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Lidocaine 50 mg/g Ointment, 1 tube

by Fougera Pharmaceuticals, LLC · 1 TUBE in 1 CARTON (0168-0204-37) / 35.44 g in 1 TUBE
NDC 00168-0204-37
🏷️ FDA NDC (as labeled) 0168-0204-37 billing pads the labeler segment with a zero
Rx only Generic On market Non-controlled
🗂️ Data synced Jul 24, 2026 · sources: openFDA · FDA label (DailyMed) · FDA Orange & Purple Book · First Databank · CMS NADAC, ASP, Medicare & Medicaid · RxNorm
📋 All sources & update times →

This page is curated, coded, and maintained by

Compiled from public FDA, CMS, DailyMed, NADAC, and related drug data sources. Editorial policy

⚠️
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 ↗

🆔 Identity & classification

FDA NDC (as labeled) 0168-0204-37
Product NDC 0168-0204
11-digit billing NDC 00168020437
NCPDP billing unit GM — per gram (weight)
RxCUI 1543069
UNII 98PI200987
UPC 0301680204376
Application # ANDA080198
SPL Set ID 88ca9cba-0c4a-482f-b502-ceefdb1bfbcd
Established class (EPC) Amide Local Anesthetic; Antiarrhythmic
Physiologic effect Local Anesthesia
Chemical class Amides
DEA schedule Non-controlled
Marketing category ANDA
Marketing status On market
FDA listing status Listed (active directory)
Marketing start 1972-06-30
Route TOPICAL
Dosage form OINTMENT
Substance LIDOCAINE
GPI-14 90850060004210
GPI class Lidocaine
GCN Seq No 014476
GCN 30750
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% OINTMENT
FDB brand name Lidocaine
Legend status F — Federal legend — prescription drug or device
TE code (Orange Book) AT · RLD · RS
Why two NDCs? The FDA registers this code as 0168-0204-37 — 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 → 00168-0204-37. 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

LabelerFougera Pharmaceuticals, LLC
Application holderFOUGERA PHARMACEUTICALS INC
FDA applicationANDA080198 (ANDA)
Labeler code00168
First marketedJun 1972
Product typeHuman Prescription Drug
Portfolio5 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% OINTMENT Ingredient Lidocaine
📗 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 OJ4Z5Z32L4
    A synthetic polymer made by linking ethylene glycol units together. It serves as a solvent, humectant to retain moisture, and film-forming agent in tablets and coatings to improve texture and drug delivery.
  • UNII 5655G9Y8AQ
    A synthetic liquid polymer used as a solvent and humectant in medications. It helps dissolve active ingredients, maintain moisture in the formulation, and improve how the medicine flows and is absorbed.

2 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 DailyMed — ingredient classCode="IACT" elements from the exact product block matched by this NDC. Label-section narrative from DailyMed / the openFDA label index is shown separately when available.

Inactive ingredient FAQ

Are inactive ingredients the same for every manufacturer?
No. Inactive ingredients can differ by manufacturer, dosage form, strength, and package / product version.
Why might an inactive ingredient be missing?
Some SPLs do not provide a complete structured inactive-ingredient list, and older or unusual labels may only include the information in narrative text.
Can inactive ingredients matter?
Yes. They can matter for allergies, intolerances, dyes, gluten / lactose concerns, preservatives, and formulation differences — but confirm with a pharmacist or the manufacturer when it’s clinically important.

💲 Pricing

A drug doesn't have one price. Each row is a different public payment system, and none is what you'd pay at the counter — that depends on your insurance. The ⓘ on each row explains what it measures.

Price systemPer gPer package
Retail pharmacies payNADAC · weekly $0.162 $5.72 / 35.44 g
Medicaid paysCMS SDUD · 12 mo $0.3643 $12.91 / 35.44 g
Medicare drug plans payPart D · Q2 2026 $0.2915 $10.33 / 35.44 g
NADAC price history (per g) — tap or hover for the price & month
Dec 2021 Jul 2022 Dec 2025 Aug 2026 $0.227 $0.157
▼ Down 26% 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 50 mg/g 51672-3008-03 Sun 50 g $0.144 AT Discontinued save 11%
Lidocaine 50 mg/g 64380-0789-23 Strides 30 g $0.158 AT Discontinued save 2%
Lidocaine 50 mg/g 33342-0405-30 Macleods 1 tube $0.161 AT Availability likely +0%
Lidocaine 50 mg/g 51672-3020-02 Sun 1 tube $0.161 AT Availability likely +0%
Lidocaine 50 mg/g 62332-0424-30 Alembic 1 tube $0.161 AT Availability likely +0%
Lidocaine 50 mg/gthis 00168-0204-37 Fougera 1 tube $0.161 AT Availability likely —
lidocaine 50 mg/g 16714-0878-01 Northstar 1 tube $0.161 AT Availability likely —
lidocaine 50 mg/g 68462-0418-20 Glenmark 1 tube $0.161 AT Availability likely —
Lidocaine 50 mg/g 70752-0113-03 QUAGEN 1 tube $0.161 AT Availability likely —
lidocaine 50 mg/g 75834-0333-30 Nivagen 30 g $0.394 — Availability likely +144%
Leader Maximum Strength Hemorrhoidal Relief 50 mg/g 70000-0650-01 Cardinal 1 tube $0.394 — Availability likely +144%
Lidocaine 5 g/100g 00362-0221-10 Septodont, 50 g — AT FDA listed —
Lidocaine 50 mg/g 17856-3008-01 ATLANTIC 120 syringes — AT FDA listed —
Lidocaine 50 mg/g 46708-0424-30 Alembic 1 tube — AT FDA listed —
lidocaine 50 mg/g 50090-7922-00 A-S 1 tube — AT FDA listed —
Lidocaine 50 mg/g 51407-0383-35 Golden 1 tube — AT FDA listed —
Lidocaine 50 mg/g 59651-0591-30 Aurobindo 1 tube — AT FDA listed —
Lidocaine 50 mg/g 63629-2503-01 Bryant 1 tube — AT FDA listed —
Lidocaine 50 mg/g 63629-2504-01 Bryant 1 tube — AT FDA listed —
Lidocaine 50 mg/g 63629-8848-01 Bryant 1 tube — AT FDA listed —
Lidocaine 50 mg/g 65162-0918-41 Amneal 150 g — AT FDA listed —
Lidocaine 50 mg/g 68071-3792-05 NuCare 1 jar — AT FDA listed —
Lidocaine 50 mg/g 68788-4050-05 Preferred 1 jar — AT FDA listed —
Lidocaine 50 mg/g 68788-7376-03 Preferred 1 tube — AT FDA listed —
Lidocaine 50 mg/g 68788-7766-05 Preferred 50 g — AT FDA listed —
lidocaine 50 mg/g 68788-8396-05 Preferred 50 g — AT FDA listed —
Lidocaine 50 mg/g 70518-3746-00 REMEDYREPACK 1 tube — AT FDA listed —
lidocaine 50 mg/g 70518-3902-00 REMEDYREPACK 50 g — AT FDA listed —
lidocaine 50 mg/g 70518-3972-00 REMEDYREPACK 50 g — AT FDA listed —
Lidocaine 50 mg/g 70518-4192-00 REMEDYREPACK 50 g — AT FDA listed —
Lidocaine 50 mg/g 71205-0288-50 Proficient 1 jar — AT FDA listed —
Lidocaine 50 mg/g 71205-0342-44 Proficient 1 tube — AT FDA listed —
Lidocaine 50 mg/g 71205-0429-30 Proficient 1 tube — AT FDA listed —
lidocaine 50 mg/g 71205-0500-44 Proficient 1 tube — AT FDA listed —
Lidocaine 50 mg/g 71205-0549-44 Proficient 35.44 g — AT FDA listed —
lidocaine 50 mg/g 71205-0717-50 Proficient 50 g — AT FDA listed —
Lidocaine 50 mg/g 71205-0814-44 Proficient 35.44 g — AT FDA listed —
Lidocaine 50 mg/g 71335-2856-01 Bryant 1 tube — AT FDA listed —
Lidocaine 50 mg/g 72162-2068-02 Bryant 1 tube — AT FDA listed —
Lidocaine 50 mg/g 72162-2084-02 Bryant 1 tube — AT FDA listed —
Lidocaine 50 mg/g 72189-0165-35 DIRECT 35.44 g — AT FDA listed —
Lidocaine 50 mg/g 72189-0168-35 DIRECT 35.44 g — AT FDA listed —
Lidocaine 50 mg/g 72189-0211-50 DIRECT 50 g — AT FDA listed —
Lidocaine 50 mg/g 72189-0488-50 Direct_Rx 50 g — AT FDA listed —
Lidocaine 50 mg/g 72189-0493-35 Direct_Rx 35.44 g — AT FDA listed —
Lidocaine 50 mg/g 72189-0499-50 Direct_Rx 50 g — AT FDA listed —
Lidocaine 50 mg/g 72189-0601-35 Direct_rx 35 g — AT FDA listed —
lidocaine 50 mg/g 76420-0125-50 Asclemed 50 g — AT FDA listed —
Lidocaine 50 mg/g 76420-0131-50 Asclemed 50 g — AT FDA listed —
lidocaine 50 mg/g 76420-0550-35 Asclemed 1 tube — AT FDA listed —
Lidocaine 50 mg/g 80425-0247-01 Advanced 50 g — AT FDA listed —
Lidocaine 50 mg/g 80425-0248-01 Advanced 50 g — AT FDA listed —
Lidocaine 50 mg/g 80425-0324-01 Advanced 1 tube — AT FDA listed —
Lidocaine 50 mg/g 80425-0442-01 Advanced 50 g — AT FDA listed —
lidocaine 50 mg/g 80425-0450-01 Advanced 1 tube — AT FDA listed —
Lidocaine 50 mg/g 80425-0509-01 Advanced 1 tube — AT FDA listed —
Lidocaine 50 mg/g 80425-0538-01 Advanced 1 jar — AT FDA listed —
lidocaine 50 mg/g 80425-0554-01 Advanced 50 g — AT FDA listed —
Lidocaine 50 mg/g 83008-0044-50 Quality 1 jar — AT FDA listed —
Lidocaine 50 mg/g 83008-0067-50 Quality 50 g — AT FDA listed —
lidocaine 50 mg/g 85509-1418-03 PHOENIX 1 tube — AT FDA listed —
Lidocaine 50 mg/g 85509-1424-05 PHOENIX 50 g — AT FDA listed —
Lidocaine 50 mg/g 85509-1918-01 PHOENIX 50 g — AT FDA listed —
Lidocaine 50 mg/g 85509-3008-05 PHOENIX 1 jar — AT FDA listed —
Lidocaine 50 mg/g 87063-0144-50 Asclemed 1 tube — AT FDA listed —
Maximum Strength Hemorrhoidal Relief 50 mg/g 51316-0226-00 CVS 1 tube — — FDA listed —
MAXIMUM STRENGTH HEMORRHOIDAL RELIEF with Finger Cots 50 mg/g 51316-0229-00 CVS 1 tube — — FDA listed —
Microcaine Topical Analgesic 50 mg/g 67194-0022-01 Unit 15 g — — FDA listed —
DR REAL NUMB Topical Anorectal 50 mg/g 83800-0430-00 FUZZYLULU 1 tube — — FDA listed —
RectaEase Hemorrhoid Relief Cream 50 mg/g 69396-0070-01 Trifecta 1 tube — — FDA listed —
Numb520 50 mg/g 63742-0033-01 Clinical 1 bottle — — FDA listed —
Numb 520 50 mg/g 72654-0033-02 Ebanel 125 g — — FDA listed —
PUREGEN LABS Maximum Strength Lidocaine 50 mg/g 80513-0813-06 Advanced 170 g — — FDA listed —
Numb Master 50 mg/g 63742-0032-01 Clinical 1 bottle — — FDA listed —
Numb25 50 mg/g 63742-0035-01 Clinical 38 g — — FDA listed —
Recticare 50 mg/g 00496-0892-15 Ferndale 15 g — — FDA listed —
Numb25 50 mg/g 72654-0036-02 Ebanel 125 g — — FDA listed —
Lmx5 50 mg/g 00496-0883-15 Ferndale 15 g — — FDA listed —
HemRid Anorectal Cream 50 mg/g 82620-0001-01 KKA 1 tube — — FDA listed —
Lidocaine 50 mg/g 58980-0823-30 STRATUS 1 tube — — FDA listed —
Quick Numb 50 mg/g 63742-0333-01 Clinical 35.43 g — — FDA listed —
Lidocaine 5% Cream 50 mg/g 82461-0420-30 Medcore 1 tube — — FDA listed —
Dr. Care Numbing Cream 50 mg/g 84019-0038-01 Shengnan 30 g — — FDA listed —
Equate Hemorrhoid Relief 50 mg/g 79903-0428-01 Walmart 1 tube — — FDA listed —
Lidocaine 50 mg/g 50090-8011-00 A-S 1 tube — AT FDA listed —
Lidocaine Cream 50 mg/g 71457-0525-15 InvaDerm 1 tube — — FDA listed —
Lidocaine 50 mg/g 50090-8040-00 A-S 1 tube — AT FDA listed —
About this product: this is a generic version of the medicine. FDA equivalence ratings are shown when available, and 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

🏛️
1972
On the market since
Jun 1972
📍
2026
Currently FDA-listed
54 years listed
🔓
·
Generic on the market
this product is a generic
✅This is a generic drug

This product is an FDA-approved generic. Other versions of the same drug are listed under Therapeutic equivalents, least expensive first.

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 00168-0204-37, 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
13.6K
Units reimbursed last 4 qtrs
707.4K
Gross reimbursed last 4 qtrs
$257.7K
Avg / prescription
$18.97
Avg / unit
$0.3643
Latest quarter Q4 2025
3.3KRx
Medicaid pays / g
$0.3643
gross reimbursed
vs
NADAC / g
$0.1615
acquisition cost
=
Spread
+$0.2028
+126% vs cost
What Medicaid paid per g (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 ⓘ
46% FFS 54% MCO
Fee-for-service · 6,305 Rx Managed care · 7,280 Rx
State Medicaid map
Alaska: 1,943 units · 265 per 100k residents AK Maine: 2,339 units · 168 per 100k residents ME Washington: 16,374 units · 210 per 100k residents WA Idaho: 3,042 units · 155 per 100k residents ID Montana: 2,023 units · 179 per 100k residents MT North Dakota: no data reported ND Minnesota: 3,759 units · 65.5 per 100k residents MN Wisconsin: 20,260 units · 343 per 100k residents WI Michigan: 20,419 units · 203 per 100k residents MI New York: 42,748 units · 218 per 100k residents NY Vermont: no data reported VT New Hampshire: no data reported NH Oregon: 15,883 units · 375 per 100k residents OR Nevada: 27,656 units · 866 per 100k residents NV Wyoming: 461 units · 78.9 per 100k residents WY South Dakota: no data reported SD Iowa: 13,056 units · 407 per 100k residents IA Illinois: 17,827 units · 142 per 100k residents IL Indiana: 4,979 units · 72.6 per 100k residents IN Ohio: 40,083 units · 340 per 100k residents OH Pennsylvania: 32,760 units · 253 per 100k residents PA New Jersey: no data reported NJ Massachusetts: 6,729 units · 96.1 per 100k residents MA California: 165,518 units · 425 per 100k residents CA Utah: 2,056 units · 60.2 per 100k residents UT Colorado: 40,348 units · 686 per 100k residents CO Nebraska: no data reported NE Missouri: 11,660 units · 188 per 100k residents MO Kentucky: 15,124 units · 334 per 100k residents KY West Virginia: 11,093 units · 627 per 100k residents WV Virginia: 13,954 units · 160 per 100k residents VA Maryland: 12,941 units · 209 per 100k residents MD Connecticut: 7,301 units · 202 per 100k residents CT Rhode Island: no data reported RI Arizona: 11,510 units · 155 per 100k residents AZ New Mexico: 20,910 units · 989 per 100k residents NM Kansas: 1,843 units · 62.7 per 100k residents KS Arkansas: 2,688 units · 87.6 per 100k residents AR Tennessee: 10,136 units · 142 per 100k residents TN North Carolina: 18,189 units · 168 per 100k residents NC South Carolina: 1,559 units · 29.0 per 100k residents SC Delaware: no data reported DE Oklahoma: 6,281 units · 155 per 100k residents OK Louisiana: 21,099 units · 461 per 100k residents LA Mississippi: 1,134 units · 38.6 per 100k residents MS Alabama: 1,609 units · 31.5 per 100k residents AL Georgia: 1,559 units · 14.1 per 100k residents GA D.C.: 4,625 units · 681 per 100k residents DC Hawaii: no data reported HI Texas: 30,791 units · 101 per 100k residents TX Florida: 21,101 units · 93.3 per 100k residents FL
Units reimbursed · per 100k residents
14.1989
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 New Mexico 989 /100k
2 Nevada 866 /100k
3 Colorado 686 /100k
4 D.C. 681 /100k
5 West Virginia 627 /100k
6 Louisiana 461 /100k
7 California 425 /100k
8 Iowa 407 /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
00168-0204-37 You're viewing this 1 TUBE in 1 CARTON (0168-0204-37) / 35.44 g in 1 TUBE 1972-06-30 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 ⏱️ Dosage and Administration ⛔ Contraindications ⚠️ Warnings 🤒 Adverse Reactions 🔄 Drug Interactions 🤰 Pregnancy 🧒 Pediatric Use 🆘 Overdosage 🧬 Clinical Pharmacology 📦 How Supplied / Storage and Handling 📋 Description 💬 Information for Patients
🎯 Indications and Usage 49 words ▾

INDICATIONS AND USAGE Lidocaine Ointment 5% is indicated for production of anesthesia of accessible mucous membranes of the oropharynx. It is also useful as an anesthetic lubricant for intubation and for the temporary relief of pain associated with minor burns, including sunburn, abrasions of the skin, and insect bites.

⏱️ Dosage and Administration ~2 min read ▾

DOSAGE AND ADMINISTRATION When Lidocaine Ointment 5% is used concomitantly with other products containing lidocaine, the total dose contributed by all formulations must be kept in mind. Adult: A single application should not exceed 5 g of Lidocaine Ointment 5%, containing 250 mg of lidocaine base (equivalent chemically to approximately 300 mg of lidocaine hydrochloride). This is roughly equivalent to squeezing a six (6) inch length of ointment from the tube.

In a 70 kg adult this dose equals 3.6 mg/kg (1.6 mg/lb) lidocaine base. No more than one-half tube, approximately 17 - 20 g of ointment or 850 - 1000 mg lidocaine base, should be administered in any one day. Although the incidence of adverse effects with Lidocaine Ointment 5% is quite low, caution should be exercised, particularly when employing large amounts, since the incidence of adverse effects is directly proportional to the total dose of local anesthetic agent administered.

Dosage for children: It is difficult to recommend a maximum dose of any drug for children since this varies as a function of age and weight. For children less than ten years who have a normal lean body mass and a normal lean body development, the maximum dose may be determined by the application of one of the standard pediatric drug formulas (e.g., Clark's rule). For example a child of five years weighing 50 lbs., the dose of lidocaine should not exceed 75 - 100 mg when calculated according to Clark's rule.

In any case, the maximum amount of lidocaine administered should not exceed 4.5 mg/kg (2.0 mg/lb) of body weight. Administration: For medical use, apply topically for adequate control of symptoms. The use of a sterile gauze pad is suggested for application to broken skin tissue.

Apply to the tube prior to intubation. In dentistry, apply to previously dried oral mucosa. Subsequent removal of excess saliva with cotton rolls or saliva ejector minimizes dilution of the ointment, permits maximum penetration, and minimizes the possibility of swallowing the topical ointment.

For use in connection with the insertion of new dentures, apply to all denture surfaces contacting mucosa. IMPORTANT: Patients should consult a dentist at intervals not exceeding 48 hours throughout the fitting period.

⛔ Contraindications 27 words ▾

CONTRAINDICATIONS Lidocaine is contraindicated in patients with a known history of hypersensitivity to local anesthetics of the amide type or to other components of Lidocaine Ointment 5%.

⚠️ Warnings ~1 min read ▾

WARNINGS EXCESSIVE DOSAGE, OR SHORT INTERVALS BETWEEN DOSES, CAN RESULT IN HIGH PLASMA LEVELS AND SERIOUS ADVERSE EFFECTS, PATIENTS SHOULD BE INSTRUCTED TO STRICTLY ADHERE TO THE RECOMMENDED DOSAGE AND ADMINISTRATION GUIDELINES AS SET FORTH IN THIS PACKAGE INSERT. THE MANAGEMENT OF SERIOUS ADVERSE REACTIONS MAY REQUIRE THE USE OF RESUSCITATIVE EQUIPMENT, OXYGEN, AND OTHER RESUSCITATIVE DRUGS. Lidocaine Ointment 5% should be used with extreme caution in the presence of sepsis or severely traumatized mucosa in the area of application, since under such conditions there is the potential for rapid systemic absorption.

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 and symptoms of methemoglobinemia may occur immediately or may be delayed some hours after exposure, and are characterized by a cyanotic skin discoloration and 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 Ointment USP, 5% and any other oxidizing agents.

Depending on the severity of the symptoms, patients may respond to supportive care, i.e., oxygen therapy, hydration. More severe symptoms may require treatment with methylene blue, exchange transfusion, or hyperbaric oxygen.

🤒 Adverse Reactions ~1 min read ▾

ADVERSE REACTIONS Adverse experiences following the administration of lidocaine are similar in nature to those observed with other amide local anesthetic agents. These adverse experiences are, in general, dose-related and may result from high plasma levels caused by excessive dosage or rapid absorption, or may result from a hypersensitivity, idiosyncrasy or diminished tolerance on the part of the patient. Serious adverse experiences are generally systemic in nature.

The following types are those most commonly reported: Central nervous system: CNS manifestations are excitatory and/or depressant and may be characterized by lightheadedness, 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. The excitatory manifestations may be very brief or may not occur at all, in which case the first manifestation of toxicity may be drowsiness merging into unconsciousness and respiratory arrest.

Drowsiness following the administration of lidocaine is usually an early sign of a high blood level of the drug and may occur as a consequence of rapid absorption. Cardiovascular system: Cardiovascular manifestations are usually depressant and are characterized by bradycardia, hypotension, and cardiovascular collapse, which may lead to cardiac arrest. Allergic: Allergic reactions are characterized by cutaneous lesions, urticaria, edema or anaphylactoid reactions.

Allergic reactions may occur as a result of sensitivity either to the local anesthetic agent or to other components in the formulation. Allergic reactions as a result of sensitivity to lidocaine are extremely rare and, if they occur, should be managed by conventional means. The detection of sensitivity by skin testing is of doubtful value.

🔄 Drug Interactions 82 words ▾

Drug Interactions Patients that are administered local anesthetics may be 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 83 words ▾

Use in Pregnancy: Teratogenic Effects. Pregnancy Category B. Reproduction studies have been performed in rats at doses up to 6.6 times the human dose and have revealed no evidence of harm to the fetus caused by lidocaine.

There are, however, no adequate and well-controlled studies in pregnant women. Animal reproduction studies are not always predictive of human response. General consideration should be given to this fact before administering lidocaine to women of childbearing potential, especially during early pregnancy when maximum organogenesis takes place.

🧒 Pediatric Use 53 words ▾

Pediatric use: Dosage in children should be reduced, commensurate with age, body weight and physical condition. Caution must be taken to avoid overdosage when applying Lidocaine Ointment 5% to large areas of injured or abraded skin, since the systemic absorption of lidocaine may be increased under such conditions. See DOSAGE and ADMINISTRATION .

🆘 Overdosage ~1 min read ▾

OVERDOSAGE Acute emergencies from local anesthetics are generally related to high plasma levels encountered during therapeutic use of local anesthetics. (see ADVERSE REACTIONS , WARNINGS , and PRECAUTIONS ). Management of local anesthetic emergencies: The first consideration is prevention, best accomplished by careful and constant monitoring of cardiovascular and respiratory vital signs and the patient's state of consciousness after each local anesthetic administration.

At the first sign of change, oxygen should be administered. The first step in the management of convulsions consists of immediate attention to the maintenance of a patent airway and assisted or controlled ventilation with oxygen and a delivery system capable of permitting immediate positive airway pressure by mask. Immediately after the institution of these ventilatory measures, the adequacy of the circulation should by evaluated, keeping in mind that drugs used to treat convulsions sometimes depress the circulation when administered intravenously.

Should convulsions persist despite adequate respiratory support, and if the status of the circulation permits, small increments of an ultra-short acting barbiturate (such as thiopental or thiamylal) or a benzodiazepine (such as diazepam) may be administered intravenously. The clinician should be familiar, prior to use of local anesthetics, with these anticonvulsant drugs. Supportive treatment of circulatory depression may require administration of intravenous fluids and, when appropriate, a vasopressor as directed by the clinical situation (e.g., ephedrine).

If not treated immediately, both convulsions and cardiovascular depression can result in hypoxia, acidosis, bradycardia, arrhythmias and cardiac arrest. If cardiac arrest should occur, standard cardiopulmonary resuscitative measures should be instituted. Dialysis is of negligible value in the treatment of acute overdosage with lidocaine.

The oral LD 50 of lidocaine HCI in non-fasted female rats is 459 (346 - 773) mg/kg (as the salt) and 214 (159 - 324) mg/kg (as the salt) in fasted female rats.

🧬 Clinical Pharmacology ~2 min read ▾

CLINICAL PHARMACOLOGY Mechanism of action: Lidocaine stabilizes the neuronal membrane by inhibiting the ionic fluxes required for the initiation and conduction of impulses, thereby effecting local anesthetic action. Onset of anesthesia: Lidocaine Ointment 5% effects local, topical anesthesia. The onset of action is 3 - 5 minutes.

It is ineffective when applied to intact skin. Hemodynamics: Excessive blood levels may cause changes in cardiac output, total peripheral resistance, and mean arterial pressure. These changes may be attributable to a direct depressant effect of the local anesthetic agent on various components of the cardiovascular system.

Pharmacokinetics and metabolism: Lidocaine may be absorbed following topical administration to mucous membranes, its rate and extent of absorption depending upon the specific site of application, duration of exposure, concentration, and total dosage. In general, the rate of absorption of local anesthetic agents following topical application occurs most rapidly after intratracheal administration. Lidocaine is also well-absorbed from the gastrointestinal tract, but little intact drug appears in the circulation because of biotransformation in the liver.

Lidocaine is metabolized rapidly by the liver, and metabolites and unchanged drug are excreted by the kidneys. Biotransformation includes oxidative N-dealkylation, ring hydroxylation, cleavage of the amide linkage, and conjugation. N-dealkylation, a major pathway of biotransformation, yields the metabolites monoethylglycinexylidide and glycinexylidide.

The pharmacological/toxicological actions of these metabolites are similar to, but less potent than, those of lidocaine. Approximately 90% of lidocaine administered is excreted in the form of various metabolites, and less than 10% is excreted unchanged. The primary metabolite in urine is a conjugate of 4-hydroxy-2,6-dimethylaniline.

The plasma binding of lidocaine is dependent on drug concentration, and the fraction bound decreases with increasing concentration. At concentrations of 1 to 4 μg of free base per mL, 60 to 80 percent of lidocaine is protein bound. Binding is also dependent on the plasma concentration of the alpha-l-acid glycoprotein.

Lidocaine crosses the blood-brain and placental barriers, presumably by passive diffusion. Studies of lidocaine metabolism following intravenous bolus injections have shown that the elimination half-life of this agent is typically 1.5 to 2.0 hours. Because of the rapid rate at which lidocaine is metabolized, any condition that affects liver function may alter lidocaine kinetics.

The half-life may be prolonged two-fold or more in patients with liver dysfunction. Renal dysfunction does not affect lidocaine kinetics but may increase the accumulation of metabolites. Factors such as acidosis and the use of CNS stimulants and depressants affect the CNS levels of lidocaine required to produce overt systemic effects.

Objective adverse manifestations become increasingly apparent with increasing venous plasma levels above 6.0 μ g free base per mL. In the rhesus monkey arterial blood levels of 18 - 21 μ g/mL have been shown to be threshold for convulsive activity.

📦 How Supplied / Storage and Handling 58 words ▾

HOW SUPPLIED Lidocaine Ointment USP, 5% is supplied in 35.44 g (1 1 / 4 oz) laminate tubes with a child-resistant cap, NDC 0168-0204-37. Store at 20°C to 25°C (68°F to 77°F); excursions permitted to 15°C to 30°C (59°F to 86°F). E. FOUGERA & CO. A division of Fougera PHARMACEUTICALS INC. Melville, New York 11747 46265489 Revised: 10/2023

📋 Description 61 words ▾

DESCRIPTION Lidocaine Ointment 5% contains a local anesthetic agent and is administered topically. See INDICATIONS AND USAGE for specific uses. Lidocaine Ointment 5% contains lidocaine, which is chemically designated as acetamide, 2-(diethylamino)- N -(2,6-dimethylphenyl)-, and has the following structural formula: Composition of Lidocaine Ointment 5%: acetamide, 2-(diethylamino)- N -(2,6-dimethylphenyl)-, (lidocaine) 5% in a water miscible ointment vehicle containing polyethylene glycols. structuralformula

💬 Information for Patients 159 words ▾

Information for Patients: 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. When topical anesthetics are used in the mouth, the patient should be aware that the production of topical anesthesia may impair swallowing and thus enhance the danger of aspiration.

For this reason, food should not be ingested for 60 minutes following the use of local anesthetic preparations in the mouth or throat area. This is particularly important in children because of their frequency of eating. Numbness of the tongue or buccal mucosa may enhance the danger of unintentional biting trauma.

Food and chewing gum should not be taken while the mouth or throat area is anesthetized.

Source: FDA Structured Product Labeling, mirrored from DailyMed / openFDA. Prefer the government’s original formatting? View this label on DailyMed ↗
← 00168-0203-60 · E. 00168-0258-15 · E. →
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.