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Lidocaine 50 mg/g Ointment, 1 tube — NDC 80425-0594-01 package photo

Lidocaine 50 mg/g Ointment, 1 tube

by Advanced Rx of Tennessee, LLC · 1 TUBE in 1 CARTON (80425-0594-1) / 35.44 g in 1 TUBE
NDC 80425-0594-01
🏷️ FDA NDC (as labeled) 80425-0594-1 billing pads the package segment with a zero
Rx only Generic On market Non-controlled
🗂️ Data synced Sep 17, 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) 80425-0594-1
Product NDC 80425-0594
11-digit billing NDC 80425059401
Application # ANDA086724
SPL Set ID 5b3b7331-8a13-b872-e063-6394a90a9dfe
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 2026-09-10
Route TOPICAL
Dosage form OINTMENT
Substance LIDOCAINE
TE code (Orange Book) AT · RLD · RS
Why two NDCs? The FDA registers this code as 80425-0594-1 — a 5-4-1 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 package segment → 80425-0594-01. Same drug, same package — only the format differs.
Where does this data come from?
Identifiers from the FDA openFDA NDC Directory and Structured Product Labeling; RxCUI from RxNorm (NLM); GPI from Medi-Span; GCN / HIC / AHFS / legend from First Databank.

🏭 Manufacturer & labeler

LabelerAdvanced Rx of Tennessee, LLC
Application holderSUN PHARMA CANADA INC
FDA applicationANDA086724 (ANDA)
Labeler code80425
First marketedSep 2026
Product typeHuman Prescription Drug
Portfolio280 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

📗 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 G2M7P15E5P
    Polyethylene glycol 3350 is a synthetic polymer used as a solvent, humectant, and thickening agent in medicines. It helps dissolve other ingredients, retain moisture in the product, and achieve the desired consistency.
  • UNII B697894SGQ
    Polyethylene glycol 400 is a clear, thick liquid made from petroleum-derived polymers. It acts as a solvent and humectant in medicines, helping dissolve active ingredients and retain moisture in the formulation.
  • UNII 6DC9Q167V3
    Propylene glycol is a clear liquid derived from petroleum or vegetable sources. It acts as a solvent, humectant, and preservative in medicines, helping dissolve active ingredients and maintain product stability.

3 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 Not in the retail survey — common for institutional, discontinued, or low-volume packs.
Medicaid paysCMS SDUD · 12 mo No recent Medicaid claims on file for this NDC — rare and low-volume NDCs are suppressed in the public data.
Medicare drug plans payPart D · quarterly No Part D plan price is available for this NDC in our data.
ℹ️
No price is published for this exact package yet. CMS surveys NADAC per package size, so a different pack of the same drug often has one.
Where does this data come from?
NADAC (National Average Drug Acquisition Cost) is the CMS weekly pharmacy-acquisition-cost survey — what pharmacies pay. ASP (Average Sales Price) is the CMS Medicare Part B drug-payment file, published quarterly. Medicaid pays is computed by us from CMS State Drug Utilization Data (total reimbursed ÷ units, trailing 12 months) — gross of rebates and inclusive of dispensing fees, so it reflects what Medicaid paid, not an acquisition cost. Medicare drug plans pay is the median negotiated point-of-sale unit cost across plans listing this NDC in the CMS quarterly Prescription Drug Plan pricing files, before rebates. The VA pays is the federal contract price (FSS, and the statutory Big 4 ceiling where listed) from the VA National Acquisition Center pharmaceutical price file. All are free public government data; each measures a different payer, so the figures are not directly comparable.

🔁 Therapeutic equivalents

ProductLabelerPackNADAC/unitTEStatusPrice vs. this
Lidocaine 50 mg/g 51672-3008-03 Sun 50 g $0.144 AT Discontinued —
Lidocaine 50 mg/g 64380-0789-23 Strides 30 g $0.158 AT Discontinued —
Lidocaine 50 mg/g 62332-0424-30 Alembic 1 tube $0.161 AT Availability likely —
Lidocaine 50 mg/g 33342-0405-30 Macleods 1 tube $0.161 AT Availability likely —
Lidocaine 50 mg/g 51672-3020-02 Sun 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 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 75834-0333-30 Nivagen 30 g $0.394 — Availability likely —
Leader Maximum Strength Hemorrhoidal Relief 50 mg/g 70000-0650-01 Cardinal 1 tube $0.394 — Availability likely —
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 71205-0500-44 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 76420-0125-50 Asclemed 50 g — AT FDA listed —
Lidocaine 50 mg/g 76420-0131-50 Asclemed 50 g — 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 —
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 —
Microcaine Topical Analgesic 50 mg/g 67194-0022-01 Unit 15 g — — FDA listed —
Lidocaine 50 mg/g 71205-0814-44 Proficient 35.44 g — AT FDA listed —
Lidocaine 50 mg/g 72162-2084-02 Bryant 1 tube — AT FDA listed —
lidocaine 50 mg/g 76420-0550-35 Asclemed 1 tube — AT FDA listed —
DR REAL NUMB Topical Anorectal 50 mg/g 83800-0430-00 FUZZYLULU 1 tube — — FDA listed —
Lidocaine 50 mg/g 80425-0509-01 Advanced 1 tube — AT FDA listed —
lidocaine 50 mg/g 85509-1418-03 PHOENIX 1 tube — AT FDA listed —
Lidocaine 50 mg/g 85509-1918-01 PHOENIX 50 g — AT FDA listed —
Lidocaine 50 mg/g 68788-7376-03 Preferred 1 tube — AT FDA listed —
RectaEase Hemorrhoid Relief Cream 50 mg/g 69396-0070-01 Trifecta 1 tube — — FDA listed —
Lidocaine 50 mg/g 72189-0168-35 DIRECT 35.44 g — AT FDA listed —
Lidocaine 50 mg/g 80425-0248-01 Advanced 50 g — AT FDA listed —
Lidocaine 50 mg/g 80425-0538-01 Advanced 1 jar — AT FDA listed —
Lidocaine 50 mg/g 87063-0144-50 Asclemed 1 tube — AT FDA listed —
Numb520 50 mg/g 63742-0033-01 Clinical 1 bottle — — FDA listed —
lidocaine 50 mg/g 70518-3902-00 REMEDYREPACK 50 g — AT FDA listed —
Lidocaine 50 mg/g 72189-0165-35 DIRECT 35.44 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 80425-0247-01 Advanced 50 g — AT FDA listed —
Lidocaine 50 mg/g 83008-0067-50 Quality 50 g — AT FDA listed —
Lidocaine 50 mg/g 68071-3792-05 NuCare 1 jar — AT FDA listed —
Lidocaine 50 mg/g 70518-3746-00 REMEDYREPACK 1 tube — AT 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 —
Lidocaine 50 mg/g 83008-0044-50 Quality 1 jar — AT FDA listed —
Lidocaine 50 mg/g 85509-1424-05 PHOENIX 50 g — AT FDA listed —
Lidocaine 50 mg/g 59651-0591-30 Aurobindo 1 tube — AT FDA listed —
Lidocaine 50 mg/g 65162-0918-41 Amneal 150 g — AT FDA listed —
Lidocaine 50 mg/g 68788-7766-05 Preferred 50 g — AT FDA listed —
Lidocaine 50 mg/g 72162-2068-02 Bryant 1 tube — AT FDA listed —
Lidocaine 50 mg/g 51407-0383-35 Golden 1 tube — AT 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 —
lidocaine 50 mg/g 68788-8396-05 Preferred 50 g — AT FDA listed —
Lidocaine 50 mg/g 70518-4192-00 REMEDYREPACK 50 g — AT FDA listed —
Lidocaine 50 mg/g 72189-0488-50 Direct_Rx 50 g — AT FDA listed —
Lidocaine 50 mg/g 72189-0601-35 Direct_rx 35 g — AT FDA listed —
Recticare 50 mg/g 00496-0892-15 Ferndale 15 g — — FDA listed —
lidocaine 50 mg/g 80425-0450-01 Advanced 1 tube — AT FDA listed —
Lidocaine 50 mg/g 17856-3008-01 ATLANTIC 120 syringes — AT FDA listed —
Numb25 50 mg/g 72654-0036-02 Ebanel 125 g — — FDA listed —
lidocaine 50 mg/g 50090-7922-00 A-S 1 tube — AT FDA listed —
Lidocaine 50 mg/g 71335-2856-01 Bryant 1 tube — AT FDA listed —
Lmx5 50 mg/g 00496-0883-15 Ferndale 15 g — — FDA listed —
Lidocaine 50 mg/g 80425-0442-01 Advanced 50 g — AT FDA listed —
lidocaine 50 mg/g 80425-0554-01 Advanced 50 g — AT FDA listed —
Lidocaine 50 mg/g 71205-0429-30 Proficient 1 tube — AT FDA listed —
HemRid Anorectal Cream 50 mg/g 82620-0001-01 KKA 1 tube — — FDA listed —
Lidocaine 50 mg/g 85509-3008-05 PHOENIX 1 jar — AT 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 50 mg/g 80425-0324-01 Advanced 1 tube — AT 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 —
Lidocaine 50 mg/g 46708-0424-30 Alembic 1 tube — AT FDA listed —
Lidocaine 50 mg/g 68788-4050-05 Preferred 1 jar — AT FDA listed —
lidocaine 50 mg/g 70518-3972-00 REMEDYREPACK 50 g — AT FDA listed —
Lidocaine 50 mg/g 72189-0211-50 DIRECT 50 g — AT 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 —
Flarestop Hemorrhoid Lidocaine 50 mg/g 87989-0013-00 Chelsea 1 tube — — FDA listed —
Lidocaine 50 mg/gthis 80425-0594-01 Advanced 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

🏛️
2026
On the market since
Sep 2026
📍
2026
Currently FDA-listed
listed with the FDA
🔓
·
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.

📊 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
80425-0594-01 You're viewing this 1 TUBE in 1 CARTON (80425-0594-1) / 35.44 g in 1 TUBE 2026-09-10 Active

🧭 About this NDC listing & data coverage

Finished prescription 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 ✓ Available
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

Why is there no price listed?
The pricing shown on our NDC pages comes from CMS NADAC, a voluntary survey of retail community pharmacy invoices. CMS does not publish a NADAC for every NDC — packages outside the retail survey (institutional and hospital products, bulk packages, discontinued items, and many OTC items) may never receive one. A missing price reflects the survey's scope, not this product's actual cost, and does not mean the product is free or unavailable.
Is the NDC printed on the package the same as the 11-digit billing NDC?
Yes, they identify this exact package in different formats. The FDA registers it as 80425-0594-1, which is what is printed on the packaging and shown on DailyMed. Insurance claims use a fixed 11-digit 5-4-2 format, so the short segment is padded with a leading zero: 80425-0594-01, written without dashes as 80425059401. The Identity section at the top of this page lists every form of this code.
What do the three segments of this NDC mean?
In 80425-0594-01, the first segment (80425) is the labeler code FDA assigned to Advanced Rx of Tennessee, LLC; the middle segment (0594) identifies this specific product — its ingredient, strength, and dosage form; and the last segment (01) identifies this exact package size and type. Together they name one specific package of one specific product.
Is this package still being marketed?
Yes, per the latest FDA NDC Directory data on this page: this package is listed as actively marketed, with no marketing end date reported by Advanced Rx of Tennessee, LLC. Listing status can change — the directory data on this page refreshes weekly.
Who lists this product with the FDA?
Advanced Rx of Tennessee, 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 a prescription product, so it is dispensed under a prescriber's order. Your pharmacist can tell you whether any over-the-counter forms of the same medication exist.
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.

📄 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.
📄 FDA label
📄 FDA label 19 words ▾

No FDA label is on file for this product yet. Labels load from openFDA / DailyMed and refresh weekly.

Source: FDA Structured Product Labeling, mirrored from DailyMed / openFDA. Prefer the government’s original formatting? View this label on DailyMed ↗
← 80425-0593-01 · Advanced 80425-0595-01 · Advanced →
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.