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Lidocore Lidocaine 3.1 g/76.5g Cream, 1 bottle — NDC 82944-0201-02 package photo
Label image from the product's FDA listing (DailyMed) — may show a different pack size or an older label revision.

Lidocore Lidocaine 3.1 g/76.5g Cream, 1 bottle — NDC 82944-201-02 (Billing 82944-0201-02)

by iON Pharma, LLC · 1 BOTTLE in 1 CARTON / 76.5 g in 1 BOTTLE

This is a package of 1 bottle of Lidocore Lidocaine 3.1 g/76.5g Cream from iON Pharma, LLC, marketed since Sep 2024 and currently FDA-listed. It is this product's only package size.

NDC 82944-0201-02
🏷️ FDA NDC (as labeled) 82944-201-02 billing pads the product segment with a zero
OTC On market Non-controlled ⇄ Compare with another NDC
🗂️ FDA directory synced Oct 8, 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 82944-201-02 alone.

Record
FDA NDC Directory package listing · Human OTC drug
Code segments
82944 labeler · 201 product · 02 package
Package marketed since
Sep 13, 2024
Sample package
No — commercial package
Listing certified through
Dec 31, 2026
Barcode (UPC-A, from the NDC)
3 8294420102 7
FDA record last changed
Jul 24, 2026
⚠️
Other active recalls for Lidocaine (different manufacturers) — 2 · tap to view
These affect other manufacturers’ products for the same ingredient — not necessarily the exact NDC on this page.
Class II · Aug 31, 2026 — Failed Content Uniformity Specifications. Out of Specification for Assay during analysis at the 24- month long term stability station, at (25¿C,60%RH). (SUN PHARMA /TARO) · FDA recall D-0848-2026
Class III · Apr 20, 2023 — Labeling: Typographical error on the upper left-hand side of the box and individual patch label that has the incorrect dosage form stating, each tablet contains instead of each adhesive patch contains. (Bryant Ranch Prepack, Inc.) · FDA recall D-0556-2023
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) 82944-201-02
Product NDC 82944-201
11-digit billing NDC 82944020102
NCPDP billing unit GM — per gram (weight)
RxCUI 1010895
UNII EC2CNF7XFP
Application # M017
SPL Set ID 204c3e50-1ac8-f442-e063-6294a90ae7b5
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 2024-09-03
Route TOPICAL
Dosage form CREAM
Substance LIDOCAINE HYDROCHLORIDE ANHYDROUS

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

GCN Seq No 075061
GCN 39982
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 LIDOCORE 4% CREAM
FDB brand name Lidocore
Legend status O — Over-the-counter (OTC) drug or device
Quick answers
  • GSN (GCN sequence number): 075061
  • GCN: 39982
  • HICL (First Databank): 001478
  • AHFS class code: 72:00.00.00
  • RxCUI (RxNorm): 1010895
Why two NDCs? The FDA registers this code as 82944-201-02 — 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 → 82944-0201-02. 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 LIDOCORE 4% CREAM Ingredient Lidocaine Hcl
📗 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 →
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
82944-0201-02 You're viewing this Main listing 1 BOTTLE in 1 CARTON / 76.5 g in 1 BOTTLE 2024-09-13 — 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/76.5gthis 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/100mL 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 —
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
Sep 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 8Z5ZAL5H3V
    A synthetic polymer made from acrylate compounds. It acts as a thickener and stabilizer in topical formulations, helping create the right texture and prevent separation of ingredients.
  • UNII 7528N5H79B
    A liquid solvent derived from grain fermentation. In medicines, it dissolves active ingredients, helps preserve the product, and improves how the body absorbs the drug.
  • UNII ZY81Z83H0X
    Aloe vera leaf is a plant extract derived from the aloe plant. It is used in medicines as a natural moisturizer and skin-soothing agent in topical formulations.
  • 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 4E05O5N49G
    Ceteth-10 phosphate is a synthetic ingredient made by combining a fatty alcohol with phosphate groups. It works as an emulsifier and surfactant to help mix oil and water in liquid formulations.
  • 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 0THT5PCI0R
    A silicone-based liquid that helps distribute active ingredients evenly throughout topical products. It acts as a solvent and emollient, allowing medicines to spread smoothly on skin while improving texture and absorption.
  • UNII 2V6E5WN99N
    A lipid compound made from fatty acids, used as an emulsifier and stabilizer in medicines to help mix oil and water-based ingredients and keep them from separating.
  • UNII 2Y53S6ATLU
    Dimethicone 350 is a silicone-based oil. It works as a lubricant and anti-foaming agent to help the medicine flow smoothly during manufacturing and reduce unwanted bubbles in the final product.
  • UNII 9E4CO0W6C5
    A silicone-based polymer that forms soft, spongy particles. Used as a texture modifier and suspending agent to improve how the product feels and flows, and to help keep ingredients evenly distributed throughout the formulation.
  • UNII 8NLQ36F6MM
    Edetate disodium anhydrous is a chemical compound that binds to metal ions in a medicine. It's used as a stabilizer to prevent unwanted chemical reactions and help keep the drug product effective during storage.
  • 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 258491E1RZ
    A waxy substance made from glycerin and stearic acid, commonly used as an emulsifier to help blend oil and water ingredients together in medicines. It also helps thicken and stabilize the product's texture.
  • UNII 86FQE96TZ4
    A synthetic polymer, this ingredient acts as a thickener and suspending agent in liquid formulations. It helps maintain uniform consistency and keeps particles evenly distributed throughout the medicine.
  • UNII 918X1OUF1E
    Isohexadecane is a synthetic hydrocarbon oil used as an emollient and solvent in topical medicines. It helps dissolve active ingredients and improves spreadability and absorption through the skin.
  • 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 53J3F32P58
    A synthetic detergent derived from stearic acid, a fatty substance. It helps dissolve or distribute oil-based ingredients evenly throughout the medicine, acting as an emulsifier and solubilizer in tablets and capsules.
  • 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.

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

The official label also statesInactive Ingredients: Acrylates/C10-30 Alkyl Acrylate Crosspolymer, Aloe barbadensis Leaf Juice, Aminomethyl Propanol, Cetearyl Alcohol (and) Dicetyl Phosphate (and) Ceteth-10 Phosphate, Cyclopentasiloxane (and) Dimethicone/Vinyl Dimethicone Crosspolymer, Dimethicone, Disodium EDTA, Ethylhexylglycerin, Glyceryl stearate, Hydroxyethyl Acrylate/Sodium Acryloyldimethyl Taurate Copolymer, Isohexadecane, Phenoxyethanol, SD Alcohol, Steareth-21, Water.

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

LabeleriON Pharma, LLC
FDA applicationM017 (OTC MONOGRAPH DRUG)
Labeler code82944
First marketedSep 2024
Product typeHuman Otc Drug
Portfolio9 products on file

More NDCs from iON Pharma, LLC labeler code 82944

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 🧪 Inactive Ingredients 🎯 Purpose 📄 When Using This Product 📄 Stop Use and Ask a Doctor If 🤰 If Pregnant or Breast-Feeding 📄 Keep Out of Reach of Children 📄 Questions or Comments 📄 Package Label / Principal Display Panel
🎯 Indications and Usage 7 words ▾

Uses Uses: For temporary relief of pain.

⏱️ Dosage and Administration 41 words ▾

Directions section Directions: Adults, or children over the age of 12, apply a thin layer to affected area every 6 to 8 hours, not to exceed 3 applications in a 24 hour period. Children 12 years and younger ask a doctor

⚠️ Warnings 32 words ▾

Do not use section Do not use on large areas of the body or on cut, irritated or swollen skin, on puncture wounds for more than one week without consulting a doctor

🧪 Inactive Ingredients 42 words ▾

Inactive Ingredients: Acrylates/C10-30 Alkyl Acrylate Crosspolymer, Aloe barbadensis Leaf Juice, Aminomethyl Propanol, Cetearyl Alcohol (and) Dicetyl Phosphate (and) Ceteth-10 Phosphate, Cyclopentasiloxane (and) Dimethicone/Vinyl Dimethicone Crosspolymer, Dimethicone, Disodium EDTA, Ethylhexylglycerin, Glyceryl stearate, Hydroxyethyl Acrylate/Sodium Acryloyldimethyl Taurate Copolymer, Isohexadecane, Phenoxyethanol, SD Alcohol, Steareth-21, Water.

🎯 Purpose 14 words ▾

drug facts Active ingredients Drug Facts Active ingredients: Purpose Lidocaine HCI 4% Topical anesthetic

📄 When Using This Product 46 words ▾

when using this product section When using this product use only as directed. Read and follow all directions and warnings on this carton. Do not allow contact with the eyes, do not bandage or apply local heat (such as heating pads) to the area of use

📄 Stop Use and Ask a Doctor If 29 words ▾

Stop use section Stop use and consult a doctor if condition worsens, symptoms persist for more than 7 days or clear up and occur again within a few days

🤰 If Pregnant or Breast-Feeding 15 words ▾

If pregnant or breastfeeding section If pregnant or breastfeeding, ask a health professional before use.

📄 Keep Out of Reach of Children 30 words ▾

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

📄 Questions or Comments 11 words ▾

Questions or comments section Questions or Comments? Call 833.711.8833 , [email protected]

📄 Package Label / Principal Display Panel 1 words ▾

Panel

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

Medicare Part D spend CMS · PART D · 2026 (Q1)

Medicare Part D (outpatient prescription) spending for Lidocaine (matched by generic name) — the program that covers self-administered drugs. 17 manufacturers.
⚠️ Drug-level data: CMS publishes Part D spending by drug, not by NDC — these figures combine every manufacturer, strength and package size sold under the name Lidocaine. CMS lists 8 products for this generic; we show the highest-spend one. That’s a different level of aggregation than the Medicaid card above, which is specific to this exact 11-digit NDC (pack size included), so the two aren’t directly comparable.
Period
Total Part D spend
$53.12M
Claims incl. refills
593.7K
Beneficiaries
367.9K
Spend / beneficiary
$144.39
Spend / claim
$89.46
Trend by period
💵 About the dollar figures: spending is what Part D plans paid before confidential manufacturer rebates, so the program’s real net cost is lower. A blank patient count means fewer than 11 people — CMS hides counts that small to protect privacy. Source: CMS Medicare Quarterly Part D Spending by Drug (data.cms.gov), updated quarterly.

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 Lidocore (this brand).

Top reported reactions

Pain3,192
Nausea3,060
Fatigue3,051
Headache2,823
Dyspnoea2,176
Pneumonia2,006
Diarrhoea1,974

Age at onset

Neonate144
Infant63
Child363
Adolescent258
Adult4,925
Elderly3,141

Reporter sex

49,060 reports
Male · 37%
Female · 63%
Unknown · 0%

Serious outcomes

Hospitalization17,655
Reports over time (by year) — tap or hover for the count & year
2019 2021 2023 2026 4,145 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 iON Pharma, LLC. Listing status can change — the directory data on this page refreshes weekly.
Who lists this product with the FDA?
iON 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.
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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.