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ZYLOTROL PAIN RELIEVING Lidocaine HCl, Menthol 4 g/100g; 1 g/100g Cream, 102 g — NDC 76420-0560-04 package photo

ZYLOTROL PAIN RELIEVING Lidocaine HCl, Menthol 4 g/100g; 1 g/100g Cream, 102 g

by Asclemed USA, Inc. · 102 g in 1 TUBE (76420-560-04)
NDC 76420-0560-04
🏷️ FDA NDC (as labeled) 76420-560-04 billing pads the product segment with a zero
This package
Contains102 g Pack sizes2 compare ↓
Also comes in: 102 g 76420-0560-02
OTC On market Non-controlled
🗂️ Data synced 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

🆔 Identity & classification

FDA NDC (as labeled) 76420-560-04
Product NDC 76420-560
11-digit billing NDC 76420056004
NCPDP billing unit GM — per gram (weight)
RxCUI 1595624
UNII V13007Z41A, L7T10EIP3A
Application # M017
SPL Set ID 1553351c-aee8-4c40-9548-35cce246bda9
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 2022-12-29
Route TOPICAL
Dosage form CREAM
Substance LIDOCAINE HYDROCHLORIDE; MENTHOL, UNSPECIFIED FORM
GCN Seq No 073227
GCN 37603
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 ZYLOTROL 4%-1% CREAM GEL
FDB brand name Zylotrol
Legend status O — Over-the-counter (OTC) drug or device
Why two NDCs? The FDA registers this code as 76420-560-04 — 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 → 76420-0560-04. 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

LabelerAsclemed USA, Inc.
FDA applicationM017 (OTC MONOGRAPH DRUG)
Labeler code76420
First marketedDec 2022
Product typeHuman Otc Drug
Portfolio652 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

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

Zylotrol Pain Relieving is a topical cream containing lidocaine hydrochloride and menthol. This product is an OTC monograph drug, meaning it is marketed under FDA's established category rules for over-the-counter pain-relief creams. Lidocaine is a local anesthetic typically used to numb skin and superficial tissues, while menthol is commonly added for its cooling sensation. Together, these ingredients are used in over-the-counter formulations intended to temporarily relieve minor aches and pains on the skin surface.

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.

💊 What it looks like

Color white
One label can cover several strengths, so colors may be combined — always confirm a loose pill against the dispensed prescription label or a pharmacist.
Where does this data come from?
Physical description (imprint, shape, color, scoring, coating) from this product’s FDA Structured Product Labeling (SPL), mirrored from DailyMed / openFDA.

🧪 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.

💲 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.
Try another pack size: 102 g
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
Walgreens Cool n Heat 1 g/100g; 4 g/100g 00363-3036-02 Walgreens 1 bottle — — FDA listed —
Triderma Pain Relief 4 g/100g; 1 g/100g 10738-0073-20 Genuine 1 jar — — FDA listed —
Icy Hot with Lidocaine Pain Relieving .4 g/g; .1 g/g 41167-1710-00 Chattem, 1 tube — — FDA listed —
Meijer Cold and Hot Pain Relieving Analgesic 40 mg/g; 10 mg/g 41250-0355-01 Meijer 1 bottle — — FDA listed —
CVS Health Maximum Strength Lidocaine Pain Relief Cream Plus Menthol 40 mg/g; 10 mg/g 59779-0910-01 CVS 1 bottle — — FDA listed —
Pain Relief 1 mg/100mg; 4 mg/100mg 72042-0001-01 HUMN 1 tube — — FDA listed —
Workvie 1 g/100g; 4 g/100g 72393-0203-25 Marketites 71 g — — FDA listed —
Insta Relief Dm 40 mg/mL; 10 mg/mL 72465-0600-00 DM 118 ml — — FDA listed —
Bakers Best Maximum Strength Pain Relief 40 mg/g; 10 mg/g 76102-0031-02 Baker's 56.7 g — — FDA listed —
Zylotrol Pain Relieving 4 g/100g; 1 g/100gthis 76420-0560-04 Asclemed 102 g — — FDA listed —
SANTO REMEDIO Alivio Pain Relieving Lavender Scent 40 mg/mL; 10 mg/mL 81352-0519-00 SANTO 1 tube — — FDA listed —
Zylotrol Pain Relieving 4 g/100g; 1 g/100g 81902-0230-01 Whitestone 102 g — — FDA listed —
BlueStop Max 40 mg/g; 10 mg/g 82714-0002-01 Clavel 1 tube — — FDA listed —
Rapid Pain-Relief Topical 40 mg/mL; 10 mg/mL 82798-0295-02 NORDIC 60 ml — — FDA listed —
LidoSync 3.1 g/76.5g; .8 g/76.5g 82944-0200-01 iON 1 bottle — — FDA listed —
Nervive Pain Relieving Cream 4 g/100g; 1 g/100g 84126-0318-03 The 1 tube — — FDA listed —
Dermatool Nerve Care 1 g/100g; 4 g/100g 84728-0359-05 Papalo 1 bottle — — FDA listed —
5Kind DMSO 4 Lidocaine HCl Pain Relieving 40 mg/mL; 10 mg/mL 85978-0929-00 5KIND 118 ml — — 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

🏛️
2022
On the market since
Dec 2022
📍
2026
Currently FDA-listed
4 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
76420-0560-04 You're viewing this 102 g in 1 TUBE (76420-560-04) 2023-05-15 Active
76420-0560-02 102 g in 1 JAR (76420-560-02) 2024-10-25 Active

Pack size FAQ

What quantity is in NDC 76420-0560-04?
NDC 76420-0560-04 contains 102 g — 102 g in 1 tube.
What is the difference between NDC 76420-0560-04 and NDC 76420-0560-02?
Both are ZYLOTROL PAIN RELIEVING Lidocaine HCl, Menthol 4 g/100g; 1 g/100g Cream — the drug itself is identical. NDC 76420-0560-04 is the 102 g package, while NDC 76420-0560-02 is the 102 g package.
What NDC number is used to bill for this package of ZYLOTROL PAIN RELIEVING Lidocaine HCl, Menthol 4 g/100g; 1 g/100g Cream?
Bill NDC 76420-0560-04 — the 11-digit billing format is 76420056004. Pharmacy and medical claims use the 11-digit form; the FDA label may print a shorter form of the same code.

🧭 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) — 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 FDA registers it as 76420-560-04, 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: 76420-0560-04, written without dashes as 76420056004. 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 76420-0560-04, the first segment (76420) is the labeler code FDA assigned to Asclemed USA, Inc.; the middle segment (0560) identifies this specific product — its ingredient, strength, and dosage form; and the last segment (04) 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 Asclemed USA, Inc.. Listing status can change — the directory data on this page refreshes weekly.
Does this product come in other package sizes?
Yes — the FDA directory lists 1 other package presentation of this same product, including 102 g (76420-0560-02). Each has its own NDC and its own page — see the package list near the top of this page.
Who lists this product with the FDA?
Asclemed USA, 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 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 🧪 Active Ingredient 🧪 Inactive Ingredients 🎯 Purpose
🎯 Indications and Usage 6 words ▾

Uses For temporarily relief of pain

⏱️ Dosage and Administration 27 words ▾

Directions Apply generously up to 3 to 4 times daily. For use on adults and children 12 years and older. Children under 12 - ask a doctor.

⚠️ Warnings 155 words ▾

Warnings For external use only. Ask a doctor before use if you have a heart condition. Do not use • if you are allergic to any other type of numbing medicine • in large quantities, particularly over raw surfaces or blistered areas • on infections • on deep puncture wounds • if pregnant or breastfeeding.

When using this product • do not use over large skin areas • do not apply heat, bandages or plastic wrap to treated areas • do not use in or near the eyes • wash hands immediately after using. Stop use and ask a doctor if • allergic reaction occurs • condition worsens or does not improve within 7 days • symptoms clear up and return within a few days • redness, irritation, swelling, pain or other symptoms begin or increase. Keep out of reach of children.

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

🧪 Active Ingredient 7 words ▾

Active ingredients Lidocaine HCl 4.0% Menthol 1.0%

🧪 Inactive Ingredients 78 words ▾

Inactive ingredients: Allantoin, Aloe Barbadensis Leaf Juice*, Acrylates/C10-30 Alkyl Acrylate Crosspolymer, Arnica Montana Flower Extract, Behenyl Alcohol, Boswellia Serrata Extract, Butyrospermum Parkii (Shea) Butter, Calophyllum Inophyllum (Tamanu) Seed Oil, Caprylic/capric Triglyceride, Ceteareth-20, Cetearyl Alcohol, Chamomilla Recutita (Matricaria) Flower Extract, Ethylhexylglycerin, Hypericum Perforatum (St. John's Wort) Flower/leaf/stem Extract, Glyceryl Stearate, Glycerin, Hydrogenated Polydecene, Isopropyl Palmitate, Peg-100 Stearate, Persea Gratissima (Avocado) Oil, Phenoxyethanol, Polysorbate 60, Propanediol, Sodium Polyacrylate, Stearyl Alcohol, Tetrahydroxypropyl Ethylenediamine, Trideceth-6, Water. *Certified Organic Ingredient - Mayacert Certifier

🎯 Purpose 4 words ▾

Purpose Topical Analgesic, Anesthetic

Source: FDA Structured Product Labeling, mirrored from DailyMed / openFDA. Prefer the government’s original formatting? View this label on DailyMed ↗
← 76420-0558-01 · Asclemed 76420-0561-10 · Asclemed →
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.