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(from DailyMed)

Danil .25 mg/g; 15 mg/g Solution, 100 g

by Jiangsu Chenpai Bond Pharmaceutical Co.,Ltd. · 100 g in 1 TUBE (84277-5665-3)
NDC 84277-5665-03
🏷️ FDA NDC (as labeled) 84277-5665-3 billing pads the package segment with a zero
OTC Discontinued Non-controlled ⚠ Inactivated by FDA
🗂️ 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 →
⚠️
Excluded from the active FDA NDC Directory. FDA inactivated this product’s listing record, so it is excluded from the active NDC Directory. The listing was last certified through Dec 2026. 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) 84277-5665-3
Product NDC 84277-5665
11-digit billing NDC 84277566503
UNII R9400W927I, 779619577M
SPL Set ID 177cf130-60df-a67c-e063-6294a90ab657
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 UNAPPROVED DRUG OTHER
Marketing status Discontinued
FDA listing status Inactivated by FDA (certified through Dec 2026)
Marketing start 2024-05-01
Route TOPICAL
Dosage form SOLUTION
Substance KETOCONAZOLE; CLOBETASOL PROPIONATE
Why two NDCs? The FDA registers this code as 84277-5665-3 — 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 → 84277-5665-03. 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.

🏭 Manufacturer & labeler

LabelerJiangsu Chenpai Bond Pharmaceutical Co.,Ltd.
Labeler code84277
First marketedMay 2024
Product typeHuman Otc Drug
Portfolio3 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 is this product?

Danil is a topical solution containing clobetasol propionate, a potent corticosteroid, and ketoconazole, an antifungal agent. Clobetasol propionate is typically used to reduce inflammation and itching in skin conditions, while ketoconazole is commonly used to treat fungal infections of the skin. This combination product is marketed without an approved FDA application and is classified as an unapproved drug.

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 95YYW1049K
    An organic compound containing a sulfur-based group, used primarily as a solvent and processing aid in pharmaceutical formulations to help dissolve or stabilize active ingredients during manufacturing.
  • UNII 52UXI5SZHT
    A positively charged chemical compound used in pharmaceutical formulations. It typically functions as a buffer or pH adjuster to help maintain stable acidity levels in medicines, ensuring the product remains effective and safe during storage.
  • UNII DSO12WL7AU
    A salt derived from citric acid, this ingredient acts as a buffer and pH regulator in medicines. It helps maintain stable acidity levels and may improve taste or aid preservation.
  • UNII 9V234MGT7F
    A plant-derived emulsifier made from coconut oil and glycerin. It helps blend water and oil ingredients together and improves texture and spreadability in topical medicines and creams.
  • UNII 617Q4OD69O
    A waxy ester made from glycol and stearic acid. It acts as a thickener, emulsifier, and texture modifier in tablets and creams, helping bind ingredients together and create a smooth, stable consistency.
  • UNII 7FLD91C86K
    Edetate disodium is a chemical compound that binds and removes certain metal ions. In medicines, it acts as a preservative and stabilizer by preventing metals like calcium from interfering with the product's shelf life and consistency.
  • UNII OMS4XQD1T0
    Eosin B is a synthetic red dye used as a colorant in medicines. It gives tablets, capsules, or liquid formulations their red or pink color for easy identification and visual appeal.
  • UNII 3L7GR2604E
    A synthetic compound derived from glycerol and formaldehyde, used as a solvent and humectant in liquid formulations to help dissolve active ingredients and maintain moisture content in the product.
  • UNII L7T10EIP3A
    A cooling compound from mint plants used as a flavoring agent and to create a fresh sensation in medicines. It helps mask bitter tastes and improve how the product feels in the mouth.
  • UNII S4S9783N13
    A synthetic compound made by combining polyethylene glycol with an organic chemical structure, then treating it with ammonium sulfate. It serves as a solubilizer and surfactant to help dissolve or distribute medicines evenly throughout a liquid formulation.
  • UNII 368GB5141J
    A detergent and foaming agent derived from coconut or palm oil. In medications, it helps break down and mix oil and water-based ingredients, aids in tablet disintegration, and improves how the drug dissolves and spreads in the mouth or digestive system.
  • 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.

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

The official label also statesClobetasol propionate 0.25mg

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 mLPer 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
Danil .25 mg/g; 15 mg/gthis 84277-5665-03 Jiangsu 100 g — — Discontinued —
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

🏛️
2024
On the market since
May 2024
📍
2026
Currently FDA-listed
2 years 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 NDCDescription Marketing startStatus
84277-5665-03 You're viewing this 100 g in 1 TUBE (84277-5665-3) 2024-05-01 Inactivated by FDA

🧭 About this NDC listing & data coverage

Over-the-counter (OTC) product Marketed without an FDA application No longer marketed (per FDA listing data)

Listed without an FDA application

This product's marketing category indicates it is marketed without an approved FDA application (no NDA, ANDA, or BLA on file). Having an NDC does not by itself establish FDA approval — the NDC Directory is a listing system, not an approval decision. Approval-linked data such as Orange Book therapeutic-equivalence ratings therefore does not apply.

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) ✓ 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 "Unapproved Drug Other". 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 84277-5665-3, 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: 84277-5665-03, written without dashes as 84277566503. 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 84277-5665-03, the first segment (84277) is the labeler code FDA assigned to Jiangsu Chenpai Bond Pharmaceutical Co.,Ltd.; the middle segment (5665) identifies this specific product — its ingredient, strength, and dosage form; and the last segment (03) identifies this exact package size and type. Together they name one specific package of one specific product.
Who lists this product with the FDA?
Jiangsu Chenpai Bond Pharmaceutical 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 33 words ▾

EXPIRATION DATE: Three years after the manufactured date. For external use only. Avoid contact with eyes. Keep out of reach of children. Do not exceed prescribed dose. Read package insert carefully before using.

⏱️ Dosage and Administration 64 words ▾

DOSAGE AND ADMINISTRATION: External use only. Apply about 5ml of DANIL solution to moist hair, massage it gently to let the solution contact with the scalp thoroughly, after 3~5 minutes, rinse cleanly with water. For treatment purpose , the DANIL solution should be used twice/thrice a week continuously for 2~4 weeks; for prevention purpose, it should be used once every one or two weeks.

⚠️ Warnings 6 words ▾

There is no any special warning.

🧪 Active Ingredient 7 words ▾

Active Ingredients: Ketoconazole 15mg Clobetasol Propionate 0.25mg

🧪 Inactive Ingredients 3 words ▾

Clobetasol propionate 0.25mg

🎯 Purpose 123 words ▾

PHARMACOLOGICAL ACTION: In vitro, DANIL solution exhibits a potent antimycotic activity. In vivo studies in animal patterns infected with superficial fungi, it is shown that DANIL solution has an excellent therapeutic effect, especially for that caused by Pityrosporum oval. Combined with Clobetasol propionate, a potent anti-inflammatory and anti-pruritic topical corticosteroid agent, DANIL solution has the actions of anti-bacterial, anti-inflammatory, anti-allergic, anti-dandruff and anti-pruritus.

Clinical trial reports that the DANIL solution has proved to be more effective and more rapid in treatment of dandruff and seborrheic dermatitis on the scalp than the single Ketoconazole lotion. Animal acute toxicity test and toxicity test for local application and clinical trial indicated that the DANIL solution is safe for use, no allergic or irritant reaction is found.

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.