dandRX 1% Ketoconazole Anti-Dandruff 1 g/100mL Liquid, 236 mL
by dandRX LLC · 236 mL in 1 BOTTLE (85521-001-01)
NDC 85521-0001-01
🏷️ FDA NDC (as labeled)
85521-001-01
billing pads the product segment with a zero
OTC
Discontinued
Non-controlled
⚠ Discontinued by firm
🗂️ Data synced Jul 14, 2026 · sources: openFDA · FDA label (DailyMed) · FDA Orange & Purple Book · First Databank · CMS NADAC, ASP, Medicare & Medicaid · RxNorm
📋 All sources & update times →
⚠️
Excluded from the active FDA NDC Directory.
The labeler reported this product as discontinued, so it is excluded from the active NDC Directory. The listing was last certified through Apr 2025. A label may still appear on DailyMed, but the NDC is no longer in the current FDA NDC Directory.
Search the FDA NDC Directory ↗
🆔 Identity & classification
FDA NDC (as labeled)
85521-001-01
Product NDC
85521-001
11-digit billing NDC
85521000101
RxCUI
240812
UNII
R9400W927I
Application #
M016
SPL Set ID
324fb7bb-4b8e-e6e6-e063-6394a90adae1
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
Discontinued
FDA listing status
Discontinued by firm (certified through Apr 2025)
Marketing start
2025-04-09
Route
TOPICAL
Dosage form
LIQUID
Substance
KETOCONAZOLE
Why two NDCs?
The FDA registers this code as 85521-001-01 — 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 → 85521-0001-01. 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
LabelerdandRX LLC
FDA applicationM016 (OTC MONOGRAPH DRUG)
Labeler code85521
First marketedApr 2025
Product typeHuman Otc Drug
Portfolio2 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
📗 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?
Patient education
Supplement & herbal interactions
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.
💬 Questions about dandRX 1% Ketoconazole Anti-Dandruff Shampoo?
Ask a pharmacist →
Ask a licensed pharmacist directly — free, answered by our team.
🧪 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.
Loading inactive ingredients from the official FDA label in the background. No external source is being called by this page request.
Where does this data come from?
Source: official FDA Structured Product Labeling (SPL) via DailyMed and the openFDA label index. Structured
IACT rows and label-wide narrative are kept separate; availability and product-level specificity depend on the submitted label.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 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. | |
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
| Product | Labeler | Pack | NADAC/unit | TE | Status | Price 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/100mLthis 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
Apr 2025
📍
2026
Currently FDA-listed
1 year 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.
📦 Packaging — all sizes for this product
| Package NDC | Description | Marketing start | Status |
|---|---|---|---|
| 85521-0001-01 You're viewing this | 236 mL in 1 BOTTLE (85521-001-01) | 2025-04-09 | Discontinued by firm |
🧭 About this NDC listing & data coverage
Over-the-counter (OTC) product
No longer marketed (per FDA listing data)
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 | — Not published for this NDC No photo available yet for this listing. |
| Inactive ingredients (structured) | — Not published for this NDC The labeler did not submit a structured excipient list, or no SPL is 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.
What does the discontinued status mean for this NDC?
The labeler reported a marketing end date (or the listing was delisted), so this specific package is no longer actively marketed. Remaining stock may still be dispensed for a time, and the NDC stays valid for historical records and claims — but data feeds (pricing, labeling) typically stop updating for it. Other package sizes or other manufacturers' versions of the same medication may still be marketed — see the equivalents section where available.
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 85521-001-01, 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: 85521-0001-01, written without dashes as 85521000101. 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 85521-0001-01, the first segment (85521) is the labeler code FDA assigned to dandRX 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.
Who lists this product with the FDA?
dandRX 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
📦 Storage and Handling
🧪 Active Ingredient
🧪 Inactive Ingredients
🎯 Purpose
🎯 Indications and Usage ▾
Use Use: for the control of the symptoms of dandruff and or seborrheic dermatitis.
⏱️ Dosage and Administration ▾
Directions Directions: for best results, use every other day or as directed by a doctor. ■ Wet hair thoroughly ■ Massage a liberal amount into your scalp. ■ Leave lather on scalp for several minutes ■ Rinse and repeat
⚠️ Warnings ▾
Warnings for external use only.
📦 Storage and Handling ▾
Other information Other information: store at room temperature between 68-78°F(20-25°C). Do not expose to excessive heat.
🧪 Active Ingredient ▾
Active Ingredient(s) KETOCONAZOLE 1%
🧪 Inactive Ingredients ▾
Inactive ingredients Aqua, Aloe Vera Leaf, Sodium Cocoyl Isethion-ate, Sodium LauroyI Methyl Isethionate, Co- camidopropyl Hydroxysultaine, Oatmeal, Pan-thenol, Chamomile, Green Tea Leaf, Calendula Officinalis Flower, Glycerin, Squalane, Cocos Nucifera (Coconut) Oil, Melaleuca Alternifolia (Tea Tree) Leaf Oil, Azadirachta Indica Flower, Leuconostoc/Radish Root Ferment Filtrate, So- dium Benzoate, Citric Acid
🎯 Purpose ▾
Purpose Anti-dandruff
No label section mentions that — try another word, or open the full label on DailyMed below.
Source: FDA Structured Product Labeling, mirrored from DailyMed / openFDA.
Prefer the government’s original formatting? View this label on DailyMed ↗
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.