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Flakes Anti Dandruff Hair and Scalp Serum Pyrithione Zinc .0025 kg/kg Liquid, 1 bottle — NDC 52261-1401-01 package photo

Flakes Anti Dandruff Hair and Scalp Serum Pyrithione Zinc .0025 kg/kg Liquid, 1 bottle

by Cosco International Inc · 1 BOTTLE, WITH APPLICATOR in 1 CARTON (52261-1401-1) / .055 kg in 1 BOTTLE, WITH APPLICATOR
NDC 52261-1401-01
🏷️ FDA NDC (as labeled) 52261-1401-1 billing pads the package 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) 52261-1401-1
Product NDC 52261-1401
11-digit billing NDC 52261140101
RxCUI 259548
UNII R953O2RHZ5
Application # 032
SPL Set ID 950c5615-ef32-4635-bd05-1c9a6032cc42
DEA schedule Non-controlled
Marketing category OTC MONOGRAPH DRUG
Marketing status On market
FDA listing status Listed (active directory)
Marketing start 2025-09-11
Route TOPICAL
Dosage form LIQUID
Substance PYRITHIONE ZINC
Why two NDCs? The FDA registers this code as 52261-1401-1 — 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 → 52261-1401-01. 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 Other dermatologicals class.

Drug family (ATC) Other dermatologicals
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

LabelerCosco International Inc
FDA application032 (OTC MONOGRAPH DRUG)
Labeler code52261
First marketedSep 2025
Product typeHuman Otc Drug
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?

Flakes Anti Dandruff Hair and Scalp Serum is a liquid product applied topically to the scalp. It contains pyrithione zinc, an ingredient commonly used in over-the-counter dandruff shampoos and scalp treatments. Pyrithione zinc is typically used to help reduce flaking and itching associated with dandruff. This product is marketed as an over-the-counter monograph drug, meaning it follows FDA's established rules for this category of anti-dandruff products.

Supplement & herbal interactions

🌿 Drug–supplement interaction checker →
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 5SHP745C61
    A quaternary ammonium compound used as an antistatic agent and conditioning ingredient in solid dosage forms. It reduces static electricity buildup during manufacturing and helps improve the texture and flow of powders and granules in tablets or capsules.
  • UNII 6SO6U10H04
    Biotin is a B-vitamin used as a nutritional supplement in some medications. It may also serve as a colorant or marker in formulations.
  • UNII O6380721VA
    A synthetic peptide made from biotin and amino acids. It's used as a conditioning agent in topical formulations to help improve skin texture and appearance.
  • UNII 3G6A5W338E
    Caffeine is a natural stimulant compound commonly extracted from coffee beans and tea leaves. In medicines, it serves as an active booster in pain relievers and cold products to enhance alertness and improve the effectiveness of other ingredients.
  • UNII C9H2L21V7U
    A fat derived from coconut or palm oil containing shorter fatty acid chains. It serves as a solvent and carrier to help dissolve or suspend active ingredients, improving absorption and stability in liquid formulations.
  • UNII 00YIU5438U
    Caprylyl glycol is a clear liquid derived from coconut oil. In medicines, it acts as a humectant to retain moisture, a preservative booster to prevent microbial growth, and a solvent to help dissolve or mix other ingredients.
  • UNII 2DMT128M1S
    A waxy solid derived from plant or animal sources. It acts as an emulsifier to blend oil and water components, and also thickens the medicine to give it the right texture and consistency.
  • UNII 6BJQ43T1I9
    A synthetic peptide made from copper and amino acids. It's used in topical formulations as an active conditioning or skin-support ingredient, though classified as an excipient in some product listings.
  • UNII 147D247K3P
    Ethylhexylglycerin is a synthetic preservative used to prevent bacteria and mold from growing in medicines and personal care products. It helps keep the product safe and stable throughout its shelf life.
  • UNII PDC6A3C0OX
    Glycerin is a clear, thick liquid derived from plant oils or fats. It acts as a humectant to retain moisture, a sweetener, and a solvent in medications.
  • UNII G46579QK1M
    A protein-derived ingredient made from keratin, the natural structural protein found in hair. It functions as a film-former and conditioner in topical products, helping to coat and soften the skin or hair.
  • UNII Y9H1V576FH
    Honey is a natural sweetener made by bees from flower nectar. In medicines, it adds sweetness to improve taste and may help soothe throat irritation in lozenges or syrups.
  • UNII VIF565UC2G
    Tea tree oil is an essential oil extracted from the leaves of the Australian tea tree plant. In medicines, it typically serves as a flavoring agent, fragrance, or antimicrobial component in topical formulations.
  • UNII 25X51I8RD4
    Niacinamide is a form of vitamin B3, a water-soluble nutrient. In medicines, it may be added as a nutritional supplement or to support skin health, though its primary role here is as an active ingredient rather than a traditional inactive filler.
  • UNII WV9CM0O67Z
    Panthenol is a humectant and skin-conditioning agent derived from pantothenic acid. It's added to medicines to help retain moisture and soothe skin irritation.
  • 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 A4V5C6R9FB
    Piroctone olamine is a antimicrobial compound used in medicines as a preservative or antifungal agent. It helps prevent bacterial and fungal growth in topical formulations like shampoos and skin products.
  • UNII GMR4PEN8PK
    A synthetic polymer used as a thickener and film-former in liquid formulations. It increases viscosity to improve texture and help the medicine spread or adhere evenly on the skin or mucous membranes.
  • UNII 6DC9Q167V3
    Propylene glycol is a clear liquid derived from petroleum or vegetable sources. It acts as a solvent, humectant, and preservative in medicines, helping dissolve active ingredients and maintain product stability.
  • UNII O414PZ4LPZ
    A beta hydroxy acid derived from willow bark or synthesized chemically. In topical medicines, it acts as a keratolytic agent that helps soften and shed dead skin cells, improving penetration of active ingredients.
  • UNII J7WWH9M8QS
    A plant-derived powder made from saw palmetto berries. It's included in some formulations as a natural ingredient and potential filler, though its primary role is typically as an active botanical rather than a structural excipient.
  • UNII YSE9PPT4TH
    Hyaluronate sodium is a natural carbohydrate that holds moisture. It's used in medicines as a lubricant, thickener, and moisture-retaining agent to improve texture and delivery of the active ingredient.
  • UNII B8WCK70T7I
    Trehalose is a natural sugar made from two glucose molecules linked together. It's used in medicines as a filler to add bulk, a sweetener for taste, and a stabilizer to help keep active ingredients effective during storage.
  • 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 V038D626IF
    A plant extract from Withania somnifera root, traditionally used in herbal preparations. It may function as an active botanical ingredient or filler in formulations, though its primary role depends on the specific product formulation.

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

The official label also statesWater, Glycerin, Cetostearyl Alcohol, Behentrimonium, Methosulfate, Caprylic/Capric Triglyceride, Polyquaternium-10, Biotinoyl Tripeptide-1, Copper Tripeptide-1, Piroctone Olamine, Sodium Hyaluronate, Saw Palmetto Extract, Hydroxypropyltrimonium Honey, Panthenol, Niacinamide, Hydrolyzed Keratin, Salicylic Acid, Caffeine, Ashwagandha Oil, Biotin, Tea Tree Oil, Propylene Glycol, Phenoxyethanol, Caprylyl Glycol, Ethylhexylglycerin, Trehalose

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
Flakes Anti Dandruff Hair and Scalp Serum .0025 kg/kgthis 52261-1401-01 Cosco 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

🏛️
2025
On the market since
Sep 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 NDCDescription Marketing startStatus
52261-1401-01 You're viewing this 1 BOTTLE, WITH APPLICATOR in 1 CARTON (52261-1401-1) / .055 kg in 1 BOTTLE, WITH APPLICATOR 2025-09-11 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 52261-1401-1, 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: 52261-1401-01, written without dashes as 52261140101. 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 52261-1401-01, the first segment (52261) is the labeler code FDA assigned to Cosco International Inc; the middle segment (1401) 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 Cosco International Inc. Listing status can change — the directory data on this page refreshes weekly.
Who lists this product with the FDA?
Cosco International Inc 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 29 words ▾

Uses: For the relief of dandruff and seborrheic dermatitis. Controls scalp flaking associated with dandruff. Helps reduce scalp dryness and relieve itching, irritation, and redness asscoiated with seborrheic dermatitis.

⏱️ Dosage and Administration 44 words ▾

Directions For the best results, apply to the affected areas one to four times daily or as directed by a doctor. Spread over the whole scalp, or only on areas affected by dandruff. Massage it gently. Leave it on the scalp until completely absorbed.

⚠️ Warnings 5 words ▾

Warnings: For external use only.

🧪 Active Ingredient 11 words ▾

DRUG FACTS Pyrithione Zinc – 0.25%

Active Ingredient: Pyrithione Zinc-0.25% (Anti-dandruff)

🧪 Inactive Ingredients 44 words ▾

Inactive ingredients: Water, Glycerin, Cetostearyl Alcohol, Behentrimonium, Methosulfate, Caprylic/Capric Triglyceride, Polyquaternium-10, Biotinoyl Tripeptide-1, Copper Tripeptide-1, Piroctone Olamine, Sodium Hyaluronate, Saw Palmetto Extract, Hydroxypropyltrimonium Honey, Panthenol, Niacinamide, Hydrolyzed Keratin, Salicylic Acid, Caffeine, Ashwagandha Oil, Biotin, Tea Tree Oil, Propylene Glycol, Phenoxyethanol, Caprylyl Glycol, Ethylhexylglycerin, Trehalose

🎯 Purpose 3 words ▾

Purpose: Anti dandruff

Source: FDA Structured Product Labeling, mirrored from DailyMed / openFDA. Prefer the government’s original formatting? View this label on DailyMed ↗
← 52261-1400-01 · Cosco 52261-4701-02 · Cosco →
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.