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Pyrithione Zinc 0.5 Dandruff .5 g/100mL Shampoo, 355 mL — NDC 52000-0416-12 package photo

Pyrithione Zinc 0.5 Dandruff .5 g/100mL Shampoo, 355 mL

by Universal Distribution Center LLC · 355 mL in 1 BOTTLE, PLASTIC (52000-416-12)
NDC 52000-0416-12
🏷️ FDA NDC (as labeled) 52000-416-12 billing pads the product segment with a zero
OTC Discontinued Non-controlled ⚠ Inactivated by FDA
🗂️ 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

⚠️
Excluded from the active FDA NDC Directory. FDA inactivated this product’s listing record, so it is excluded from the active NDC Directory. The listing was last certified through Dec 2026. A label may still appear on DailyMed, but the NDC is no longer in the current FDA NDC Directory. Search the FDA NDC Directory ↗

🆔 Identity & classification

FDA NDC (as labeled) 52000-416-12
Product NDC 52000-416
11-digit billing NDC 52000041612
RxCUI 1043014
UNII R953O2RHZ5
Application # M032
SPL Set ID bb8128e0-c589-4ac6-902a-322d3ab6d512
DEA schedule Non-controlled
Marketing category OTC MONOGRAPH DRUG
Marketing status Discontinued
FDA listing status Inactivated by FDA (certified through Dec 2026)
Marketing start 2024-05-17
Route TOPICAL
Dosage form SHAMPOO
Substance PYRITHIONE ZINC
Why two NDCs? The FDA registers this code as 52000-416-12 — 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 → 52000-0416-12. 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

LabelerUniversal Distribution Center LLC
FDA applicationM032 (OTC MONOGRAPH DRUG)
Labeler code52000
First marketedMay 2024
Product typeHuman Otc Drug
Portfolio92 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?

This is an over-the-counter shampoo containing pyrithione zinc, an antimicrobial ingredient typically used in dandruff and seborrheic dermatitis products. The product is applied topically to the scalp and hair. Pyrithione zinc is commonly formulated in shampoos to help reduce flaking and itching associated with these scalp conditions. This is an OTC monograph drug, meaning it is marketed under established FDA category rules rather than through individual product 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 ZY81Z83H0X
    Aloe vera leaf is a plant extract derived from the aloe plant. It is used in medicines as a natural moisturizer and skin-soothing agent in topical formulations.
  • UNII JZ1374NL9E
    A synthetic polymer made from acrylic compounds that forms a flexible coating. It's used to coat tablets and capsules to control where and how the medicine dissolves in the digestive system, or to protect the ingredient from moisture and stomach acid.
  • 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 7FLD91C86K
    Edetate disodium is a chemical compound that binds and removes certain metal ions. In medicines, it acts as a preservative and stabilizer by preventing metals like calcium from interfering with the product's shelf life and consistency.
  • 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 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 L7T10EIP3A
    A cooling compound from mint plants used as a flavoring agent and to create a fresh sensation in medicines. It helps mask bitter tastes and improve how the product feels in the mouth.
  • 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 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 368GB5141J
    A detergent and foaming agent derived from coconut or palm oil. In medications, it helps break down and mix oil and water-based ingredients, aids in tablet disintegration, and improves how the drug dissolves and spreads in the mouth or digestive system.
  • 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.

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

The official label also statesWater, Sodium Lauryl Sulfate, Cocamidopropyl Betaine, Sodium Chloride, Cocamide Mea, Acrylated Co Polymer, Glycerin, Fragrance, Citric Acid, Disodium Edta, Aloe Barbadensis Leaf Juice, Methylchloroisothiazolinone, Methylisothiazolinone, Guar Hydroxypropyltrimonium Chloride, Glycol Distearate, Menthol, Fd & C Blue No.1

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
CeraVe Anti-Dandruff Hydrating Conditioner 5 mg/mL 49967-0242-01 L'Oreal 266 ml — — FDA listed —
Pyrithione Zinc 0.5 2in1 Dandruff Conditioner .5 g/100mL 52000-0415-12 Universal 355 ml — — Discontinued —
Pyrithione Zinc 0.5 Dandruff .5 g/100mLthis 52000-0416-12 Universal 355 ml — — Discontinued —
13.5oz 2 In 1 Dandruff Hair Cleanse and Conditioner - Eucalyptus and Mint .5 g/100mL 57337-0178-01 Rejoice 400 ml — — FDA listed —
13.5oz 2 In 1 Dandruff Hair Cleanse and Conditioner - Shea and Cocoa Butter .5 g/100mL 57337-0179-01 Rejoice 400 ml — — FDA listed —
13.5oz 2 In 1 Dandruff Hair Cleanse and Conditioner - Eucalyptus and Mint .5 g/100mL 58503-0210-01 China 400 ml — — FDA listed —
13.5oz 2 In 1 Dandruff Hair Cleanse and Conditioner - Shea and Cocoa Butter .5 g/100mL 58503-0211-01 China 400 ml — — FDA listed —
Dove .5 g/100mL 64942-2447-01 Conopco 355 ml — — FDA listed —
WeCare Anti-Dandruff 5 g/1000mL 67777-0139-80 Dynarex 12 bottles — — FDA listed —
Head and Shoulders Conditioner Smooth and Silky .5 g/100mL 69423-0103-10 The 10 ml — — FDA listed —
Head and Shoulders Dry Scalp Care Hair and Scalp Conditioner .5 g/100mL 69423-0160-32 The 325 ml — — FDA listed —
Head and Shoulders Hair and Scalp Conditioner Green Apple .5 g/100mL 69423-0172-32 The 325 ml — — FDA listed —
Head and Shoulders White Charcoal Daily Hair and Scalp Conditioner .5 g/100mL 69423-0279-31 The 315 ml — — FDA listed —
Head and Shoulders Coconut Daily Hair and Scalp Conditioner .5 g/100mL 69423-0319-25 The 250 ml — — FDA listed —
Head and Shoulders Supreme Detox and Hydrate Conditioner .5 g/100mL 69423-0347-27 The 278 ml — — FDA listed —
Head and Shoulders Supreme Nourish and Smooth Conditioner .5 g/100mL 69423-0348-27 The 278 ml — — FDA listed —
Head and Shoulders Supreme Soothe and Strengthen Conditioner .5 g/100mL 69423-0349-27 The 278 ml — — FDA listed —
Head and Shoulders Supreme Color Protect Conditioner .5 g/100mL 69423-0350-27 The 278 ml — — FDA listed —
Royal Oils by head and shoulders Moisture Renewal Scalp Balancing Conditioner .5 g/100mL 69423-0571-40 The 400 ml — — FDA listed —
nioxin PRO CLINICAL SCALP RECOVERY moisturizing conditioner .5 g/100mL 82157-0012-10 Wella 1000 ml — — FDA listed —
Head and Shoulders Smooth and Silky Conditioner .5 g/100mL 84126-0234-31 The 315 ml — — FDA listed —
Mielle Lavender and Lychee Scalp Soothing Conditioner .5 g/100mL 84126-0258-35 The 355 ml — — FDA listed —
Head and Shoulders Deep Moisture Hair and Scalp Conditioner .5 g/100mL 69423-0197-31 The 315 ml — — FDA listed —
Head and Shoulders Shea Butter Hair and Scalp Conditioner .5 g/100mL 69423-0669-32 The 325 ml — — FDA listed —
Smooth And Soft Dandruff .5 g/100mL 52000-0452-12 Universal 355 ml — — FDA listed —
Everyday Clean Dandruff .5 g/100mL 76176-0131-01 NINGBO 355 ml — — FDA listed —
Smooth And Soft Dandruff .5 g/100mL 76176-0132-01 NINGBO 355 ml — — FDA listed —
TEA TREE Oil DANDRUFF .5 g/100mL 52000-0455-12 Universal 355 ml — — FDA listed —
Itchy Scalp Relief Dandruff .5 g/100mL 76176-0134-01 NINGBO 355 ml — — FDA listed —
Itchy Scalp Relief Dandruff .5 g/100mL 52000-0453-12 Universal 355 ml — — FDA listed —
Everyday Clean Dandruff .5 g/100mL 52000-0454-12 Universal 355 ml — — FDA listed —
TEA TREE Oil DANDRUFF .5 g/100mL 76176-0133-01 NINGBO 355 ml — — FDA listed —
Head and Shoulders Scalp Restore Nourishing Conditioner .5 g/100mL 84126-0906-31 The 315 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

🏛️
2024
On the market since
May 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 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 60 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
52000-0416-12 You're viewing this 355 mL in 1 BOTTLE, PLASTIC (52000-416-12) 2024-05-17 Inactivated by FDA

🧭 About this NDC listing & data coverage

Over-the-counter (OTC) product No longer marketed (per FDA listing data)
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.
What does the discontinued status mean for this NDC?
The labeler reported a marketing end date (or the listing was delisted), so this specific package is no longer actively marketed. Remaining stock may still be dispensed for a time, and the NDC stays valid for historical records and claims — but data feeds (pricing, labeling) typically stop updating for it. Other package sizes or other manufacturers' versions of the same medication may still be marketed — see the equivalents section where available.
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 52000-416-12, 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: 52000-0416-12, written without dashes as 52000041612. 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 52000-0416-12, the first segment (52000) is the labeler code FDA assigned to Universal Distribution Center LLC; the middle segment (0416) identifies this specific product — its ingredient, strength, and dosage form; and the last segment (12) identifies this exact package size and type. Together they name one specific package of one specific product.
Who lists this product with the FDA?
Universal Distribution Center LLC 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: Helps prevent recurrence of flaking and itching associated with dandruff.

⏱️ Dosage and Administration 25 words ▾

Directions: Wet hair, massage onto scalp, rinse. Repeat if desired. For best results use at least twice a week or as directed by a doctor.

⚠️ Warnings 61 words ▾

WARNINGS: For external use only. 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 of this product as directed. If swallowed, get medical help or contact a Poison Control Center right away. Keep out of reach of children.

📦 Storage and Handling 10 words ▾

Other Information: Store at 20°C to 25°C (68°F to 77°F)

🧪 Active Ingredient 6 words ▾

Active Ingredient: Pyrithione zinc 0.5% W/V

🧪 Inactive Ingredients 38 words ▾

Inactive Ingredients: Water, Sodium Lauryl Sulfate, Cocamidopropyl Betaine, Sodium Chloride, Cocamide Mea, Acrylated Co Polymer, Glycerin, Fragrance, Citric Acid, Disodium Edta, Aloe Barbadensis Leaf Juice, Methylchloroisothiazolinone, Methylisothiazolinone, Guar Hydroxypropyltrimonium Chloride, Glycol Distearate, Menthol, Fd & C Blue No.1

🎯 Purpose 2 words ▾

Purpose: Anti-dandruff

Source: FDA Structured Product Labeling, mirrored from DailyMed / openFDA. Prefer the government’s original formatting? View this label on DailyMed ↗
← 52000-0415-12 · Universal 52000-0417-12 · Universal →
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.