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Lidochill(TM) Gel Lidocaine HCl 4%, Menthol 1% 40 mg/mL; 10 mg/mL Gel, 237 mL — NDC 59088-240-16 (Billing 59088-0240-16)

by PureTek Corporation · 237 mL in 1 BOTTLE, PUMP

This is a package of 237 mL of Lidochill(TM) Gel Lidocaine HCl 4%, Menthol 1% 40 mg/mL; 10 mg/mL Gel from PureTek Corporation, marketed since Sep 2025 and currently FDA-listed. It is this product's only package size.

NDC 59088-0240-16
🏷️ FDA NDC (as labeled) 59088-240-16 billing pads the product segment with a zero
OTC On market Non-controlled ⇄ Compare with another NDC
🗂️ FDA directory synced Oct 1, 2026 · this listing last changed Jul 24, 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

NDC database record

One package, one record: these facts belong to NDC 59088-240-16 alone.

Record
FDA NDC Directory package listing · Human OTC drug
Code segments
59088 labeler · 240 product · 16 package
Package marketed since
Sep 8, 2025
Sample package
No — commercial package
Listing certified through
Dec 31, 2026
Billing quantity
237 mL per package
Barcode (UPC-A, from the NDC)
3 5908824016 8
FDA record last changed
Jul 24, 2026

Identity & classification

Regulatory identifiers FDA, NLM and CMS codes for this package

FDA NDC (as labeled) 59088-240-16
Product NDC 59088-240
11-digit billing NDC 59088024016
NCPDP billing unit ML — per mL (volume)
RxCUI 1373137
UNII V13007Z41A, L7T10EIP3A
Application # M015
SPL Set ID d2a9aeb6-8a94-49e7-ab46-84403560b6c8
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 2025-09-08
Route TOPICAL
Dosage form GEL
Substance LIDOCAINE HYDROCHLORIDE; MENTHOL

Drug-database identifiers Medi-Span GPI and First Databank GCN / HICL / AHFS classification

GCN Seq No 077805
GCN 43952
HICL code 036762
Ingredient (HICL) Lidocaine Hcl/Menthol
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 DERMACINRX LIDOCHILL 4%-1% GEL
FDB brand name Dermacinrx Lidochill
Legend status O — Over-the-counter (OTC) drug or device
Quick answers
  • GSN (GCN sequence number): 077805
  • GCN: 43952
  • HICL (First Databank): 036762
  • AHFS class code: 72:00.00.00
  • RxCUI (RxNorm): 1373137
Why two NDCs? The FDA registers this code as 59088-240-16 — 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 → 59088-0240-16. 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.

Clinical

Label name DERMACINRX LIDOCHILL 4%-1% GEL Ingredient Lidocaine Hcl/Menthol
🧪 What is this product?

Lidochill Gel is a topical over-the-counter product that combines lidocaine and menthol. Lidocaine is a local anesthetic commonly used to numb skin and reduce discomfort, while menthol produces a cooling sensation often sought for temporary relief of minor pain or irritation. This gel is applied directly to the skin as an OTC monograph drug, meaning it is marketed under FDA's established rules for this category of topical analgesic products.

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.

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.

Packaging — all sizes for this product

Package NDCDescription Marketing startMarketing endStatus
59088-0240-16 You're viewing this Main listing 237 mL in 1 BOTTLE, PUMP 2025-09-08 — Active

Therapeutic equivalents

ProductLabelerPackNADAC/unitTEStatusPrice vs. this
Mentholatum Lidocaine Ice 40 mg/mL; 10 mg/mL 10742-1389-01 The 1 bottle — — FDA listed —
Heal and Rescue Bunion Pain Relief 1 g/100g; 4 g/100g 29784-0410-02 Rooftop 1 bottle — — FDA listed —
Lidochill(TM) Gel 40 mg/mL; 10 mg/mLthis 59088-0240-16 PureTek 237 ml — — FDA listed —
Lidozen 40 mg/mL; 10 mg/mL 63187-0892-64 Proficient 2 bottles — — Discontinued —
Lidozen Gel 40 mg/mL; 10 mg/mL 71205-0715-72 Proficient 120 ml — — FDA listed —
Lidozen 40 mg/mL; 10 mg/mL 71574-0300-72 Village 1 bottle — — FDA listed —
Lidozen Gel 40 mg/mL; 10 mg/mL 71574-0305-72 Village 120 ml — — FDA listed —
DCH Nerve Pain Relief Roll-On 1 g/100g; 4 g/100g 72839-0014-03 Derma 85 g — — FDA listed —
Zylotrol 4 g/100g; 1 g/100g 76420-0145-04 Asclemed 1 tube — — FDA listed —
Zylotrol 4 g/100g; 1 g/100g 81902-0201-04 Whitestone 1 tube — — FDA listed —
BlueStop Max 10 mg/g; 40 mg/g 82714-0001-01 Clavel 1 applicator — — 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

🏛️
2025
On the market since
Sep 2025
📍
2026
Currently FDA-listed
1 year 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.

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.

Loading inactive ingredients from the official FDA label in the background. No external source is being called by this page request.
Where does this data come from?
Source: official FDA Structured Product Labeling (SPL) via DailyMed and the openFDA label index. Structured IACT rows and label-wide narrative are kept separate; availability and product-level specificity depend on the submitted label.

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.

Manufacturer & labeler

LabelerPureTek Corporation
FDA applicationM015 (OTC MONOGRAPH DRUG)
Labeler code59088
First marketedSep 2025
Product typeHuman Otc Drug
Portfolio178 products on file

More NDCs from PureTek Corporation labeler code 59088

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.

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 📄 Do Not Use 📄 When Using This Product 📄 Stop Use and Ask a Doctor If 🤰 If Pregnant or Breast-Feeding 📄 Keep Out of Reach of Children 📄 Package Label / Principal Display Panel
🎯 Indications and Usage 28 words ▾

Uses For the temporary relief of pain and itching associated with: ■ minor burns ■ sunburn ■ minor cuts ■ scrapes ■ insect bites ■ minor skin irritations

⏱️ Dosage and Administration 36 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 doctor.

⚠️ Warnings 96 words ▾

Warnings For external use only ■ Do not apply to wounds or damaged skin ■ Do not bandage tightly When using this product ■ Avoid contact with the eyes Stop use and ask a doctor if 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 breast-feeding, ask a health professional before use. Keep out of reach of children.

If swallowed, get medical help or contact a Poison Control Center right away.

📦 Storage and Handling 15 words ▾

Other information Store at 20° to 25°C (68° to 77°F). [See USP Controlled Room Temperature]

🧪 Active Ingredient 9 words ▾

Active ingredients (% w/w) Lidocaine HCL 4% Menthol 1%

🧪 Inactive Ingredients 12 words ▾

Inactive ingredients Aqua (Purified Water), Bisabolol, Carbomer, Ethylhexylglycerin, Glycerin, Phenoxyethanol, Sodium Hydroxide.

🎯 Purpose 10 words ▾

Purposes Topical Anesthetic (Lidocaine HCL 4%) Topical Analgesic (Menthol 1%)

📄 Do Not Use 14 words ▾

■ Do not apply to wounds or damaged skin ■ Do not bandage tightly

📄 When Using This Product 10 words ▾

When using this product ■ Avoid contact with the eyes

📄 Stop Use and Ask a Doctor If 38 words ▾

Stop use and ask a doctor if 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 Breast-Feeding 10 words ▾

If pregnant or breast-feeding, ask a health professional before use.

📄 Keep Out of Reach of Children 19 words ▾

Keep out of reach of children. If swallowed, get medical help or contact a Poison Control Center right away.

📄 Package Label / Principal Display Panel 26 words ▾

Manufactured in the USA by: PureTek Corporation San Fernando, CA 91340 877-921-7873 DermacinRx ® Lidochill™ Gel (Lidocaine HCL 4% / Menthol 1%) Topical Anesthetic and Analgesic

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

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 — Not published for this NDC No photo available yet for this listing.
Inactive ingredients (structured) — Not published for this NDC The labeler did not submit a structured excipient list, or no SPL is 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 form printed on the packaging and shown on DailyMed is the one the FDA registered. Insurance claims use a fixed 11-digit 5-4-2 format, so the short segment is padded with a leading zero and the dashes are dropped. The Identity section at the top of this page lists each form of this code.
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 PureTek Corporation. Listing status can change — the directory data on this page refreshes weekly.
Who lists this product with the FDA?
PureTek Corporation 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.
← 59088-0239-07 · PureTek 59088-0241-07 · PureTek →
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.