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Lidocaine 50 mg/g Patch, 30 pouches — NDC 00603-1880-16 package photo

Lidocaine 50 mg/g Patch, 30 pouches

by Par Health USA, LLC · 30 POUCH in 1 CARTON (0603-1880-16) / 1 g in 1 POUCH (0603-1880-10)
NDC 00603-1880-16
🏷️ FDA NDC (as labeled) 0603-1880-16 billing pads the labeler segment with a zero
Rx only Brand 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 →
⚠️
Other active recalls for Lidocaine (different manufacturers) — 1 · tap to view
These affect other manufacturers’ products for the same ingredient — not necessarily the exact NDC on this page.
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 ↗
Past resolved recalls for this product (1)
Class II · Apr 13, 2022 · Terminated — cGMP deviations: Temperature abuse (Mckesson Medical-Surgical Inc. Corporate Office) · FDA recall D-1043-2022

🆔 Identity & classification

FDA NDC (as labeled) 0603-1880-16
Product NDC 0603-1880
11-digit billing NDC 00603188016
NCPDP billing unit EA — each (per item)
RxCUI 1745091
UNII 98PI200987
Application # NDA020612
SPL Set ID 2ce8a4fe-8aa6-4dc5-ad0f-3984ae68c4bc
Established class (EPC) Amide Local Anesthetic; Antiarrhythmic
Physiologic effect Local Anesthesia
Chemical class Amides
DEA schedule Non-controlled
Marketing category NDA AUTHORIZED GENERIC
Marketing status On market
FDA listing status Listed (active directory)
Marketing start 2014-05-02
Route CUTANEOUS
Dosage form PATCH
Substance LIDOCAINE
GPI-14 90850060005930
GPI class Lidocaine
GCN Seq No 043256
GCN 50272
HICL code 010705
Ingredient (HICL) Lidocaine
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 LIDOCAINE 5% PATCH
FDB brand name Lidocaine
Legend status F — Federal legend — prescription drug or device
TE code (Orange Book) AB · RLD · RS
Why two NDCs? The FDA registers this code as 0603-1880-16 — a 4-4-2 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 labeler segment → 00603-1880-16. Same drug, same package — only the format differs.
Where does this data come from?
Identifiers from the FDA openFDA NDC Directory and Structured Product Labeling; RxCUI from RxNorm (NLM); GPI from Medi-Span; GCN / HIC / AHFS / legend from First Databank.

🏷️ RxNorm drug class

This medicine belongs to the Antiarrhythmic class.

Pharmacologic class Antiarrhythmic, Amide Local Anesthetic
Drug family (ATC) Antiarrhythmics, class Ib, Local anesthetics, Anesthetics for topical use
Where does this data come from?
Therapeutic classes from RxNorm RxClass (U.S. National Library of Medicine) — Established Pharmacologic Class (FDA), ATC drug family (WHO) and mechanism of action, matched by this product’s RxCUI.

🏭 Manufacturer & labeler

LabelerPar Health USA, LLC
Application holderTEIKOKU PHARMA USA INC
FDA applicationNDA020612 (NDA AUTHORIZED GENERIC)
Labeler code00603
First marketedMay 2014
Product typeHuman Prescription Drug
Portfolio212 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 LIDOCAINE 5% PATCH Ingredient Lidocaine
📖 What it is MedlinePlus · NLM

Prescription lidocaine transdermal (Dermalid, Lidoderm, Ztildo) is used to relieve the pain of post-herpetic neuralgia (PHN; burning, stabbing pains, or aches that may last for months or years after a shingles infection). Nonprescription (over-the-counter) lidocaine (Absorbine Jr, Aspercreme, Lidocare, Salonpas, others) is also available to relieve minor pain in shoulders, arms, neck and legs in adults and children 12 years of age and older. Lidocaine is in a class of medications called local anesthetics. It works by stopping nerves from sending pain signals.

Read the full MedlinePlus article ↗
📗 Our plain-language guide HelloPharmacist
  • It's best to avoid using two lidocaine products at the same time unless your doctor says it's okay. When you use multiple products containing a local anesthetic, the total amount a...
  • Can I use a lidocaine patch and a lidocaine cream at the same time?
  • No — please don't do this. Heat significantly increases how much lidocaine is absorbed through your skin, which can push drug levels in your blood higher than they should be. Stick...
  • Can I put a heating pad on the area where I applied 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.

🧪 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 K679OBS311
    Carboxymethylcellulose sodium is a plant-derived thickening agent made from cellulose. In medicines, it acts as a binder to hold ingredients together, a disintegrant to help the tablet break apart, or a thickener in liquids.
  • UNII DO250MG0W6
    A mineral compound containing aluminum that acts as an antacid and buffering agent. It helps neutralize stomach acid and is used as a pH buffer to stabilize the medicine's formulation.
  • 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 2G86QN327L
    Gelatin is a protein derived from animal collagen, commonly used in medicines as a gelling agent and capsule material. It helps create soft or hard capsule shells that hold and release medication, and can also thicken liquid formulations.
  • UNII PDC6A3C0OX
    Glycerin is a clear, thick liquid derived from plant oils or fats. It acts as a humectant to retain moisture, a sweetener, and a solvent in medications.
  • UNII 24H4NWX5CO
    Kaolin is a naturally occurring clay mineral. It's used in tablets and capsules as a filler and absorbent to add bulk, improve texture, and help bind ingredients together.
  • UNII A2I8C7HI9T
    Methylparaben is a preservative derived from benzoic acid that prevents growth of bacteria, fungi, and mold in medicines. It extends the product's shelf life and maintains safety during storage.
  • UNII 9G2MAD7J6W
    Polyacrylic acid is a synthetic polymer used as a binder and thickening agent in medicines. It helps hold tablet ingredients together and can increase the viscosity of liquid or semi-solid formulations.
  • UNII 532B59J990
    Polyvinyl alcohol is a synthetic polymer made from plant-derived materials. It's used as a binder to hold ingredients together, a film-former in coatings, and a thickener in liquid formulations.
  • 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 Z8IX2SC1OH
    Propylparaben is a chemical preservative used to prevent bacterial and fungal growth in medicines and personal care products. It helps extend shelf life and maintain product safety during storage.
  • UNII 05I15JNI2J
    A synthetic polymer that absorbs and holds moisture. Used in tablets and capsules as a super-disintegrant to help the medicine break apart quickly when swallowed, allowing faster drug release.
  • UNII 506T60A25R
    Sorbitol is a natural sugar alcohol derived from glucose. It serves as a sweetener, humectant, and bulking agent in medications to improve taste and help maintain moisture in the product.
  • UNII W4888I119H
    Tartaric acid is a natural organic acid found in grapes and tamarinds. In medicines, it works as a buffer to control acidity, an antioxidant to prevent spoilage, and sometimes a flavoring or binding agent.
  • UNII 8W8T17847W
    A nitrogen-containing chemical compound used in pharmaceuticals as a humectant to retain moisture, and sometimes as a keratolytic agent in topical formulations to help soften and remove dead skin cells.

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

Where does this data come from?
Data sourced from official FDA Structured Product Labeling (SPL) via DailyMedingredient 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 eaPer package
Retail pharmacies payNADAC · weekly $2.031 $60.93 / 30 pouches
Medicaid paysCMS SDUD · 12 mo $2.25 $67.37 / 30 pouches
Medicare drug plans payPart D · Q2 2026 $2.72 $81.65 / 30 pouches
NADAC price history (per ea) — tap or hover for the price & month
Dec 2021 Jul 2022 Dec 2025 Aug 2026 $2.118 $1.807
▲ Up 3% over the last 24 months.
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
Lidocaine 5% 50 mg/g 82347-0505-05 YARAL 30 patches $1.915 AB FDA listed save 6%
Lidocaine 50 mg/g 00591-2679-30 Actavis 30 pouches $2.031 AB Availability likely
Lidocaine 50 mg/g 00591-3525-30 Actavis 30 pouches $2.031 AB Availability likely
Lidocaine 50 mg/gthis 00603-1880-16 Par 30 pouches $2.031 AB Availability likely
Lidocan IV 50 mg/g 59088-0910-54 PURETEK 30 pouches $2.031 AB Availability likely
Lidocaine 700 mg 65162-0791-08 Amneal 30 patches $2.031 AB Availability likely
Tridacaine XL 50 mg/g 73352-0845-30 Trifluent 30 packets $2.031 AB Availability likely
Lidocaine 700 mg 42291-0477-30 AvKARE 30 patches AB FDA listed
Lidocaine 50 mg/g 42291-0495-30 AVKARE 30 pouches AB FDA listed
Lidocaine 50 mg/g 50090-1359-02 A-S 30 pouches AB FDA listed
Lidocaine 5% 50 mg/g 50090-7857-02 A-S 30 pouches AB FDA listed
Lidocaine 700 mg 50090-7894-02 A-S 30 patches AB FDA listed
Lidocaine 50 mg/g 51407-0827-30 Golden 30 pouches AB FDA listed
Lidocaine 50 mg/g 55154-2665-05 Cardinal 5 pouches AB FDA listed
Lidocaine 50 mg/g 55154-7228-05 Cardinal 5 patches AB FDA listed
Lidocaine 50 mg/g 55700-0142-30 Quality 30 pouches AB FDA listed
LidoPure Patch 59088-0712-00 PureTek 1 kit FDA listed
Lidoxryl 59088-0722-00 PureTek 1 kit FDA listed
Lidocan VII 50 mg/g 59088-0900-54 PURETEK 30 pouches AB FDA listed
Lidocan 700 mg 59088-0905-54 PURETEK 30 patches AB FDA listed
Lidocan III 50 mg/g 59088-0907-54 PURETEK 30 patches AB FDA listed
Lidocan V 50 mg/g 59088-0909-54 PURETEK 30 pouches AB FDA listed
Lidocan VI 50 mg/g 59088-0911-54 PURETEK 30 pouches AB FDA listed
Lidocaine 5% 50 mg/g 60760-0657-05 St. 5 patches AB FDA listed
Lidocaine 50 mg/g 60760-0880-05 St. 5 pouches AB FDA listed
Lidocaine 50 mg/g 61919-0588-30 DIRECT 1 g AB FDA listed
Lidoderm 700 mg 61959-0001-30 TPU 30 patches AB FDA listed
Lidocaine 50 mg/g 63629-5094-01 Bryant 30 pouches AB FDA listed
Lidocaine 50 mg/g 63629-7059-01 Bryant 30 pouches AB FDA listed
Lidocaine 50 mg/g 63629-8755-01 Bryant 30 pouches AB FDA listed
Lidocaine 5% 700 mg 68071-3620-03 NuCare 30 patches AB FDA listed
Lidocaine 50 mg/g 68788-7159-03 Preferred 30 pouches AB FDA listed
Lidocaine 700 mg 68788-8344-03 Preferred 30 patches AB FDA listed
Lidocaine 50 mg 70518-0566-00 REMEDYREPACK 30 patches AB FDA listed
Lidocaine 5% 50 mg/g 70518-4487-00 REMEDYREPACK 30 pouches AB FDA listed
Lidocaine 50 mg/g 70518-4502-00 REMEDYREPACK 30 pouches AB FDA listed
Lidocaine 50 mg/g 71335-1934-01 Bryant 30 pouches AB FDA listed
Lidocaine 700 mg 71335-1971-01 Bryant 30 patches AB FDA listed
Lidocaine 700 mg 72162-2085-03 Bryant 30 patches AB FDA listed
Lidocaine Patch 700 mg 72189-0387-30 Direct_Rx 30 patches AB FDA listed
Tridacaine III 50 mg/g 73352-0835-15 Trifluent 15 packets AB FDA listed
Lidocaine 50 mg/g 76420-0037-30 Asclemed 30 pouches AB FDA listed
Lidocaine 50 mg/g 76420-0887-30 Asclemed 30 pouches AB FDA listed
Lidocaine 5% 50 mg/g 76420-0899-30 Asclemed 30 pouches AB FDA listed
Lidocaine 700 mg 80425-0325-01 Advanced 30 patches AB FDA listed
Lidocaine 50 mg/g 80425-0404-01 Advanced 30 pouches AB FDA listed
Lidocaine 5% Patch 700 mg 82461-0611-15 Medcore 15 patches AB FDA listed
Lidocaine 50 mg/g 85509-2880-03 PHOENIX 30 pouches AB FDA listed
Lidocaine 50 mg/g 85766-0169-30 Sportpharm 30 pouches AB FDA listed
Lidocaine 700 mg 85766-0170-30 Sportpharm 30 patches AB FDA listed
Lidox 5 Patch 50 mg/g 87234-0505-03 Injecta 30 pouches AB FDA listed
About this product: this is an authorized generic — the brand-name product marketed without its brand name. Other versions are listed above, least expensive first.
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

🏛️
2014
On the market since
May 2014
📍
2026
Currently FDA-listed
12 years listed
🔒
·
Generic approved (availability unconfirmed)
see note
🔒Generic approved by FDA, but pharmacy availability is not confirmed

The FDA lists approved generic versions of this medicine, but that does not always mean a pharmacy can get one today. Patent rules, launch agreements, supply and pricing can affect when generics actually arrive.

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.

🗺️ Medicaid utilization & spend

📍 This exact package only: Medicaid data is reported per full 11-digit NDC — labeler, product and pack size — so every number here is for 00603-1880-16, not the drug overall. Other pack sizes report separately.
💊 Pharmacy benefit only: These are Medicaid outpatient pharmacy claims, billed by NDC. They exclude the medical benefit — clinic- or hospital-administered drugs billed under HCPCS J-codes — so drugs used mostly that way (e.g. Avastin, Lucentis, Keytruda) can look low or missing here. That’s expected, not an error.
📅 Q1 2025 – Q4 2025 · 4 quarters of data
ⓘ The newest quarter is usually incomplete when first published; states restate recent quarters in later CMS releases, so the latest figures typically revise upward. State coverage-policy changes can also shift quarter-to-quarter totals.
Prescriptions last 4 qtrs
962.6K
Units reimbursed last 4 qtrs
29.9M
Gross reimbursed last 4 qtrs
$67.09M
Avg / prescription
$69.70
Avg / unit
$2.2456
Latest quarter Q4 2025
233.1KRx
Medicaid pays / ea
$2.2456
gross reimbursed
vs
NADAC / ea
$2.0310
acquisition cost
=
Spread
+$0.2146
+11% vs cost
What Medicaid paid per ea (before rebates; includes the pharmacy’s dispensing fee) compared with NADAC — the average price pharmacies pay to buy the drug. A positive spread means Medicaid reimbursed more than the purchase price, before manufacturer rebates.
Fee-for-service vs managed care
49% FFS 51% MCO
Fee-for-service · 473,780 Rx Managed care · 488,823 Rx
State Medicaid map
Alaska: 91,061 units · 12,423 per 100k residents AK Maine: 134,017 units · 9,607 per 100k residents ME Washington: 894,399 units · 11,449 per 100k residents WA Idaho: 146,856 units · 7,477 per 100k residents ID Montana: 78,184 units · 6,907 per 100k residents MT North Dakota: 45,878 units · 5,859 per 100k residents ND Minnesota: 29,111 units · 507 per 100k residents MN Wisconsin: 861,403 units · 14,575 per 100k residents WI Michigan: 125,883 units · 1,254 per 100k residents MI New York: 3,198,314 units · 16,342 per 100k residents NY Vermont: 49,066 units · 7,584 per 100k residents VT New Hampshire: 43,810 units · 3,125 per 100k residents NH Oregon: 34,606 units · 818 per 100k residents OR Nevada: 177,899 units · 5,570 per 100k residents NV Wyoming: 13,222 units · 2,264 per 100k residents WY South Dakota: 46,637 units · 5,075 per 100k residents SD Iowa: 10,467 units · 326 per 100k residents IA Illinois: 1,501,823 units · 11,968 per 100k residents IL Indiana: 831,776 units · 12,121 per 100k residents IN Ohio: 2,581,413 units · 21,904 per 100k residents OH Pennsylvania: 2,409,193 units · 18,588 per 100k residents PA New Jersey: 150,293 units · 1,618 per 100k residents NJ Massachusetts: 1,709,397 units · 24,416 per 100k residents MA California: 5,574,411 units · 14,306 per 100k residents CA Utah: 124,439 units · 3,642 per 100k residents UT Colorado: 737,091 units · 12,540 per 100k residents CO Nebraska: 46,403 units · 2,346 per 100k residents NE Missouri: 691,205 units · 11,156 per 100k residents MO Kentucky: 1,000,251 units · 22,100 per 100k residents KY West Virginia: 190,716 units · 10,775 per 100k residents WV Virginia: 1,501,312 units · 17,225 per 100k residents VA Maryland: 325,372 units · 5,265 per 100k residents MD Connecticut: 1,602,862 units · 44,315 per 100k residents CT Rhode Island: 158,252 units · 14,452 per 100k residents RI Arizona: 80,399 units · 1,082 per 100k residents AZ New Mexico: 105,956 units · 5,012 per 100k residents NM Kansas: 92,330 units · 3,140 per 100k residents KS Arkansas: 1,207 units · 39.4 per 100k residents AR Tennessee: 135,010 units · 1,895 per 100k residents TN North Carolina: 354,379 units · 3,271 per 100k residents NC South Carolina: 28,111 units · 523 per 100k residents SC Delaware: 90,679 units · 8,795 per 100k residents DE Oklahoma: 197,074 units · 4,862 per 100k residents OK Louisiana: 578,373 units · 12,645 per 100k residents LA Mississippi: 5,630 units · 191 per 100k residents MS Alabama: 151,699 units · 2,970 per 100k residents AL Georgia: 266,209 units · 2,414 per 100k residents GA D.C.: 47,907 units · 7,056 per 100k residents DC Hawaii: 974 units · 67.9 per 100k residents HI Texas: 175,509 units · 575 per 100k residents TX Florida: 447,566 units · 1,980 per 100k residents FL
Units reimbursed · per 100k residents
39.444,315
gray = no data reported
Colors are per 100,000 residents, so big states don’t automatically dominate. Tap or hover a state for its actual totals.
Tap or hover a state
…for its Medicaid breakdown
🏆 Top states by units · per 100k residents
1 Connecticut 44,315 /100k
2 Massachusetts 24,416 /100k
3 Kentucky 22,100 /100k
4 Ohio 21,904 /100k
5 Pennsylvania 18,588 /100k
6 Virginia 17,225 /100k
7 New York 16,342 /100k
8 Wisconsin 14,575 /100k
National units — by quarter
💵 About the dollar figures: “reimbursed” is what Medicaid paid pharmacies before confidential manufacturer rebates, so the program’s real net cost is lower than these numbers. Fee-for-service and managed-care claims are combined unless split above. Source: CMS State Drug Utilization Data; per-100k rates use 2023 Census population estimates.

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

Medicare Part D (outpatient prescription) spending for Lidocaine — 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. 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 Lidocaine — the ingredient across all brands.

Top reported reactions

Pain5,190
Nausea4,961
Fatigue4,867
Headache4,439
Product Quality Issue3,920
Dyspnoea3,658
Product Adhesion Issue3,514

Age at onset

Neonate191
Infant95
Child490
Adolescent342
Adult7,266
Elderly4,622

Reporter sex

96,036 reports
Male · 33%
Female · 66%
Unknown · 0%

Serious outcomes

Hospitalization26,850
Death7,429
Life-threatening6,105
Disabling2,002
Reports over time (by year) — tap or hover for the count & year
2019 2021 2023 2026 7,424 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
00603-1880-16 You're viewing this 30 POUCH in 1 CARTON (0603-1880-16) / 1 g in 1 POUCH (0603-1880-10) 2014-05-02 Active

📄 Full prescribing information FDA SPL

The complete FDA label for this product — the official prescribing information, verbatim, section by section. Jump with a chip, search within the label, or expand everything.
🎯 Indications and Usage 25 words

INDICATION AND USAGE LIDOCAINE PATCH 5% is indicated for relief of pain associated with post-herpetic neuralgia. It should be applied only to intact skin .

⏱️ Dosage and Administration 146 words

DOSAGE AND ADMINISTRATION Apply LIDOCAINE PATCH 5% to intact skin to cover the most painful area. Apply the prescribed number of patches (maximum of 3), only once for up to 12 hours within a 24 hour period. Patches may be cut into smaller sizes with scissors prior to removal of the release liner.

(See HANDLING AND DISPOSAL ) Clothing may be worn over the area of application. Smaller areas of treatment are recommended in a debilitated patient, or a patient with impaired elimination. If irritation or a burning sensation occurs during application, remove the patch(es) and do not reapply until the irritation subsides.

When LIDOCAINE PATCH 5% is used concomitantly with other products containing local anesthetic agents, the amount absorbed from all formulations must be considered. LIDOCAINE PATCH 5% may not stick if it gets wet. Avoid contact with water, such as bathing, swimming or showering.

Contraindications 29 words

CONTRAINDICATIONS LIDOCAINE PATCH 5% is contraindicated in patients with a known history of sensitivity to local anesthetics of the amide type, or to any other component of the product.

⚠️ Warnings ~2 min read

WARNINGS Risk of Methemoglobinemia Cases of methemoglobinemia have been reported in association with local anesthetic use. Although all patients are at risk for methemoglobinemia, patients with glucose-6-phosphate dehydrogenase deficiency, congenital or idiopathic methemoglobinemia, cardiac or pulmonary compromise, infants under 6 months of age, and concurrent exposure to oxidizing agents or their metabolites are more susceptible to developing clinical manifestations of the condition. If local anesthetics must be used in these patients, close monitoring for symptoms and signs of methemoglobinemia is recommended.

Signs of methemoglobinemia may occur immediately or may be delayed some hours after exposure, and are characterized by a cyanotic skin discoloration and/or abnormal coloration of the blood. Methemoglobin levels may continue to rise; therefore, immediate treatment is required to avert more serious central nervous system and cardiovascular adverse effects, including seizures, coma, arrhythmias, and death. Discontinue LIDOCAINE PATCH 5% and any other oxidizing agents.

Depending on the severity of the signs and symptoms, patients may respond to supportive care, i.e., oxygen therapy, hydration. A more severe clinical presentation may require treatment with methylene blue, exchange transfusion, or hyperbaric oxygen. Accidental Exposure in Children Even a used LIDOCAINE PATCH 5% patch contains a large amount of lidocaine (at least 665 mg).

The potential exists for a small child or a pet to suffer serious adverse effects from chewing or ingesting a new or used LIDOCAINE PATCH 5% patch, although the risk with this formulation has not been evaluated. It is important for patients to store and dispose of LIDOCAINE PATCH 5% out of the reach of children, pets and others . (See HANDLING AND DISPOSAL ) Excessive Dosing Excessive dosing by applying LIDOCAINE PATCH 5% to larger areas or for longer than the recommended wearing time could result in increased absorption of lidocaine and high blood concentrations, leading to serious adverse effects (see ADVERSE REACTIONS, Systemic Reactions ).

Lidocaine toxicity could be expected at lidocaine blood concentrations above 5 mcg/mL. The blood concentration of lidocaine is determined by the rate of systemic absorption and elimination. Longer duration of application, application of more than the recommended number of patches, smaller patients, or impaired elimination may all contribute to increasing the blood concentration of lidocaine.

With recommended dosing of LIDOCAINE PATCH 5%, the average peak blood concentration is about 0.13 mcg/mL, but concentrations higher than 0.25 mcg/mL have been observed in some individuals.

🤒 Adverse Reactions ~1 min read

ADVERSE REACTIONS Application Site Reactions During or immediately after treatment with LIDOCAINE PATCH 5%, the skin at the site of application may develop blisters, bruising, burning sensation, depigmentation, dermatitis, discoloration, edema, erythema, exfoliation, irritation, papules, petechia, pruritus, vesicles, or may be the locus of abnormal sensation. These reactions are generally mild and transient, resolving spontaneously within a few minutes to hours. Allergic Reactions Allergic and anaphylactoid reactions associated with lidocaine, although rare, can occur.

They are characterized by angioedema, bronchospasm, dermatitis, dyspnea, hypersensitivity, laryngospasm, pruritus, shock, and urticaria. If they occur, they should be managed by conventional means. The detection of sensitivity by skin testing is of doubtful value.

Other Adverse Events Due to the nature and limitation of spontaneous reports in postmarketing surveillance, causality has not been established for additional reported adverse events including: Asthenia, confusion, disorientation, dizziness, headache, hyperesthesia, hypoesthesia, lightheadedness, metallic taste, nausea, nervousness, pain exacerbated, paresthesia, somnolence, taste alteration, vomiting, visual disturbances such as blurred vision, flushing, tinnitus, and tremor. Systemic (Dose-Related) Reactions Systemic adverse reactions following appropriate use of LIDOCAINE PATCH 5% are unlikely, due to the small dose absorbed (see CLINICAL PHARMACOLOGY, Pharmacokinetics ).

Systemic adverse effects of lidocaine are similar in nature to those observed with other amide local anesthetic agents, including CNS excitation and/or depression (light headedness, nervousness, apprehension, euphoria, confusion, dizziness, drowsiness, tinnitus, blurred or double vision, vomiting, sensations of heat, cold or numbness, twitching, tremors, convulsions, unconsciousness, respiratory depression and arrest). Excitatory CNS reactions may be brief or not occur at all, in which case the first manifestation may be drowsiness merging into unconsciousness.

Cardiovascular manifestations may include bradycardia, hypotension and cardiovascular collapse leading to arrest.

🔄 Drug Interactions 148 words

Drug Interactions Antiarrhythmic Drugs LIDOCAINE PATCH 5% should be used with caution in patients receiving Class I antiarrhythmic drugs (such as tocainide and mexiletine) since the toxic effects are additive and potentially synergistic. Local Anesthetics When LIDOCAINE PATCH 5% is used concomitantly with other products containing local anesthetic agents, the amount absorbed from all formulations must be considered. Drugs That May Cause Methemoglobinemia When Used with LIDOCAINE PATCH 5% Patients who are administered local anesthetics are at increased risk of developing methemoglobinemia when concurrently exposed to the following drugs, which could include other local anesthetics: Examples of Drugs Associated with Methemoglobinemia: Class Examples Nitrates/Nitrites nitric oxide, nitroglycerin, nitroprusside, nitrous oxide Local anesthetics articaine, benzocaine, bupivacaine, lidocaine, mepivacaine, prilocaine, procaine, ropivacaine, tetracaine Antineoplastic agents cyclophosphamide, flutamide, hydroxyurea, ifosfamide, rasburicase Antibiotics dapsone, nitrofurantoin, para-aminosalicylic acid, sulfonamides Antimalarials chloroquine, primaquine Anticonvulsants Phenobarbital, phenytoin, sodium valproate Other drugs acetaminophen, metoclopramide, quinine, sulfasalazine

🤰 Pregnancy 78 words

Pregnancy Teratogenic Effects Pregnancy Category B. LIDOCAINE PATCH 5% has not been studied in pregnancy. Reproduction studies with lidocaine have been performed in rats at doses up to 30 mg/kg subcutaneously and have revealed no evidence of harm to the fetus due to lidocaine.

There are, however, no adequate and well-controlled studies in pregnant women. Because animal reproduction studies are not always predictive of human response, LIDOCAINE PATCH 5% should be used during pregnancy only if clearly needed.

🧒 Pediatric Use 12 words

Pediatric Use Safety and effectiveness in pediatric patients have not been established.

🆘 Overdosage 150 words

OVERDOSAGE Lidocaine overdose from cutaneous absorption is rare, but could occur. If there is any suspicion of lidocaine overdose (see ADVERSE REACTIONS, Systemic Reactions ), drug blood concentration should be checked. The management of overdose includes close monitoring, supportive care, and symptomatic treatment.

Dialysis is of negligible value in the treatment of acute overdose with lidocaine. In the absence of massive topical overdose or oral ingestion, evaluation of symptoms of toxicity should include consideration of other etiologies for the clinical effects, or overdosage from other sources of lidocaine or other local anesthetics. The oral LD 50 of lidocaine HCl is 459 (346-773) mg/kg (as the salt) in non-fasted female rats and 214 (159-324) mg/kg (as the salt) in fasted female rats, which are equivalent to roughly 4000 mg and 2000 mg, respectively, in a 60 to 70 kg man based on the equivalent surface area dosage conversion factors between species.

🧬 Clinical Pharmacology ~3 min read

CLINICAL PHARMACOLOGY Pharmacodynamics Lidocaine is an amide-type local anesthetic agent and is suggested to stabilize neuronal membranes by inhibiting the ionic fluxes required for the initiation and conduction of impulses. The penetration of lidocaine into intact skin after application of LIDOCAINE PATCH 5% is sufficient to produce an analgesic effect, but less than the amount necessary to produce a complete sensory block. Pharmacokinetics Absorption The amount of lidocaine systemically absorbed from LIDOCAINE PATCH 5% is directly related to both the duration of application and the surface area over which it is applied.

In a pharmacokinetic study, three LIDOCAINE PATCH 5% patches were applied over an area of 420 cm 2 of intact skin on the back of normal volunteers for 12 hours. Blood samples were withdrawn for determination of lidocaine concentration during the application and for 12 hours after removal of patches. The results are summarized in Table 1.

Table 1 Absorption of lidocaine from LIDOCAINE PATCH 5% Normal volunteers (n = 15, 12-hour wearing time) LIDOCAINE PATCH 5% Patch Application Site Area (cm 2 ) Dose Absorbed (mg) C max (mcg/mL) T max (hr) 3 patches (2100 mg) Back 420 64 ± 32 0.13 ± 0.06 11 hr When LIDOCAINE PATCH 5% is used according to the recommended dosing instructions, only 3 ± 2% of the dose applied is expected to be absorbed. At least 95% (665 mg) of lidocaine will remain in a used patch. Mean peak blood concentration of lidocaine is about 0.13 mcg/mL (about 1/10 of the therapeutic concentration required to treat cardiac arrhythmias).

Repeated application of three patches simultaneously for 12 hours (recommended maximum daily dose), once per day for three days, indicated that the lidocaine concentration does not increase with daily use. The mean plasma pharmacokinetic profile for the 15 healthy volunteers is shown in Figure 1. Figure 1 Mean lidocaine blood concentrations after three consecutive daily applications of three LIDOCAINE PATCH 5% patches simultaneously for 12 hours per day in healthy volunteers (n = 15).

Figure 1 Distribution When lidocaine is administered intravenously to healthy volunteers, the volume of distribution is 0.7 to

2.7L/kg (mean 1.5 ±

0.6SD, n=15). At concentrations produced by application of LIDOCAINE PATCH 5%, lidocaine is approximately 70% bound to plasma proteins, primarily alpha‑1‑acid glycoprotein. At much higher plasma concentrations (1 to 4 mcg/mL of free base), the plasma protein binding of lidocaine is concentration dependent.

Lidocaine crosses the placental and blood brain barriers, presumably by passive diffusion. Metabolism It is not known if lidocaine is metabolized in the skin. Lidocaine is metabolized rapidly by the liver to a number of metabolites, including monoethylglycinexylidide (MEGX) and glycinexylidide (GX), both of which have pharmacologic activity similar to, but less potent than that of lidocaine.

A minor metabolite, 2, 6-xylidine, has unknown pharmacologic activity but is carcinogenic in rats. The blood concentration of this metabolite is negligible following application of LIDOCAINE PATCH 5%. Following intravenous administration, MEGX and GX concentrations in serum range from 11 to 36% and from 5 to 11% of lidocaine concentrations, respectively.

Excretion Lidocaine and its metabolites are excreted by the kidneys. Less than 10% of lidocaine is excreted unchanged. The half-life of lidocaine elimination from the plasma following IV administration is 81 to 149 minutes (mean 107 ± 22 SD, n = 15).

The systemic clearance is 0.33 to

0.90L/min (mean 0.64 ±

0.18SD, n = 15).

📦 How Supplied / Storage and Handling 66 words

HOW SUPPLIED LIDOCAINE PATCH 5% is available as the following: Carton of 30 patches, packaged into individual child-resistant envelopes NDC 0603-1880-16 Store at 25 o C (77 o F); excursions permitted to 15 o -30 o C (59 o -86 o F). [See USP Controlled Room Temperature]. For more information, call Par Health at 1-800-828-9393. Manufactured for: Par Health USA Rochester, MI 48307 Revised: December 2025

📦 Storage and Handling 81 words

HANDLING AND DISPOSAL Hands should be washed after the handling of LIDOCAINE PATCH 5%, and eye contact with LIDOCAINE PATCH 5% should be avoided. Do not store patch outside the sealed envelope. Apply immediately after removal from the protective envelope.

Fold used patches so that the adhesive side sticks to itself and safely discard used patches or pieces of cut patches where children and pets cannot get to them. LIDOCAINE PATCH 5% should be kept out of the reach of children.

📋 Description 127 words

DESCRIPTION LIDOCAINE PATCH 5% is comprised of an adhesive material containing 5% lidocaine, which is applied to a non‑woven polyester felt backing and covered with a polyethylene terephthalate (PET) film release liner. The release liner is removed prior to application to the skin. The size of the patch is 10 cm x 14 cm.

Lidocaine is chemically designated as acetamide, 2‑(diethylamino)‑N‑(2,6‑ dimethylphenyl), has an octanol: water partition ratio of 43 at pH 7.4, and has the following structure: Each adhesive patch contains 700 mg of lidocaine (50 mg per gram adhesive) in an aqueous base. It also contains the following inactive ingredients: dihydroxyaluminum aminoacetate, disodium edetate, gelatin, glycerin, kaolin, methylparaben, polyacrylic acid, polyvinyl alcohol, propylene glycol, propylparaben, sodium carboxymethylcellulose, sodium polyacrylate, D-sorbitol, tartaric acid, and urea.

Description

💬 Information for Patients 64 words

Information for Patients Methemoglobinemia Inform patients that use of local anesthetics may cause methemoglobinemia, a serious condition that must be treated promptly. Advise patients or caregivers to stop use and seek immediate medical attention if they or someone in their care experience the following signs or symptoms: pale, gray, or blue colored skin (cyanosis); headache; rapid heart rate; shortness of breath; lightheadedness; or fatigue.

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