NDC 71819-0001-04 — Zinc Therapy Pyrithione 2 g/100g Soap, 113 g

🆔 Identity & classification

FDA NDC (as labeled) 71819-001-04

Product NDC 71819-001

11-digit billing NDC 71819000104

RxCUI 283707

UNII R953O2RHZ5

Application # M032

SPL Set ID 6b2de5ba-ad4b-5d43-e053-2991aa0ac3b2

DEA schedule Non-controlled

Marketing category OTC MONOGRAPH DRUG

Marketing status On market

FDA listing status Listed (active directory)

Marketing start 2018-05-01

Route TOPICAL

Dosage form SOAP

Substance PYRITHIONE ZINC

Why two NDCs? The FDA registers this code as 71819-001-04 — 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 → 71819-0001-04. 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 marketedMay 2018

Product typeHuman Otc Drug

Portfolio19 products on file

🔎 All NDCs from D3 Development, 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?

This is an over-the-counter soap product containing pyrithione zinc, marketed under FDA's OTC monograph rules for topical skin cleansers. Pyrithione zinc is commonly used in cleansing products for its antimicrobial and antifungal properties. The soap is applied topically during regular washing and is typically used to help manage conditions affecting the skin and scalp where such properties may be desired.

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 A7E6112E4N
A form of vitamin E used as an antioxidant in medicines. It prevents oils and fats in the product from breaking down, helping maintain stability and 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 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 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 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 R1TQH25F4I
Sodium cocoate is a salt derived from coconut oil. It acts as an emulsifier and surfactant in medicines, helping to mix ingredients that normally don't blend together and improve product texture and stability.
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 15FIX9V2JP
Titanium dioxide is a bright white mineral powder commonly used as a colorant and opacifying agent. It makes pills and tablets white or lighter in color and helps make coatings non-transparent.
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.

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

The official label also statesInactive ingredients Sodium palmate, sodium cocoate*, sodium palm kernelate*, water, glycerin, titanium dioxide, Avena Sativa (oat) kernel flour, olive oil, vitamin E, table salt, pentasodium pentetate

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.

Try another pack size: 28 g 113 g 226 g

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
Vanicream Z-Bar 2 g/100g 45334-0392-35	Pharmaceutical	99 g	—	—	FDA listed	—
Zinc Therapy 2 g/100gthis 71819-0001-04	D3	113 g	—	—	FDA listed	—
Dermaharmony Bar Peppermint 2 g/100g 71819-0005-04	D3	113 g	—	—	FDA listed	—
Dermaharmony Face and Body 2 g/100g 71819-0008-04	D3	113 g	—	—	FDA listed	—
111MedCo Medicated Bar 2 Pyrithione Zinc 20 mg/g 72811-0002-04	111MedCo	113 g	—	—	FDA listed	—
RoyceDerm Seborrheic Dermatitis and Dandruff Medicated Cleansing Bar 4.52 g/226g 85424-0008-01	RoyceDerm	226 g	—	—	FDA listed	—
Dermaharmony Unscented Bar 2 g/100g 71819-0019-04	D3	113 g	—	—	FDA listed	—
DermaZinc 2 g/100g 35324-0004-04	WynnPharm	120 g	—	—	FDA listed	—
Dermaharmony Tea Tree Bar 2 g/100g 71819-0018-04	D3	113 g	—	—	FDA listed	—
Dermaharmony Pyrithione Zinc with Shea Butter 2 g/100g 71819-0017-37	D3	105 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

🏛️

2018

On the market since

May 2018

📍

2026

Currently FDA-listed

8 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.

📦 Packaging — all sizes for this product

Package NDC	Description	Marketing start	Status
71819-0001-01	28 g in 1 CELLO PACK (71819-001-01)	2018-05-01	Active
71819-0001-04 You're viewing this	113 g in 1 CELLO PACK (71819-001-04)	2018-05-01	Active
71819-0001-44	226 g in 1 CELLO PACK (71819-001-44)	2020-03-24	Active
71819-0001-05	113 g in 1 CARTON (71819-001-05)	2025-12-01	Active

Pack size FAQ

What quantity is in NDC 71819-0001-04?

NDC 71819-0001-04 contains 113 g — 113 g in 1 cello pack.

What is the difference between NDC 71819-0001-04 and NDC 71819-0001-01?

Both are Zinc Therapy Pyrithione 2 g/100g Soap — the drug itself is identical. NDC 71819-0001-04 is the 113 g package, while NDC 71819-0001-01 is the 28 g package.

What NDC number is used to bill for this package of Zinc Therapy Pyrithione 2 g/100g Soap?

Bill NDC 71819-0001-04 — the 11-digit billing format is 71819000104. Pharmacy and medical claims use the 11-digit form; the FDA label may print a shorter form of the same code.

🧭 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 71819-001-04, 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: 71819-0001-04, written without dashes as 71819000104. 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 71819-0001-04, the first segment (71819) is the labeler code FDA assigned to D3 Development, Inc.; the middle segment (0001) 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.

Does this product come in other package sizes?

Yes — the FDA directory lists 3 other package presentations of this same product, including 28 g (71819-0001-01), 113 g (71819-0001-05), 226 g (71819-0001-44). 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?

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 40 words ▾

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

⚠️ Warnings 5 words ▾

Warnings For external use only

📦 Storage and Handling 16 words ▾

Other information Store at room temperature Lot number and expiration date are printed on back panel.

🧪 Active Ingredient 5 words ▾

Active ingredient Pyrithione zinc 2%

🧪 Inactive Ingredients 26 words ▾

Inactive ingredients Sodium palmate, sodium cocoate*, sodium palm kernelate*, water, glycerin, titanium dioxide, Avena Sativa (oat) kernel flour, olive oil, vitamin E, table salt, pentasodium pentetate

🎯 Purpose 4 words ▾

Purpose Dandruff, Seborrheic dermatitis

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 D3 labeler NDCsLabeler code 71819