package in different formats. The FDA registers it as 10223-0221-1, which is what is printed on the packaging and shown on DailyMed. Insurance claims use a fixed 11-digit 5-4-2 format, so the short segment is padded with a leading zero: 10223-0221-01, written without dashes as 10223022101. The Identity section at the top of this page lists every form of this code.
What do the three segments of this NDC mean?
In 10223-0221-01, the first segment (10223) is the labeler code FDA assigned to Cetylite Industries, Inc.; the middle segment (0221) identifies this specific product — its ingredient, strength, and dosage form; and the last segment (01) identifies this exact package size and type. Together they name one specific package of one specific product.
Is this package still being marketed?
Yes, per the latest FDA NDC Directory data on this page: this package is listed as actively marketed, with no marketing end date reported by Cetylite Industries, Inc.. Listing status can change — the directory data on this page refreshes weekly.
Who lists this product with the FDA?
Cetylite Industries, Inc. is the labeler of record for this NDC — the company under whose FDA-assigned code the package is listed. The labeler may be the manufacturer itself or a distributor marketing the product under its own code.
Do I need a prescription for this product?
This NDC is listed with FDA as a prescription product, so it is dispensed under a prescriber's order. Your pharmacist can tell you whether any over-the-counter forms of the same medication exist.
This page identifies an FDA-listed package (the NDC) and reports public regulatory and pricing data about the listing. It is reference information, not a medical recommendation — talk to your pharmacist or prescriber about your own medication.
Where does this data come from?
Listing facts (marketing category, packager status, marketing dates) from the FDA openFDA NDC Directory; label availability from DailyMed; pricing coverage from CMS NADAC; equivalence scope from the FDA Orange Book.

📄 Full prescribing information FDA SPL

The complete FDA label for this product — the official prescribing information, verbatim, section by section. Jump with a chip, search within the label, or expand everything.
🎯 Indications and Usage ⏱️ Dosage and Administration ⛔ Contraindications ⚠️ Warnings 🔄 Drug Interactions 🤰 Pregnancy 🧬 Mechanism of Action 📦 How Supplied / Storage and Handling 📋 Description
🎯 Indications and Usage 68 words ▾

Indications Cetacaine Topical Anesthetic Gel is a topical anesthetic indicated for the production of anesthesia of all accessible mucous membrane except the eyes. Cetacaine Topical Anesthetic Gel is indicated for use to control pain and for use for surgical or endoscopic procedures, or other procedures in the ear, nose, mouth, pharynx, larynx, trachea, bronchi, and esophagus. It may also be used for vaginal or rectal procedures where feasible.

⏱️ Dosage and Administration ~1 min read ▾

Dosage and Administration Only a limited quantity of Cetacaine Topical Anesthetic Gel is required for anesthesia. Dispense 200 mg of gel (a bead approximately 1/4 to 1/2 inches long) by gently depressing the pump. Dispensing a bead of gel in excess of 400 mg is contraindicated.

Spread thinly and evenly over the desired area using a cotton swab. In the unlikely event that a Cetacaine Gel pump jar won't dispense, attempt the following: Using a gloved hand, depress the pump fully using the thumb and middle finger. While depressed, cover the center orifice with the index finger.

With the orifice still covered, slowly allow the pump to return to its original starting position. Repeat until Cetacaine Gel is dispensed (usually about 3-4 repeated attempts). An appropriate pediatric dosage has not been established for Cetacaine Topical Anesthetic Gel.

Dosages should be reduced in the debilitated elderly, acutely ill, and very young patients. Do not use Cetacaine Gel to treat infants or children younger than 2 years. Tissue need not be dried prior to application of Cetacaine Topical Anesthetic Gel.

Cetacaine Topical Anesthetic Gel should be applied directly to the site where pain control is required. Anesthesia is produced in approximately 30 seconds with an approximate duration of thirty to sixty minutes. Each 200 mg dose of Cetacaine Topical Anesthetic Gel contains 28 mg of benzocaine, 4 mg of butamben and 4 mg of tetracaine HCl.

⛔ Contraindications 137 words ▾

Contraindications Do not use Cetacaine Gel to treat infants or children younger than 2 years. Cetacaine is not suitable and should never be used for injection. Do not use on the eyes.

To avoid excessive systemic absorption, Cetacaine Topical Anesthetic Gel should not be applied to large areas of denuded or inflamed tissue. Cetacaine Topical Anesthetic Gel should not be administered to patients who are hypersensitive to any of its ingredients or to patients known to have cholinesterase deficiencies. Tolerance may vary with status of the patient.

Cetacaine Topical Anesthetic Gel should not be used under dentures or cotton rolls, as retention of the active gel ingredients under a denture or cotton roll could possibly cause an escharotic effect. Routine precaution for the use of any topical anesthetic should be observed when using Cetacaine Topical Anesthetic Gel.

⚠️ Warnings 177 words ▾

WARNINGS AND PRECAUTIONS Methemoglobinemia Cases of methemoglobinemia have been reported in association with local anesthetic use. Although all patients are at risk for methemoglobinemia, patients with glucose-6-phosphate dehydrogenase deficiency, congenital or idiopathic methemoglobinemia, cardiac or pulmonary compromise, infants under 6 months of age, and concurrent exposure to oxidizing agents or their metabolites are more susceptible to developing clinical manifestations of the condition. If local anesthetics must be used in these patients, close monitoring for symptoms and signs of methemoglobinemia is recommended.

Signs and symptoms of methemoglobinemia may occur immediately or may be delayed some hours after exposure and are characterized by a cyanotic skin discoloration and abnormal coloration of the blood. Methemoglobin levels may continue to rise; therefore, immediate treatment is required to avert more serious central nervous system and cardiovascular adverse effects, including seizures, coma, arrhythmias, and death. Discontinue Cetacaine and any other oxidizing agents.

Depending on the severity of the symptoms, patients may respond to supportive care, i.e., oxygen therapy, hydration. More severe symptoms may require treatment with methylene blue, exchange transfusion, or hyperbaric oxygen.

🔄 Drug Interactions 74 words ▾

DRUG INTERACTIONS Patients that are administered local anesthetics may be at increased risk of developing methemoglobinemia when concurrently exposed to the following oxidizing agents: Class Examples Nitrates/Nitrites nitroglycerin, nitroprusside, nitric oxide, nitrous oxide Local anesthetics benzocaine, lidocaine, bupivacaine, mepivacaine, tetracaine, prilocaine, procaine, articaine, ropivacaine Antineoplastic agents cyclophosphamide, flutamide, rasburicase, ifosfamide, hydroxyurea Antibiotics dapsone, sulfonamides, nitrofurantoin, para-aminosalicylic acid Antimalarials chloroquine, primaquine Anticonvulsants phenytoin, sodium valproate, phenobarbital Other drugs acetaminophen, metoclopramide, sulfa drugs (i.e., sulfasalazine), quinine

🤰 Pregnancy 68 words ▾

Use in Pregnancy Safe use of Cetacaine Topical Anesthetic Gel has not been established with respect to possible adverse effects upon fetal development. Therefore, Cetacaine Topical Anesthetic Gel should not be used during early pregnancy, unless in the judgement of a physician, the potential benefits outweigh the unknown hazards. Routine precaution for the use of any topical anesthetic should be observed when Cetacaine Topical Anesthetic Gel is used.

🧬 Mechanism of Action 121 words ▾

Action The onset of Cetacaine Topical Anesthetic Gel produced anesthesia is rapid (approximately 30 seconds) and the duration of anesthesia is typically 30-60 minutes, when used as directed. This effect is due to the rapid onset, but short duration of action of Benzocaine coupled with the slow onset, but extended duration of Tetracaine HCl and bridged by the intermediate action of Butamben. It is believed that all of these agents act by reversibly blocking nerve conduction.

Speed and duration of action is determined by the ability of the agent to be absorbed by the mucous membrane and nerve sheath and then to diffuse out, and ultimately be metabolized (primarily by plasma cholinesterases) to inert metabolites which are excreted in the urine.

📦 How Supplied / Storage and Handling 26 words ▾

How Supplied Cetacaine Topical Anesthetic Gel (Strawberry), 32 g jar NDC 10223-0217-3 Item# 0217 Cetacaine Topical Anesthetic Gel (Mint), 32 g jar NDC 10223-0221-1 Item# 0221

📋 Description 24 words ▾

Active Ingredients: in a base consisting of polyethylene glycol, purified water, saccharin, cetyldimethylethylammonium bromide, flavoring and color Benzocaine 14.0% Butamben 2.0% Tetracaine Hydrochloride 2.0%

Source: FDA Structured Product Labeling, mirrored from DailyMed / openFDA. Prefer the government’s original formatting? View this label on DailyMed ↗
← 10223-0217-03 · Cetylite 10223-0225-01 · Cetylite →
For educational and professional reference only — not medical advice. Pricing reflects published NADAC and CMS ASP (free public data) and may differ from your acquisition cost; always verify before billing or dispensing.