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Dr.Johnes Lidocaine 4% Topical Analgesic Cream Lidocaine HCl,Menthol .04 g/g; .01 g/g Cream, 227 g — NDC 85818-0007-01 package photo

Dr.Johnes Lidocaine 4% Topical Analgesic Cream Lidocaine HCl,Menthol .04 g/g; .01 g/g Cream, 227 g

by Dr.Johnes LLC · 227 g in 1 JAR (85818-007-01)
NDC 85818-0007-01
🏷️ FDA NDC (as labeled) 85818-007-01 billing pads the product segment with a zero
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) 85818-007-01
Product NDC 85818-007
11-digit billing NDC 85818000701
UNII 98PI200987, L7T10EIP3A
Application # M017
SPL Set ID 6144708d-4b0f-4f0d-88e3-6925ba2d004d
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 2026-06-29
Route TOPICAL
Dosage form CREAM
Substance LIDOCAINE; MENTHOL, UNSPECIFIED FORM
Why two NDCs? The FDA registers this code as 85818-007-01 — 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 → 85818-0007-01. 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.

🏭 Manufacturer & labeler

LabelerDr.Johnes LLC
FDA applicationM017 (OTC MONOGRAPH DRUG)
Labeler code85818
First marketedJun 2026
Product typeHuman Otc Drug
Portfolio7 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?

Dr. Johnes Lidocaine 4% Topical Analgesic Cream is an over-the-counter topical cream containing lidocaine and menthol. Lidocaine is a local anesthetic that works by numbing nerve endings in the skin, while menthol provides a cooling sensation. Together, these ingredients are typically used to temporarily reduce minor pain, aches, and itching when applied to the skin. This product is marketed under FDA's over-the-counter monograph rules for topical pain-relief creams.

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 9E8X80D2L0
    A synthetic form of vitamin E used as an antioxidant and preservative in medications. It helps prevent the active ingredients from degrading when exposed to oxygen or light.
  • UNII A9EJ3J61HQ
    A synthetic liquid derived from benzoic acid and long-chain alcohols. It functions as a solvent and penetration enhancer in topical formulations, helping active ingredients dissolve and absorb into the skin.
  • UNII RUE8E6T4NB
    Aloe vera leaf juice is a clear gel extracted from aloe vera plant leaves. It's used in medicines as a lubricant, emollient, and preservative to soothe skin contact and help keep the product stable.
  • UNII 73Y7P0K73Y
    Thioctic acid, also called alpha-lipoic acid, is an antioxidant compound. In medicines, it may be used as a stabilizer to protect other active ingredients from breaking down.
  • UNII LU49E6626Q
    A synthetic organic compound used as a pH buffer and neutralizing agent in medicines. It helps maintain the proper acidity level in liquid formulations to improve stability and comfort.
  • UNII OZ0E5Y15PZ
    A plant extract from arnica flowers, used as a flavoring agent or fragrance component in medicines. It may also provide mild soothing properties to certain topical formulations.
  • UNII 3XUS85K0RA
    Butylene glycol is a clear liquid derived from petroleum or plants that acts as a humectant, solvent, and preservative booster in medicines. It helps keep formulations stable, dissolve active ingredients, and maintain moisture in topical products.
  • UNII 4Q93RCW27E
    A synthetic polymer made from acrylic acid that's crosslinked for stability. It acts as a thickener and gelling agent in creams and gels, helping the medicine spread evenly and maintain its texture.
  • UNII 2DMT128M1S
    A waxy solid derived from plant or animal sources. It acts as an emulsifier to blend oil and water components, and also thickens the medicine to give it the right texture and consistency.
  • UNII 92RU3N3Y1O
    Dimethicone is a silicone-based oil that acts as an anti-foaming agent and lubricant in medicines. It reduces gas bubbles in liquid formulations and helps coat and protect the stomach lining when ingested.
  • UNII SA6A6V432S
    Dimethyl isosorbide is a clear liquid solvent derived from natural sugar sources. It helps dissolve active ingredients and improve their absorption in liquid medicines and topical products.
  • UNII 9H4PO4Z4FT
    A sulfur-containing organic compound used as a solvent and penetration enhancer in medicines. It helps dissolve active ingredients and improve their absorption through skin or mucous membranes.
  • 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 230OU9XXE4
    A waxy substance made from glycerin and stearic acid that acts as an emulsifier to blend oily and watery ingredients together. It also helps thicken and stabilize the medicine's texture.
  • UNII 02F3473H9O
    A mineral salt used in medications as a source of magnesium. It helps bind ingredients together, improve texture, and maintain the product's stability during storage.
  • UNII C9H2L21V7U
    A fat derived from coconut or palm oil containing shorter fatty acid chains. It serves as a solvent and carrier to help dissolve or suspend active ingredients, improving absorption and stability in liquid formulations.
  • UNII YD01N1999R
    A waxy substance made from polyethylene glycol and stearic acid. It helps mix oil and water-based ingredients together and serves as an emulsifier and solubilizer in liquid and semi-solid medicines.
  • 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 5965N8W85T
    Propanediol is a clear liquid organic compound derived from vegetable sources or synthesized chemically. It acts as a humectant to retain moisture, a solvent to dissolve active ingredients, and a preservative booster in liquid medications and supplements.
  • UNII 68Y4CF58BV
    Pyridoxine hydrochloride is a form of vitamin B6, added to medicines as a nutritional supplement or to meet dietary requirements. It supports the body's metabolism and nerve function.
  • 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.

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

The official label also statesInactive ingredients: The difference in ingredient naming between the SPL submission and the product packaging is due to differences in regulatory nomenclature and consumer-facing labeling conventions. The SPL uses standardized pharmaceutical ingredient names required for regulatory identification and electronic drug listing purposes, while the product packaging uses simplified or common names intended for consumer readability. Both representations refer to the same formulation and identical active and inactive ingredients, with no differences in strength, dosage form, or composition of the finished drug product. Any variation in terminology (e.g., INCI/common names vs. pharmacopoeial names) is solely for labeling clarity and does not reflect any difference in product identity or formulation. All naming differences are non-substantive and do not affect regulatory identity. Purified Water (Water) Propanediol Butylene Glycol MSM (Dimethyl Sulfone) Magnesium Chloride Aloe Vera Leaf Juice (Aloe Barbadensis Leaf Juice) Caprylic/Capric Triglyceride (Medium Chain Triglycerides) C12-15 Alkyl Benzoate (Alkyl Benzoate) Dimethicone Glyceryl Stearate (Glyceryl Monostearate) PEG-100 Stearate (PEG-100 Monostearate) Cetearyl Alcohol Carbomer (Carbomer Homopolymer Type C) Aminomethyl Propanol (Aminomethylpropanol) Disodium EDTA (Edetate Disodium) Phenoxyethanol Ethylhexylglycerin Dimethyl Isosorbide Arnica Montana Flower Extract (Arnica Montana Flower) Alpha Lipoic Acid Tocopheryl Acetate (Vitamin E Acetate) Pyridoxine Hydrochloride (Vitamin B6)

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 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
Dr.Johnes Lidocaine 4% Topical Analgesic Cream .04 g/g; .01 g/gthis 85818-0007-01 Dr.Johnes 227 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

🏛️
2026
On the market since
Jun 2026
📍
2026
Currently FDA-listed
listed with the FDA
🔒
·
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.

🔬 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 Lidocaine HCl,Menthol — the ingredient across all brands.

Top reported reactions

Fatigue7
Nausea5
Diarrhoea4
Erythema4
Paraesthesia4
Pruritus4
Rash4

Age at onset

Adult1

Reporter sex

33 reports
Reports over time (by year) — tap or hover for the count & year
2019 2021 2023 2026 5 0
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 NDCDescription Marketing startStatus
85818-0007-01 You're viewing this 227 g in 1 JAR (85818-007-01) 2026-06-29 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 85818-007-01, 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: 85818-0007-01, written without dashes as 85818000701. 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 85818-0007-01, the first segment (85818) is the labeler code FDA assigned to Dr.Johnes LLC; the middle segment (0007) 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 Dr.Johnes LLC. Listing status can change — the directory data on this page refreshes weekly.
Who lists this product with the FDA?
Dr.Johnes 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 🧪 Active Ingredient 🧪 Inactive Ingredients 🎯 Purpose
🎯 Indications and Usage 28 words ▾

Uses: For temporary relief of minor aches and pains of muscles and joints associated with: Back pain Leg pain Hand and foot pain Minor nerve discomfort Muscle soreness

⏱️ Dosage and Administration 26 words ▾

Directions: Apply a thin layer to affected area. Use up to 3–4 times daily. Rub gently until fully absorbed. Wash hands after application unless treating hands.

⚠️ Warnings 104 words ▾

For external use only Do not use: on open wounds or damaged skin. in large quantities, especially over raw surfaces. if allergic to lidocaine, menthol, or any ingredients in this product. When using this product: Avoid contact with eyes and mucous membranes. Do not bandage tightly or use heating pad.

Discontinue use if excessive irritation occurs. Stop use and ask a doctor if: condition worsens. Symptoms persist for more than 7 days.

Severe burning, redness, or irritation develops. If pregnant or breast-feeding Ask a health professional before use Keep out of reach of children. If swallowed, get medical help or contact Poison Control immediately.

🧪 Active Ingredient 7 words ▾

Active ingredient: Lidocaine HCl 4% Menthol 1%

🧪 Inactive Ingredients 194 words ▾

Inactive ingredients: The difference in ingredient naming between the SPL submission and the product packaging is due to differences in regulatory nomenclature and consumer-facing labeling conventions. The SPL uses standardized pharmaceutical ingredient names required for regulatory identification and electronic drug listing purposes, while the product packaging uses simplified or common names intended for consumer readability. Both representations refer to the same formulation and identical active and inactive ingredients, with no differences in strength, dosage form, or composition of the finished drug product.

Any variation in terminology (e.g., INCI/common names vs. pharmacopoeial names) is solely for labeling clarity and does not reflect any difference in product identity or formulation. All naming differences are non-substantive and do not affect regulatory identity. Purified Water (Water) Propanediol Butylene Glycol MSM (Dimethyl Sulfone) Magnesium Chloride Aloe Vera Leaf Juice (Aloe Barbadensis Leaf Juice) Caprylic/Capric Triglyceride (Medium Chain Triglycerides) C12-15 Alkyl Benzoate (Alkyl Benzoate) Dimethicone Glyceryl Stearate (Glyceryl Monostearate) PEG-100 Stearate (PEG-100 Monostearate) Cetearyl Alcohol Carbomer (Carbomer Homopolymer Type C) Aminomethyl Propanol (Aminomethylpropanol) Disodium EDTA (Edetate Disodium) Phenoxyethanol Ethylhexylglycerin Dimethyl Isosorbide Arnica Montana Flower Extract (Arnica Montana Flower) Alpha Lipoic Acid Tocopheryl Acetate (Vitamin E Acetate) Pyridoxine Hydrochloride (Vitamin B6)

🎯 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 ↗
← 85818-0006-01 · Dr.Johnes 85818-0008-01 · Dr.Johnes →
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.