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Anti Dandruff KETOCONAZOLE 1 g/100mL Shampoo, 200 mL — NDC 85593-0033-01 package photo

Anti Dandruff KETOCONAZOLE 1 g/100mL Shampoo, 200 mL

by Guangzhou ChuanMa International Trading Co.,Ltd. · 200 mL in 1 BOTTLE (85593-033-01)
NDC 85593-0033-01
🏷️ FDA NDC (as labeled) 85593-033-01 billing pads the product 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) 85593-033-01
Product NDC 85593-033
11-digit billing NDC 85593003301
RxCUI 240812
UNII R9400W927I
Application # M005
SPL Set ID 4cfe234c-49c0-18e8-e063-6294a90a0b1d
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 2026-03-14
Route TOPICAL
Dosage form SHAMPOO
Substance KETOCONAZOLE
Why two NDCs? The FDA registers this code as 85593-033-01 — 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 → 85593-0033-01. 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

LabelerGuangzhou ChuanMa International Trading Co.,Ltd.
FDA applicationM005 (OTC MONOGRAPH DRUG)
Labeler code85593
First marketedMar 2026
Product typeHuman Otc Drug
Portfolio37 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 K3CD5CYV6S
    Aminopropyl dimethicone is a silicone-based liquid that acts as a lubricant and anti-foaming agent in medications. It helps reduce friction between powder particles and prevents excessive foam formation during manufacturing and use.
  • UNII Q7AO2R1M0B
    Ammonium lauryl sulfate is a mild detergent and foaming agent derived from plant oils. It helps mix water and oil-based ingredients together and creates a light foam in topical formulations like shampoos and cleansers.
  • 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.
  • UNII U6S376X80D
    A synthetic surfactant derived from petroleum-based alcohols. It acts as an emulsifier and solubilizer in medicines, helping mix ingredients that don't naturally blend together and improving how the body absorbs certain active ingredients.
  • UNII 9GLX7JL13M
    A synthetic compound made from plant-based fatty acids and lactic acid. It acts as an emulsifier and solvent to help mix ingredients and improve texture in liquid or semi-solid formulations.
  • 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 92005F972D
    A foaming and thickening agent derived from coconut oil. It's used in liquid medicines to improve texture, help distribute active ingredients evenly, and create a pleasant consistency for easier swallowing or application.
  • UNII 5OCF3O11KX
    A plant-derived surfactant made from coconut oil. It helps mix oil and water ingredients together in the formulation and can improve how the medicine spreads or feels on the skin.
  • UNII MVW5LK6LFT
    A modified plant-based gum derived from guar seeds, chemically altered to be positively charged. Used as a thickener, conditioner, and antistatic agent in liquid or semi-solid formulations to improve texture and stability.
  • UNII VNX7251543
    A plant-derived emulsifier made from coconut oil and polyethylene glycol. It helps mix oil and water-based ingredients together and improves how the medicine spreads or absorbs.
  • 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 OJ245FE5EU
    Sodium benzoate is a salt derived from benzoic acid, a preservative. It's added to medicines to prevent growth of bacteria, fungi, and other microorganisms that could spoil the product.
  • UNII 451W47IQ8X
    Sodium chloride is common table salt. It's used in medicines as a buffer to maintain proper pH, as a filler to add bulk, or to adjust the osmotic balance in liquid formulations.
  • UNII ZZQ59TY3KG
    Sodium laureth-2 sulfate is a cleansing agent made from coconut oil. It helps medicines dissolve properly and can reduce foaming or improve how the product spreads on skin.
  • UNII YFY3KG5Y7O
    A synthetic detergent and emulsifier derived from coconut oil. It helps mix oil and water-based ingredients together and improves how the medicine spreads or absorbs in the body.

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

The official label also statesAqua, Sodium Laureth Sulfate, Cocamide DEA,Sodium Chloride, Cocamidopropyl Betaine,Ammonium LaurylSulfate, Ketoconazole,Fragrance, Phenoxyethanol, PEG-7 GlycerylCocoate, Bis-Aminopropyl Dimethicone,Hydroxypropyl Guar HydroxypropyltrimoniumChloride, C12-13 Pareth Lactate, CitricAcid, C11-15 Pareth-9, Trideceth-12, Sodium Benzoate.

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/mL 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/100mLthis 85593-0033-01 Guangzhou 200 ml — — FDA listed —
Anti Dandruff 1 g/100mL 85593-0122-01 Guangzhou 200 ml — — FDA listed —
Anti Dandruff 1 g/100mL 85593-0121-01 Guangzhou 230 ml — — FDA listed —
Anti-Dandruff 1 g/100mL 85593-0128-01 Guangzhou 230 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

🏛️
2026
On the market since
Mar 2026
📍
2026
Currently FDA-listed
listed with the FDA
🔓
·
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.

📦 Packaging — all sizes for this product

Package NDCDescription Marketing startStatus
85593-0033-01 You're viewing this 200 mL in 1 BOTTLE (85593-033-01) 2026-03-14 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 85593-033-01, 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: 85593-0033-01, written without dashes as 85593003301. 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 85593-0033-01, the first segment (85593) is the labeler code FDA assigned to Guangzhou ChuanMa International Trading Co.,Ltd.; the middle segment (0033) 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 Guangzhou ChuanMa International Trading Co.,Ltd.. Listing status can change — the directory data on this page refreshes weekly.
Who lists this product with the FDA?
Guangzhou ChuanMa International Trading Co.,Ltd. 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 48 words ▾

For best results, follow these stepscarefully:1.Wet hair and scalp thoroughly with lukewarm water. 2.Apply a sufficient amount of shampoo to generate a rich lather. 3.Gently massage the lather into your scalp and hair.4.Leavethe latheron the scalp for3-5minutes. This contact time is crucialforthemedication to work effectively.5.Rinse thoroughly with water.

⏱️ Dosage and Administration 17 words ▾

Use every 3-4 days for up to 8 weeks. Afterthat, use only as needed to control dandruff.

⚠️ Warnings 4 words ▾

For external use only

🧪 Active Ingredient 2 words ▾

ketoconazole 1%

🧪 Inactive Ingredients 27 words ▾

Aqua, Sodium Laureth Sulfate, Cocamide DEA,Sodium Chloride, Cocamidopropyl Betaine,Ammonium LaurylSulfate, Ketoconazole,Fragrance, Phenoxyethanol, PEG-7 GlycerylCocoate, Bis-Aminopropyl Dimethicone,Hydroxypropyl Guar HydroxypropyltrimoniumChloride, C12-13 Pareth Lactate, CitricAcid, C11-15 Pareth-9, Trideceth-12, Sodium Benzoate.

🎯 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 ↗
← 85593-0030-01 · Guangzhou 85593-0036-01 · Guangzhou →
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.