NDC 35324-0004-04 — DermaZinc pyrithione zinc 2 g/100g Soap, 120 g

🆔 Identity & classification

FDA NDC (as labeled) 35324-004-04

Product NDC 35324-004

11-digit billing NDC 35324000404

RxCUI 244458, 1721127

UNII R953O2RHZ5

UPC 0638344000204

Application # M032

SPL Set ID 1a3bf938-fd9d-5544-e063-6294a90a9b64

DEA schedule Non-controlled

Marketing category OTC MONOGRAPH DRUG

Marketing status On market

FDA listing status Listed (active directory)

Marketing start 2024-03-01

Route TOPICAL

Dosage form SOAP

Substance PYRITHIONE ZINC

Why two NDCs? The FDA registers this code as 35324-004-04 — 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 → 35324-0004-04. 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

LabelerWynnPharm Inc

FDA applicationM032 (OTC MONOGRAPH DRUG)

Labeler code35324

First marketedMar 2024

Product typeHuman Otc Drug

Portfolio4 products on file

🔎 All NDCs from WynnPharm Inc

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?

DermaZinc is an over-the-counter bar soap containing pyrithione zinc, a topical antimicrobial agent. Pyrithione zinc is commonly used in cleansing products to help reduce bacteria and fungi on the skin. This soap is applied to the skin during bathing or washing. As an OTC monograph drug, it is marketed under FDA's established rules for this category of antimicrobial cleansers.

Patient education

📘 MedlinePlus patient leaflet ↗

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 5P8D0Z74RG
A finely ground grain from oats. Used as a filler and natural thickening agent to add bulk to the medicine and help it hold together in solid forms.
UNII 512OYT1CRR
Cocoa butter is a natural fat extracted from cocoa beans. It's used in medicines as a base for suppositories and as a lubricant to help pills dissolve smoothly.
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 930MLC8XGG
A plant oil extracted from grape seeds, used as an emollient and solvent in medicines. It helps dissolve active ingredients and improve the texture and absorption of topical or liquid formulations.
UNII 6UYK2W1W1E
A natural oil extracted from olives. It acts as an emollient and lubricant in formulations, helping to soften ingredients and improve how the medicine spreads or flows.
UNII 961TOZ5L7T
Pentasodium pentetate is a chelating agent, a chemical that binds and removes metal ions from solutions. In medicines, it helps prevent unwanted metal contamination and improves product stability during storage.
UNII K49155WL9Y
Shea butter is a fat extracted from shea tree nuts. It's used in medicines as an emollient and lubricant to soften the product, improve texture, and help ingredients blend smoothly together.
UNII 451W47IQ8X
Sodium chloride is common table salt. It's used in medicines as a buffer to maintain proper pH, as a filler to add bulk, or to adjust the osmotic balance in liquid formulations.
UNII 6H91L1NXTW
A processed palm kernel oil derivative used as an emulsifier and surfactant in medications. It helps mix oil and water-based ingredients together and improves how the medicine spreads and dissolves in the body.
UNII S0A6004K3Z
Sodium palmate is a salt made from palm oil. It acts as an emulsifier and surfactant in medicines, helping mix ingredients that normally don't blend well together and improving product texture and consistency.
UNII 5EHL50I4MY
A sodium salt compound used as a chelating agent in medicines. It binds to metals and minerals to improve stability, prevent discoloration, and help the medication stay effective longer.
UNII O03S90U1F2
A synthetic compound combining vitamin E with polyethylene glycol and succinic acid. It acts as a solubilizer and antioxidant in medicines, helping dissolve poorly water-soluble drugs and prevent degradation of active ingredients.
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.

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

The official label also statesSodium Palmate, Sodium Cocoate, Water, Glycerin, Avena Sativa (Oat Kernel) Flour, Sodium Chloride, Grape Seed Oil, Olea Europaea (Olive) Fruit Oil, Butyrospermum Parkii (Shea Butter), Theobroma Cacao (Cocoa) Seed Butter, Tetrasodium Glutamate Diacetate, Natural Vitamin E, Pentasodium Pentatate.

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 system	Per each	Per 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

Product	Labeler	Pack	NADAC/unit	TE	Status	Price 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/100gthis 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/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	—
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

🏛️

2024

On the market since

Mar 2024

📍

2026

Currently FDA-listed

2 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 DermaZinc (this brand).

Top reported reactions

Headache15

Psoriasis15

Arthralgia11

Arthritis11

Neck Pain11

Alopecia9

Back Pain9

Age at onset

Adult8

Elderly5

Reporter sex

Male · 49%

Female · 51%

Serious outcomes

Hospitalization18

Life-threatening1

Reports over time (by year) — tap or hover for the count & year

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 NDC	Description	Marketing start	Status
35324-0004-04 You're viewing this	120 g in 1 BOX (35324-004-04)	2024-03-01	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 35324-004-04, 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: 35324-0004-04, written without dashes as 35324000404. 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 35324-0004-04, the first segment (35324) is the labeler code FDA assigned to WynnPharm Inc; the middle segment (0004) 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 WynnPharm Inc. Listing status can change — the directory data on this page refreshes weekly.

Who lists this product with the FDA?

WynnPharm 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 12 words ▾

Controls, reduces and helps stop the symptoms of dandruff and seborrheic dermatitis.

⏱️ Dosage and Administration 40 words ▾

-Use on affected areas in place of regular soap. -For best results, use at least twice a week, or as directed by your doctor. -Work up a rich lather using warm water and massage gently into affected areas. -Rinse well.

⚠️ Warnings 92 words ▾

Warnings ■ 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 the 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 of this product as directed. If pregnant or breast-feeding, ask a health professional before use. Keep out of reach of children.

If swallowed, get medical help or contact a Poison Control Center right away. ■ For external use only.

🧪 Active Ingredient 3 words ▾

Pyrithione Zinc 2%

🧪 Inactive Ingredients 38 words ▾

Sodium Palmate, Sodium Cocoate, Water, Glycerin, Avena Sativa (Oat Kernel) Flour, Sodium Chloride, Grape Seed Oil, Olea Europaea (Olive) Fruit Oil, Butyrospermum Parkii (Shea Butter), Theobroma Cacao (Cocoa) Seed Butter, Tetrasodium Glutamate Diacetate, Natural Vitamin E, Pentasodium Pentatate.

🎯 Purpose 4 words ▾

Dandruff, Seborrheic Dermatitis treatment

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

🔗 Related NDC lookups

🧪 All Pyrithione Zinc NDCsSame ingredient 🏭 All WynnPharm labeler NDCsLabeler code 35324