Econazole Nitrate 10 mg/g Cream — NDC 45802-466-53 (Billing 45802-0466-53)
This is a package of Econazole Nitrate 10 mg/g Cream from Padagis Israel Pharmaceuticals Ltd, marketed since Aug 2006 and currently FDA-listed; retail pharmacies pay about $0.2116 per g (NADAC). It is the main listing for this product, which comes in 3 package sizes.
NDC database record
One package, one record: these facts belong to NDC 45802-466-53 alone.
- Record
- FDA NDC Directory package listing · Human prescription drug
- Code segments
- 45802 labeler · 466 product · 53 package
- Package marketed since
- Aug 8, 2006
- Sample package
- No — commercial package
- Listing certified through
- Dec 31, 2026
- Barcode (UPC-A, from the NDC)
- 3 4580246653 2
- Medicaid fills, this package
- 7,815 prescriptions in the last four reported quarters
- FDA record last changed
- Jul 24, 2026
Identity & classification
Regulatory identifiers FDA, NLM and CMS codes for this package
Drug-database identifiers Medi-Span GPI and First Databank GCN / HICL / AHFS classification
- GSN (GCN sequence number): 007371
- GCN: 30430
- GPI-14 (Medi-Span): 90154035103705
- HICL (First Databank): 016904
- AHFS class code: 84:04.08.08
- RxCUI (RxNorm): 857366
Where does this data come from?
- FDA openFDA NDC Directory · synced Oct 1, 2026
- FDA label on DailyMed · label index refreshed Oct 6, 2026
- RxNorm (NLM RxNav) · catalog refreshed Oct 1, 2026
- Medi-Span GPI (licensed)
- First Databank (licensed) · refreshed Oct 1, 2026
RxNorm drug class
This medicine belongs to the Azole Antifungal class.
Where does this data come from?
- RxClass (NLM) · catalog refreshed Oct 1, 2026
Clinical
- It treats fungal skin infections. The foam is for athlete's foot between the toes in people 12 and older. The cream is used for athlete's foot, ringworm of the groin and body, tine...
- The cream goes on once a day for most tinea infections and twice a day for skin yeast infections. The foam is used once daily for athlete's foot. Follow your prescriber's direction...
- Keep going even if you feel better early. The cream is typically used for two weeks for yeast infections, groin and body ringworm, and one month for athlete's foot. This lowers the...
- Side effects are uncommon. In foam trials, skin reactions where it was applied happened in less than 1% of people, about the same as the foam without medicine.
Patient education
Supplement & herbal interactions
Some supplements/herbs that may interact with Econazole Nitrate — tap one for details:
Where does this data come from?
- MedlinePlus (NLM) · refreshed Oct 1, 2026
- FDA label on DailyMed · label index refreshed Oct 6, 2026
Ask a licensed pharmacist directly — free, answered by our team.
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 | $0.212 | $17.99 / 85 g |
| Medicaid paysCMS SDUD · 12 mo | $0.3341 | $28.40 / 85 g |
| Medicare drug plans payPart D · Q2 2026 | $0.4803 | $40.83 / 85 g |
Where does this data come from?
- CMS NADAC weekly file · file of Sep 30, 2026
- CMS ASP pricing files · refreshed Sep 20, 2026
- CMS Medicaid State Drug Utilization Data · through Q1 2026
- CMS Part D plan pricing files · refreshed Sep 24, 2026
- VA National Acquisition Center price file
Packaging — all sizes for this product
| Package NDC | Description | Per unit | Per pack | Marketing start | Marketing end | Status |
|---|---|---|---|---|---|---|
| 45802-0466-11 45802-466-11 | 1 TUBE in 1 CARTON / 30 g in 1 TUBE | $0.3509 / g | $10.53 | 2006-11-10 | — | Active |
| 45802-0466-35 45802-466-35 | 1 TUBE in 1 CARTON / 15 g in 1 TUBE | $0.3973 / g | $5.96 | 2006-12-21 | — | Active |
| 45802-0466-53 You're viewing this Main listing | 1 TUBE in 1 CARTON / 85 g in 1 TUBE | $0.2116 / g | $17.99 | 2006-08-08 | — | Active |
This pack has the lowest per-g cost of the 3 priced pack sizes ($0.2116 NADAC).
In Medicaid, this is the most-dispensed pack of this product — about 37% of fills over the last four reported quarters. See all packs ↓
Pack size FAQ
What quantity is in this package?
What NDC number is used to bill for this package of Econazole Nitrate 10 mg/g Cream?
Prices are the latest CMS NADAC pharmacy acquisition cost per NDC; per-pack figures are per-unit × pack quantity, shown only when the pack is denominated in the same measure NADAC prices.
Therapeutic equivalents
| Product | Labeler | Pack | NADAC/unit | TE | Status | Price vs. this |
|---|---|---|---|---|---|---|
| Econazole Nitrate 10 mg/gthis 45802-0466-53 | Padagis | 1 tube | $0.212 | AB | Availability likely | — |
| Econazole Nitrate 10 mg/g 51672-1303-01 | Sun | 1 tube | $0.397 | AB | Availability likely | +88% |
| Econazole Nitrate 10 mg/g 59651-0945-14 | Aurobindo | 1 tube | — | AB | FDA listed | — |
| Econazole Nitrate 10 mg/g 63629-8645-01 | Bryant | 1 tube | — | AB | FDA listed | — |
| Econazole Nitrate 10 mg/g 63629-8646-01 | Bryant | 1 tube | — | AB | FDA listed | — |
| Econazole Nitrate 10 mg/g 63629-8647-01 | Bryant | 1 tube | — | AB | FDA listed | — |
| Econazole Nitrate 10 mg/g 68788-8170-03 | Preferred | 1 tube | — | AB | FDA listed | — |
| Econazole Nitrate 10 mg/g 68788-8174-01 | Preferred | 1 tube | — | AB | FDA listed | — |
| Econazole Nitrate 10 mg/g 68788-8884-03 | Preferred | 1 tube | — | AB | FDA listed | — |
| Econazole Nitrate 10 mg/g 72162-1410-04 | Bryant | 1 tube | — | AB | FDA listed | — |
| Econazole Nitrate 10 mg/g 21922-0111-04 | Encube | 1 tube | — | AB | FDA listed | — |
Where does this data come from?
- FDA openFDA NDC Directory · synced Oct 1, 2026
- FDA Orange Book · refreshed Oct 3, 2026
- CMS NADAC weekly file · file of Sep 30, 2026
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?
- FDA Orange Book · refreshed Oct 3, 2026
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.
🧪 Avoiding an ingredient? See Econazole Topical inactive ingredients by manufacturer: every current product's list side by side, so you can ask your pharmacy for the version that does not list it.
💡 Tap an ingredient (hover on desktop) to see what it is and why it’s used.
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UNII 8SKN0B0MIM
Benzoic acid is a naturally occurring organic acid used as a preservative in medicines and foods. It helps prevent bacterial and fungal growth to extend shelf life and maintain product stability.
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UNII REK4960K2U
Butylated hydroxyanisole is a synthetic preservative that prevents oils and fats in medicines from spoiling or becoming rancid. It keeps the medicine stable and extends its shelf life.
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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 0240V77G50
A synthetic compound made by combining polyethylene glycol with oleic acid (a natural fatty acid). It acts as an emulsifier and solubilizer to help mix water and oil-based ingredients in the medicine.
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UNII 3EW5AXE5X5
A synthetic surfactant derived from polyethylene glycol and stearic acid. It helps mix oil and water-based ingredients together and improves how the medicine dissolves and is absorbed in the body.
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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.
6 inactive ingredients listed in the exact product block matched to this NDC.
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.- FDA label on DailyMed · label index refreshed Oct 6, 2026
- FDA openFDA NDC Directory · synced Oct 1, 2026
Inactive ingredient FAQ
Are inactive ingredients the same for every manufacturer?
Why might an inactive ingredient be missing?
Can inactive ingredients matter?
Manufacturer & labeler
More NDCs from Padagis Israel Pharmaceuticals Ltd labeler code 45802
- Penciclovir 10 mg/g Cream NDC 45802-440-75
- fluticasone propionate .5 mg/mL Lotion NDC 45802-441-02
- TAZAROTENE 1 mg/g Gel NDC 45802-442-01
- ESTRADIOL 1 mg/g Gel NDC 45802-452-30
- Adapalene .1 g/100g Cream NDC 45802-453-84
- Ketoconazole 20 mg/mL Shampoo, Suspension NDC 45802-465-64
- Hydrocortisone Acetate Pramoxine Hcl 2.5 g/100g; 1 g/100g Cream NDC 45802-472-53
- Fluocinolone acetonide .01 mg/100mL Oil NDC 45802-485-26
- Docusate Sodium 100 mg Capsule, Liquid Filled NDC 45802-486-78
- Naproxen Sodium 220 mg Tablet, Film Coated NDC 45802-490-71
- cyanocobalamin 500 ug Spray NDC 45802-491-84
- Ammonium Lactate 12 g/100g Cream NDC 45802-493-26
Where does this data come from?
- FDA openFDA NDC Directory · synced Oct 1, 2026
- Drugs@FDA
Full prescribing information FDA SPL
🎯 Indications and Usage ▾
INDICATIONS AND USAGE Econazole Nitrate Cream is indicated for topical application in the treatment of tinea pedis, tinea cruris, and tinea corporis caused by Trichophyton rubrum, Trichophyton mentagrophytes, Trichophyton tonsurans, Microsporum canis, Microsporum audouini, Microsporum gypseum, and Epidermophyton floccosum, in the treatment of cutaneous candidiasis, and in the treatment of tinea versicolor.
⏱️ Dosage and Administration ▾
DOSAGE AND ADMINISTRATION Sufficient Econazole Nitrate Cream, 1% should be applied to cover affected areas once daily in patients with tinea pedis, tinea cruris, tinea corporis, and tinea versicolor, and twice daily (morning and evening) in patients with cutaneous candidiasis. Early relief of symptoms is experienced by the majority of patients and clinical improvement may be seen fairly soon after treatment is begun; however, candidal infections and tinea cruris and corporis should be treated for two weeks and tinea pedis for one month in order to reduce the possibility of recurrence.
If a patient shows no clinical improvement after the treatment period, the diagnosis should be redetermined. Patients with tinea versicolor usually exhibit clinical and mycological clearing after two weeks of treatment.
⛔ Contraindications ▾
CONTRAINDICATIONS Econazole Nitrate Cream is contraindicated in individuals who have shown hypersensitivity to any of its ingredients.
⚠️ Warnings ▾
WARNINGS Econazole Nitrate Cream is not for ophthalmic use.
🤒 Adverse Reactions ▾
ADVERSE REACTIONS During clinical trials, approximately 3% of patients treated with econazole nitrate cream, 1% reported side effects thought possibly to be due to the drug, consisting mainly of burning, itching, stinging, and erythema. One case of pruritic rash has also been reported.
🔄 Drug Interactions ▾
Drug Interactions Warfarin Concomitant administration of econazole and warfarin has resulted in enhancement of anticoagulation effect. Most cases reported product application with use under occlusion, genital application, or application to large body surface area which may increase the systemic absorption of econazole nitrate. Monitoring of International Normalized Ratio (INR) and/or prothrombin time may be indicated especially for patients who apply econazole to large body surface areas, in the genital area, or under occlusion.
🤰 Pregnancy ▾
Pregnancy Econazole nitrate has not been shown to be teratogenic when administered orally to mice, rabbits or rats. Fetotoxic or embryotoxic effects were observed in Segment I oral studies with rats receiving 10 to 40 times the human dermal dose. Similar effects were observed in Segment II or Segment III studies with mice, rabbits and/or rats receiving oral doses 80 or 40 times the human dermal dose.
Econazole nitrate should be used in the first trimester of pregnancy only when the physician considers it essential to the welfare of the patient. The drug should be used during the second and third trimesters of pregnancy only if clearly needed.
🆘 Overdosage ▾
OVERDOSE Overdosage of econazole nitrate in humans has not been reported to date. In mice, rats, guinea pigs and dogs, the oral LD 50 values were found to be 462, 668, 272, and >160 mg/kg, respectively.
🧬 Clinical Pharmacology ▾
CLINICAL PHARMACOLOGY After topical application to the skin of normal subjects, systemic absorption of econazole nitrate is extremely low. Although most of the applied drug remains on the skin surface, drug concentrations were found in the stratum corneum which, by far, exceeded the minimum inhibitory concentration for dermatophytes . Inhibitory concentrations were achieved in the epidermis and as deep as the middle region of the dermis.
Less than 1% of the applied dose was recovered in the urine and feces. Microbiology: Econazole nitrate has been shown to be active against most strains of the following microorganisms, both in vitro and in clinical infections as described in the INDICATIONS AND USAGE section. Dermatophytes Yeasts Epidermophyton floccosum Trichophyton mentagrophytes Candida albicans Microsporum audouini Trichophyton rubrum Malassezia furfur Microsporum canis Trichophyton tonsurans Microsporum gypseum Econazole nitrate exhibits broad-spectrum antifungal activity against the following organisms in vitro , but the clinical significance of these data is unknown .
Dermatophytes Yeasts Trichophyton verrucosum Candida guillermondii Candida parapsilosis Candida tropicalis
📦 How Supplied / Storage and Handling ▾
HOW SUPPLIED Econazole Nitrate Cream, 1% is available as follows: 15 g tube (NDC 45802- 466 -35) 30 g tube (NDC 45802- 466 -11) 85 g tube (NDC 45802- 466 -53) Store at 20-25ºC (68-77ºF) [see USP Controlled Room Temperature]. To report SUSPECTED ADVERSE REACTIONS, contact Padagis ® at 1-866-634-9120 or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch for voluntary reporting of adverse reactions. Manufactured by Padagis ® Yeruham, Israel www.padagis.com Rev 11-23 71D00 RC PH2
📋 Description ▾
DESCRIPTION Econazole Nitrate Cream contains the antifungal agent, econazole nitrate 1%, in a water-miscible base consisting of benzoic acid, butylated hydroxyanisole, mineral oil, peglicol 5 oleate, pegoxol-7 stearate, and purified water. The white to off-white soft cream is for topical use only. Chemically, econazole nitrate is 1-[2-{(4-chlorophenyl)methoxy}-2-(2,4-dichlorophenyl)ethyl]-1H-imidazole mononitrate.
Its structure is as follows: Structural Formula Image
⚠️ Precautions ▾
PRECAUTIONS General If a reaction suggesting sensitivity or chemical irritation should occur, use of the medication should be discontinued. For external use only. Avoid introduction of Econazole Nitrate Cream into the eyes.
Drug Interactions Warfarin Concomitant administration of econazole and warfarin has resulted in enhancement of anticoagulation effect. Most cases reported product application with use under occlusion, genital application, or application to large body surface area which may increase the systemic absorption of econazole nitrate. Monitoring of International Normalized Ratio (INR) and/or prothrombin time may be indicated especially for patients who apply econazole to large body surface areas, in the genital area, or under occlusion.
Carcinogenesis, mutagenesis, impairment of fertility Long-term animal studies to determine carcinogenic potential have not been performed. Oral administration of econazole nitrate in rats has been reported to produce prolonged gestation. Intravaginal administration in humans has not shown prolonged gestation or other adverse reproductive effects attributable to econazole nitrate therapy.
Pregnancy Econazole nitrate has not been shown to be teratogenic when administered orally to mice, rabbits or rats. Fetotoxic or embryotoxic effects were observed in Segment I oral studies with rats receiving 10 to 40 times the human dermal dose. Similar effects were observed in Segment II or Segment III studies with mice, rabbits and/or rats receiving oral doses 80 or 40 times the human dermal dose.
Econazole nitrate should be used in the first trimester of pregnancy only when the physician considers it essential to the welfare of the patient. The drug should be used during the second and third trimesters of pregnancy only if clearly needed. Nursing Mothers It is not known whether econazole nitrate is excreted in human milk.
Following oral administration of econazole nitrate to lactating rats, econazole and/or metabolites were excreted in milk and were found in nursing pups. Also, in lactating rats receiving large oral doses (40 or 80 times the human dermal dose), there was a reduction in post partum viability of pups and survival to weaning; however, at these high doses, maternal toxicity was present and may have been a contributing factor. Caution should be exercised when econazole nitrate is administered to a nursing woman.
Geriatric Use Clinical studies of econazole nitrate cream did not include sufficient numbers of subjects aged 65 and over to determine whether they respond differently from younger subjects. Other reported clinical experience has not identified differences in responses between the elderly and younger patients. In general, dose selection for an elderly patient should be cautious, usually starting at the low end of the dosing range, reflecting the greater frequency of decreased hepatic, renal, or cardiac function, and of concomitant disease or other drug therapy.
🍼 Nursing Mothers ▾
Nursing Mothers It is not known whether econazole nitrate is excreted in human milk. Following oral administration of econazole nitrate to lactating rats, econazole and/or metabolites were excreted in milk and were found in nursing pups. Also, in lactating rats receiving large oral doses (40 or 80 times the human dermal dose), there was a reduction in post partum viability of pups and survival to weaning; however, at these high doses, maternal toxicity was present and may have been a contributing factor.
Caution should be exercised when econazole nitrate is administered to a nursing woman.
📄 Carcinogenesis, Mutagenesis, Impairment of Fertility ▾
Carcinogenesis, mutagenesis, impairment of fertility Long-term animal studies to determine carcinogenic potential have not been performed. Oral administration of econazole nitrate in rats has been reported to produce prolonged gestation. Intravaginal administration in humans has not shown prolonged gestation or other adverse reproductive effects attributable to econazole nitrate therapy.
📄 Package Label / Principal Display Panel ▾
Principal Display Panel NDC 45802-466-35 Rx Only Econazole Nitrate Cream, 1% For Topical Use Only. Not For Ophthalmic Use. NET WT 15 g The following image is a placeholder representing the product identifier that is either affixed or imprinted on the drug package label during the packaging operation. carton image serialization-template.jpg