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Lidocaine hydrochloride 20 mg/mL Solution, 100 mL — NDC 72888-0125-26 package photo
Label image from the product's FDA listing (DailyMed) — may show a different pack size or an older label revision.

Lidocaine hydrochloride 20 mg/mL Solution, 100 mL — NDC 72888-125-26 (Billing 72888-0125-26)

by Advagen Pharma Ltd · 100 mL in 1 BOTTLE

This is a package of 100 mL of Lidocaine hydrochloride 20 mg/mL Solution from Advagen Pharma Ltd, marketed since Mar 2023 and currently FDA-listed; retail pharmacies pay about $0.0825 per mL (NADAC). It is this product's only package size.

NDC 72888-0125-26
🏷️ FDA NDC (as labeled) 72888-125-26 billing pads the product segment with a zero
Rx only Generic On market Non-controlled ⇄ Compare with another NDC
🗂️ FDA directory synced Oct 1, 2026 · this listing last changed Jul 24, 2026 · sources: openFDA · FDA label (DailyMed) · FDA Orange & Purple Book · First Databank · CMS NADAC, ASP, Medicare & Medicaid · RxNorm
📋 All sources & update times →

This page is curated, coded, and maintained by

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

NDC database record

One package, one record: these facts belong to NDC 72888-125-26 alone.

Record
FDA NDC Directory package listing · Human prescription drug
Code segments
72888 labeler · 125 product · 26 package
Package marketed since
Mar 28, 2023
Sample package
No — commercial package
Listing certified through
Dec 31, 2027
Billing quantity
100 mL per package
Barcode (UPC)
0372888125268
Medicaid fills, this package
162,557 prescriptions in the last four reported quarters
FDA record last changed
Jul 24, 2026
⚠️
Other active recalls for Lidocaine Hydrochloride (different manufacturers) — 6 · tap to view
These affect other manufacturers’ products for the same ingredient — not necessarily the exact NDC on this page.
Class II · Jul 16, 2026 — Presence of Particulate Matter: Hair was found in products (Fresenius Kabi USA, LLC) · FDA recall D-0726-2026
Class II · Jun 8, 2026 — Lack of Assurance of Sterility (Asclemed USA Inc.) · FDA recall D-0658-2026
Class II · Apr 2, 2026 — Lack of Assurance of Sterility (Huons Co., Ltd.) · FDA recall D-0529-2026
Class II · Apr 2, 2026 — Lack of Assurance of Sterility (Huons Co., Ltd.) · FDA recall D-0532-2026
Class II · Nov 30, 2021 — Superpotent Drug: Minimally superpotent (Teligent Pharma, Inc.) · FDA recall D-0296-2022
Class I · Nov 30, 2021 — Superpotent Drug (Teligent Pharma, Inc.) · FDA recall D-0295-2022
Each entry is an official FDA enforcement report — look up any recall number in the FDA recall database ↗

Identity & classification

Regulatory identifiers FDA, NLM and CMS codes for this package

FDA NDC (as labeled) 72888-125-26
Product NDC 72888-125
11-digit billing NDC 72888012526
NCPDP billing unit ML — per mL (volume)
RxCUI 1010739
UNII V13007Z41A
UPC 0372888125268
Application # ANDA216780
SPL Set ID ae40021b-8df8-4b16-aac0-dcec88f76c7d
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 2023-03-28
Route ORAL, TOPICAL
Dosage form SOLUTION
Substance LIDOCAINE HYDROCHLORIDE
TE code (Orange Book) AT · RLD · RS

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

GPI-14 88350065102050
GCN Seq No 003411
GCN 11941
HICL code 001478
Ingredient (HICL) Lidocaine Hcl
HIC1 code H
Therapeutic class — broad (HIC1) Nervous System (Except Autonomic)
HIC2 code H0
Therapeutic class — intermediate (HIC2) Act On Non-Autonomic Nervous System
HIC3 code H0A
Therapeutic class — specific (HIC3) Local Anesthetics
AHFS code 52:16.00.00
AHFS class Local Anesthetics (Eent)
FDB label name LIDOCAINE 2% VISCOUS SOLN
FDB brand name Lidocaine Hcl Viscous
Legend status F — Federal legend — prescription drug or device
Quick answers
  • GSN (GCN sequence number): 003411
  • GCN: 11941
  • GPI-14 (Medi-Span): 88350065102050
  • HICL (First Databank): 001478
  • AHFS class code: 52:16.00.00
  • RxCUI (RxNorm): 1010739
Why two NDCs? The FDA registers this code as 72888-125-26 — 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 → 72888-0125-26. Same drug, same package — only the format differs.
Where does this data come from?
Identifiers from the FDA openFDA NDC Directory and Structured Product Labeling; RxCUI from RxNorm (NLM); GPI from Medi-Span; GCN / HIC / AHFS / legend from First Databank.

RxNorm drug class

This medicine belongs to the Antiarrhythmic class.

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

Clinical

Label name LIDOCAINE 2% VISCOUS SOLN Ingredient Lidocaine Hcl
📖 What it is MedlinePlus · NLM

Lidocaine viscous mouth rinse is used to relieve pain of inflammation or sores of the mouth or throat. It is also used to reduce gagging during x-rays of the mouth or dental x-rays. Lidocaine is a local anesthetic. It works by blocking nerves from sending pain signals.

Read the full MedlinePlus article ↗
📗 Our plain-language guide HelloPharmacist
  • Lidocaine numbs the area where it is used. Clinicians inject it for procedures. Skin products are used for pain, itching, minor burns, insect bites, hemorrhoid discomfort, and in s...
  • Clean and dry the skin first, then apply as your product’s directions say. Wash your hands afterward. Don’t exceed the number of uses on the label. Ask a doctor before using a prod...
  • No. Heat can increase how much lidocaine your body absorbs. Don’t bandage tightly either. Also avoid using other topical pain products at the same time.
  • Can I use a heating pad with a lidocaine patch?
📖 Read our full Lidocaine guide →

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.

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 mLPer package
Retail pharmacies payNADAC · weekly $0.083 $8.25 / 100 ml
Medicaid paysCMS SDUD · 12 mo $0.0973 $9.73 / 100 ml
Medicare drug plans payPart D · quarterly No Part D plan price is available for this NDC in our data.
NADAC price history (per mL) — tap or hover for the price & month
Dec 2023 Jan 2026 May 2026 Sep 2026 $0.099 $0.079
▼ Down 12% over the last 13 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.

Packaging — all sizes for this product

Package NDCDescription Marketing startMarketing endStatus
72888-0125-26 You're viewing this Main listing 100 mL in 1 BOTTLE 2023-03-28 — Active

Therapeutic equivalents

ProductLabelerPackNADAC/unitTEStatusPrice vs. this
Lidocaine Viscous 20 mg/mL 00054-3500-49 Hikma 1 bottle $0.082 AT Availability likely —
Lidocaine Hydrochloride 20 mg/mL 00121-0950-03 PAI 12 bottles $0.082 AT Availability likely —
Lidocaine Hydrochloride 20 mg/mL 62135-0712-42 Chartwell 100 ml $0.082 AT Availability likely —
Lidocaine hydrochloride 20 mg/mLthis 72888-0125-26 Advagen 100 ml $0.082 AT Availability likely —
Lidocaine hydrochloride 20 mg/mL 00116-4027-10 Xttrium 100 ml — AT FDA listed —
Lidocaine Hydrochloride 20 mg/mL 00121-4950-40 PAI 10 cups — AT FDA listed —
Lidocaine hydrochloride 20 mg/mL 17856-0138-01 ATLANTIC 50 cups — AT FDA listed —
Lidocaine hydrochloride 20 mg/mL 17856-8138-01 Atlantic 50 cups — AT FDA listed —
Lidocaine Viscous 20 mg/mL 50090-6186-00 A-S 1 bottle — AT FDA listed —
Lidocaine hydrochloride 20 mg/mL 50090-7040-00 A-S 100 ml — AT FDA listed —
Lidocaine Hydrochloride 20 mg/mL 59651-0943-01 Aurobindo 100 ml — AT FDA listed —
Lidocaine hydrochloride 20 mg/mL 60687-0870-64 American 10 cups — AT FDA listed —
Lidocaine Hydrochloride 20 mg/mL 62135-0871-24 Chartwell 10 cups — AT FDA listed —
Lidocaine Hydrochloride 20 mg/mL 66267-0962-00 NuCare 100 ml — — FDA listed —
Lidocaine Hydrochloride 20 mg/mL 68071-3449-02 NuCare 1 bottle — AT FDA listed —
Lidocaine hydrochloride 20 mg/mL 68071-3486-00 NuCare 100 ml — AT FDA listed —
Lidocaine hydrochloride 20 mg/mL 68788-8507-01 Preferred 100 ml — AT FDA listed —
Lidocaine Hydrochloride 20 mg/mL 68788-8847-01 Preferred 100 ml — AT FDA listed —
Lidocaine Hydrochloride 20 mg/mL 68999-0871-24 Chartwell 10 cups — AT FDA listed —
Lidocaine hydrochloride 20 mg/mL 70518-4030-00 REMEDYREPACK 100 ml — AT FDA listed —
Lidocaine Viscous 20 mg/mL 70518-4278-00 REMEDYREPACK 1 bottle — 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

🏛️
2023
On the market since
Mar 2023
📍
2026
Currently FDA-listed
3 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.

What it looks like

FlavorBanana
One label can cover several strengths, so colors may be combined — always confirm a loose pill against the dispensed prescription label or a pharmacist.
Where does this data come from?
Physical description (imprint, shape, color, scoring, coating) from this product’s FDA Structured Product Labeling (SPL), mirrored from DailyMed / openFDA.

Inactive Ingredients / Excipients

Inactive ingredients, also called excipients, are components of the drug product other than the active ingredient. They may include fillers, dyes, coatings, preservatives, flavors, or other formulation ingredients.

💡 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 QTT17582CB
    A strong acid used to adjust and maintain the proper pH level in liquid medicines, ensuring stability and preventing breakdown of active ingredients.
  • 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 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 SB8ZUX40TY
    Saccharin sodium is an artificial sweetener made from saccharin salt. It's added to medicines to improve taste, especially in liquid formulations for children or bitter drugs.
  • UNII 55X04QC32I
    A strong alkaline chemical used to adjust and maintain the pH balance of liquid medicines. It helps keep the medicine stable and ensures it stays effective during storage.
  • UNII 059QF0KO0R
    Water is a liquid solvent that dissolves and mixes ingredients together in liquid medicines, syrups, and injections. It helps distribute the active drug evenly throughout the product.

7 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.

Manufacturer & labeler

LabelerAdvagen Pharma Ltd
Application holderRUBICON RESEARCH LTD
FDA applicationANDA216780 (ANDA)
Labeler code72888
First marketedMar 2023
Product typeHuman Prescription Drug
Portfolio101 products on file

More NDCs from Advagen Pharma Ltd labeler code 72888

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.

Full prescribing information FDA SPL

The complete FDA label for this product — the official prescribing information, verbatim, section by section. Very long sections are excerpted here and marked; the full text is on DailyMed (linked in the sources below). Jump with a chip, search within the label, or expand everything.
🚨 Boxed Warning 🎯 Indications and Usage ⏱️ Dosage and Administration ⛔ Contraindications ⚠️ Warnings 🤒 Adverse Reactions 🔄 Drug Interactions 🤰 Pregnancy 🧒 Pediatric Use 🆘 Overdosage 🧬 Clinical Pharmacology 🧬 Mechanism of Action 📦 How Supplied / Storage and Handling 📋 Description 💬 Information for Patients ⚠️ Precautions 🍼 Nursing Mothers 🧬 Pharmacokinetics 📖 Instructions for Use 📄 Package Label / Principal Display Panel
🚨 Boxed Warning 147 words ▾

WARNING: Life-threatening and fatal events in infants and young children Postmarketing cases of seizures, cardiopulmonary arrest, and death in patients under the age of 3 years have been reported with use of Lidocaine Hydrochloride Oral Topical Solution 2% (Viscous) when it was not administered in strict adherence to the dosing and administration recommendations. In the setting of teething pain, Lidocaine Hydrochloride Oral Topical Solution 2% (Viscous) should generally not be used. For other conditions, the use of the product in patients less than 3 years of age should be limited to those situations where safer alternatives are not available or have been tried but failed.

To decrease the risk of serious adverse events with use of Lidocaine Hydrochloride Oral Topical Solution 2% (Viscous), instruct caregivers to strictly adhere to the prescribed dose and frequency of administration and store the prescription bottle safely out of reach of children.

🎯 Indications and Usage 45 words ▾

INDICATIONS AND USAGE Lidocaine Hydrochloride Oral Topical Solution 2% (Viscous) is indicated for the production of topical anesthesia of irritated or inflamed mucous membranes of the mouth and pharynx. It is also useful for reducing gagging during the taking of X-ray pictures and dental impressions.

⏱️ Dosage and Administration ~2 min read ▾

DOSAGE AND ADMINISTRATION Adult: The maximum recommended single dose of Lidocaine Hydrochloride Oral Topical Solution 2% (Viscous) for healthy adults should be such that the dose of lidocaine does not exceed 4.5 mg/kg or 2 mg/lb body weight and does not in any case exceed a total of 300 mg. For symptomatic treatment of irritated or inflamed mucous membranes of the mouth and pharynx, the usual adult dose is one 15 mL undiluted. For use in the mouth, the solution should be swished around in the mouth and spit out.

For use in the pharynx, the undiluted solution should be gargled and may be swallowed. This dose should not be administered at intervals of less than three hours, and not more than eight doses should be given in a 24-hour period. The dosage should be adjusted commensurate with the patient's age, weight and physical condition (see PRECAUTIONS ).

Pediatric: Care must be taken to ensure correct dosage in all pediatric patients as there have been cases of overdose due to inappropriate dosing. 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 over 3 years of age who have a normal lean body mass and normal body development, the maximum dose is determined by the child's weight or age.

For example: in a child of 5 years weighing 50 lbs., the dose of lidocaine hydrochloride should not exceed 75 to 100 mg (3.7 to 5 mL of Lidocaine Hydrochloride Oral Topical Solution 2% Viscous). For infants and in children under 3 years of age, the solution should be accurately measured and no more than 1.2 mL be applied to the immediate area with a cotton-tipped applicator. Wait at least 3 hours before giving the next dose; a maximum of four doses may be given in a 12-hour period.

Lidocaine Hydrochloride Oral Topical Solution 2% (Viscous) should only be used if the underlying condition requires treatment with a volume of product that is less than or equal to 1.2 mL.

⛔ Contraindications 26 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 the solution.

⚠️ Warnings ~2 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 should be used with extreme caution if the mucosa in the area of application has been traumatized, since under such conditions there is the potential for rapid systemic absorption. Life-threatening and fatal events in infants and young children Postmarketing cases of seizures, cardiopulmonary arrest, and death in patients under the age of 3 years have been reported with use of Lidocaine Hydrochloride Oral Topical Solution 2% (Viscous) when it was not administered in strict adherence to the dosing and administration recommendations.

In the setting of teething pain, Lidocaine Hydrochloride Oral Topical Solution 2% (Viscous) should generally not be used. For other conditions, the use of the product in patients less than 3 years of age should be limited to those situations where safer alternatives are not available or have been tried but failed. 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 Hydrochloride Oral Topical Solution 2% (Viscous) 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.

🤒 Adverse Reactions 75 words ▾

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:

🔄 Drug Interactions 81 words ▾

Drug Interactions: 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 65 words ▾

Pregnancy Teratogenic Effects. 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. Because animal reproduction studies are not always predictive of human response, this drug should be used in pregnancy only if clearly needed.

🧒 Pediatric Use 21 words ▾

Pediatric Use: Dosages in children should be reduced, commensurate with age, body weight and physical condition. 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. 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.

In situations where trained personnel are readily available, ventilation should be maintained and oxygen should be delivered by 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 be 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 indicated 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 LD50 of lidocaine in non-fasted female rats is 459 (346 to 773) mg/kg (as the salt) and 214 (159 to 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. 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.

The net effect is normally a modest hypotension when the recommended dosages are not exceeded. Pharmacokinetics and Metabolism: Lidocaine is absorbed following topical administration to mucous membranes, its rate and extent of absorption being dependent upon concentration and total dose administered, the specific site of application, and duration of exposure. In general, the rate of absorption of local anestheticagents following topical application occurs most rapidly after intratracheal administration.

Lidocaine is also well-absorbed from the gastrointestinal tract, but little intact drug appears inthe circulation because of biotransformation in the liver. The plasma binding of lidocaine is dependent on drug concentration, and the fraction bound decreases with increasing concentration. At concentrations of 1 to 4 mcg 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. 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 elimination half-life of lidocaine following an intravenous bolus injection 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 6.0 mcg free baseper mL. In the rhesus monkey arterial blood levels of 18 to 21 mcg/mL have been shown to be threshold for convulsive activity.

🧬 Mechanism of Action 26 words ▾

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.

📦 How Supplied / Storage and Handling 59 words ▾

HOW SUPPLIED Lidocaine Hydrochloride Oral Topical Solution USP, 2% (Viscous) is a clear, colorless , viscous solution supplied in 100 mL low density polyethylene squeeze bottles. Supplied with press-in bottle adapter. NDC 72888-125-26 Store at 20º to 25ºC (68º to 77ºF); excursions permitted to 15° to 30°C (59° to 86°F) [See USP Controlled Room Temperature]. SHAKE WELL BEFORE USE.

📋 Description 63 words ▾

DESCRIPTION Lidocaine Hydrochloride Oral Topical Solution USP, 2% (Viscous) contains a local anesthetic agent and is administered topically. Lidocaine Hydrochloride Oral Topical Solution USP, 2% (Viscous) contains lidocaine hydrochloride, which is chemically designated as acetamide, 2-(diethylamino)-N-(2,6-dimethylphenyl)-, monohydrochloride and has the following structural formula: The molecular formula of lidocaine is C 14 H 22 N 2 O. The molecular weight is 234.34.

Chemical Structure

💬 Information for Patients ~1 min read ▾

Information for Patients: Parents and caregivers should be cautioned about the following: For patients under 3 years of age, special care must be given to accurately measuring the prescribed dose and not administering the product more often than prescribed. To ensure accuracy, we recommend you use a measuring device to carefully measure the correct volume. The product should only be used for the prescribed indication.

To reduce the risk of accidental ingestion, the product container should be tightly closed and the product should be stored well out of reach of all children immediately after each use. If the patient shows signs of systemic toxicity (e.g., lethargy, shallow breathing, seizure activity) emergency medical attention should be sought immediately and no additional product should be administered. Unused product should be discarded in a manner that prevents possible exposureto children andpets.

All patients should be aware that when topical anesthetics are used in the mouth or throat, 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 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 increase the danger of biting trauma. For this reason food and/or chewing gum should not be used while the mouth or throat area is anesthetized. Inform patients that use of local anesthetics may cause methemoglobinemia, a serious condition that must be treated promptly.

Advise patients or caregivers to 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".

⚠️ Precautions ~3 min read ▾

PRECAUTIONS Information for Patients: Parents and caregivers should be cautioned about the following: For patients under 3 years of age, special care must be given to accurately measuring the prescribed dose and not administering the product more often than prescribed. To ensure accuracy, we recommend you use a measuring device to carefully measure the correct volume. The product should only be used for the prescribed indication.

To reduce the risk of accidental ingestion, the product container should be tightly closed and the product should be stored well out of reach of all children immediately after each use. If the patient shows signs of systemic toxicity (e.g., lethargy, shallow breathing, seizure activity) emergency medical attention should be sought immediately and no additional product should be administered. Unused product should be discarded in a manner that prevents possible exposureto children andpets.

All patients should be aware that when topical anesthetics are used in the mouth or throat, 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 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 increase the danger of biting trauma. For this reason food and/or chewing gum should not be used while the mouth or throat area is anesthetized. Inform patients that use of local anesthetics may cause methemoglobinemia, a serious condition that must be treated promptly.

Advise patients or caregivers to 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". General: The safety and effectiveness of lidocaine depend on proper dosage, correct technique, adequate precautions, and readiness for emergencies (see WARNINGS and ADVERSE REACTIONS ). The lowest dosage that results in effective anesthesia should be used to avoid high plasma levels and serious adverse effects.

Repeated doses of lidocaine may cause significant increases in blood levels with each repeated dose because of slow accumulation of the drug and/or its metabolites. Tolerance varies with the status of the patient. Debilitated, elderly patients, acutely ill patients, and children should be given reduced doses commensurate with their age, weight and physical condition.

Lidocaine should also be used with caution in patients with severe shock or heart block. Lidocaine Hydrochloride Oral Topical Solution 2% (Viscous) should be used with caution in persons with known drug sensitivities. Patients allergic to paraaminobenzoic acid derivatives (procaine, tetracaine, benzocaine, etc.) have not shown cross sensitivity to lidocaine.

Drug Interactions: 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 Carcinogenesis, Mutagenesis, Impairment of Fertility: Studies of lidocaine in animals to evaluate the carcinogenic and mutagenic potential or the effect on fertility have not been conducted.

Pregnancy Teratogenic Effects. Re… [Excerpted — this section continues on DailyMed.]

🍼 Nursing Mothers 33 words ▾

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 lidocaine is administered to nursing women.

🧬 Pharmacokinetics ~2 min read ▾

Pharmacokinetics and Metabolism: Lidocaine is absorbed following topical administration to mucous membranes, its rate and extent of absorption being dependent upon concentration and total dose administered, the specific site of application, and duration of exposure. In general, the rate of absorption of local anestheticagents following topical application occurs most rapidly after intratracheal administration. Lidocaine is also well-absorbed from the gastrointestinal tract, but little intact drug appears inthe circulation because of biotransformation in the liver.

The plasma binding of lidocaine is dependent on drug concentration, and the fraction bound decreases with increasing concentration. At concentrations of 1 to 4 mcg 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. 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 elimination half-life of lidocaine following an intravenous bolus injection 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 6.0 mcg free baseper mL. In the rhesus monkey arterial blood levels of 18 to 21 mcg/mL have been shown to be threshold for convulsive activity.

📖 Instructions for Use ~1 min read ▾

Lidocaine Hydrochloride Oral Topical Solution, USP Each ml contains 2% Lidocaine Instructions for Use Read these instructions carefully to learn how to use the medicine dispensing system correctly. The Medicine Dispensing System There are 2 parts to the dispensing system: A plastic adapter that you push into the neck of the bottle the first time that you open the bottle. The adapter must always stay in the bottle.

A bottle containing the medicine with a child resistant cap. Always replace the cap after use. Preparing the Bottle Remove the child-resistant cap by pushing it firmly down and turning it counterclockwise - to the left (as shown on the top of the cap).

Note: Save the cap so you can close the bottle after each use. Hold the open bottle upright on a table and push the plastic adapter firmly into the neck of the bottle as far as you can. Replace the cap to be sure that the adapter has been fully forced into the neck of the bottle.

Note: You may not be able to push the adapter fully down, but it will be forced into the bottle when you screw the cap back on. The adapter must always stay in the bottle. The child-resistant cap should seal the bottle in between use.

Taking the Medicine Shake the bottle well. Prepare the dose right away. Push and turn the child-resistant cap to open the bottle.

Note: Always replace the cap after use. Squeeze bottle to dispense contents. Replace the child-resistant cap after use.

Distributed by: Advagen Pharma Ltd., East Windsor, NJ 08520, USA Revised: 00, 10/2024 image description image description image description image description

📄 Package Label / Principal Display Panel 52 words ▾

PACKAGE LABEL-PRINCIPAL DISPLAY PANEL Lidocaine Hydrochloride Oral Topical Solution, USP (Viscous) 2% - NDC 72888-125-26 -100 mL Bottle Label Lidocaine Hydrochloride Oral Topical Solution, USP (Viscous) 2% - NDC 72888-125-26 -100 mL Carton Label Lidocaine Hydrochloride Oral Topical Solution, USP (Viscous) 2% - NDC 72888-125-26 - 100 mL Bottle label image description

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

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 this package alone, 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 – Q1 2026 · 5 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
162.6K
Units reimbursed last 4 qtrs
28.1M
Gross reimbursed last 4 qtrs
$2.73M
Avg / prescription
$16.82
Avg / unit
$0.0973
Latest quarter Q1 2026
38.2KRx
Medicaid pays / mL
$0.0973
gross reimbursed
vs
NADAC / mL
$0.0825
acquisition cost
=
Spread
+$0.0148
+18% vs cost
What Medicaid paid per mL (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 ⓘ
35% FFS 65% MCO
Fee-for-service · 57,067 Rx Managed care · 105,490 Rx
State Medicaid map
Alaska: 95,577 units · 13,039 per 100k residents AK Maine: 83,540 units · 5,989 per 100k residents ME Washington: 863,635 units · 11,055 per 100k residents WA Idaho: 141,322 units · 7,196 per 100k residents ID Montana: 71,616 units · 6,327 per 100k residents MT North Dakota: 20,646 units · 2,637 per 100k residents ND Minnesota: 219,942 units · 3,834 per 100k residents MN Wisconsin: 300,075 units · 5,077 per 100k residents WI Michigan: 8,949,216 units · 89,162 per 100k residents MI New York: 2,176,698 units · 11,122 per 100k residents NY Vermont: 36,638 units · 5,663 per 100k residents VT New Hampshire: 29,380 units · 2,096 per 100k residents NH Oregon: 422,034 units · 9,970 per 100k residents OR Nevada: 216,296 units · 6,772 per 100k residents NV Wyoming: 19,434 units · 3,328 per 100k residents WY South Dakota: 9,631 units · 1,048 per 100k residents SD Iowa: 78,614 units · 2,451 per 100k residents IA Illinois: 670,558 units · 5,344 per 100k residents IL Indiana: 474,051 units · 6,908 per 100k residents IN Ohio: 1,786,369 units · 15,158 per 100k residents OH Pennsylvania: 876,118 units · 6,760 per 100k residents PA New Jersey: 430,520 units · 4,634 per 100k residents NJ Massachusetts: 118,378 units · 1,691 per 100k residents MA California: 1,746,399 units · 4,482 per 100k residents CA Utah: 161,764 units · 4,734 per 100k residents UT Colorado: 476,436 units · 8,105 per 100k residents CO Nebraska: 58,683 units · 2,967 per 100k residents NE Missouri: 472,366 units · 7,624 per 100k residents MO Kentucky: 807,510 units · 17,842 per 100k residents KY West Virginia: 328,109 units · 18,537 per 100k residents WV Virginia: 714,753 units · 8,200 per 100k residents VA Maryland: 609,050 units · 9,855 per 100k residents MD Connecticut: 112,442 units · 3,109 per 100k residents CT Rhode Island: 15,740 units · 1,437 per 100k residents RI Arizona: 404,405 units · 5,442 per 100k residents AZ New Mexico: 128,996 units · 6,102 per 100k residents NM Kansas: 94,594 units · 3,217 per 100k residents KS Arkansas: 116,363 units · 3,794 per 100k residents AR Tennessee: 439,398 units · 6,166 per 100k residents TN North Carolina: 742,125 units · 6,849 per 100k residents NC South Carolina: 117,021 units · 2,178 per 100k residents SC Delaware: 60,920 units · 5,909 per 100k residents DE Oklahoma: 183,112 units · 4,518 per 100k residents OK Louisiana: 404,756 units · 8,849 per 100k residents LA Mississippi: 121,065 units · 4,118 per 100k residents MS Alabama: 143,797 units · 2,815 per 100k residents AL Georgia: 393,392 units · 3,567 per 100k residents GA D.C.: 26,274 units · 3,870 per 100k residents DC Hawaii: 46,152 units · 3,216 per 100k residents HI Texas: 779,727 units · 2,556 per 100k residents TX Florida: 288,480 units · 1,276 per 100k residents FL
Units reimbursed · per 100k residents
1,04889,162
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 Michigan 89,162 /100k
2 West Virginia 18,537 /100k
3 Kentucky 17,842 /100k
4 Ohio 15,158 /100k
5 Alaska 13,039 /100k
6 New York 11,122 /100k
7 Washington 11,055 /100k
8 Oregon 9,970 /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.
← 72888-0124-00 · Advagen 72888-0130-00 · Advagen →
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.