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Anti Dandruff Ketoconazole 1 mg/100mg Liquid, 200 mg — NDC 74458-0157-01 package photo
Label image from the product's FDA listing (DailyMed) — may show a different pack size or an older label revision.

Anti Dandruff Ketoconazole 1 mg/100mg Liquid, 200 mg — NDC 74458-157-01 (Billing 74458-0157-01)

by Guangzhou Yilong Cosmetics.,Ltd · 200 mg in 1 BOTTLE

This is a package of 200 mg of Anti Dandruff Ketoconazole 1 mg/100mg Liquid from Guangzhou Yilong Cosmetics.,Ltd, no longer marketed (first marketed Jul 2026), no longer in the FDA NDC Directory. It is this product's only package size.

NDC 74458-0157-01
🏷️ FDA NDC (as labeled) 74458-157-01 billing pads the product segment with a zero
OTC Discontinued Non-controlled ⚠ Inactivated by FDA ⇄ Compare with another NDC
🗂️ FDA directory synced Oct 1, 2026 · this listing last changed 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

NDC database record

One package, one record: these facts belong to NDC 74458-157-01 alone.

Record
FDA NDC Directory package listing · Human OTC drug
Code segments
74458 labeler · 157 product · 01 package
Package marketed since
Jul 4, 2026
Sample package
No — commercial package
Listing certified through
Dec 31, 2027
Barcode (UPC-A, from the NDC)
3 7445815701 3
FDA record last changed
Jul 24, 2026
⚠️
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 2027. 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

Regulatory identifiers FDA, NLM and CMS codes for this package

FDA NDC (as labeled) 74458-157-01
Product NDC 74458-157
11-digit billing NDC 74458015701
UNII R9400W927I
Application # M032
SPL Set ID 55c44ff5-f76d-c24b-e063-6394a90a7e74
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 Inactivated by FDA (certified through Dec 2027)
Marketing start 2026-07-04
Route TOPICAL
Dosage form LIQUID
Substance KETOCONAZOLE
Why two NDCs? The FDA registers this code as 74458-157-01 — 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 → 74458-0157-01. 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.

Clinical

📗 Our plain-language guide HelloPharmacist
  • It depends on the form. The tablets treat serious fungal infections like blastomycosis and histoplasmosis. The creams, foam and shampoos treat skin and scalp conditions like ringwo...
  • Take them with a meal, since that helps your body absorb them best. Follow your prescriber's directions. If you take acid-reducing medicine, ask me how to time it, because it can l...
  • Nausea, stomach upset, headache and dizziness are among the more common ones. Call your doctor right away if you notice yellow skin or eyes, dark urine, unusual tiredness, fainting...
  • The tablets have caused serious liver injury, sometimes fatal, even in people with no known liver problems. That's why you'll have liver blood tests before and during treatment. Av...
📖 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.

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.

Packaging — all sizes for this product

Package NDCDescription Marketing startMarketing endStatus
74458-0157-01 You're viewing this Main listing 200 mg in 1 BOTTLE 2026-07-04 — Inactivated by FDA

Therapeutic equivalents

ProductLabelerPackNADAC/unitTEStatusPrice vs. this
Anti Dandruff 1 mg/100mgthis 74458-0157-01 Guangzhou 200 mg — — 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

🏛️
2026
On the market since
Jul 2026
📍
2026
Currently FDA-listed
listed with the FDA
🔒
·
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.

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.

🧪 Avoiding an ingredient? See Ketoconazole inactive ingredients by manufacturer: every current product's list side by side, so you can ask your pharmacy for the version that does not list it.

💡 Tap an ingredient (hover on desktop) to see what it is and why it’s used.

  • 50 mg / 100 mg 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.

1 inactive ingredient 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 Lauryl Sulfate Fragrance Phenoxyethanol PEG-7 Glyceryl Cocoate Bis-Aminopropyl Dimethicone Hydroxypropyl Guar Hydroxypropyltrimonium Chloride C12-13 Pareth Lactate Citric Acid 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.

Manufacturer & labeler

LabelerGuangzhou Yilong Cosmetics.,Ltd
FDA applicationM032 (OTC MONOGRAPH DRUG)
Labeler code74458
First marketedJul 2026
Product typeHuman Otc Drug
Portfolio10 products on file

More NDCs from Guangzhou Yilong Cosmetics.,Ltd labeler code 74458

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.

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 🧪 Inactive Ingredients 🎯 Purpose 📄 Keep Out of Reach of Children 📄 Recent Major Changes 📄 Package Label / Principal Display Panel
🎯 Indications and Usage 52 words ▾

DIRECTIONS FOR USE For best results, follow these stepscarefully: 1.Wet hair and scalp thoroughly with lukewarm water. 2.Applya sufficient amountof shampoo to generate a rich lather. 3.Gently massage the lather into your scalp and hair. 4.Leave the lather on the scalpfor3-5minutes. 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 41 words ▾

PRECAUTIONS For externaluse only.Avoid contact witheyes. Ifcontactoccurs, rinse thoroughlywithwater.Stop use and consult a doctor if youexperience severe irritation, rash, oranysigns of an allergic reaction (e.g., swelling,dizziness, trouble breathing). Before usingthis shampoo if you have known allergiesto ketoconazole or any other ingredients.

🧪 Inactive Ingredients 34 words ▾

Aqua Sodium Laureth Sulfate Cocamide DEA Sodium Chloride Cocamidopropyl Betaine Ammonium Lauryl Sulfate Fragrance Phenoxyethanol PEG-7 Glyceryl Cocoate Bis-Aminopropyl Dimethicone Hydroxypropyl Guar Hydroxypropyltrimonium Chloride C12-13 Pareth Lactate Citric Acid C11-15 Pareth-9 Trideceth-12 Sodium Benzoate

🎯 Purpose 4 words ▾

Ketoconazole 1% w/w....Anti-dandruff shampoo

📄 Keep Out of Reach of Children 22 words ▾

STORAGE Store at room temperature away frommoisture and direct sunlight. Keep the bottle tightlyclosed. Keep out of reach of children and pets.

📄 Recent Major Changes 17 words ▾

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

📄 Package Label / Principal Display Panel 1 words ▾

1

Source: FDA Structured Product Labeling, mirrored from DailyMed / openFDA. Prefer the government’s original formatting? View this label on DailyMed ↗

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 Anti Dandruff (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

14,691 reports
Male · 49%
Female · 51%
Unknown · 0%

Serious outcomes

Hospitalization3,141
Disabling302
Life-threatening289
Reports over time (by year) — tap or hover for the count & year
2020 2022 2024 2026 1,691 0
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.

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 ✓ 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.
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 form printed on the packaging and shown on DailyMed is the one the FDA registered. Insurance claims use a fixed 11-digit 5-4-2 format, so the short segment is padded with a leading zero and the dashes are dropped. The Identity section at the top of this page lists each form of this code.
Who lists this product with the FDA?
Guangzhou Yilong Cosmetics.,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.
← 74458-0132-01 · Guangzhou 74458-0189-01 · 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.