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Gembooxt Ketoconazole 1% Medicated Shampoos .01 g/mL Liquid, 450 mL — NDC 76986-0025-02 package photo
Label image from the product's FDA listing (DailyMed) — may show a different pack size or an older label revision.

Gembooxt Ketoconazole 1% Medicated Shampoos .01 g/mL Liquid, 450 mL — NDC 76986-025-02 (Billing 76986-0025-02)

by Guangdong Quadrant Ecological Technology Co., Ltd. · 450 mL in 1 BOTTLE

This is a package of 450 mL of Gembooxt Ketoconazole 1% Medicated Shampoos .01 g/mL Liquid from Guangdong Quadrant Ecological Technology Co., Ltd., marketed since Jan 2026 and currently FDA-listed.

NDC 76986-0025-02
🏷️ FDA NDC (as labeled) 76986-025-02 billing pads the product segment with a zero
This package
Contains450 mL Pack sizes3 compare ↓
Product page 76986-0025-01 Also comes in: 300 ml 76986-025-01 750 ml 76986-025-03
OTC On market Non-controlled ⇄ Compare with another NDC
🗂️ FDA directory synced Oct 1, 2026 · this listing last changed Sep 10, 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 76986-025-02 alone.

Record
FDA NDC Directory package listing · Human OTC drug
Code segments
76986 labeler · 025 product · 02 package
Package marketed since
Jan 30, 2026
Sample package
No — commercial package
Listing certified through
Dec 31, 2027
Barcode (UPC)
6977863764704
FDA record last changed
Sep 10, 2026

Identity & classification

Regulatory identifiers FDA, NLM and CMS codes for this package

FDA NDC (as labeled) 76986-025-02
Product NDC 76986-025
11-digit billing NDC 76986002502
RxCUI 240812
UNII R9400W927I
UPC 6977863764704
Application # 505G(a)(3)
SPL Set ID 49965e91-43c3-65d7-e063-6294a90abaec
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 2026-01-30
Route TOPICAL
Dosage form LIQUID
Substance KETOCONAZOLE
Quick answers
  • RxCUI (RxNorm): 240812
Why two NDCs? The FDA registers this code as 76986-025-02 — 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 → 76986-0025-02. 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.

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.
Try another pack size: 300 ml 750 ml
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
76986-0025-01 76986-025-01 Main listing 300 mL in 1 BOTTLE 2026-01-30 — Active
76986-0025-02 You're viewing this 450 mL in 1 BOTTLE 2026-01-30 — Active
76986-0025-03 76986-025-03 750 mL in 1 BOTTLE 2026-01-30 — Active

You're viewing one of 3 pack sizes for this product.

Pack size FAQ

What quantity is in this package?
This package contains 450 mL — 450 ml in 1 bottle.
How does this package differ from NDC 76986-0025-01?
Both are Gembooxt Ketoconazole 1% Medicated Shampoos .01 g/mL Liquid — the drug itself is identical. This page's package is the 450 mL one, while NDC 76986-0025-01 is the 300 ml package.
What NDC number is used to bill for this package of Gembooxt Ketoconazole 1% Medicated Shampoos .01 g/mL Liquid?
Use the 11-digit billing form listed in the identifiers section of this page. Pharmacy and medical claims use the 11-digit form; the FDA label may print a shorter form of the same code.

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/mLthis 76986-0025-02 Guangdong 450 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/100mL 85593-0033-01 Guangzhou 200 ml — — FDA listed —
Cysndra Ketoconazole 1% Medicated Shampoos .01 g/mL 87681-0014-01 Guangzhou 1 bottle — — FDA listed —
Gemachlich ZuHause Ketoconazole 1% Anti-dandruff Shampoos .01 g/mL 87681-0009-01 Guangzhou 1 bottle — — 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
Jan 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.

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.

Manufacturer & labeler

LabelerGuangdong Quadrant Ecological Technology Co., Ltd.
FDA application505G(a)(3) (OTC MONOGRAPH DRUG)
Labeler code76986
First marketedJan 2026
Product typeHuman Otc Drug
Portfolio35 products on file

More NDCs from Guangdong Quadrant Ecological Technology Co., Lt... labeler code 76986

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 🧪 Active Ingredient 🧪 Inactive Ingredients 🎯 Purpose 📄 Do Not Use 📄 When Using This Product 📄 Stop Use and Ask a Doctor If 📄 Keep Out of Reach of Children 📄 Package Label / Principal Display Panel
🎯 Indications and Usage 8 words ▾

Controls flaking, scaling and itching associated with dandruff

⏱️ Dosage and Administration 50 words ▾

For adults and children 12 years and older: 1. Wet hair thoroughly. 2. Apply shampoo, generously lather, rinse thoroughly. Repeat. 3. 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: Ask a doctor.

⚠️ Warnings 4 words ▾

For external use only.

🧪 Active Ingredient 2 words ▾

Ketoconazole 1%

🧪 Inactive Ingredients 36 words ▾

WATER SODIUM LAUROYL SARCOSINATE COCAMIDOPROPYL BETAINE WATER PARFUM GLYCERYL CAPRYLATE GLYCERYL LAURATE PHENOXYETHANOL WATER LAURYL LACTATE CITRIC ACID POLYQUATERNIUM-10 DISODIUM EDTA HYDROLYZED RHODOPHYCEAE EXTRACT BUTYLENE GLYCOL 1,2-HEXANEDIOL PENTYLENE GLYCOL PROPANEDIOL CAPRYLHYDROXAMIC ACID ETHYLHEXYLGLYCERIN BIOTIN POTASSIUM HYDROXIDE

🎯 Purpose 2 words ▾

Anti-dandruff shampoo

📄 Do Not Use 16 words ▾

on scalp that is broken or inflamed. if you are allergic to ingredients in this product.

📄 When Using This Product 24 words ▾

When using this products. Avoid contact with eyes. lf contact occurs, rinse thoroughly with water. If pregnant or breast-feeding, ask a doctor before use.

📄 Stop Use and Ask a Doctor If 11 words ▾

rash appears. condition worsens or does not improve in 2-4 weeks.

📄 Keep Out of Reach of Children 19 words ▾

Keep out of reach of children. lf swallowed, get medical help or contact a Poison Control Center right away.

📄 Package Label / Principal Display Panel 2 words ▾

label label2

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.

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) — 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.
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.
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 Guangdong Quadrant Ecological Technology Co., Ltd.. Listing status can change — the directory data on this page refreshes weekly.
Does this product come in other package sizes?
Yes — the FDA directory lists 2 other package presentations of this same product, including 300 ml (76986-0025-01), 750 ml (76986-0025-03). Each has its own NDC and its own page — see the package list near the top of this page.
Who lists this product with the FDA?
Guangdong Quadrant Ecological Technology 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.
← 76986-0024-01 · Guangdong 76986-0026-01 · Guangdong →
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.