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1% ketoconazole 10 mg/mL Shampoo, 250 mL — NDC 85384-0001-01 package photo

1% ketoconazole 10 mg/mL Shampoo, 250 mL

by TAGRID LLC · 250 mL in 1 BOTTLE (85384-0001-1)
NDC 85384-0001-01
🏷️ FDA NDC (as labeled) 85384-0001-1 billing pads the package segment with a zero
OTC On market Non-controlled
🗂️ Data synced Jul 24, 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

FDA NDC (as labeled) 85384-0001-1
Product NDC 85384-0001
11-digit billing NDC 85384000101
RxCUI 240812
UNII R9400W927I
Application # M005
SPL Set ID 30b75584-3a1e-c125-e063-6294a90acaa7
Established class (EPC) Azole Antifungal
Mechanism of action Cytochrome P450 3A4 Inhibitors; Cytochrome P450 3A5 Inhibitors; P-Glycoprotein Inhibitors
Chemical class Azoles
DEA schedule Non-controlled
Marketing category OTC MONOGRAPH DRUG
Marketing status On market
FDA listing status Listed (active directory)
Marketing start 2025-03-31
Route TOPICAL
Dosage form SHAMPOO
Substance KETOCONAZOLE
Why two NDCs? The FDA registers this code as 85384-0001-1 — a 5-4-1 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 package segment → 85384-0001-01. 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.

🏷️ RxNorm drug class

This medicine belongs to the Cortisol Synthesis Inhibitor class.

Pharmacologic class Cortisol Synthesis Inhibitor, Azole Antifungal
Drug family (ATC) Anticorticosteroids, Imidazole and triazole derivatives, Imidazole derivatives
How it works Cytochrome P450 2B6 Inhibitors, Cytochrome P450 3A4 Inhibitors, Cytochrome P450 17A1 Inhibitors, P-Glycoprotein Inhibitors
Where does this data come from?
Therapeutic classes from RxNorm RxClass (U.S. National Library of Medicine) — Established Pharmacologic Class (FDA), ATC drug family (WHO) and mechanism of action, matched by this product’s RxCUI.

🏭 Manufacturer & labeler

LabelerTAGRID LLC
FDA applicationM005 (OTC MONOGRAPH DRUG)
Labeler code85384
First marketedMar 2025
Product typeHuman Otc Drug
Portfolio24 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.

🩺 Clinical

📖 What it is MedlinePlus · NLM

Ketoconazole cream is used to treat tinea corporis (ringworm; fungal skin infection that causes a red scaly rash on different parts of the body), tinea cruris (jock itch; fungal infection of the skin in the groin or buttocks), tinea pedis (athlete's foot; fungal infection of the skin on the feet and between the toes), tinea versicolor (fungal infection of the skin that causes brown or light colored spots on the chest, back, arms, legs, or neck), and yeast infections of the skin. Prescription ketoconazole shampoo is used to treat tinea versicolor. Over-the-counter ketoconazole shampoo is used t...

Read the full MedlinePlus article ↗
📗 Our plain-language guide HelloPharmacist
  • Tinea versicolor is a fungal infection caused by a yeast that normally lives on everyone's skin. When it overgrows, it creates light or dark patches — most commonly on the chest, b...
  • What exactly is tinea versicolor, and will this clear it up completely?
  • The key is to never dispense it directly onto your hands — the foam starts melting the moment it hits warm skin. Instead, press the nozzle into the cap of the can or any cool surfa...
  • How do I actually apply this foam without making a mess?
📖 Read our full Ketoconazole guide →
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.

🧪 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 2968PHW8QP
    A weak organic acid derived from citrus fruits or made through fermentation. It works as a buffer to control pH, a preservative to extend shelf life, and a flavoring agent in medications.
  • UNII V1IA3S3CUS
    A plant extract derived from Cnidium monnieri fruit, commonly used in traditional Asian medicine preparations. In formulations, it may serve as an active botanical ingredient or flavoring agent, though its specific role depends on the product type.
  • UNII LA97176ILS
    A plant-derived ingredient from the root bark of Dictamnus dasycarpus. It may function as a natural extract or traditional ingredient to support formulation stability or consistency in herbal preparations.
  • UNII L13YF113GN
    A plant extract from Euphorbia hirta, a tropical herb. It functions as a natural flavoring agent and may help preserve the medicine by providing antimicrobial properties in the formulation.
  • UNII 26LKE578NY
    A natural plant extract from the thorns of the Chinese honey locust tree. It's used in formulations as a binder and thickening agent to help hold ingredients together and adjust product texture.
  • UNII VIF565UC2G
    Tea tree oil is an essential oil extracted from the leaves of the Australian tea tree plant. In medicines, it typically serves as a flavoring agent, fragrance, or antimicrobial component in topical formulations.
  • UNII N2285224W8
    Mentha canadensis top oil is a natural peppermint-like essential oil used as a flavoring and fragrance agent in medicines. It provides a cooling taste and aroma to make the product more pleasant to take.
  • UNII 05O8B64OS2
    A plant-derived ingredient made from the whole herb Mosla cavaleriei. It may serve as a flavoring, fragrance component, or traditional botanical additive in the formulation.
  • UNII 20IWV81WFV
    A plant extract from the root bark of Murraya paniculata, a tropical shrub. It may be used in formulations for flavoring or as a botanical ingredient to add taste or aroma to the medicine.
  • UNII PBG27B754G
    Phellodendron amurense bark is a plant-derived ingredient from the cork tree. It functions as a natural preservative and antimicrobial agent to help maintain product stability and prevent microbial growth.
  • UNII PES3YXA3LR
    A plant extract from the smilax glabra tuber root. It may be used as a natural flavoring agent or traditional herbal ingredient to enhance taste or provide botanical character to the medicine.
  • UNII IYR6K8KQ5K
    A plant extract from sophora flavescens root used as a natural colorant and flavoring agent in medicines. It may also help preserve the product and provide texture.
  • UNII 80N0P0DD9J
    A plant-derived ingredient from Stellera chamaejasme used in traditional medicine formulations. It may serve as a natural extract or botanical component in the preparation.
  • UNII EKG8030U4N
    A plant-derived ingredient from the Stemona sessilifolia root. It may be used as a natural binder or thickening agent to help hold tablet or capsule ingredients together and improve product texture.
  • UNII 9OI75F9NAC
    A plant extract from Viola yezoensis (a type of violet flower) used as a natural colorant or flavoring agent in medicines. It may also provide antioxidant properties to help preserve the product.
  • 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.

16 inactive ingredients listed in the exact product block matched to this NDC.

The official label also statesCitric Acid, Herba Violae, Euphorbia Hirta, Murraya Paniculata,Mentha Canadensis, Sophora Flavescens, Dittany Bark, Glabrous Greenbrier Rhizome, Mosla Cavaleriei Levl,Stellera Chamaejasme, Huang Bai, Sessile Stemona Root, Gleditsia Sinensis, Common Cnidium Fruit, Fructus Kochiae, Tea Tree Oil, Water

Label-section wording can be broader than the structured product block and may mention additional formulation ingredients.

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.

💲 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.

🔁 Therapeutic equivalents

ProductLabelerPackNADAC/unitTEStatusPrice vs. this
Nizoral 10 mg/mL 55505-0196-33 Kramer 1 bottle — — FDA listed —
Nizoral 1 g/100mL 55505-0232-65 Kramer 400 ml — — FDA listed —
Nizoral 10 mg/mL 55505-0233-65 Kramer 400 ml — — FDA listed —
Gembooxt Ketoconazole 1% Medicated Shampoos .01 g/mL 76986-0025-01 Guangdong 300 ml — — FDA listed —
1% ketoconazole 10 mg/mLthis 85384-0001-01 TAGRID 250 ml — — FDA listed —
dandRX 1% Ketoconazole Anti-Dandruff 1 g/100mL 85521-0001-01 dandRX 236 ml — — Discontinued —
Anti Dandruff 1 g/100mL 85593-0033-01 Guangzhou 200 ml — — 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

🏛️
2025
On the market since
Mar 2025
📍
2026
Currently FDA-listed
1 year listed
🔓
·
Generic versions listed
see equivalents
✅Generic appears available

FDA-approved generic versions are listed, and recent pricing/market data suggests they may be available — see Therapeutic equivalents.

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.

📊 Medicare Part D spend CMS · PART D · 2026 (Q1)

Medicare Part D (outpatient prescription) spending for Ketoconazole (matched by generic name) — the program that covers self-administered drugs. 13 manufacturers.
⚠️ Drug-level data: CMS publishes Part D spending by drug, not by NDC — these figures combine every manufacturer, strength and package size sold under the name Ketoconazole. CMS lists 2 products for this generic; we show the highest-spend one. That’s a different level of aggregation than the Medicaid card above, which is specific to this exact 11-digit NDC (pack size included), so the two aren’t directly comparable.
Period
Total Part D spend
$20.47M
Claims incl. refills
1.2M
Beneficiaries
831.7K
Spend / beneficiary
$24.61
Spend / claim
$17.69
Trend by period
💵 About the dollar figures: spending is what Part D plans paid before confidential manufacturer rebates, so the program’s real net cost is lower. A blank patient count means fewer than 11 people — CMS hides counts that small to protect privacy. Source: CMS Medicare Quarterly Part D Spending by Drug (data.cms.gov), updated quarterly.

🔬 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 1% ketoconazole (this brand).

Top reported reactions

Fatigue833
Pruritus820
Rash743
Nausea726
Diarrhoea694
Headache647
Pain628

Age at onset

Neonate11
Infant21
Child64
Adolescent93
Adult1,825
Elderly1,343

Reporter sex

14,692 reports
Male · 49%
Female · 51%
Unknown · 0%

Serious outcomes

Hospitalization3,143
Death931
Disabling303
Life-threatening289
Reports over time (by year) — tap or hover for the count & year
2025 2026 1,418 719
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.

📦 Packaging — all sizes for this product

Package NDCDescription Marketing startStatus
85384-0001-01 You're viewing this 250 mL in 1 BOTTLE (85384-0001-1) 2025-03-31 Active

🧭 About this NDC listing & data coverage

Over-the-counter (OTC) product
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 "Otc Monograph Drug". 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 FDA registers it as 85384-0001-1, which is what is printed on the packaging and shown on DailyMed. Insurance claims use a fixed 11-digit 5-4-2 format, so the short segment is padded with a leading zero: 85384-0001-01, written without dashes as 85384000101. The Identity section at the top of this page lists every form of this code.
What do the three segments of this NDC mean?
In 85384-0001-01, the first segment (85384) is the labeler code FDA assigned to TAGRID LLC; the middle segment (0001) identifies this specific product — its ingredient, strength, and dosage form; and the last segment (01) identifies this exact package size and type. Together they name one specific package of one specific product.
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 TAGRID LLC. Listing status can change — the directory data on this page refreshes weekly.
Who lists this product with the FDA?
TAGRID LLC 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 an over-the-counter product, so it does not require a prescription. Follow the package directions, and ask your pharmacist if you are unsure whether it is right for you.
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.

📄 FDA label — Drug Facts FDA SPL

The complete FDA label for this product — the official Drug Facts labeling, verbatim, section by section. Jump with a chip, search within the label, or expand everything.
🎯 Indications and Usage ⏱️ Dosage and Administration ⚠️ Warnings 🧪 Active Ingredient 🧪 Inactive Ingredients 🎯 Purpose
🎯 Indications and Usage 17 words ▾

Targets Stubborn Dandruff, Seborrheic Dermatitis, and itching ​Prevention, Treatment, and control of fungus that can cause dandruff

⏱️ Dosage and Administration 52 words ▾

adults and children 12 years and over • wet hair thoroughly • apply shampoo, generously lather, rinse thoroughly. Repeat • use every 3-4 days for up to 8 weeks or as directed by a doctor. Then use only as needed to control dandruff Children under 12 years old • Ask a doctor

⚠️ Warnings 66 words ▾

For external use only on the scalp that is broken or inflamed if you are allergic to ingredients in this product do not get into the eyes. If eye contact occurs, rinse thoroughly with water. If the rash appears or the condition worsens does not improve in 2-4 weeks. ask a doctor before use If swallowed, get medical help or contact a Posion Control Center immediately

🧪 Active Ingredient 2 words ▾

ketoconazole 1%

🧪 Inactive Ingredients 38 words ▾

Citric Acid, Herba Violae, Euphorbia Hirta, Murraya Paniculata ,Mentha Canadensis, Sophora Flavescens, Dittany Bark, Glabrous Greenbrier Rhizome, Mosla Cavaleriei Levl ,Stellera Chamaejasme, Huang Bai, Sessile Stemona Root, Gleditsia Sinensis, Common Cnidium Fruit, Fructus Kochiae, Tea Tree Oil, Water

🎯 Purpose 2 words ▾

Anti Dandruff

Source: FDA Structured Product Labeling, mirrored from DailyMed / openFDA. Prefer the government’s original formatting? View this label on DailyMed ↗
← 85382-0203-50 · DAISY'S 85384-0002-01 · TAGRID →
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.