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IKONIK TONIK Lidocaine Hydrochloride 4 g/100mL Cream — NDC 85132-0001-30 package photo
Label image from the product's FDA listing (DailyMed) — may show a different pack size or an older label revision.

IKONIK TONIK Lidocaine Hydrochloride 4 g/100mL Cream — NDC 85132-001-30 (Billing 85132-0001-30)

by IKONIK CARE, LLC · 1 TUBE in 1 BOX / 30 mL in 1 TUBE

This is a package of IKONIK TONIK Lidocaine Hydrochloride 4 g/100mL Cream from IKONIK CARE, LLC, marketed since Dec 2024 and currently FDA-listed. It is this product's only package size.

NDC 85132-0001-30
🏷️ FDA NDC (as labeled) 85132-001-30 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 85132-001-30 alone.

Record
FDA NDC Directory package listing · Human OTC drug
Code segments
85132 labeler · 001 product · 30 package
Package marketed since
Dec 1, 2024
Sample package
No — commercial package
Listing certified through
Dec 31, 2026
Barcode (UPC-A, from the NDC)
3 8513200130 0
FDA record last changed
Jul 24, 2026
⚠️
Other active recalls for Lidocaine Hydrochloride (different manufacturers) — 6 · tap to view
These affect other manufacturers’ products for the same ingredient — not necessarily the exact NDC on this page.
Class II · Jul 16, 2026 — Presence of Particulate Matter: Hair was found in products (Fresenius Kabi USA, LLC) · FDA recall D-0726-2026
Class II · Jun 8, 2026 — Lack of Assurance of Sterility (Asclemed USA Inc.) · FDA recall D-0658-2026
Class II · Apr 2, 2026 — Lack of Assurance of Sterility (Huons Co., Ltd.) · FDA recall D-0529-2026
Class II · Apr 2, 2026 — Lack of Assurance of Sterility (Huons Co., Ltd.) · FDA recall D-0532-2026
Class II · Nov 30, 2021 — Superpotent Drug: Minimally superpotent (Teligent Pharma, Inc.) · FDA recall D-0296-2022
Class I · Nov 30, 2021 — Superpotent Drug (Teligent Pharma, Inc.) · FDA recall D-0295-2022
Each entry is an official FDA enforcement report — look up any recall number in the FDA recall database ↗

Identity & classification

Regulatory identifiers FDA, NLM and CMS codes for this package

FDA NDC (as labeled) 85132-001-30
Product NDC 85132-001
11-digit billing NDC 85132000130
RxCUI 1010895
UNII V13007Z41A
Application # M017
SPL Set ID 122fdfe8-b5fa-46d1-9fd9-3df9887ed320
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 2024-12-01
Route TOPICAL
Dosage form CREAM
Substance LIDOCAINE HYDROCHLORIDE
Quick answers
  • RxCUI (RxNorm): 1010895
Why two NDCs? The FDA registers this code as 85132-001-30 — 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 → 85132-0001-30. 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

📗 Our plain-language guide HelloPharmacist
  • Lidocaine numbs the area where it is used. Clinicians inject it for procedures. Skin products are used for pain, itching, minor burns, insect bites, hemorrhoid discomfort, and in s...
  • Clean and dry the skin first, then apply as your product’s directions say. Wash your hands afterward. Don’t exceed the number of uses on the label. Ask a doctor before using a prod...
  • No. Heat can increase how much lidocaine your body absorbs. Don’t bandage tightly either. Also avoid using other topical pain products at the same time.
  • Can I use a heating pad with a lidocaine patch?
📖 Read our full Lidocaine guide →

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
85132-0001-30 You're viewing this Main listing 1 TUBE in 1 BOX / 30 mL in 1 TUBE 2024-12-01 — Active

Therapeutic equivalents

ProductLabelerPackNADAC/unitTEStatusPrice vs. this
GNP Lidocaine Maximum Strength 4 g/100g 46122-0614-10 AMERISOURCE 1 bottle $0.052 — Availability likely —
Leader 4 g/100g 70000-0098-01 Cardinal 1 bottle $0.052 — Availability likely —
Lidocaine HCL 4 g/100g 87137-0101-07 Matthias 1 bottle $0.052 — Availability likely —
Pain and Itch Relief 4% Lidocaine .04 g/40g 00363-3001-24 Walgreens 1 tube — — FDA listed —
Walgreens Pain Relieving Cream 4 g/100g 00363-3037-02 Walgreens 76.5 g — — FDA listed —
Mentholatum Lidocaine Heat 40 mg/mL 10742-8386-01 The 1 bottle — — FDA listed —
Signature Care Lidocaine Cream 40 mg/g 21130-0544-27 Better 1 bottle — — FDA listed —
Kroger Analgesic Analgesic 40 mg/g 30142-0260-01 THE 1 bottle — — FDA listed —
TopCare Pain Relieving Analgesic 40 mg/g 36800-0470-01 Topco 1 bottle — — FDA listed —
Gold Bond Medicated Pain and Itch Relief 4 g/100g 41167-0529-00 Chattem, 1 bottle — — FDA listed —
Aspercreme Lidocaine with Rosemary and Mint 4 g/100g 41167-0565-00 Chattem, 1 bottle — — FDA listed —
Aspercreme Lidocaine with Eucalyptus Essential Oil 4 g/100g 41167-0566-00 Chattem, 1 tube — — FDA listed —
Aspercreme with Lidocaine Pain Relieving Creme 4 g/100g 41167-0582-01 Chattem, 1 bottle — — FDA listed —
Aspercreme with Lidocaine Foot Pain Creme 4 g/100g 41167-0586-02 Chattem, 1 bottle — — FDA listed —
Aspercreme with Lidocaine Pain Relieving Creme 4 g/100g 41167-0587-07 Chattem, 1 bottle — — FDA listed —
Aspercreme Lidocaine Foot (Diabetic) 4 g/100g 41167-0597-00 Chattem, 1 bottle — — FDA listed —
LidoStat 40 mg/g 44577-0704-02 Clinical 1 tube — — FDA listed —
Equate Pain Relief Cream 4 mg/100mL 49035-0634-97 Walmart, 74 ml — — FDA listed —
Equate Pain Relieving Cream Lidocaine 40 mg/g 49035-0860-01 Wal-Mart 1 bottle — — FDA listed —
CVS Lidocaine Pain Relief Cream 40 mg/g 51316-0379-43 CVS 1 bottle — — FDA listed —
Launch Medical 4 g/100mL 54723-0018-01 Sambria 30 ml — — FDA listed —
BeardedMoney 4 g/100g 54723-0032-01 Sambria 15 g — — FDA listed —
NeuroMed 7 Topical Pain Relief 4 g/100g 54723-0175-22 Sambria 1 tube — — FDA listed —
DG Health Pain Relieving 40 mg/g 55910-0759-01 DOLGENCORP, 1 bottle — — FDA listed —
T-Relief Lidocaine HCL 4% 3.4 g/85g 62795-6050-07 Medinatura 85 g — — FDA listed —
QC Lidocaine Maximum Strength 4 g/100g 63868-0956-01 Chain 1 bottle — — FDA listed —
Pain Itch Relief 4 g/100g 69396-0120-17 Trifecta 1 bottle — — FDA listed —
Lidocaine 4 Percent 4 g/100g 69420-6262-01 SA3, 120 g — — FDA listed —
CVS Health Lidocaine Cream 40 mg/g 69842-0814-77 CVS 1 bottle — — FDA listed —
CVS Lidocaine Maximum Strength 4 g/100g 69842-0921-49 CVS 1 bottle — — FDA listed —
CVS Health Lidocaine Pain Relief 40 mg/g 69842-0980-01 CVS 1 bottle — — FDA listed —
BENGAY Tropical Jasmine 40 mg/g 69968-0614-03 Kenvue 1 tube — — FDA listed —
NumbR-X 4 g/100g 70171-0001-01 Prodigy 1 jar — — FDA listed —
Dr Lido 4 g/100g 70171-0002-01 Prodigy 1 jar — — FDA listed —
Inked Inspired 4 g/100g 70171-0003-01 Prodigy 1 jar — — FDA listed —
Dr Tatty Numbing 4 g/100g 70171-0020-01 Prodigy 1 jar — — FDA listed —
TattooGirl Numbing 4 g/100g 70171-0021-01 Prodigy 1 tube — — FDA listed —
InkKulture Numbing 4 g/100g 70171-0022-01 Prodigy 1 tube — — FDA listed —
Inkorporated Numbing 4 g/100g 70171-0028-01 Prodigy 1 jar — — FDA listed —
Ink Scribd Numbing 4 g/100g 70171-0029-01 Prodigy 1 jar — — FDA listed —
LidoPlus Pain Relief 40 mg/mL 70372-0723-01 Centura 1 tube — — FDA listed —
TheraCare Pain Relieving Lidocaine Cream 4 g/100g 71101-0056-01 Veridian 1 bottle — — FDA listed —
TheraCare Pain Relieving Lidocaine Cream 4 g/100g 71101-0057-01 Veridian 1 bottle — — FDA listed —
HealthWise 4% Lidocaine Cream 2.7 oz 4 g/100g 71101-0102-01 Veridian 1 bottle — — FDA listed —
HealthWise Pain Relief Lidocaine 4 g/100g 71101-0107-47 Veridian 1 bottle — — FDA listed —
HealthWise 4% Lidocaine Cream 4 g/100g 71101-0919-27 Veridian 1 bottle — — FDA listed —
TheraCare 4% Lidocaine Cream 4 g/100g 71101-0930-01 Veridian 1 bottle — — FDA listed —
HealthWise Pain Relief Cream with Lidocaine 4 g/100g 71101-0932-01 Veridian 1 bottle — — FDA listed —
Lidocaine HCl 4 Percent 4 g/100g 71436-0026-01 ARI 120 g — — FDA listed —
Lidozall Plus 4 g/100g 72835-0114-15 V2 15 packets — — FDA listed —
Lidozall Pro 4 g/100g 72835-0445-05 V2 5 packets — — FDA listed —
DCH Pain Relief 4 g/100g 72839-0361-02 Derma 76.5 g — — FDA listed —
SUGAR BRANDS Rescue Pain Relief and Recovery 40 mg/mL 73313-0075-04 Sugar 118 ml — — FDA listed —
Lidocaine HCI 40 mg/g 73352-0204-60 Trifluent 30 g — — FDA listed —
LidoGuard 4 g/100g 73492-0272-30 ALAINA 1 tube — — FDA listed —
TopCare Pain Relieving Cream 40 mg/g 76162-0291-02 Topco 1 bottle — — FDA listed —
Sting Master 40 mg/g 80324-0078-00 Les 1 jar — — FDA listed —
Lidocaine Pain Relief Roll-On 4 g/100mL 82645-0013-97 Pharma 1 bottle — — FDA listed —
Westlake Lidocaine 4 g/100g 82895-0717-50 Westlake 1 bottle — — FDA listed —
Westlake Outdoor Pain and Itch Relieving 40 mg/g 82895-0718-50 WESTLAKE 49 g — — FDA listed —
Lidocore 3.1 g/76.5g 82944-0201-02 iON 1 bottle — — FDA listed —
Gold Bond Maximum Strength Foot Pain Relief 4 g/100g 84714-0427-06 Gold 1 bottle — — FDA listed —
Gold Bond Medicated Pain and Itch Relief 4 g/100g 84714-0529-00 Gold 1 bottle — — FDA listed —
Ikonik Tonik 4 g/100mLthis 85132-0001-30 IKONIK 1 tube — — FDA listed —
LidoGuard 4 g/100g 85231-0200-30 ViolaCare, 1 tube — — FDA listed —
Alcemiste 4 g/100mL 87087-0001-01 Price 1 jar — — FDA listed —
Tattoo Numbx Numbing Pain Relieving 40 mg/mL 87460-0905-00 Scyberco 1 tube — — FDA listed —
Alocane Emergency Burn 4 g/100mL 68229-0201-02 Quest 1 tube — — FDA listed —
Satohap Lidocaine Hydrochloride 4 Percent Pain Relieving 4 g/100mL 49873-0618-01 Sato 1 bottle — — FDA listed —
Painless Tattoo Numbing Cream 4 g/100mL 54723-0020-01 Sambria 15 ml — — FDA listed —
Alocane Emergency Burn Pads 4 g/100mL 68229-0403-02 Quest 10 pouches — — FDA listed —
Now Numb Numbing Cream 4 g/100mL 54723-0022-02 Sambria 5 ml — — FDA listed —
SunBurnt PLUS 4 g/100mL 68229-0600-01 Quest 1 tube — — Discontinued —
SunBurnt PLUS 4 g/100mL 68229-0601-02 Quest 1 tube — — 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
Dec 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.

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.

🧪 Avoiding an ingredient? See Lidocaine inactive ingredients by manufacturer: every current product's list side by side, so you can ask your pharmacy for the version that does not list it.

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

  • UNII TR046Y3K1G
    A liquid alcohol derived from petroleum or plant sources. It acts as a solvent and humectant in medicines, helping dissolve active ingredients and retain moisture in the formulation.
  • UNII L4EL31FWIL
    A synthetic peptide (short chain of amino acids) used as a conditioning or texture-enhancing agent in topical formulations. It helps improve product feel and skin compatibility in creams and lotions.
  • UNII 2X51AD1X3T
    A fermented grain-derived polysaccharide used as a thickening and stabilizing agent in liquid formulations to improve texture and help maintain consistent suspension of active ingredients.
  • 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 936JST6JCN
    Cetyl alcohol is a waxy, fatty substance derived from plant or animal sources. It acts as an emulsifier and thickener in medicines, helping blend oil and water components and giving products a smooth, creamy texture.
  • UNII 0F32U78V2Q
    Chloroxylenol is a synthetic antimicrobial chemical used as a preservative in medicines and personal care products. It prevents bacterial and fungal growth to help keep the medication safe and effective during storage.
  • UNII T3064TZ75A
    A silicone-based polymer mixture used as an anti-foaming agent and skin protectant in topical formulations. It helps reduce surface bubbles during manufacturing and creates a smooth, water-resistant barrier on the skin.
  • 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 8L4OOQ76AM
    A waxy compound made from polyethylene glycol and stearic acid that acts as an emulsifier and thickener. It helps blend oil and water-based ingredients together and gives the medicine its proper texture and consistency.
  • UNII PO4D55T1IG
    A synthetic peptide made of five amino acids linked together. It is used in skincare and cosmetic formulations as an active conditioning agent to help improve skin texture and appearance.
  • 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 6OZP39ZG8H
    Polysorbate 80 is a synthetic emulsifier derived from sorbitol and oleic acid. It helps mix oil and water-based ingredients together in medications and improves how the product disperses in the body.
  • UNII 34N07GUJ3X
    A synthetic conditioning agent derived from coconut oil. It functions as an emulsifier and thickener, helping blend water and oil-based ingredients together and improving the texture and feel of the formulation.
  • UNII 6DC9Q167V3
    Propylene glycol is a clear liquid derived from petroleum or vegetable sources. It acts as a solvent, humectant, and preservative in medicines, helping dissolve active ingredients and maintain product stability.
  • UNII 8ZQ0AYU1TT
    Pullulan is a natural polysaccharide, a type of carbohydrate made from yeast. It acts as a binder and film-former to hold tablet ingredients together and create protective coatings on capsules.
  • UNII 285CYO341L
    Sodium polyacrylate is a synthetic polymer that absorbs and holds water. In medicines, it acts as a disintegrant, helping tablets break apart quickly in the stomach, and as a binder, holding tablet ingredients together.
  • UNII 1DI56QDM62
    A natural fatty substance from soybeans that helps mix oil and water-based ingredients together. It acts as an emulsifier and lubricant in medicines to improve texture and help the product break down properly in your body.
  • 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.

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

The official label also statesAcetyl Hexapeptide-8 Amide, Butylene Glycol, Cetyl Alcohol, Chloroxylenol, Dimethicone/Divinyldimethicone/Silsesquioxane Crosspolymer, Ethylhexylglycerin, Glyceryl Monostearate, 1,2, Hexanediol, Lecithin, PEG-150 Pentaerythrityl Tetrastearate, Pentapeptide-18, Phenoxyethanol, Polysorbate-80, PPG-2 Hydroxyethyl Cocamide, Propylene Glycol, Pullulan, Sclerotium Gum, Sodium Polyacrylate, Water, 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.

Manufacturer & labeler

LabelerIKONIK CARE, LLC
FDA applicationM017 (OTC MONOGRAPH DRUG)
Labeler code85132
First marketedDec 2024
Product typeHuman Otc Drug
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 📄 Keep Out of Reach of Children 📄 Questions or Comments 📄 Package Label / Principal Display Panel
🎯 Indications and Usage 18 words ▾

Uses for the temporary relief of pain and itching associated with • minor cuts • minor skin irritations

⏱️ Dosage and Administration 92 words ▾

Directions • use only as directed • clean and dry the affected area before applying the cream • adults and children 2 years of age and older: Apply a thin layer to affected area not more than 3 to 4 times daily • children under 2 years of age: do not use, consult a doctor • do not rub in • wash hands thoroughly after application unless you are using the product for your hands • do not cover the treated area with a bandage or wrap unless instructed by a doctor

⚠️ Warnings 131 words ▾

Warnings For external use only Do not use in large quantities, particularly over • raw surfaces • blistered areas • deep puncture wounds • serious burns When using this product • avoid contact with the eyes, mouth or mucous membranes • avoid excessive use or prolonged application. Overuse may lead to increased risk of side effects Stop use and ask a doctor if • condition worsens, or if symptoms persist for more than 7 days or clear up and occur again within a few days • allergic reaction occurs, or if redness, irritation, swelling, pain or other symptoms begin to increase 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 16 words ▾

Other information • this package is child-resistant • store at room temperature, away from direct sunlight

🧪 Active Ingredient 6 words ▾

Active ingredient Lidocaine HCL 4% w/v

🧪 Inactive Ingredients 37 words ▾

Inactive ingredients Acetyl Hexapeptide-8 Amide, Butylene Glycol, Cetyl Alcohol, Chloroxylenol, Dimethicone/Divinyldimethicone/Silsesquioxane Crosspolymer, Ethylhexylglycerin, Glyceryl Monostearate, 1,2, Hexanediol, Lecithin, PEG-150 Pentaerythrityl Tetrastearate, Pentapeptide-18, Phenoxyethanol, Polysorbate-80, PPG-2 Hydroxyethyl Cocamide, Propylene Glycol, Pullulan, Sclerotium Gum, Sodium Polyacrylate, Water, Xanthan Gum

🎯 Purpose 3 words ▾

Purpose External analgesic

📄 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.

📄 Questions or Comments 22 words ▾

Questions? +1 908-765-8789 You may also report serious side effects to this phone number. Mon - Fri 9:30 AM - 5:30 PM

📄 Package Label / Principal Display Panel 2 words ▾

Packaging IKONCream-3

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

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 Hydrochloride — the ingredient across all brands.

Top reported reactions

Nausea3,763
Pain3,703
Fatigue3,572
Headache3,357
Dyspnoea2,805
Diarrhoea2,527
Pneumonia2,313

Reporter sex

60,364 reports
Male · 37%
Female · 63%
Unknown · 0%

Serious outcomes

Hospitalization22,005
Death6,098
Reports over time (by year) — tap or hover for the count & year
2019 2021 2023 2026 5,912 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.

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 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 IKONIK CARE, LLC. Listing status can change — the directory data on this page refreshes weekly.
Who lists this product with the FDA?
IKONIK CARE, 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.
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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.