LIDOCAINE HYDROCHLORIDE 20 mg/mL Jelly
Other active recalls for Lidocaine Hydrochloride (different manufacturers) — 6 · tap to view
🆔 Identity & classification
Where does this data come from?
🏷️ RxNorm drug class
This medicine belongs to the Antiarrhythmic class.
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🏭 Manufacturer & labeler
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🩺 Clinical
- 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?
Patient education
Supplement & herbal interactions
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Ask a licensed pharmacist directly — free, answered by our team.
🧪 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.
Where does this data come from?
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?
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Can inactive ingredients matter?
💲 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 system | Per each | Per 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. | |
Where does this data come from?
🔁 Therapeutic equivalents
| Product | Labeler | Pack | NADAC/unit | TE | Status | Price vs. this |
|---|---|---|---|---|---|---|
| Lidocaine Hydrochloride 20 mg/mL 76329-3013-05 | International | 25 vials | $0.704 | AT | Availability likely | — |
| glydo 20 mg/mL 25021-0673-76 | Sagent | 10 syringes | $0.887 | AT | Availability likely | — |
| Lidocaine Hydrochloride 20 mg/mL 76329-3011-05 | International | 25 vials | $1.167 | AT | Availability likely | — |
| Lidocaine Hydrochloride 20 mg/mL 76329-3012-05 | International | 25 vials | $1.167 | AT | Availability likely | — |
| Lidocaine Hydrochloride 20 mg/mL 00404-9898-10 | Henry | 1 vial | — | AT | FDA listed | — |
| Lidocaine Hydrochloride 20 mg/mL 00404-9899-20 | Henry | 1 vial | — | AT | FDA listed | — |
| Lidocaine Hydrochloride 20 mg/mL 00404-9900-05 | Henry | 1 vial | — | AT | FDA listed | — |
| First Aid Only Lidocaine Hydrochloride Analgesic Burn Gel 20 mg/g 00924-5004-00 | Acme | 3.5 g | — | — | FDA listed | — |
| First Aid Only Burn 20 mg/g 00924-5010-00 | Acme | 3.5 g | — | — | FDA listed | — |
| Burn 20 mg/g 43473-0048-01 | Nantong | 9 g | — | — | FDA listed | — |
| PO First Aid Series BURN 2 g/100g 43473-0062-01 | Nantong | 9 g | — | — | FDA listed | — |
| JJ Care BURN 2 g/100g 43473-0069-01 | Nantong | 9 g | — | — | FDA listed | — |
| Lightning X Burn Relief Gel 2 g/100g 43473-0121-01 | Nantong | 9 g | — | — | FDA listed | — |
| Medi-First Burn 20 mg/g 47682-0477-69 | Unifirst | 6 packets | — | — | FDA listed | — |
| Lidocaine Hci 20 mg/mL 51662-1389-01 | HF | 5 ml | — | AT | FDA listed | — |
| Lidocaine Hydrochloride 20 mg/mLthis 51662-1551-03 | HF | 25 pouches | — | AT | FDA listed | — |
| Lidocaine Hydrochloride 20 mg/mL 51662-1552-03 | HF | 25 pouches | — | AT | FDA listed | — |
| Burn Ease 2 g/100g 58228-2010-01 | ProStat | 25 packets | — | — | FDA listed | — |
| PROSTAT FIRST AID Burn Ease, 0.9g 2 g/100g 58228-2012-01 | ProStat | 25 packets | — | — | FDA listed | — |
| Burn Ease Cooling 2 g/100g 58228-2893-05 | ProStat | 2000 packets | — | — | FDA listed | — |
| Burn Ease 2 g/100g 58228-3831-02 | ProStat | 20 packets | — | — | FDA listed | — |
| Burn Ease 2 g/100g 58228-3832-02 | ProStat | 6 packets | — | — | FDA listed | — |
| PS-3866 Burn Ease, 0.9g 2 g/100g 58228-3866-01 | ProStat | 10 packets | — | — | FDA listed | — |
| PROSTAT FIRST AID Burn Ease, 0.9g 2 g/100g 58228-3867-01 | ProStat | 10 packets | — | — | FDA listed | — |
| Burn Ease, 3.5g 2 g/100g 58228-3883-01 | ProStat | 2000 packets | — | — | FDA listed | — |
| PS-3885 Burn Ease, 3.5g 2 g/100g 58228-3885-01 | ProStat | 6 packets | — | — | FDA listed | — |
| Burn Ease 2 g/100g 58228-6210-01 | Front | 25 packets | — | — | FDA listed | — |
| FL Burn Ease, 0.9g 2 g/100g 58228-6212-01 | ProStat | 25 packets | — | — | FDA listed | — |
| Burn Ease 3.5g 2 g/100g 58228-6231-01 | Front | 20 packets | — | — | FDA listed | — |
| Burn Ease 3.5g 2 g/100g 58228-6232-01 | Front | 6 packets | — | — | FDA listed | — |
| Burn Ease 3.5g 2 g/100g 58228-6283-01 | Front | 2000 packets | — | — | FDA listed | — |
| Lidoease 2% 20 mg/g 59088-0221-03 | PureTek | 28.35 g | — | — | FDA listed | — |
| Burn Jel 2 g/100mL 59898-0200-11 | Water-Jel | 24 bottles | — | — | FDA listed | — |
| Lidocaine Hydrochloride 20 mg/g 61010-5000-00 | Safetec | 3.3 g | — | — | FDA listed | — |
| Aloe Ice Sunburn Relief 2 g/100mL 61477-0101-11 | Aloe | 60 ml | — | — | FDA listed | — |
| Regenecare Ha 20 mg/g 66977-0107-03 | MPM | 85 g | — | — | FDA listed | — |
| XeroBurn Burn Gel 2 g/100g 67777-0129-02 | Dynarex | 1728 packets | — | — | FDA listed | — |
| Burn Gel .02 g/g 69396-0106-09 | Trifecta | 144 packets | — | — | FDA listed | — |
| Redicare Burn Gel 20 mg/g 71105-0500-02 | Redicare | 15 packets | — | — | FDA listed | — |
| Jelcaine Sterile 20 mg/mL 71351-0025-30 | Brookfield | 30 ml | — | — | FDA listed | — |
| Lidocaine 20 mg/mL 72485-0611-10 | ARMAS | 1 tube | — | AT | FDA listed | — |
| Lidocaine Hydrochloride 20 mg/mL 76329-3015-05 | International | 25 vials | — | AT | FDA listed | — |
| Burn 20 mg/g 82942-1001-01 | J&A | 9 g | — | — | FDA listed | — |
| Lidomax 20 mg/g 85477-0304-07 | Oncora | 85 g | — | — | FDA listed | — |
| Collavera 20 mg/g 85477-0305-07 | Oncora | 28.33 g | — | — | FDA listed | — |
| Lidocaine Hydrochloride 2% 2 g/100g 87236-0015-35 | Aldermed | 25 packets | — | — | FDA listed | — |
| Lidocaine 20 mg/mL 70244-0039-01 | Sentiss | 1 tube | — | AT | FDA listed | — |
Where does this data come from?
⏳ Availability & generic status
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?
🔬 Reported adverse events (FAERS)
Top reported reactions
Reporter sex
Serious outcomes
Where does this data come from?
📦 Packaging — all sizes for this product
| Package NDC | Description | Marketing start | Status |
|---|---|---|---|
| 51662-1551-03 You're viewing this | 25 POUCH in 1 CASE (51662-1551-3) / 1 VIAL, SINGLE-USE in 1 POUCH (51662-1551-2) / 20 mL in 1 VIAL, SINGLE-USE | 2021-06-14 | Active |
🧭 About this NDC listing & data coverage
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) | — Not published for this NDC The labeler did not submit a structured excipient list, or no SPL is 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. |
Questions about this listing
Why is there no price listed?
Is the NDC printed on the package the same as the 11-digit billing NDC?
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Is this package still being marketed?
Who lists this product with the FDA?
Do I need a prescription for this product?
Where does this data come from?
📄 Full prescribing information FDA SPL
🎯 Indications and Usage ▾
INDICATIONS & USAGE Lidocaine Hydrochloride Jelly USP, 2% is indicated for prevention and control of pain in procedures involving the male and female urethra for topical treatment of painful urethritis, and as an anesthetic lubricant for endotracheal intubation (oral and nasal).
⏱️ Dosage and Administration ▾
DOSAGE & ADMINISTRATION When Lidocaine Hydrochloride Jelly USP, 2% is used concomitantly with other products containing lidocaine, the total dose contributed by all formulations must be kept in mind. The dosage varies and depends upon the area to be anesthetized, vascularity of the tissues, individual tolerance, and the technique of anesthesia. The lowest dosage needed to provide effective anesthesia should be administered.
Dosages should be reduced for children and for elderly and debilitated patients. Although the incidence of adverse effects with Lidocaine Hydrochloride Jelly USP, 2% is quite low, caution should be exercised, particularly when employing large amounts, since the incidence of adverse effects is directly proportional to the total dose of local anesthetic agent administered. For surface anesthesia of the male adult urethra The outer orifice is washed and disinfected.
The plastic tip is introduced into the orifice, where it is firmly held in position. The jelly is instilled by an easy syringe-like action, until the patient has a feeling of tension or until about 15 mL (i.e., 300 mg of lidocaine hydrochloride) is instilled. A penile clamp is then applied for several minutes at the corona and then additional jelly (about 15 mL) is instilled.
To save time, the injection is performed against the resistance of the sphincter, possibly assisted by asking the patient to strain as for defecation or to press as in voiding. The jelly will then pass into the posterior urethra. Prior to sounding or cystoscopy, a penile clamp should be applied for 5 to 10 minutes to obtain adequate anesthesia.
If the instrument is introduced immediately, a lubricant is unnecessary. Otherwise some jelly can be expressed from the vial and applied to the instrument tip. About 30 mL (i.e., 600 mg) may be required to fill and dilate the male urethra.
When it is desired to anesthetize only the anterior male urethra, as prior to catheterization, considerably smaller volumes, such as the contents from a 5 mL (i.e., 100 mg) or 10 mL (i.e., 200 mg) size vial, are usually adequate for lubrication. For surface anesthesia of the female adult urethra 3 to 5 mL of the jelly is instilled slowly into the urethra by gently expressing the contents of the vial. If desired, some jelly may be deposited on a cotton swab and introduced into the urethra.
In order to obtain adequate anesthesia, several minutes should be allowed prior to performing urological procedures. Lubrication for endotracheal intubation Apply a moderate amount of jelly to the external surface of the endotracheal tube shortly before use. Care should be taken to avoid introducing the product into the lumen of the tube.
Do not use the jelly to lubricate endotracheal stylettes. See WARNINGS and ADVERSE REACTIONS concerning rare reports of inner lumen occlusion. It is also recommended that use of endotracheal tubes with dried jelly on the external surface be avoided for lack of lubricating effect.
MAXIMUM DOSAGE No more than 600 mg of lidocaine hydrochloride should be given in any 12 hour period. Children It is difficult to recommend a maximum dose of any drug for children since this varies as a function of age and weight. For children less than ten years who have a normal lean body mass and a normal lean body development, the maximum dose may be determined by the application of one of the standard pediatric drug formulas (e.g., Clark's rule).
For example, in a child of five years weighing 50 lbs., the dose of lidocaine hydrochloride should not exceed 75–100 mg when calculated according to Clark's rule. In any case, the maximum amount of lidocaine administered should not exceed 4.5 mg / kg (2 mg / lb) of body weight.
⛔ Contraindications ▾
CONTRAINDICATION Lidocaine is contraindicated in patients with a known history of hypersensitivity to local anesthetics of the amide type or to other components of Lidocaine Hydrochloride Jelly USP, 2%.
⚠️ Warnings ▾
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 Hydrochloride Jelly USP, 2% should be used with extreme caution in the presence of sepsis or severely traumatized mucosa in the area of application, since under such conditions there is the potential for rapid systemic absorption. When used for endotracheal tube lubrication, care should be taken to avoid introducing the product into the lumen of the tube. Do not use the jelly to lubricate the endotracheal stylettes. lf allowed into the inner lumen, the jelly may dry on the inner surface leaving a residue which tends to clump with flexion, narrowing the lumen.
There have been rare reports in which this residue has caused the lumen to occlude. See also ADVERSE REACTIONS and DOSAGE AND ADMINISTRATION .
🤒 Adverse Reactions ▾
ADVERSE REACTIONS dverse 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: There have been rare reports of endotracheal tube occlusion associated with the presence of dried jelly residue in the inner lumen of the tube. See also WARNINGS and DOSAGE AND ADMINISTRATION . Central nervous system CNS manifestations are excitatory and/or depressant and may be characterized by lightheadedness, nervousness, apprehension, euphoria, confusion, dizziness, drowsiness, tinnitus, blurred or double vision, vomiting, sensations of heat, cold or numbness, twitching, tremors, convulsions, unconsciousness, respiratory depression and arrest.
The excitatory manifestations may be very brief or may not occur at all, in which case the first manifestation of toxicity may be drowsiness merging into unconsciousness and respiratory arrest. Drowsiness following the administration of lidocaine is usually an early sign of a high blood level of the drug and may occur as a consequence of rapid absorption. Cardiovascular system Cardiovascular manifestations are usually depressant and are characterized by bradycardia, hypotension, and cardiovascular collapse, which may lead to cardiac arrest.
Allergic Allergic reactions are characterized by cutaneous lesions, urticaria, edema or anaphylactoid reactions. Allergic reactions may occur as a result of sensitivity either to the local anesthetic agent or to other components in the formulation. Allergic reactions as a result of sensitivity to lidocaine are extremely rare and, if they occur, should be managed by conventional means.
The detection of sensitivity by skin testing is of doubtful value.
🆘 Overdosage ▾
OVERDOSAGE Acute emergencies from local anesthetics are generally related to high plasma levels encountered during therapeutic use of local anesthetics. (See ADVERSE REACTIONS , WARNINGS , and PRECAUTIONS ) Management of local anesthetic emergencies The first consideration is prevention, best accomplished by careful and constant monitoring of cardiovascular and respiratory vital signs and the patient's state of consciousness after each local anesthetic administration. At the first sign of change, oxygen should be administered.
The first step in the management of convulsions consists of immediate attention to the maintenance of a patent airway and assisted or controlled ventilation with oxygen and a delivery system capable of permitting immediate positive airway pressure by mask. Immediately after the institution of these ventilatory measures, the adequacy of the circulation should 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 directed by the clinical situation (e.g. ephedrine). If not treated immediately, both convulsions and cardiovascular depression can result in hypoxia, acidosis, bradycardia, arrhythmias and cardiac arrest.
If cardiac arrest should occur, standard cardiopulmonary resuscitative measures should be instituted. Dialysis is of negligible value in the treatment of acute overdosage with lidocaine. The oral LD50 of lidocaine hydrochloride in non-fasted female rats is 459 (346–773) mg / kg (as the salt) and 214 (159–324) mg / kg (as the salt) in fasted female rats.
🧬 Clinical Pharmacology ▾
CLINICAL PHARMACOLOGY Mechanism of action Lidocaine stabilizes the neuronal membrane by inhibiting the ionic fluxes required for the initiation and conduction of impulses, thereby effecting local anesthetic action. Onset of action The onset of action is 3–5 minutes. It is ineffective when applied to intact skin.
Hemodynamics Excessive blood levels may cause changes in cardiac output, total peripheral resistance, and mean arterial pressure. These changes may be attributable to a direct depressant effect of the local anesthetic agent on various components of the cardiovascular system. Pharmacokinetics and metabolism Lidocaine may be absorbed following topical administration to mucous membranes, its rate and extent of absorption varies depending upon concentration and total dose administered, the specific site of application and duration of exposure.
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 may appear 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 mono-ethylglycinexylidide and glycinexylidide. The pharmacological / toxicological actions of these metabolites are similar to, but less potent than, those of lidocaine.
Approximately 90% of lidocaine administered is excreted in the form of various metabolites, and less than 10% is excreted unchanged. The primary metabolite in urine is a conjugate of 4-hydroxy-2,6-dimethylaniline. The plasma binding of lidocaine is dependent on drug concentration, and the fraction bound decreases with increasing concentration.
At concentrations of 1 to 4 µg of free base per mL, 60 to 80 percent of lidocaine is protein bound. Binding is also dependent on the plasma concentration of the alpha-I-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 µg free base per mL.
In the rhesus monkey arterial blood levels of 18–21 µg / mL have been shown to be the threshold for convulsive activity
📦 How Supplied / Storage and Handling ▾
HOW SUPPLIED Lidocaine Hydrochloride Jelly USP, 2% Box of 25 In unit use packages containing one single use vial and a URO-JET® vial injector. In unit use packages containing one single use vial and a URO-JET® AC (Anatomically Constricted) vial injector. Box of 25 Syringe Assembly Directions USE ASEPTIC TECHNIQUE Do not assemble until ready to use. * CAUTION: IMPROPER ENGAGING MAY CAUSE GLASS BREAKAGE AND SUBSEQUENT INJURY.
Store at controlled room temperature 15° to 30°C (59° to 86°F). hs1 hs2 hs3
📋 Description ▾
DESCRIPTION Lidocaine Hydrochloride Jelly USP, 2% is a sterile aqueous product that contains a local anesthetic agent and is administered topically. See INDICATIONS for specific uses. Lidocaine Hydrochloride Jelly USP, 2% contains lidocaine hydrochloride which is chemically designated as acetamide, 2-(diethylamino)-N-(2,6-dimethylphenyl)-, monohydrochloride and has the following structural formula: Composition of Lidocaine Hydrochloride Jelly USP, 2% Each mL contains 20 mg of lidocaine hydrochloride, and sodium carboxymethylcellulose as a viscosity-increasing agent.
Sodium hydroxide may have been added to adjust pH to meet USP limits of 6 to 7. Carboxymethylcellulose sodium adjusts the resulting mixture to a suitable consistency, to enhance contact with mucosa and provide lubrication for instrumentation. This product contains no preservative and any unused portion should be discarded after initial use.
DESCRIPTION