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Flakes Cedar Mint Anti Dandruff Pyrithione Zinc .02 kg/kg Lotion/Shampoo, 266 kg — NDC 52261-1400-01 package photo
Label image from the product's FDA listing (DailyMed) — may show a different pack size or an older label revision.

Flakes Cedar Mint Anti Dandruff Pyrithione Zinc .02 kg/kg Lotion/Shampoo, 266 kg — NDC 52261-1400-1 (Billing 52261-1400-01)

by Cosco International, Inc. · .266 kg in 1 BOTTLE, PLASTIC

This is a package of 266 kg of Flakes Cedar Mint Anti Dandruff Pyrithione Zinc .02 kg/kg Lotion/Shampoo from Cosco International, Inc., marketed since Dec 2022 and currently FDA-listed. It is the main listing for this product, which comes in 2 package sizes.

NDC 52261-1400-01
🏷️ FDA NDC (as labeled) 52261-1400-1 billing pads the package segment with a zero
This package
Contains266 kg Pack sizes2 compare ↓
Main listing for product 52261-1400 · Also comes in: 085 kg 52261-1400-2
OTC On market Non-controlled ⇄ 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 52261-1400-1 alone.

Record
FDA NDC Directory package listing · Human OTC drug
Code segments
52261 labeler · 1400 product · 1 package
Package marketed since
Dec 1, 2022
Sample package
No — commercial package
Listing certified through
Dec 31, 2027
Barcode (UPC-A, from the NDC)
3 5226114001 9
FDA record last changed
Jul 24, 2026

Identity & classification

Regulatory identifiers FDA, NLM and CMS codes for this package

FDA NDC (as labeled) 52261-1400-1
Product NDC 52261-1400
11-digit billing NDC 52261140001
RxCUI 244458
UNII R953O2RHZ5
Application # M032
SPL Set ID 8575e7a0-4290-40a0-949c-317951b440b8
DEA schedule Non-controlled
Marketing category OTC MONOGRAPH DRUG
Marketing status On market
FDA listing status Listed (active directory)
Marketing start 2022-12-01
Route TOPICAL
Dosage form LOTION/SHAMPOO
Substance PYRITHIONE ZINC
Quick answers
  • RxCUI (RxNorm): 244458
Why two NDCs? The FDA registers this code as 52261-1400-1 — 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 → 52261-1400-01. 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.

Clinical

🧪 What is this product?

Flakes Cedar Mint Anti Dandruff is a topical lotion/shampoo containing pyrithione zinc, an over-the-counter monograph product. Pyrithione zinc is commonly used in dandruff shampoos and anti-itch scalp products to help reduce flaking and irritation associated with dandruff and seborrheic dermatitis. This product combines the active ingredient with cedar mint scent in a lotion/shampoo formulation intended for scalp application.

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.

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 gPer 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: 085 kg
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
52261-1400-01 You're viewing this Main listing .266 kg in 1 BOTTLE, PLASTIC 2022-12-01 — Active
52261-1400-02 52261-1400-2 .085 kg in 1 BOTTLE, PLASTIC 2024-05-21 — Active

Pack size FAQ

What quantity is in this package?
This package contains 266 kg — .266 kg in 1 bottle, plastic.
How does this package differ from NDC 52261-1400-02?
Both are Flakes Cedar Mint Anti Dandruff Pyrithione Zinc .02 kg/kg Lotion/Shampoo — the drug itself is identical. This page's package is the 266 kg one, while NDC 52261-1400-02 is the 085 kg package.
What NDC number is used to bill for this package of Flakes Cedar Mint Anti Dandruff Pyrithione Zinc .02 kg/kg Lotion/Shampoo?
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
Dhs Zinc 20 mg/mL 00096-0735-08 Person 240 ml — — Discontinued —
Dhs Zinc 20 mg/mL 00096-0811-08 Person 240 ml — — FDA listed —
DermaZinc 2 g/100mL 35324-0003-08 WynnPharm 240 ml — — FDA listed —
DermaZinc 2 g/100g 35324-0004-04 WynnPharm 120 g — — FDA listed —
Vanicream 2 g/100mL 45334-0206-07 Pharmaceutical 7.4 ml — — FDA listed —
Zolidyne 20 mg/mL 51326-0203-67 Topiderm, 200 ml — — FDA listed —
Flakes Cedar Mint Anti Dandruff .02 kg/kgthis 52261-1400-01 Cosco 266 kg — — FDA listed —
Denorex Severe Flakes Medicated Anti Dandruff .02 g/mL 62673-0176-10 Neoteric 1 bottle — — FDA listed —
Divine Dandrene 2% 2 g/100mL 69188-0200-07 DS 205 ml — — FDA listed —
Dermaharmony Pyrithione Zinc with Shea Butter 2 g/100g 71819-0017-37 D3 105 g — — FDA listed —
Dermaharmony Tea Tree Bar 2 g/100g 71819-0018-04 D3 113 g — — FDA listed —
Dermaharmony Unscented Bar 2 g/100g 71819-0019-04 D3 113 g — — FDA listed —
Dzul Anti-Dandruff Conditioner 2 g/100mL 83037-0002-08 Caball 236 ml — — FDA listed —
Dandrx Anti-Dandruff 2 g/100mL 85521-0002-08 dandRX 237 ml — — FDA listed —
Happy Head Anti-Dandruff 20 mg/mL 87117-0970-00 Happy 177 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

🏛️
2022
On the market since
Dec 2022
📍
2026
Currently FDA-listed
4 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.

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 Q7UI015FF9
    A synthetic polymer material used as a thickener and stabilizer in liquid formulations. It helps create the right texture and prevents separation of ingredients in medicines and topical products.
  • 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 2968PHW8QP
    A weak organic acid derived from citrus fruits or made through fermentation. It works as a buffer to control pH, a preservative to extend shelf life, and a flavoring agent in medications.
  • UNII 5OCF3O11KX
    A plant-derived surfactant made from coconut oil. It helps mix oil and water ingredients together in the formulation and can improve how the medicine spreads or feels on the skin.
  • UNII C80684146D
    A foaming agent and thickener derived from coconut oil. It helps create a smooth texture and stable foam in liquid or semi-solid medicines, improving how the product feels and applies.
  • 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 B16G315W7A
    A plant-derived thickener made from guar gum that has been chemically modified to carry a positive charge. It's used in medicines as a thickening agent and to help keep ingredients evenly mixed throughout the product.
  • UNII 1530WMS90S
    A thickening agent derived from guar gum, a natural polysaccharide from guar bean seeds. It increases viscosity in liquid formulations to improve texture, stability, and how the medicine flows or coats.
  • UNII 6QOP5A9489
    A synthetic organic compound used as a solvent and penetration enhancer in topical formulations. It helps dissolve active ingredients and improve their absorption through the skin.
  • UNII AV092KU4JH
    A natural oil extracted from peppermint plants. It's used as a flavoring agent to mask bitter tastes and add a refreshing mint flavor to medicines, making them easier to take.
  • 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 O9W3D3YF5U
    A synthetic surfactant derived from petroleum-based olefins. It helps dissolve or suspend active ingredients and other substances in liquid formulations, improving how the medicine mixes and flows.
  • 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 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.

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

The official label also statesInactive Ingredients: WATER, SODIUM C14-16 OLEFIN SULFONATE, COCAMIDOPROPYL BETAINE, COCO MONOETHANOLAMIDE, FRAGRANCE, GLYCERIN, PHENOXYETHANOL, PEPPERMINT OIL, HYDROXYPROPYL GUAR, HYDROXYPROPYL TRIMONIUM CHLORIDE, CAPRYLYL GLYCOL, POLYACRYLATE CROSSPOLYMER-6, METHYL DIISOPROPYL PROPIONAMIDE, TEA TREE OIL, CITRIC ACID

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

LabelerCosco International, Inc.
FDA applicationM032 (OTC MONOGRAPH DRUG)
Labeler code52261
First marketedDec 2022
Product typeHuman Otc Drug
Portfolio25 products on file

More NDCs from Cosco International, Inc. labeler code 52261

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 📦 Storage and Handling 🧪 Active Ingredient 🧪 Inactive Ingredients 🎯 Purpose 📄 When Using This Product 📄 Keep Out of Reach of Children 📄 Questions or Comments 📄 Package Label / Principal Display Panel
🎯 Indications and Usage 21 words ▾

Stop use and ask a doctor if condition worsens or does not improve after regular use of this product as directed.

⏱️ Dosage and Administration 40 words ▾

Directions: for best results, use at least twice a week 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 5 words ▾

Warnings for external use only

📦 Storage and Handling 15 words ▾

Other Information Store at room temperature between 68-77°F (20-25°C). Do not expose to excessive heat

🧪 Active Ingredient 9 words ▾

DRUG FACTS Active Ingredients: Purpose: Pyrithione Zinc 2%..................Anti dandruff

🧪 Inactive Ingredients 33 words ▾

Inactive Ingredients: WATER, SODIUM C14-16 OLEFIN SULFONATE, COCAMIDOPROPYL BETAINE, COCO MONOETHANOLAMIDE, FRAGRANCE, GLYCERIN, PHENOXYETHANOL, PEPPERMINT OIL, HYDROXYPROPYL GUAR, HYDROXYPROPYL TRIMONIUM CHLORIDE, CAPRYLYL GLYCOL, POLYACRYLATE CROSSPOLYMER-6, METHYL DIISOPROPYL PROPIONAMIDE, TEA TREE OIL, CITRIC ACID

🎯 Purpose 13 words ▾

Use: For the control of the symptoms of dandruff and or seborrheic dermatitis

📄 When Using This Product 16 words ▾

When using this product avoid contact with eyes. If contact occurs, rinse eyes thoroughly with water.

📄 Keep Out of Reach of Children 18 words ▾

Keep out of reach of children. If swallowed, get medical help or contact a Poison Control Center immediately.

📄 Questions or Comments 2 words ▾

Questions? [email protected]

📄 Package Label / Principal Display Panel 4 words ▾

266ml label

85ml label

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

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 Flakes Cedar Mint Anti Dandruff (this brand).

Top reported reactions

Death2
Dehydration2
Drug Interaction2
Headache2
Nausea2
Periproctitis2
Pyrexia2

Age at onset

Adult2
Elderly2

Reporter sex

0 reports
Male · 69%
Female · 31%

Serious outcomes

Death2
Life-threatening1
Disabling1
Reports over time (by year) — tap or hover for the count & year
2020 2022 2024 2026 7 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
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 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 Cosco International, Inc.. 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 1 other package presentation of this same product, including 085 kg (52261-1400-02). 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?
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.
← 52261-1130-01 · Cosco 52261-1401-01 · 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.