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Zolidyne Pyrithione Zinc 20 mg/mL Shampoo, 200 mL — NDC 51326-0203-67 package photo

Zolidyne Pyrithione Zinc 20 mg/mL Shampoo, 200 mL

by Topiderm, Inc. · 200 mL in 1 TUBE (51326-203-67)
NDC 51326-0203-67
🏷️ FDA NDC (as labeled) 51326-203-67 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) 51326-203-67
Product NDC 51326-203
11-digit billing NDC 51326020367
RxCUI 244458
UNII R953O2RHZ5
UPC 0358211203674
Application # M032
SPL Set ID 6d5eaecc-a3a1-4739-ae5b-66df4a15cd21
DEA schedule Non-controlled
Marketing category OTC MONOGRAPH DRUG
Marketing status On market
FDA listing status Listed (active directory)
Marketing start 1993-01-22
Route TOPICAL
Dosage form SHAMPOO
Substance PYRITHIONE ZINC
Why two NDCs? The FDA registers this code as 51326-203-67 — 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 → 51326-0203-67. 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

LabelerTopiderm, Inc.
FDA applicationM032 (OTC MONOGRAPH DRUG)
Labeler code51326
First marketedJan 1993
Product typeHuman Otc Drug
Portfolio46 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?

Zolidyne Pyrithione Zinc is an over-the-counter shampoo containing pyrithione zinc, a topical ingredient commonly used in hair and scalp products. Pyrithione zinc is typically used to help reduce flaking, itching, and irritation associated with dandruff and seborrheic dermatitis of the scalp. This product is marketed as an OTC monograph drug, meaning it follows established FDA rules for this category of scalp treatment products rather than undergoing individual drug approval.

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 Q7AO2R1M0B
    Ammonium lauryl sulfate is a mild detergent and foaming agent derived from plant oils. It helps mix water and oil-based ingredients together and creates a light foam in topical formulations like shampoos and cleansers.
  • 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 H3R47K3TBD
    FD&C Blue No. 1 is a synthetic blue dye approved for use in foods and medicines. It serves as a colorant to give the medication its distinctive appearance and help with product identification.
  • 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 13W7MDN21W
    A waxy compound made from glycol and stearic acid. It's used as an emulsifier to help blend oil and water-based ingredients, and as a thickener to give the medicine its desired texture and consistency.
  • UNII 3NXW29V3WO
    Hypromellose is a plant-based thickener made from cellulose. It's used in medicines as a binder to hold ingredients together, a coating for tablets, and a thickener for liquids.
  • UNII 82DUX3RRVU
    A cleansing agent derived from lauric acid and isopropanolamine. It helps remove oils and impurities in topical formulations and may act as an emulsifier to mix water and oil-based ingredients together.
  • UNII DEL7T5QRPN
    A synthetic preservative that kills bacteria and fungi. It's added to medications to prevent microbial growth and extend shelf life, especially in liquid or topical formulations.
  • UNII 229D0E1QFA
    Methylisothiazolinone is a synthetic chemical preservative that prevents bacterial and fungal growth in liquid medicines and topical products. It helps keep the medication safe and extends shelf life during storage.
  • UNII BPV390UAP0
    Sodium laureth sulfate is a mild detergent and surfactant derived from coconut oil or petroleum. It helps mix oil and water in formulations and is often used as a cleaning or foaming agent in topical products like shampoos and cleansers.
  • 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.

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

The official label also statesAmmonium Lauryl Sulfate, Citric Acid, Cocamidopropyl Betaine, Ethylene Glycol Distearate, FD&C Blue #1, Fragrance, Glycerin, Hydroxypropyl Methylcellulose, Lauramide MIPA, Methylchloroisothiazolinone, Methylisothiazolinone, Sodium Laureth Sulfate, Water.

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/mLthis 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 —
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

🏛️
1993
On the market since
Jan 1993
📍
2026
Currently FDA-listed
33 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 Zolidyne (this brand).

Top reported reactions

Death2
Dehydration2
Drug Interaction2
Headache2
Nausea2
Periproctitis2
Pyrexia2

Age at onset

Adult2
Elderly2

Reporter sex

29 reports
Male · 69%
Female · 31%

Serious outcomes

Hospitalization10
Death2
Life-threatening1
Disabling1
Reports over time (by year) — tap or hover for the count & year
2025 2026 1 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
51326-0203-67 You're viewing this 200 mL in 1 TUBE (51326-203-67) 1993-01-22 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 51326-203-67, 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: 51326-0203-67, written without dashes as 51326020367. 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 51326-0203-67, the first segment (51326) is the labeler code FDA assigned to Topiderm, Inc.; the middle segment (0203) identifies this specific product — its ingredient, strength, and dosage form; and the last segment (67) 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 Topiderm, Inc.. Listing status can change — the directory data on this page refreshes weekly.
Who lists this product with the FDA?
Topiderm, 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 19 words ▾

Uses A gentle, specially formulated shampoo for the control of flaking and itching associated with dandruff or seborrheic dermatitis.

⏱️ Dosage and Administration 31 words ▾

Directions Massage into wet scalp, lather well and rinse, leaving lather on scalp for 3-5 minutes For best results, use at least twice a week or as directed by your doctor.

⚠️ Warnings 72 words ▾

Warnings For external use only Avoid contact with eyes. If contact occurs, rinse eyes thoroughly with water If condition worsens or does not improve after regular use of this product as directed, consult a doctor If condition covers a large area of the body, consult your doctor before using this product Keep out of reach of children. In case of accidental ingestion, seek professional assistance or contact a Poison Control Center immediately.

🧪 Active Ingredient 5 words ▾

Active ingredient Zinc Pyrithione, 2%

🧪 Inactive Ingredients 27 words ▾

Inactive ingredients Ammonium Lauryl Sulfate, Citric Acid, Cocamidopropyl Betaine, Ethylene Glycol Distearate, FD&C Blue #1, Fragrance, Glycerin, Hydroxypropyl Methylcellulose, Lauramide MIPA, Methylchloroisothiazolinone, Methylisothiazolinone, Sodium Laureth Sulfate, Water.

🎯 Purpose 4 words ▾

Purpose Antidandruff, Seborrheic Dermatitis

Source: FDA Structured Product Labeling, mirrored from DailyMed / openFDA. Prefer the government’s original formatting? View this label on DailyMed ↗
← 51326-0201-01 · Topiderm, 51326-0206-01 · Topiderm, →
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.