Exelderm Sulconazole Nitrate 10 mg/mL Solution — NDC 69489-721-30 (Billing 69489-0721-30)
This is a package of Exelderm Sulconazole Nitrate 10 mg/mL Solution from Journey Medical Corporation, marketed since Jun 2019 and currently FDA-listed, this package's marketing is listed to end Oct 2027.
NDC database record
One package, one record: these facts belong to NDC 69489-721-30 alone.
- Record
- FDA NDC Directory package listing · Human prescription drug
- Code segments
- 69489 labeler · 721 product · 30 package
- Package marketed since
- Jun 7, 2019
- Package marketing ended
- Oct 31, 2027
- Sample package
- No — commercial package
- Barcode (UPC-A, from the NDC)
- 3 6948972130 2
- 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): 007377
- GCN: 46900
- GPI-14 (Medi-Span): 90154075002010
- HICL (First Databank): 003206
- AHFS class code: 84:04.08.08
- RxCUI (RxNorm): 208118
Where does this data come from?
- FDA openFDA NDC Directory · synced Oct 1, 2026
- FDA label on DailyMed · label index refreshed Oct 3, 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
Sulconazole is used to treat skin infections such as athlete's foot (cream only), jock itch, and ringworm. This medication is sometimes prescribed for other uses; ask your doctor or pharmacist for more information.
Read the full MedlinePlus article ↗- Sulconazole topical solution is approved to treat three fungal skin infections: tinea cruris (jock itch), tinea corporis (ringworm on the body), and tinea versicolor, which causes...
- What skin infections does sulconazole actually treat?
- Most people start to feel some relief — less itching, burning, or discomfort — within a few days of starting treatment. You should see visible improvement within about a week. That...
- Apply a small amount of the cream and gently massage it into the affected area and a little of the skin around it — not just the very center of the rash. Do this once or twice a da...
Patient education
Supplement & herbal interactions
Where does this data come from?
- MedlinePlus (NLM) · refreshed Oct 1, 2026
- FDA label on DailyMed · label index refreshed Oct 3, 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 mL | 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?
- CMS NADAC weekly file
- CMS ASP pricing files · refreshed Sep 20, 2026
- CMS Medicaid State Drug Utilization Data · refreshed Oct 4, 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 | Marketing start | Marketing end | Status |
|---|---|---|---|---|
| 69489-0721-05 69489-721-05 Main listing | 5 mL in 1 BOTTLE | 2021-03-15 | — | Discontinued by firm |
| 69489-0721-30 You're viewing this | 1 BOTTLE in 1 CARTON / 30 mL in 1 BOTTLE | 2019-06-07 | Oct 31, 2027 | Active |
Pack size FAQ
What quantity is in this package?
What NDC number is used to bill for this package of Exelderm Sulconazole Nitrate 10 mg/mL Solution?
Therapeutic equivalents
| Product | Labeler | Pack | NADAC/unit | TE | Status | Price vs. this |
|---|---|---|---|---|---|---|
| Exelderm 10 mg/mLthis 69489-0721-30 | Journey | 1 bottle | — | — | FDA listed | — |
| Sulconazole Nitrate 10 mg/mL 72143-0321-30 | JG | 1 bottle | — | — | 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
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?
- 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.
💡 Tap an ingredient (hover on desktop) to see what it is and why it’s used.
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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 411VRN1TV4
Nitric acid is a strong chemical used in small amounts during drug manufacturing to adjust and maintain the proper acid-base balance of a medicine, ensuring stability and correct formulation.
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UNII TUF2IVW3M2
Poloxamer 407 is a synthetic polymer made from ethylene oxide and propylene oxide. In medicines, it acts as a thickener, emulsifier, and solubilizer to help mix ingredients and create the right texture.
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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.
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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 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 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?
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 3, 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 Journey Medical Corporation labeler code 69489
- EMROSI Minocycline Hydrochloride Extended-Release 40 mg Capsule NDC 69489-131-07
- AMZEEQ Minocycline 40 mg/g Aerosol, Foam NDC 69489-201-03
- ZILXI Minocycline 15 mg/g Aerosol, Foam NDC 69489-212-03
- Eurax crotamiton 100 mg/g Cream NDC 69489-311-60
- Qbrexza glycopyrronium 2.4 g/100g Cloth NDC 69489-411-05
- Exelderm Sulconazole Nitrate 10 mg/g Cream NDC 69489-711-60
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 EXELDERM (sulconazole nitrate, USP) SOLUTION, 1.0% is a broad-spectrum antifungal agent indicated for the treatment of tinea cruris and tinea corporis caused by Trichophyton rubrum, Trichophyton mentagrophytes, Epidermophyton floccosum, and Microsporum canis; and for the treatment of tinea versicolor. Effectiveness has not been proven in tinea pedis (athlete's foot). Symptomatic relief usually occurs within a few days after starting EXELDERM SOLUTION and clinical improvement usually occurs within one week.
⏱️ Dosage and Administration ▾
DOSAGE AND ADMINISTRATION A small amount of solution should be gently massaged into the affected and surrounding skin areas once or twice daily. Symptomatic relief usually occurs within a few days after starting EXELDERM (sulconazole nitrate) SOLUTION, 1.0%, and clinical improvement usually occurs within 1 week. To reduce the possibility of recurrence, tinea cruris, tinea corporis, and tinea versicolor should be treated for 3 weeks.
If significant clinical improvement is not seen after 4 weeks of treatment, an alternate diagnosis should be considered.
⛔ Contraindications ▾
CONTRAINDICATIONS EXELDERM (sulconazole nitrate, USP) SOLUTION, 1.0% is contraindicated in patients who have a history of hypersensitivity to any of the ingredients.
🤒 Adverse Reactions ▾
ADVERSE REACTIONS There were no systemic effects and only infrequent cutaneous adverse reactions in 370 patients treated with sulconazole nitrate solution in controlled clinical trials. Approximately 1% of these patients reported itching and 1% burning or stinging. These complaints did not usually interfere with treatment.
🤰 Pregnancy ▾
Pregnancy Sulconazole nitrate has been shown to be embryotoxic in rats when given in doses 125 times the human dose (in mg/kg). The drug at this dose given orally to rats also resulted in prolonged gestation and dystocia. Several females died during the perinatal period, most likely due to labor complications.
Sulconazole nitrate was not teratogenic in rats or rabbits at oral doses of 50 mg/kg/day. There are no adequate and well-controlled studies in pregnant women. Sulconazole nitrate should be used during pregnancy only if the potential benefit justifies the potential risk to the fetus.
🧒 Pediatric Use ▾
Pediatric Use Safety and effectiveness in children have not been established.
🧓 Geriatric Use ▾
Geriatric Use Clinical studies of EXELDERM SOLUTION, 1.0%, did not include sufficient numbers of patients aged 65 years and over to determine whether they respond differently than younger patients. Other reported clinical experience has not identified differences in responses between elderly and younger patients.
🧬 Clinical Pharmacology ▾
CLINICAL PHARMACOLOGY Sulconazole nitrate is an imidazole derivative that inhibits the growth of the common pathogenic dermatophytes including Trichophyton rubrum, Trichophyton mentagrophytes, Epidermophyton floccosum, and Microsporum canis. It also inhibits the organism responsible for tinea versicolor, Malassezia furfur, and certain gram-positive bacteria. A maximization test with sulconazole nitrate solution showed no evidence of irritation or contact sensitization.
📦 How Supplied / Storage and Handling ▾
HOW SUPPLIED EXELDERM (sulconazole nitrate, USP) SOLUTION, 1.0% is a clear, slightly viscous, colorless to slightly yellow liquid with a slight characteristic odor. It is supplied as follows: 30 mL plastic bottle – NDC 69489-721-30 Avoid excessive heat, above 40° C (104° F), and protect from light. To report SUSPECTED ADVERSE REACTIONS, contact the FDA at 1-800-FDA-1088 or www.fda.gov/medwatch.
JOURNEY ® MEDICAL CORPORATION Manufactured for: Journey Medical Corp. Scottsdale, AZ 85258 www.JMCderm.com 141112 Revised March 2021
📋 Description ▾
DESCRIPTION EXELDERM (sulconazole nitrate, USP) SOLUTION, 1.0% is a broad-spectrum antifungal agent intended for topical application. Sulconazole nitrate, USP, the active ingredient in EXELDERM SOLUTION, is an imidazole derivative with antifungal and antiyeast activity. Its chemical name is (±)-1-[2,4-dichloro-β-[(p-chlorobenzyl)-thio]-phenethyl] imidazole mononitrate and it has the following chemical structure: Sulconazole nitrate, USP is a white to off-white crystalline powder with a molecular weight of 460.77.
It is freely soluble in pyridine; slightly soluble in ethanol, acetone, and chloroform; and very slightly soluble in water. It has a melting point of about 130°C. EXELDERM SOLUTION contains sulconazole nitrate, USP 10 mg/mL in a solution of propylene glycol, poloxamer 407, polysorbate 20, butylated hydroxyanisole, and purified water, with sodium hydroxide and, if necessary, nitric acid added to adjust the pH.
Chemical Structure
💬 Information for Patients ▾
Information for Patients Patients should be told to use EXELDERM SOLUTION as directed by the physician, to use it externally only, and to avoid contact with the eyes.
⚠️ Precautions ▾
PRECAUTIONS General EXELDERM (sulconazole nitrate, USP) SOLUTION, 1.0% is for external use only. Avoid contact with the eyes. If irritation develops, the solution should be discontinued and appropriate therapy instituted.
Information for Patients Patients should be told to use EXELDERM SOLUTION as directed by the physician, to use it externally only, and to avoid contact with the eyes. Carcinogenesis, Mutagenesis, Impairment of Fertility Long-term animal studies to determine carcinogenic potential have not been performed. In vitro studies have shown no mutagenic activity.
Pregnancy Sulconazole nitrate has been shown to be embryotoxic in rats when given in doses 125 times the human dose (in mg/kg). The drug at this dose given orally to rats also resulted in prolonged gestation and dystocia. Several females died during the perinatal period, most likely due to labor complications.
Sulconazole nitrate was not teratogenic in rats or rabbits at oral doses of 50 mg/kg/day. There are no adequate and well-controlled studies in pregnant women. Sulconazole nitrate should be used during pregnancy only if the potential benefit justifies the potential risk to the fetus.
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 sulconazole nitrate is administered to a nursing woman. Pediatric Use Safety and effectiveness in children have not been established.
Geriatric Use Clinical studies of EXELDERM SOLUTION, 1.0%, did not include sufficient numbers of patients aged 65 years and over to determine whether they respond differently than younger patients. Other reported clinical experience has not identified differences in responses between elderly and younger patients.
🍼 Nursing Mothers ▾
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 sulconazole 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. In vitro studies have shown no mutagenic activity.
📄 Package Label / Principal Display Panel ▾
Principal Display Panel – 30 mL Bottle Label NDC 69489-721-30 Exelderm ® (sulconazole nitrate, USP) Solution, 1.0% 30 mL Rx only For topical use only. Not for ophthalmic use. JOURNEY MEDICAL CORPORATION Principal Display Panel – 30 mL Carton Label
Principal Display Panel – 30 mL Bottle Label Exelderm ® NDC 69489-721-30 (sulconazole nitrate, USP) Solution, 1.0% Rx only For topical use only. Not for ophthalmic use. 30 mL Principal Display Panel – 30 mL Bottle Label
Medicare Part D spend CMS · PART D · 2026 (Q1)
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) | ✓ 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. |