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Lidothol LIDOCAINE HCl, MENTHOL 5 g/100g; 4.5 g/100g Gel, 1 tube — NDC 76420-0253-04 package photo
Label image from the product's FDA listing (DailyMed) — may show a different pack size or an older label revision.

Lidothol LIDOCAINE HCl, MENTHOL 5 g/100g; 4.5 g/100g Gel, 1 tube — NDC 76420-253-04 (Billing 76420-0253-04)

by Asclemed USA, Inc. · 1 TUBE in 1 BOX / 99.2 g in 1 TUBE

This is a package of 1 tube of Lidothol LIDOCAINE HCl, MENTHOL 5 g/100g; 4.5 g/100g Gel from Asclemed USA, Inc., marketed since Apr 2019 and currently FDA-listed. It is this product's only package size.

NDC 76420-0253-04
🏷️ FDA NDC (as labeled) 76420-253-04 billing pads the product segment with a zero
Rx only On market Non-controlled ⇄ Compare with another NDC
🗂️ FDA directory synced Oct 1, 2026 · this listing last changed Aug 27, 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

Regulatory identifiers FDA, NLM and CMS codes for this package

FDA NDC (as labeled) 76420-253-04
Product NDC 76420-253
11-digit billing NDC 76420025304
NCPDP billing unit GM — per gram (weight)
UNII L7T10EIP3A, V13007Z41A
SPL Set ID 6d7adaca-67dd-4a4b-a85c-d1c2a568dee2
Established class (EPC) Amide Local Anesthetic; Antiarrhythmic
Physiologic effect Local Anesthesia
Chemical class Amides
DEA schedule Non-controlled
Marketing category UNAPPROVED DRUG OTHER
Marketing status On market
FDA listing status Listed (active directory)
Marketing start 2019-04-01
Route TOPICAL
Dosage form GEL
Substance MENTHOL; LIDOCAINE HYDROCHLORIDE
Why two NDCs? The FDA registers this code as 76420-253-04 — 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 → 76420-0253-04. 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.

Clinical

🧪 What is this product?

Lidothol is a topical gel containing lidocaine hydrochloride and menthol. Lidocaine is a local anesthetic commonly used to numb skin and reduce pain sensation in the area where it is applied. Menthol is typically included in topical products for its cooling sensation and mild counterirritant properties. This product is marketed without an approved FDA application.

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

Packaging — all sizes for this product

Package NDCDescription Marketing startMarketing endStatus
76420-0253-04 You're viewing this Main listing 1 TUBE in 1 BOX / 99.2 g in 1 TUBE 2022-07-19 — Active

Therapeutic equivalents

ProductLabelerPackNADAC/unitTEStatusPrice vs. this
Lidothol Gel 4.5 g/100g; 5 g/100g 72189-0621-35 Direct_Rx 1 g — — FDA listed —
Lidothol 5 g/100g; 4.5 g/100gthis 76420-0253-04 Asclemed 1 tube — — FDA listed —
Lidothol 5 g/100g; 4.5 g/100g 80425-0516-01 Advanced 1 tube — — FDA listed —
Lidothol 5 g/100g; 4.5 g/100g 83881-0455-35 Clinic 1 tube — — FDA listed —
Lidothol 5 g/100g; 4.5 g/100g 87063-0218-99 ASCLEMED 1 tube — — 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

🏛️
2019
On the market since
Apr 2019
📍
2026
Currently FDA-listed
7 years 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.

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 3K9958V90M
    A liquid solvent derived from fermentation or chemical synthesis. In medicines, alcohol dissolves active ingredients, helps preserve the product, and improves how the body absorbs certain drugs.
  • UNII OZ0E5Y15PZ
    A plant extract from arnica flowers, used as a flavoring agent or fragrance component in medicines. It may also provide mild soothing properties to certain topical formulations.
  • UNII 5T1XCE6K8K
    A plant oil extracted from boswellia serrata resin, a tree native to India and Africa. Used as a flavoring agent, fragrance component, or carrier oil in formulations.
  • UNII 3XUS85K0RA
    Butylene glycol is a clear liquid derived from petroleum or plants that acts as a humectant, solvent, and preservative booster in medicines. It helps keep formulations stable, dissolve active ingredients, and maintain moisture in topical products.
  • UNII 0A5MM307FC
    A synthetic polymer that absorbs water and forms a thick, gel-like substance. In medicines, it works as a thickener and stabilizer to improve texture and help ingredients stay mixed together in creams, gels, and lotions.
  • UNII 9H4PO4Z4FT
    A sulfur-containing organic compound used as a solvent and penetration enhancer in medicines. It helps dissolve active ingredients and improve their absorption through skin or mucous membranes.
  • UNII 147D247K3P
    Ethylhexylglycerin is a synthetic preservative used to prevent bacteria and mold from growing in medicines and personal care products. It helps keep the product safe and stable throughout its shelf life.
  • UNII 1Q953B4O4F
    Ilex paraguariensis leaf, commonly known as yerba mate, is a plant extract used in medicines as a flavoring agent and to add botanical content. It may also contribute mild preservative properties to the formulation.
  • UNII DE08037SAB
    Magnesium sulfate is a mineral salt that acts as an osmotic agent in medications. It draws water into the intestines to soften stool or is used as a filler and processing aid in some solid dosage forms.
  • UNII HIE492ZZ3T
    Phenoxyethanol is a synthetic preservative and antimicrobial agent used to prevent bacterial and fungal growth in medicines and cosmetic products, extending shelf life and maintaining product safety.
  • UNII 7T1F30V5YH
    A synthetic emulsifier derived from sorbitol and oleic acid. It helps mix oil and water-based ingredients together and keeps them from separating in liquid formulations.
  • UNII 9O3K93S3TK
    Trolamine is an alkaline compound used as a pH buffer and emulsifier in medicines. It helps neutralize acids, stabilize formulations, and enable mixing of oil and water-based ingredients.
  • 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.

13 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

LabelerAsclemed USA, Inc.
Labeler code76420
First marketedApr 2019
Product typeHuman Prescription Drug
Portfolio653 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.

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 ⏱️ Dosage and Administration ⚠️ Warnings 🤒 Adverse Reactions 🆘 Overdosage 🧬 Clinical Pharmacology 📦 How Supplied / Storage and Handling 📦 Storage and Handling 📋 Description ⚠️ Precautions 📄 Package Label / Principal Display Panel
🎯 Indications and Usage 29 words ▾

INDICATION AND USAGE Lidothol Gel is indicated for relief of pain associated with arthritis, backache, cramps, discomfort, neckache, soreness, sprains, strains. It should be applied only to intact skin.

⏱️ Dosage and Administration 114 words ▾

CONTRAINDICATIONS Lidothol Gel is contraindicated in patients with a known history of sensitivity to local anesthetics of the amide type, or to any other component of the product.

DOSAGE AND ADMINISTRATION Apply Lidothol Gel to intact skin to cover the most painful area. Clean and dry the affected area. Apply product directly to your skin, up to 4 times daily.

Clothing may be worn over the area of application. If irritation or a burning sensation occurs during application, wash the product off your skin and do not reapply until the irritation subsides. When Lidothol Gel is used concomitantly with other products containing local anesthetic agents, the amount absorbed from all formulations must be considered.

⚠️ Warnings ~1 min read ▾

WARNINGS Medicines intended to be applied to the skin should not be swallowed. Lidothol Gel is flammable. Keep away from open flame.

You should never heat, microwave, or add the medicine to hot water. Risk of Methemoglobinemia Cases of methemoglobinemia have been reported in association with lidocaine 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 the condition.

If lidocaine 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.

Excessive Dosing Excessive dosing by applying Lidothol Gel to larger areas could result in increased absorption of lidocaine and high blood concentrations, leading to serious adverse effects (see ADVERSE REACTIONS, Systemic Reactions). Lidocaine toxicity could be expected at lidocaine blood concentrations above 5 mcg/mL. The blood concentration of lidocaine is determined by the rate of systemic absorption and elimination.

Longer duration of application of more than the recommended number of doses, smaller patients, or impaired elimination may all contribute to increased blood concentration of lidocaine.

🤒 Adverse Reactions ~1 min read ▾

ADVERSE REACTIONS Application Site Reactions During or immediately after treatment with Lidothol Gel, the skin at the site of application may develop blisters, bruising, burning sensation, depigmentation, dermatitis, discoloration, edema, erythema, exfoliation, irritation, papules, petechia, pruritus, vesicles, or may be the locus of abnormal sensation. These reactions are generally mild and transient, resolving spontaneously within a few minutes to hours. Other Adverse Events Due to the nature and limitation of spontaneous reports in post marketing surveillance, causality has not been established for additional reported adverse events including: Asthenia, confusion, disorientation, dizziness, headache, hyperesthesia, hypoesthesia, lightheadedness, metallic taste, nausea, nervousness, pain exacerbated, paresthesia, somnolence, taste alteration, vomiting, visual disturbances such as blurred vision, flushing, tinnitus, and tremor.

Systemic (Dose-Related) Reactions Systemic adverse reactions following appropriate use of Lidothol Gel are unlikely, due to the small dose absorbed (see CLINICAL PHARMACOLOGY, Pharmacokinetics). Systemic adverse effects of lidocaine is similar in nature to those observed with other amide local anesthetic agents, including CNS excitation and/or depression (light headedness, 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).

Excitatory CNS reactions may be brief or not occur at all, in which case the first manifestation may be drowsiness merging into unconsciousness. Cardiovascular manifestations may include bradycardia, hypotension and cardiovascular collapse leading to arrest. Sensitivity reactions associated with the use of mentholated products have been reported.

Use of mentholated nasal drops in infants has evidently caused isolated cases of spasm of the larynx, and a few cases of nervous or digestive system disturbance have been associated with excessive inhalation or oral exposure to menthol

🆘 Overdosage 91 words ▾

OVERDOSAGE Lidocaine overdose from cutaneous absorption is rare but could occur. If there is any suspicion of lidocaine overdose (see ADVERSE REACTIONS, Systemic Reactions), drug blood concentration should be checked. The management of overdose includes close monitoring, supportive care, and symptomatic treatment.

Dialysis is of negligible value in the treatment of acute overdose with lidocaine. In the absence of massive topical overdose or oral ingestion, evaluation of symptoms of toxicity should include consideration of other etiologies for the clinical effects, or overdosage from other sources of lidocaine or other local anesthetics.

🧬 Clinical Pharmacology ~1 min read ▾

CLINICAL PHARMACOLOGY Pharmacodynamics Lidocaine is an amide-type local anesthetic agent. The penetration of lidocaine into intact skin after application of Lidothol Gel is sufficient to produce annalgesic effect, but less than the amount necessary to produce a complete sensory block. Menthol is a covalent organic compound made synthetically or obtained from peppermint or other mint oils.

Menthol induces a cooling sensation on the skin upon topical application by stimulating the cold-sensitive receptors expressed on the skin, without actually causing a drop in the skin temperature. Pharmacokinetics Absorption The amount of lidocaine systemically absorbed from Lidothol Gel is directly related to both the duration of application and the surface area over which it is applied. Menthol occurs in numerous over-the-counter products.

Although extensively used, there have been no estimates of human exposure following administration via dermal application. Distribution At concentrations produced by application of Lidothol Gel, approximately 70% of the lidocaine dose is reported to be bound to plasma proteins, primarily alpha-1-acid glycoprotein. At higher plasma concentrations (1 to 4 mcg/mL of free base), the plasma protein binding of lidocaine is concentration dependent.

Metabolism It is not known if Lidothol Gel is metabolized in the skin. Excretion Lidocaine and its metabolites are excreted by the kidneys. Less than 10% of lidocaine is excreted unchanged.

The half-life of lidocaine elimination from the plasma following IV administration is 81 to 149 minutes (mean 107 ± 22 SD, n = 15). The systemic clearance is 0.33 to

0.90L/min (mean 0.64 ± 2 max max

0.18SD, n = 15).

📦 How Supplied / Storage and Handling 46 words ▾

HOW SUPPLIED Lidothol Gel is available as the following: 1 tube, 3.5oz NDC 76420-253-04 (relabeled from NDC 53225-1026-1) Store at 25°C (77°F); excursions permitted to 15°-30°C (59°-86°F). [See USP Controlled Room Temperature]. For more information, contact Terrain Pharmaceuticals. [email protected] Relabeled by: Enovachem PHARMACEUTICALS Torrance, CA 90501

📦 Storage and Handling 43 words ▾

HANDLING AND DISPOSAL Hands should be washed after the handling of Lidothol Gel, and eye contact with Lidothol Gel should be avoided. Store in a cool, dry place with lid tightly closed. Lidothol Gel should be kept out of the reach of children.

📋 Description 56 words ▾

DESCRIPTION Lidothol Gel (Lidocaine 4.5%, Menthol 5%) is comprised of a gel inside of a tube containing 4.5% Lidocaine and 5% Menthol. Inactive ingredients: Acrylates/C10-30 Alkyl Acrylate Crosspolymer, Arnica Montana Flower Extract, Boswellia Serrata Gum Extract, Butylene Glycol, Dimethyl Sulfone, Ethylhexylglycerin, llex Paraguariensis Leaf Extract, Magnesium Sulfate, Phenoxyethanol, Polysorbate-20, Propylene Glycol, SD Alcohol 40-B, Triethanolamine, Water

⚠️ Precautions ~2 min read ▾

PRECAUTIONS General Hepatic Disease Patients with severe hepatic disease are at greater risk of developing toxic blood concentrations of Lidocaine and menthol, because of their inability to metabolize lidocaine and menthol normally. Allergic Reactions Patients allergic to para-aminobenzoic acid derivatives (procaine, tetracaine, benzocaine, etc.) have not shown cross sensitivity to lidocaine. However, Lidothol Gel should be used with caution in patients with a history of drug sensitivities, especially if the etiologic agent is uncertain.

Although rare, get emergency medical help if you have signs of an allergic reaction from oral or topical application of menthol: hives, difficulty breathing, or swelling of your face, lips, tongue, or throat. Non-intact Skin Application to broken or inflamed skin, although not tested, may result in higher blood concentrations of lidocaine and menthol from increased absorption. Lidothol Gel is only recommended for use on intact skin.

External Heat Sources Placement of external heat sources, such as heating pads or electric blankets, over Lidothol Gel is not recommended as this has not been evaluated and may increase plasma lidocaine levels. Eye Exposure The contact of Lidothol Gel with eyes, although not studied, should be avoided based on the findings of severe eye irritation with the use of similar products in animals. If eye contact occurs, immediately wash out the eye with water or saline and protect the eye until sensation returns.

Information for Patients Methemoglobinemia Inform patients that use of local anesthetics may cause methemoglobinemia, a serious condition that must be treated promptly. Advise patients or caregivers to stop use and 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. Drug Interactions Antiarrhythmic Drugs Lidothol Gel should be used with caution in patients receiving Class I antiarrhythmic drugs (such as tocainide and mexiletine) since the toxic effects are additive and potentially synergistic.

Local Anesthetics When Lidothol Gel is used concomitantly with other products containing local anesthetic agents, the amount absorbed from all formulations must be considered. Drugs That May Cause Methemoglobinemia When Used with Lidothol Gel 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 The effect of Lidothol Gel on fertility has not been studied.

Pregnancy Teratogenic Effects Pregnancy Category B. Lidothol Gel has not been studied in pregnancy. Labor and Delivery Lidothol Gel has not been studied in labor and delivery.

Nursing Mothers Lidothol Gel has not been studied in nursing mothers. Pediatric Use Safety and effectiveness in pediatric patients have not been established.

📄 Package Label / Principal Display Panel 3 words ▾

lidotholbox lidotholinsertp1 lidotholinsertp2

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

Reported adverse events (FAERS)

Read carefully: FAERS reports are voluntary and unverified. Counts are not incidence, do not establish causation, are subject to reporting bias, and cannot be used to compare one drug to another. Shown for signal context only. Reports for Lidothol (this brand).

Top reported reactions

Hospitalisation1
Post Procedural Infection1

Reporter sex

2 reports
Male · 100%

Serious outcomes

Hospitalization2
Reports over time (by year) — tap or hover for the count & year
2019 2021 2023 2026 2 0
Most recent year is provisional (FAERS lags ~3 months).
Where does this data come from?
Adverse-event reports from the FDA Adverse Event Reporting System (FAERS) via openFDA. FAERS reports are voluntary and unverified — counts are not incidence and don’t establish causation.

About this NDC listing & data coverage

Finished prescription product Marketed without an FDA application

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.

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 form printed on the packaging and shown on DailyMed is the one the FDA registered. Insurance claims use a fixed 11-digit 5-4-2 format, so the short segment is padded with a leading zero and the dashes are dropped. The Identity section at the top of this page lists each form of this code.
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 Asclemed USA, Inc.. Listing status can change — the directory data on this page refreshes weekly.
Who lists this product with the FDA?
Asclemed USA, Inc. 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.
← 76420-0252-01 · Asclemed 76420-0254-05 · Asclemed →
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.