Home › NDC Lookup › Ingredients › Lidocaine Hcl, Diclofenac Sodium › 59088-0806-00
Diclolidol Kit Lidocaine HCl, Diclofenac Sodium Kit — NDC 59088-0806-00 package photo

Diclolidol Kit Lidocaine HCl, Diclofenac Sodium Kit

by PureTek Corporation · 1 KIT in 1 KIT (59088-806-00) * 85 g in 1 BOTTLE, WITH APPLICATOR (59088-327-07) * 1 TUBE in 1 CARTON (43598-977-10) / 100 g in 1 TUBE
NDC 59088-0806-00
🏷️ FDA NDC (as labeled) 59088-806-00 billing pads the product segment with a zero
Rx only 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

🆔 Identity & classification

FDA NDC (as labeled) 59088-806-00
Product NDC 59088-806
11-digit billing NDC 59088080600
NCPDP billing unit GM — per gram (weight)
RxCUI 855633, 1010057
UPC 0359088806005
SPL Set ID 3e63324b-e761-9367-e063-6394a90a2981
DEA schedule Non-controlled
Marketing category UNAPPROVED DRUG OTHER
Marketing status On market
FDA listing status Listed (active directory)
Marketing start 2025-09-09
Dosage form KIT
Why two NDCs? The FDA registers this code as 59088-806-00 — a 5-3-2 layout, and that's what's printed on the package and shown on DailyMed. For insurance claims, every NDC is standardized to a uniform 11-digit 5-4-2 format by adding a zero to the product segment → 59088-0806-00. 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 Nonsteroidal Anti-inflammatory Drug class.

Pharmacologic class Nonsteroidal Anti-inflammatory Drug
Drug family (ATC) Other dermatologicals, Acetic acid derivatives and related substances, Antiinflammatory preparations, non-steroids for topical use
How it works Cyclooxygenase Inhibitors
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

LabelerPureTek Corporation
Labeler code59088
First marketedSep 2025
Product typeHuman Prescription Drug
Portfolio176 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

🧪 What is this product?

This is an unapproved prescription drug kit containing lidocaine hydrochloride and diclofenac sodium. Lidocaine is a local anesthetic typically used to numb tissue, while diclofenac is a nonsteroidal anti-inflammatory drug commonly used to reduce pain and inflammation. The kit form suggests these two medicines are packaged together, possibly for combined pain relief and numbing effects, though this product has not received FDA approval for marketing in the United States.

Supplement & herbal interactions

🌿 Drug–supplement interaction checker →
Where does this data come from?
Plain-language summary from MedlinePlus (U.S. National Library of Medicine); supplement & herbal interactions and nutrient depletion data from the Natural Medicines database; our full guide is HelloPharmacist editorial content.

🧪 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.

From the label’s inactive-ingredient sectionCarbomer Homopolymer Type C, Coco-Caprylate/caprate, Isopropyl Alcohol, Mineral Oil, Polyoxyl 20 Cetostearyl Ether, Propylene Glycol, Purified Water, Strong Ammonia Solution

This is label-wide narrative text, not a normalized exact-product ingredient list. A label can cover multiple strengths or packages.

Where does this data come from?
Source: official FDA Structured Product Labeling (SPL) via DailyMed and the openFDA label index. Structured IACT rows and label-wide narrative are kept separate; availability and product-level specificity depend on the submitted label.

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 eachPer 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
Diclolidol Kitthis 59088-0806-00 PureTek 1 kit — — FDA listed —
About this product: other versions of the same ingredient, strength and form are listed above, least expensive first, with FDA equivalence ratings where available.
Where does this data come from?
Equivalents are other NDCs of the same ingredient, form and route from the openFDA NDC Directory, ranked least-expensive-first by NADAC. Therapeutic-equivalence (AB) ratings come from the FDA Orange Book; biologics use the FDA Purple Book for biosimilar & interchangeable status.

⏳ Availability & generic status

🏛️
2025
On the market since
Sep 2025
📍
2026
Currently FDA-listed
1 year listed
🔒
·
No generic listed yet
brand only
ℹ️No FDA-approved generic found

We did not find an FDA-approved generic match for this exact strength, form and route.

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.

📦 Packaging — all sizes for this product

Package NDCDescription Marketing startStatus
59088-0806-00 You're viewing this 1 KIT in 1 KIT (59088-806-00) * 85 g in 1 BOTTLE, WITH APPLICATOR (59088-327-07) * 1 TUBE in 1 CARTON (43598-977-10) / 100 g in 1 TUBE 2025-09-09 Active

🧭 About this NDC listing & data coverage

Finished prescription product Marketed without an FDA application Kit / multi-component package

Listed without an FDA application

This product's marketing category indicates it is marketed without an approved FDA application (no NDA, ANDA, or BLA on file). Having an NDC does not by itself establish FDA approval — the NDC Directory is a listing system, not an approval decision. Approval-linked data such as Orange Book therapeutic-equivalence ratings therefore does not apply.

Kit / multi-component package

This NDC identifies a kit — a package containing more than one component. Structured data (pricing, ingredients, equivalents) is often reported per component rather than for the kit NDC itself, which can make this page look thinner than the components' own pages.

What data is (and isn’t) available for this NDC — tap to expand
NDC identity (package / product / labeler codes) ✓ Available
Labeler ✓ Available
Product & package description ✓ Available
Marketing category & status ✓ Available
Active ingredient / dosage form / route ✓ Available
FDA label (SPL via DailyMed) ✓ Available
Package photos ✓ Available
Inactive ingredients (structured) ✓ Available
NADAC pharmacy acquisition price (CMS) — Not published for this NDC CMS publishes NADAC only for NDCs reported in its retail-pharmacy survey.
Orange Book / therapeutic-equivalence data — Not published for this NDC Applies only to products approved under an NDA/ANDA; many listings are out of scope.
HCPCS J-code billing crosswalk — Not published for this NDC Most self-administered / retail products have no J-code — that is normal.
Medicaid utilization (CMS SDUD) — Not published for this NDC CMS reports utilization only for NDCs with Medicaid claims above its privacy threshold.
“Not published” reflects what the public FDA / CMS / NLM sources provide for this exact package code — it is a property of the data feeds, not a judgment about the product.

Questions about this listing

Is this NDC FDA-approved?
An NDC listing does not by itself establish FDA approval — the NDC Directory records that a product is listed with FDA, not that it was reviewed and approved. This listing's marketing category is "Unapproved Drug Other". Products approved under an application carry an NDA, ANDA, or BLA number.
Why is there no price listed?
The pricing shown on our NDC pages comes from CMS NADAC, a voluntary survey of retail community pharmacy invoices. CMS does not publish a NADAC for every NDC — packages outside the retail survey (institutional and hospital products, bulk packages, discontinued items, and many OTC items) may never receive one. A missing price reflects the survey's scope, not this product's actual cost, and does not mean the product is free or unavailable.
Is the NDC printed on the package the same as the 11-digit billing NDC?
Yes, they identify this exact package in different formats. The FDA registers it as 59088-806-00, 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: 59088-0806-00, written without dashes as 59088080600. 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 59088-0806-00, the first segment (59088) is the labeler code FDA assigned to PureTek Corporation; the middle segment (0806) identifies this specific product — its ingredient, strength, and dosage form; and the last segment (00) 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 PureTek Corporation. Listing status can change — the directory data on this page refreshes weekly.
Who lists this product with the FDA?
PureTek Corporation 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.
🎯 Indications and Usage ⛔ Contraindications ⚠️ Warnings 🤒 Adverse Reactions 🧬 Clinical Pharmacology 📦 How Supplied / Storage and Handling 📦 Storage and Handling 🧪 Inactive Ingredients 🎯 Purpose 📋 Description
🎯 Indications and Usage ~1 min read ▾

Indications: For the temporary relief of arthritis pain ONLY in the following areas: hand, wrist, elbow (upper body areas) foot, ankle, knee (lower body areas) this product may take up to 7 days to work for arthritis pain; it is not for immediate relief. If no pain relief in 7 days, stop use. Directions: These highlights do not include all the information needed to use Diclofenac Sodium 1% Topical Gel safely and effectively.

See full prescribing information for Diclofenac Sodium 1% Topical Gel. Initial U.S. Approval: 1988 Use up to 21 days unless directed by your doctor Not for strains, sprains, bruises or sports injuries.

This product has not been shown to work for these types of injuries. Daily for your arthritis pain: Use 4 times per day every day Do not use on more than 2 body areas at the same time Per dose use ENCLOSED DOSING CARD to measure a dose. For each upper body area (hand, wrist, or elbow) – Squeeze out 2.25 inches (2 grams) For each lower body area (foot, ankle or knee) –Squeeze out 4.5 inches (4 grams) Read the enclosed User Guidefor complete instructions: use only as directed do not use more than directed or for longer than directed apply only to clean, dry skin that does not have any cuts, open wounds, infections or rashes do not apply in same area as any other product do not apply with external heat such as heating pad do not apply a bandage over the treated area store ENCLOSED DOSING CARD with your Diclofenac Sodium Topical Gel, 1% Arthritis Pain.

The dosing card is re-usable.

⛔ Contraindications 43 words ▾

CONTRAINDICATIONS: Tuberculous or fungal lesions of skin vaccinia, varicella and acute herpes simplex and in persons who have shown hypersensitivity to any of its components. Lidocaine is contraindicated in patients with a known history of hypersensitivity to local anesthetics of the amide type.

⚠️ Warnings ~2 min read ▾

Warnings: see full prescribing information for Diclofenac Sodium For external use only Allergy alert: Diclofenac may cause a severe allergic reaction, especially in people allergic to aspirin. Symptoms may include: • hives • asthma (wheezing) • skin reddening • blisters • facial swelling • shock • rash If an allergic reaction occurs, stop use and seek medical help right away. Liver warning: This product contains diclofenac.

Liver damage may occur if you apply more or for a longer time than directed when using other drugs containing diclofenac Stomach bleeding warning: T his product contains an NSAID, which may cause severe stomach bleeding. The chance is small but higher if you are age 60 or older have had stomach ulcers or bleeding problems take a blood thinning (anticoagulant) or steroid drug take other drugs containing prescription or non-prescription NSAIDs (aspirin, ibuprofen, naproxen, or others) have 3 or more alcoholic drinks every day while using this product apply more or for longer than directed Heart attack and stroke warning: NSAIDs, except aspirin, increase the risk of heart attack, heart failure, and stroke.

These can be fatal. The risk is higher if you use more than directed or for longer than directed.

WARNINGS: For external use only. Not for ophthalmic use. PRECAUTIONS: If irritation or sensitivity occurs or infection appears, discontinue use and institute appropriate therapy.

Lidotral® 5% Roll on Gel should be used with caution in ill, elderly, debilitated patients and children who may be more sensitive to the systemic effects of lidocaine. Carcinogenesis, Mutagenesis and Impairment of Fertility: Studies of lidocaine in animals to evaluate the carcinogenic and mutagenic potential of the effect on fertility have not been conducted. Use in Pregnancy: Teratogenic Effects; Pregnancy Category B.

Reproduction studies have been performed for lidocaine 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. Nursing Mothers: It is not known whether this drug is excreted in human milk. Because many drugs are excreted in human milk, caution should be exercised when this drug is administered to a nursing mother.

Pediatric Use: Dosage in pediatric patients would be reduced commensurate with age, body weight and physical condition.

🤒 Adverse Reactions 27 words ▾

ADVERSE REACTIONS: During or immediately after treatment, the skin at the site of treatment may develop erythema or edema or may be the locus of abnormal sensation.

🧬 Clinical Pharmacology ~2 min read ▾

CLINICAL PHARMACOLOGY: Mechanism of Action: Lidotral® 5% Roll on Gel releases lidocaine from a mild acidic vehicle to stabilize the neuronal membrane by inhibiting the ionic fluxes required for initiation and conduction of impulses, thereby effecting local anesthetic action. A mild acidic vehicle lowers pH to increase protection against alkaline irritants and to provide a favorable environment for healing. Pharmacokinetics: 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 g 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-1-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 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 g free base per mL.

In the rhesus monkey, arterial blood levels of 18-21 g/mL have been shown to be threshold for convulsive activity.

📦 How Supplied / Storage and Handling 44 words ▾

HOW SUPPLIED: Lidotral® 5% Roll on Gel is supplied in a 3 oz. (85 g) roll on bottle (NDC 59088-327-07). KEEP THIS AND ALL MEDICATIONS OUT OF THE REACH OF CHILDREN. Store at 20º-25ºC (68º-77º F) [see USP Controlled Room Temperature]. Protect from freezing.

📦 Storage and Handling 31 words ▾

Other information: Store at 20-25 oC (68°F - 77°F). Keep from freezing. read all product information before using. Keep the dossing card, the carton and accompanying User guide for important information.

🧪 Inactive Ingredients 22 words ▾

Inactive ingredients: Carbomer Homopolymer Type C, Coco-Caprylate/caprate, Isopropyl Alcohol, Mineral Oil, Polyoxyl 20 Cetostearyl Ether, Propylene Glycol, Purified Water, Strong Ammonia Solution

🎯 Purpose 11 words ▾

Purpose: Arthritis pain reliever

INDICATIONS: For the temporary relief of pain.

📋 Description 119 words ▾

Diclofenac Sodium 1% Topical Gel Active ingredient: Diclofenac sodium (NSAID*) 1% *nonsteroidal anti‑inflammatory drug Inactive ingredients: Carbomer Homopolymer Type C, Coco-Caprylate/caprate, Isopropyl Alcohol, Mineral Oil, Polyoxyl 20 Cetostearyl Ether, Propylene Glycol, Purified Water, Strong Ammonia Solution

DESCRIPTION: Lidotral® 5% Roll on Gel Lidotral® 5% Roll on Gel contains 50 mg of Lidocaine HCI per gram in a mild acidic vehicle with Acrylates/C10-30 Alkyl Acrylate Crosspolymer, Aloe Barbadensis (Aloe Vera) Leaf Juice, Aminomethyl Propanol, Aqua (Purified Water), Arnica Montana (Arnica) Flower Extract, Benzyl Alcohol, C30-45 Alkyl Cetearyl Dimethicone Crosspolymer, Cetearyl Alcohol, Ceteth-20 Phosphate, Cyclopentasiloxane, Dicetyl Phosphate, Dimethicone, Disodium EDTA, Ethyl Alcohol, Glycerin, Glyceryl Stearate, Steareth-21.

Lidocaine HCl is chemically designated as acetamide, 2-(diethylamino)-N-(2,6 dimethylphenyl), and has the following structure: lido

Source: FDA Structured Product Labeling, mirrored from DailyMed / openFDA. Prefer the government’s original formatting? View this label on DailyMed ↗
← 59088-0805-00 · PureTek 59088-0807-00 · PureTek →
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.