Lidocaine Hydrochloride and Hydrocortisone Acetate 30 mg/g; 25 mg/g Gel
🆔 Identity & classification
Where does this data come from?
🏷️ RxNorm drug class
This medicine belongs to the Corticosteroid class.
Where does this data come from?
🏭 Manufacturer & labeler
Where does this data come from?
🩺 Clinical
Rectal hydrocortisone is used along with other medications to treat proctitis (swelling in the rectum) and ulcerative colitis (a condition which causes swelling and sores in the lining of the large intestine and rectum). It is also used to relieve itching and swelling from hemorrhoids and other rectal problems. Hydrocortisone is in a class of medications called corticosteroids. It works by activating natural substances in the skin to reduce swelling, redness, and itching.
Read the full MedlinePlus article ↗This is a rectal gel containing lidocaine hydrochloride and hydrocortisone acetate. Lidocaine is a local anesthetic typically used to numb tissue and reduce pain and itching, while hydrocortisone is a corticosteroid commonly used to reduce inflammation and irritation. The combination is intended for rectal application. This product is marketed without an approved FDA application.
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🧪 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.
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UNII 34S289N54E
Aluminum sulfate is a salt compound used in medicines as an astringent and buffering agent. It helps regulate acidity and can be used in topical or oral formulations to reduce moisture and control pH levels.
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UNII XF417D3PSL
Anhydrous citric acid is a sour, crystalline powder derived from citric acid with water removed. In medicines, it acts as a buffer to control pH, adds tartness to improve taste, and helps tablets disintegrate.
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UNII Y882YXF34X
Calcium acetate is a mineral salt made from calcium and acetic acid. In medicines, it acts as a binder to hold ingredients together and can help control the acidity level of the formulation.
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UNII 936JST6JCN
Cetyl alcohol is a waxy, fatty substance derived from plant or animal sources. It acts as an emulsifier and thickener in medicines, helping blend oil and water components and giving products a smooth, creamy texture.
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UNII FCZ5MH785I
A waxy substance made from glycerin and stearic acid. It works as an emulsifier to help mix oil and water ingredients together, and as a thickener to give the medicine its proper texture and consistency.
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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.
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UNII T5L8T28FGP
Mineral oil is a clear, odorless liquid derived from crude oil. It acts as a lubricant and emollient in medications, helping pills slide smoothly during manufacturing and aiding moisture retention in topical products.
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UNII YD01N1999R
A waxy substance made from polyethylene glycol and stearic acid. It helps mix oil and water-based ingredients together and serves as an emulsifier and solubilizer in liquid and semi-solid medicines.
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UNII 6F36Q0I0AC
PEG-150 distearate is a waxy substance made by combining polyethylene glycol with stearic acid. It acts as an emulsifier and surfactant to help blend water and oil-based ingredients, and may also function as a thickener or lubricant in the formulation.
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UNII 4T6H12BN9U
Petrolatum is a purified mineral oil-based jelly derived from petroleum. In medicines, it acts as an emollient, lubricant, and moisture barrier to soften skin, reduce friction, and help prevent water loss from formulations.
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UNII W25LM17A4W
Polycarbophil is a synthetic polymer that absorbs water and swells. It's used as a binder to hold tablet ingredients together and as a disintegrant to help the tablet break apart in the digestive system.
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UNII 6DC9Q167V3
Propylene glycol is a clear liquid derived from petroleum or vegetable sources. It acts as a solvent, humectant, and preservative in medicines, helping dissolve active ingredients and maintain product stability.
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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.
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UNII 1Q73Q2JULR
Sodium citrate is a salt derived from citric acid. It works as a buffer to maintain the medicine's pH level and may also help improve taste or act as a preservative in the formulation.
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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.
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UNII 2KR89I4H1Y
Stearyl alcohol is a waxy, fatty substance derived from natural oils or made synthetically. It acts as an emulsifier and thickener in medicines, helping mix ingredients together and give the product the right texture.
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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.
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UNII TTV12P4NEE
Xanthan gum is a thickening and stabilizing ingredient made from fermented corn or other sugars. It's added to medicines to improve texture, prevent separation of liquids and solids, and help the product stay consistent.
18 inactive ingredients listed in the exact product block matched to this NDC.
Label-section wording can be broader than the structured product block and may mention additional formulation ingredients.
Where does this data come from?
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
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💲 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 g | Per package |
|---|---|---|
| Retail pharmacies payNADAC · weekly | Not in the retail survey — common for institutional, discontinued, or low-volume packs. | |
| Medicaid paysCMS SDUD · 12 mo | $0.6302 | $88.23 / 140 g |
| 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 and Hydrocortisone Acetate 30 mg/g; 25 mg/gthis 13925-0164-20 | Seton | 20 tubes | — | — | FDA listed | — |
| Lidocaine Hydrochloride, Hydrocortisone Acetate 30 mg/g; 25 mg/g 24470-0964-20 | Cintex | 20 tubes | — | — | FDA listed | — |
| Lidocaine HCl - Hydrocortisone Acetate 30 mg/g; 25 mg/g 59088-0838-20 | PureTek | 20 tubes | — | — | Discontinued | — |
Where does this data come from?
⏳ Availability & generic status
We did not find an FDA-approved generic match for this exact strength, form and route.
Where does this data come from?
🗺️ Medicaid utilization & spend
📦 Packaging — all sizes for this product
| Package NDC | Description | Marketing start | Status |
|---|---|---|---|
| 13925-0164-20 You're viewing this | 20 TUBE in 1 KIT (13925-164-20) / 7 g in 1 TUBE (13925-164-07) | 2011-06-17 | Active |
🧭 About this NDC listing & data coverage
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) | ✓ Available |
Questions about this listing
Is this NDC FDA-approved?
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Where does this data come from?
📄 Full prescribing information FDA SPL
⏱️ Dosage and Administration ▾
DOSAGE AND ADMINISTRATION: Apply product to the affected area(s) twice daily or as directed by a physician. Product should not be used in excess of recommendations or for prolonged use in the anal canal. If the condition does not respond to repeated courses of product or should worsen, discontinue use and seek the advice of your physician.
Patient Directions for Rectal Administration: Remove moist wipe from box, tear open the package, gently clean the affected area and discard moist wipe. (Note: The moist wipe does not contain any of the prescribed active ingredients.) The cap and foil seal should be removed from the tube and the applicator tip firmly screwed onto the end of the tube and tightened. (Do not over tighten.) While holding the tube, gently squeeze the tube until a small amount of cream/gel comes out of the applicator openings.
This will lubricate the applicator tip. Gently insert the applicator tip into anal area. Continue squeezing the body of the tube as you move it around the areas of discomfort, and lastly, around and in the anal opening (if directed by physician).
Do not completely insert the applicator and tube into the anus or insert deep into the rectum. Do not insert a loose applicator tip into the anus or rectum. Once application is completed, the tube and applicator tip should be gently removed and discarded.
⛔ Contraindications ▾
CONTRAINDICATIONS: Product should not be used in patients with a history of sensitivity to any of its ingredients or adverse reactions to lidocaine or amide anesthetics, which usually do not cross-react with “caine” ester type anesthetics. If excessive irritation and significant worsening occur, discontinue use and seek the advice of your physician. Product and topical lidocaine should be used cautiously in those with impaired liver function, as well as the very ill or very elderly and those with significant liver disease.
Product should be used with caution on patients receiving antiarrhythmic drugs of Class I since the adverse effects are additive and generally synergistic. These products are contraindicated for tuberculous or fungal lesions or skin vaccinia, varicella and acute herpes simplex. Topical corticosteroids are contraindicated in those patients with a history of hypersensitivity to any of the components of the preparation.
⚠️ Warnings ▾
WARNINGS: For external use only. Not for ophthalmic use. Product, applicators and moist wipes could harm small children if chewed or swallowed.
Keep product, moist wipes and applicators out of the reach of children. Methemoglobinemia Cases of methemoglobinemia have been reported in association with local anesthetic use. Although all patients are at risk for methemoglobinemia, patients with glucose-6-phosphate dehydrogenase deficiency, congenital or idiopathic methemoglobinemia, cardiac or pulmonary compromise, infants under 6 months of age, and concurrent exposure to oxidizing agents or their metabolites are more susceptible to developing clinical manifestations of the condition.
If local anesthetics must be used in these patients, close monitoring for symptoms and signs of methemoglobinemia is recommended. Signs and symptoms of methemoglobinemia may occur immediately or may be delayed some hours after exposure and are characterized by a cyanotic skin discoloration and abnormal coloration of the blood. Methemoglobin levels may continue to rise; therefore, immediate treatment is required to avert more serious central nervous system and cardiovascular adverse effects, including seizures, coma, arrhythmias, and death.
Discontinue [the use of this product] and any other oxidizing agents. Depending on the severity of the symptoms, patients may respond to supportive care, i.e., oxygen therapy, hydration. More severe symptoms may require treatment with methylene blue, exchange transfusion, or hyperbaric oxygen.
🤒 Adverse Reactions ▾
ADVERSE REACTIONS: During, immediately, or following application of product, there may be transient stinging or burning from open areas of skin, or transient blanching (lightening), or erythema (redness) of the skin. CALL YOUR DOCTOR ABOUT SIDE EFFECTS. You may report side effects to the FDA at 1-800-FDA-1088.
🔄 Drug Interactions ▾
DRUG INTERACTIONS: Patients that are administered local anesthetics may be at increased risk of developing methemoglobinemia when concurrently exposed to the following oxidizing agents: Class Examples Nitrates/Nitrites nitroglycerin, nitroprusside, nitric oxide, nitrous oxide Local anesthetics benzocaine, lidocaine, bupivacaine, mepivacaine, tetracaine, prilocaine, procaine, articaine, ropivacaine Antineoplastic agents cyclophosphamide, flutamide, rasburicase, ifosfamide, hydroxyurea Antibiotics dapsone, sulfonamides, nitrofurantoin, para-aminosalicylic acid Antimalarials chloroquine, primaquine Anticonvulsants phenytoin, sodium valproate, phenobarbital Other drugs acetaminophen, metoclopramide, sulfa drugs (i.e., sulfasalazine), quinine
🤰 Pregnancy ▾
USE IN PREGNANCY: Teratogenic Effects: Pregnancy Category C. 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. Corticosteroids are generally teratogenic in laboratory animals when administered systemically at relatively low dosage levels.
The more potent corticosteroids have been shown to be teratogenic after dermal application in laboratory animals. There are no adequate and well controlled studies in pregnant women on teratogenic effects from topically applied corticosteroids. Therefore, topical corticosteroids should be used during pregnancy only if the potential benefit justifies the potential risk to the fetus.
Drugs of this class should not be used extensively on pregnant patients, in large amounts, or for prolonged periods of time.
🧒 Pediatric Use ▾
PEDIATRIC USE: Safety and efficacy in children have not been established.
🧬 Clinical Pharmacology ▾
CLINICAL PHARMACOLOGY: MECHANISM OF ACTION: Product releases lidocaine to stabilize the neuronal membrane by inhibiting the ionic fluxes required for initiation and conduction of impulses, thereby effecting local anesthetic action. Hydrocortisone acetate provides relief of inflammatory and pruritic manifestations of corticosteroid responsive dermatoses. Lidocaine is chemically designated as acetamide, 2-(diethylamino)-N-(2,6-dimethylphenyl), and has the following structure: Hydrocortisone acetate has a chemical name pregn-4-ene-3, 20-dione, 21-(acetyloxy)-11,17- dihydroxy-(11ß)-.
It has the following structural formula: Lidocaine Structure Hydrocortisone Structure
🧬 Mechanism of Action ▾
MECHANISM OF ACTION: Product releases lidocaine to stabilize the neuronal membrane by inhibiting the ionic fluxes required for initiation and conduction of impulses, thereby effecting local anesthetic action. Hydrocortisone acetate provides relief of inflammatory and pruritic manifestations of corticosteroid responsive dermatoses. Lidocaine is chemically designated as acetamide, 2-(diethylamino)-N-(2,6-dimethylphenyl), and has the following structure: Hydrocortisone acetate has a chemical name pregn-4-ene-3, 20-dione, 21-(acetyloxy)-11,17- dihydroxy-(11ß)-.
It has the following structural formula: Lidocaine Structure Hydrocortisone Structure
📦 How Supplied / Storage and Handling ▾
HOW SUPPLIED: Lidocaine 3% - Hydrocortisone 2.5% Gel Kit 20 Count Kit, NDC 13925-164-20 Containing: 20 single use ¼ oz (7g) Tubes (NDC 13925-164-07) of Lidocaine 3% - Hydrocortisone 2.5% Gel (a white gel), 20 Applicators and 20 Moist Wipes
📦 Storage and Handling ▾
STORAGE AND HANDLING SECTION: Store at 20ºC to 25ºC (68ºF to 77ºF), excursions permitted between 15ºC and 30ºC (between 59ºF and 86ºF). See USP Controlled Room Temperature. Protect from freezing. KEEP THIS AND ALL MEDICATIONS OUT OF THE REACH OF CHILDREN.
🧪 Inactive Ingredients ▾
INACTIVE INGREDIENTS: aluminum sulfate, calcium acetate, cetyl alcohol, citric acid, glyceryl stearate (and) PEG-100 stearate, methylparaben, mineral oil, PEG-150 distearate, petrolatum, polycarbophil, propylene glycol, propylparaben, purified water, sodium citrate, sodium hydroxide, stearyl alcohol, xanthan gum.
📋 Description ▾
DESCRIPTION: Lidocaine 3% - Hydrocortisone 2.5% Gel Kit are indicated for the anti-inflammatory and anesthetic relief of itching, pain, soreness, and discomfort due to hemorrhoids, anal fissures, pruritus ani and similar conditions of the anal area.