NDC 73352-0620-01 — Trilogel Lidocaine Hydrochloride 28 mg/g Gel

🆔 Identity & classification

FDA NDC (as labeled) 73352-620-01

Product NDC 73352-620

11-digit billing NDC 73352062001

NCPDP billing unit GM — per gram (weight)

RxCUI 2562183

UNII V13007Z41A

UPC 0373352620012

Application # M017

SPL Set ID 22af7d63-6a56-4a38-a95b-0f88410b23cb

Established class (EPC) Amide Local Anesthetic; Antiarrhythmic

Physiologic effect Local Anesthesia

Chemical class Amides

DEA schedule Non-controlled

Marketing category OTC MONOGRAPH DRUG

Marketing status On market

FDA listing status Listed (active directory)

Marketing start 2024-06-24

Route TOPICAL

Dosage form GEL

Substance LIDOCAINE HYDROCHLORIDE

GPI-14 90850060104009

GCN Seq No 082619

GCN 50276

HICL code 001478

Ingredient (HICL) Lidocaine Hcl

HIC1 code Q

Therapeutic class — broad (HIC1) Ear/Eye/Nose/Rectum/Topical/Vagina/Other

HIC2 code Q5

Therapeutic class — intermediate (HIC2) Agents Acting Principally On The Skin

HIC3 code Q5H

Therapeutic class — specific (HIC3) Topical Local Anesthetics

AHFS code 72:00.00.00

AHFS class Local Anesthetics

FDB label name TRILOGEL 2.8% GEL

FDB brand name Trilogel

Legend status O — Over-the-counter (OTC) drug or device

Why two NDCs? The FDA registers this code as 73352-620-01 — a 5-3-2 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 product segment → 73352-0620-01. 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 Antiarrhythmic class.

Pharmacologic class Antiarrhythmic, Amide Local Anesthetic

Drug family (ATC) Antiarrhythmics, class Ib, Local anesthetics, Anesthetics for topical use

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

LabelerTrifluent Pharma LLC

FDA applicationM017 (OTC MONOGRAPH DRUG)

Labeler code73352

First marketedJun 2024

Product typeHuman Otc Drug

Portfolio17 products on file

🔎 All NDCs from Trifluent Pharma LLC

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

Label name TRILOGEL 2.8% GEL Ingredient Lidocaine Hcl

📗 Our plain-language guide HelloPharmacist

It's best to avoid using two lidocaine products at the same time unless your doctor says it's okay. When you use multiple products containing a local anesthetic, the total amount a...
Can I use a lidocaine patch and a lidocaine cream at the same time?
No — please don't do this. Heat significantly increases how much lidocaine is absorbed through your skin, which can push drug levels in your blood higher than they should be. Stick...
Can I put a heating pad on the area where I applied a lidocaine patch?

📖 Read our full Lidocaine guide →

Patient education

📘 MedlinePlus patient leaflet ↗

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 00YIU5438U
Caprylyl glycol is a clear liquid derived from coconut oil. In medicines, it acts as a humectant to retain moisture, a preservative booster to prevent microbial growth, and a solvent to help dissolve or mix other ingredients.
UNII 7FLD91C86K
Edetate disodium is a chemical compound that binds and removes certain metal ions. In medicines, it acts as a preservative and stabilizer by preventing metals like calcium from interfering with the product's shelf life and consistency.
UNII 147D247K3P
Ethylhexylglycerin is a synthetic preservative used to prevent bacteria and mold from growing in medicines and personal care products. It helps keep the product safe and stable throughout its shelf life.
UNII PDC6A3C0OX
Glycerin is a clear, thick liquid derived from plant oils or fats. It acts as a humectant to retain moisture, a sweetener, and a solvent in medications.
UNII KEH0A3F75J
Hexylene glycol is a clear liquid alcohol used as a solvent and preservative in medicines. It helps dissolve other ingredients and keeps the product stable during storage.
UNII 9XZ8H6N6OH
A plant-based cellulose derivative used as a binder to hold tablet ingredients together, a thickener in liquids, and a coating agent to control how fast the medicine dissolves.
UNII KU94FIY6JB
A natural enzyme extract from papaya fruit that helps break down proteins. It's used in some medicines as a digestive aid ingredient and may help tablets dissolve or break apart in the stomach.
UNII HIE492ZZ3T
Phenoxyethanol is a synthetic preservative and antimicrobial agent used to prevent bacterial and fungal growth in medicines and cosmetic products, extending shelf life and maintaining product safety.
UNII TU7HW0W0QT
A salt derived from lactic acid, sodium lactate acts as a buffer and pH stabilizer in medicines. It helps maintain the product's acidity level and can also serve as a humectant to retain moisture.
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.
UNII TTV12P4NEE
Xanthan gum is a thickening and stabilizing ingredient made from fermented corn or other sugars. It's added to medicines to improve texture, prevent separation of liquids and solids, and help the product stay consistent.

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

The official label also statesCaprylyl Glycol, Carica Papaya (Papaya) Fruit Extract, Disodium EDTA, Ethylhexylglycerin, Glycerin, Hexylene Glycol, Hydroxypropylcellulose, Phenoxyethanol, Purified Water, Sodium Lactate, Xanthan Gum.

Label-section wording can be broader than the structured product block and may mention additional formulation ingredients.

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 system	Per g	Per 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

Product	Labeler	Pack	NADAC/unit	TE	Status	Price vs. this
Lidogel 28 mg/g 59088-0466-07	PureTek	100 g	—	—	FDA listed	—
Lidorex 28 mg/g 59088-0475-07	PureTek	100 g	—	—	FDA listed	—
Trilogel 28 mg/gthis 73352-0620-01	Trifluent	1 tube	—	—	FDA listed	—
Lidogel 28 mg/g 80425-0372-01	Advanced	100 g	—	—	FDA listed	—
Lidovara 28 mg/g 85477-0303-07	Oncora	100 g	—	—	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

🏛️

2024

On the market since

Jun 2024

📍

2026

Currently FDA-listed

2 years listed

🔓

·

Generic versions listed

see equivalents

✅Generic appears available

FDA-approved generic versions are listed, and recent pricing/market data suggests they may be available — see Therapeutic equivalents.

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.

🔬 Reported adverse events (FAERS)

Read carefully: FAERS reports are voluntary and unverified. Counts are not incidence, do not establish causation, are subject to reporting bias, and cannot be used to compare one drug to another. Shown for signal context only. Reports for Trilogel (this brand).

Top reported reactions

Infusion Site Pain729

Nausea492

Infusion Site Erythema456

Headache438

Dyspnoea426

Diarrhoea423

Fatigue369

Reporter sex

Serious outcomes

Death561

Reports over time (by year) — tap or hover for the count & year

Most recent year is provisional (FAERS lags ~3 months).

Where does this data come from?

Adverse-event reports from the FDA Adverse Event Reporting System (FAERS) via openFDA. FAERS reports are voluntary and unverified — counts are not incidence and don’t establish causation.

📦 Packaging — all sizes for this product

Package NDC	Description	Marketing start	Status
73352-0620-01 You're viewing this	1 TUBE in 1 POUCH (73352-620-01) / 57 g in 1 TUBE	2024-06-24	Active

🧭 About this NDC listing & data coverage

Over-the-counter (OTC) product

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 "Otc Monograph Drug". 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 73352-620-01, 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: 73352-0620-01, written without dashes as 73352062001. 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 73352-0620-01, the first segment (73352) is the labeler code FDA assigned to Trifluent Pharma LLC; the middle segment (0620) 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 Trifluent Pharma LLC. Listing status can change — the directory data on this page refreshes weekly.

Who lists this product with the FDA?

Trifluent Pharma LLC 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 an over-the-counter product, so it does not require a prescription. Follow the package directions, and ask your pharmacist if you are unsure whether it is right for you.

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.

📄 FDA label — Drug Facts FDA SPL

The complete FDA label for this product — the official Drug Facts labeling, verbatim, section by section. Jump with a chip, search within the label, or expand everything.

🎯 Indications and Usage ⏱️ Dosage and Administration ⚠️ Warnings 📦 Storage and Handling 🧪 Active Ingredient 🧪 Inactive Ingredients 🎯 Purpose

🎯 Indications and Usage 21 words ▾

Uses For the temporary relief of pain associated with minor burns, sunburn, minor cuts, scrapes, insect bites, and minor skin irritations.

⏱️ Dosage and Administration 34 words ▾

Directions Adults and children 2 years of age and older: Apply to affected area not more than 3 to 4 times daily. Children under 2 years of age: Do not use; consult a physician.

⚠️ Warnings 92 words ▾

Warnings For external use only Do not use in large quantities, particularly over raw surfaces or blistered areas. When using this product avoid contact with eyes Stop use and ask a physician if condition worsens, or if symptoms persist for more than 7 days or clear up and occur again within a few days, discontinue use of this product and consult a physician. If pregnant or breastfeeding, ask a health professional before use.

Keep out of reach of children. If swallowed, get medical help or contact a Poison Control Center (1-800-222-1222) immediately.

📦 Storage and Handling 9 words ▾

Other Information Store at 20-25°C (68-77°F). Protect from freezing.

🧪 Active Ingredient 6 words ▾

Active Ingredient Lidocaine HCl, USP 2.8%

🧪 Inactive Ingredients 23 words ▾

Inactive Ingredients Caprylyl Glycol, Carica Papaya (Papaya) Fruit Extract, Disodium EDTA, Ethylhexylglycerin, Glycerin, Hexylene Glycol, Hydroxypropylcellulose, Phenoxyethanol, Purified Water, Sodium Lactate, Xanthan Gum.

🎯 Purpose 3 words ▾

Purpose Topical analgesic

Source: FDA Structured Product Labeling, mirrored from DailyMed / openFDA. Prefer the government’s original formatting? View this label on DailyMed ↗

🔗 Related NDC lookups

🧪 All Lidocaine Hydrochloride NDCsSame ingredient 🏭 All Trifluent labeler NDCsLabeler code 73352 📚 All Amide Local Anesthetic NDCsDrug class

💊 Related drugs in this class

Other drugs that share this product’s specific therapeutic class — Topical Local Anesthetics.

Pramoxine Hcl 00316-0230-75 Dyclonine Hcl 00362-3971-05 Dibucaine 00536-1211-95 Tetracaine/Benzocaine/Butamben 10223-0201-03 Benzocaine 16864-0640-01 Benzocaine/Benzethon Cl 16864-0670-01 Benzocaine/Menthol 16864-0680-01 Lidocaine 24357-0701-06 Lidocaine/Aloe Vera 46122-0555-28 Lidocaine/Menthol 46122-0574-21 Lidocaine Hcl/Benzalkonium Chl 46122-0656-25 Benzocaine/Resorcinol 63868-0949-01 Dyclonine Hcl/Benzethonium Cl 70000-0599-01

Where does this data come from?

Other drugs sharing this product’s First Databank therapeutic class (HIC3). Each links to that NDC’s page in our directory.