Home › NDC Lookup › Ingredients › Pyrithione Zinc › 71819-0018-04
🧴image loading
(from DailyMed)

Dermaharmony Tea Tree Bar Pyrithione Zinc 2 g/100g Shampoo, 113 g

by D3 Development, Inc. · 113 g in 1 CARTON (71819-018-04)
NDC 71819-0018-04
🏷️ FDA NDC (as labeled) 71819-018-04 billing pads the product 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) 71819-018-04
Product NDC 71819-018
11-digit billing NDC 71819001804
RxCUI 244458
UNII R953O2RHZ5
Application # M032
SPL Set ID e9d5eb14-1840-ae21-e053-2a95a90aa321
DEA schedule Non-controlled
Marketing category OTC MONOGRAPH DRUG
Marketing status On market
FDA listing status Listed (active directory)
Marketing start 2022-09-29
Route TOPICAL
Dosage form SHAMPOO
Substance PYRITHIONE ZINC
Why two NDCs? The FDA registers this code as 71819-018-04 — 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 → 71819-0018-04. 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

LabelerD3 Development, Inc.
FDA applicationM032 (OTC MONOGRAPH DRUG)
Labeler code71819
First marketedSep 2022
Product typeHuman Otc Drug
Portfolio19 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?

Dermaharmony Tea Tree Bar is a shampoo containing pyrithione zinc, an antimicrobial agent typically used in hair care products to help reduce dandruff and scalp irritation. This is an OTC monograph product, meaning it is marketed under FDA's established rules for over-the-counter shampoos rather than as an individually reviewed drug application. Pyrithione zinc functions as an antifungal and antibacterial ingredient commonly included in dandruff shampoos and medicated hair cleansers.

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 4V59G5UW9X
    Argan oil is a plant-derived oil from argan tree kernels. It's used in medicines as an emollient and skin-conditioning agent to help soften and moisturize the product's texture.
  • UNII LKG8494WBH
    Benzyl alcohol is a clear liquid used as a preservative and solvent in medicines. It helps prevent bacterial and fungal growth and dissolves other ingredients to create uniform liquid formulations.
  • 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 ICS790225B
    A plant-derived cleaning agent made from coconut oil and glucose. It works as a surfactant and emulsifier to help mix oil and water-based ingredients together in the formulation.
  • UNII 40U37V505D
    A fatty acid derived from coconut oil. It acts as an emulsifier to help mix water and oil-based ingredients, and may also serve as a surfactant or lubricant in tablet and capsule formulations.
  • UNII 2KAG279R6R
    Dehydroacetic acid is a synthetic preservative that prevents mold, yeast, and bacterial growth in medicines. It extends shelf life by protecting the product from spoilage during storage and use.
  • UNII 329M3829G2
    A sulfur-containing cleansing compound derived from lauric acid. It acts as a surfactant and emulsifier, helping to mix oil and water-based ingredients and improve how the medicine spreads or dissolves in the formulation.
  • UNII EX438O2MRT
    Ferric oxide yellow is a naturally occurring iron compound used as a colorant in medications. It gives tablets, capsules, and other forms a yellow or golden hue for identification and appearance.
  • UNII 8PI54V663Y
    Oatmeal is ground oat grain used as a natural filler and texture agent in medicines. It absorbs moisture, adds bulk to the formulation, and may help create a soothing base in topical products.
  • UNII YRC528SWUY
    A waxy emulsifier made from plant-derived fatty alcohols. It helps blend oil and water-based ingredients together and improves how the medicine spreads and absorbs.
  • UNII 518XTE8493
    A gentle cleanser derived from coconut oil, sodium cocoyl isethionate serves as a surfactant and foaming agent in topical products. It helps the medicine spread evenly on skin and creates lather.
  • UNII 3R36J71C17
    A salt compound derived from isethionic acid, used as a buffering agent and pH stabilizer in medications to maintain proper acidity levels and improve product stability.
  • UNII 8730J0D3EV
    A food-derived emulsifier made from lactic acid and stearic acid. It helps blend oil and water components in the medicine, improves texture, and helps keep ingredients mixed together.
  • UNII I39GGJ23HV
    A synthetic cleaning agent derived from lauric acid. It acts as a surfactant and emulsifier in medicines, helping blend oil and water-based ingredients and improve how the medicine dissolves and spreads in the body.
  • UNII J8C5W5HH18
    A synthetic surfactant and solubilizer derived from soy-based materials. It helps dissolve or suspend active ingredients in liquid formulations and may improve how the medicine spreads and is absorbed.
  • UNII 4ELV7Z65AP
    Stearic acid is a fatty acid derived from plant or animal sources. It acts as a binder and lubricant in tablets and capsules, helping them hold together and flow smoothly during manufacturing.
  • UNII 3H18P0UK73
    Sucrose cocoate is a natural emulsifier made from coconut oil and sugar. It helps blend water and oil-based ingredients together in formulations.
  • 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.

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

The official label also statesInactive ingredients Sodium cocoyl isethionate (SCI), stearic acid, coconut fatty acid, sodium isethionate, tea tree (Melaleuca Alternifolia) leaf oil, water, soyethyl morpholinium ethosulfate, coco glucoside, cetearyl alcohol & ceteareth-20, benzyl alcohol, dehydroacetic acid, oat (Avena Sativa) flour, sodium methyl 2 sulfolaurate & disodium 2-sulfolaurate, argan oil, sucrose cocoate, sodium isostearoyl lactylate, iron oxides (ochre).

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 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.
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
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/kg 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/100gthis 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 —
Dermaharmony Face and Body 2 g/100g 71819-0008-04 D3 113 g — — FDA listed —
Dermaharmony Bar Peppermint 2 g/100g 71819-0005-04 D3 113 g — — FDA listed —
Vanicream Z-Bar 2 g/100g 45334-0392-35 Pharmaceutical 99 g — — FDA listed —
Zinc Therapy 2 g/100g 71819-0001-01 D3 28 g — — 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
Sep 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.

🔬 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 Pyrithione Zinc — the ingredient across all brands.

Top reported reactions

Pruritus93
Dry Skin58
Rash58
Skin Exfoliation42
Dermatitis Atopic35
Erythema35
Headache32

Age at onset

Infant3
Child31
Adolescent24
Adult140
Elderly61

Reporter sex

582 reports
Male · 42%
Female · 58%

Serious outcomes

Hospitalization89
Disabling11
Death10
Life-threatening2
Reports over time (by year) — tap or hover for the count & year
2019 2021 2023 2026 57 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.

📦 Packaging — all sizes for this product

Package NDCDescription Marketing startStatus
71819-0018-04 You're viewing this 113 g in 1 CARTON (71819-018-04) 2022-09-29 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 — 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 "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 71819-018-04, 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: 71819-0018-04, written without dashes as 71819001804. 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 71819-0018-04, the first segment (71819) is the labeler code FDA assigned to D3 Development, Inc.; the middle segment (0018) identifies this specific product — its ingredient, strength, and dosage form; and the last segment (04) 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 D3 Development, Inc.. Listing status can change — the directory data on this page refreshes weekly.
Who lists this product with the FDA?
D3 Development, 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 📦 Storage and Handling 🧪 Active Ingredient 🧪 Inactive Ingredients 🎯 Purpose
🎯 Indications and Usage 11 words ▾

Uses Controls and reduces the symptoms of dandruff and seborrheic dermatitis.

⏱️ Dosage and Administration 51 words ▾

Directions Use on affected areas in place of your regular shampoo For best results use at least twice a week or as directed by a doctor Rub between hands to create a lather, or apply bar directly onto hair Massage into the hair and scalp for 60-90 seconds, then rinse well

⚠️ Warnings 76 words ▾

Warnings For external use only Ask a doctor before use if you have a condition that covers a large area of the body. When using this product avoid contact with eyes. If contact occurs, rinse eyes thoroughly with water. Stop use and ask a doctor if condition worsens or does not improve after regular use as directed. Keep out of reach of children. If swallowed, get medical help or contact a Poison Control Center right away.

📦 Storage and Handling 6 words ▾

Other information Store at room temperature

🧪 Active Ingredient 5 words ▾

Active ingredient Pyrithione zinc 2%

🧪 Inactive Ingredients 54 words ▾

Inactive ingredients Sodium cocoyl isethionate (SCI), stearic acid, coconut fatty acid, sodium isethionate, tea tree (Melaleuca Alternifolia) leaf oil, water, soyethyl morpholinium ethosulfate, coco glucoside, cetearyl alcohol & ceteareth-20, benzyl alcohol, dehydroacetic acid, oat (Avena Sativa) flour, sodium methyl 2 sulfolaurate & disodium 2-sulfolaurate, argan oil, sucrose cocoate, sodium isostearoyl lactylate, iron oxides (ochre).

🎯 Purpose 6 words ▾

Purpose Dandruff / seborrheic dermatitis shampoo

Source: FDA Structured Product Labeling, mirrored from DailyMed / openFDA. Prefer the government’s original formatting? View this label on DailyMed ↗
← 71819-0017-37 · D3 71819-0019-04 · D3 →
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.