NDC 45334-0206-07 — Vanicream Pyrithione Zinc 2 g/100mL, 7.4 mL

🆔 Identity & classification

FDA NDC (as labeled) 45334-206-07

Product NDC 45334-206

11-digit billing NDC 45334020607

RxCUI 244458

UNII R953O2RHZ5

Application # M032

SPL Set ID d124a093-f739-0666-e053-2995a90a52ed

DEA schedule Non-controlled

Marketing category OTC MONOGRAPH DRUG

Marketing status On market

FDA listing status Listed (active directory)

Marketing start 2022-01-03

Route TOPICAL

Dosage form SHAMPOO

Substance PYRITHIONE ZINC

Why two NDCs? The FDA registers this code as 45334-206-07 — 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 → 45334-0206-07. 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

LabelerPharmaceutical Specialties, Inc.

FDA applicationM032 (OTC MONOGRAPH DRUG)

Labeler code45334

First marketedJan 2022

Product typeHuman Otc Drug

Portfolio4 products on file

🔎 All NDCs from Pharmaceutical Specialties, 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?

Vanicream Pyrithione Zinc is a shampoo applied to the scalp and hair. It contains pyrithione zinc, an antimicrobial ingredient commonly used in shampoos to reduce fungal growth and control flaking and itching associated with certain scalp conditions. This product is sold over the counter as a non-prescription, standard-category shampoo and is marketed under FDA's monograph rules for over-the-counter antidandruff and similar scalp products.

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.

Loading inactive ingredients from the official FDA label in the background. No external source is being called by this page request.

Where does this data come from?

Source: official FDA Structured Product Labeling (SPL) via DailyMed and the openFDA label index. Structured IACT rows and label-wide narrative are kept separate; availability and product-level specificity depend on the submitted label.

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 g	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: 237 ml

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/100g 35324-0004-04	WynnPharm	120 g	—	—	FDA listed	—
Vanicream 2 g/100mLthis 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	—

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

Jan 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 Vanicream (this brand).

Top reported reactions

Pruritus77

Dry Skin54

Rash51

Skin Exfoliation40

Dermatitis Atopic34

Erythema31

Injection Site Pain21

Age at onset

Infant3

Child31

Adolescent23

Adult103

Elderly45

Reporter sex

Male · 40%

Female · 60%

Serious outcomes

Death7

Disabling6

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
45334-0206-07 You're viewing this	7.4 mL in 1 TUBE (45334-206-07)	2022-01-03	Active
45334-0206-08	237 mL in 1 BOTTLE, PLASTIC (45334-206-08)	2022-01-03	Active

Pack size FAQ

What quantity is in NDC 45334-0206-07?

NDC 45334-0206-07 contains 7.4 mL — 7.4 ml in 1 tube.

What is the difference between NDC 45334-0206-07 and NDC 45334-0206-08?

Both are Vanicream Pyrithione Zinc 2 g/100mL Shampoo — the drug itself is identical. NDC 45334-0206-07 is the 7.4 mL package, while NDC 45334-0206-08 is the 237 ml package.

What NDC number is used to bill for this package of Vanicream Pyrithione Zinc 2 g/100mL Shampoo?

Bill NDC 45334-0206-07 — the 11-digit billing format is 45334020607. 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)	— Not published for this NDC The labeler did not submit a structured excipient list, or no SPL is 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 45334-206-07, 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: 45334-0206-07, written without dashes as 45334020607. 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 45334-0206-07, the first segment (45334) is the labeler code FDA assigned to Pharmaceutical Specialties, Inc.; the middle segment (0206) identifies this specific product — its ingredient, strength, and dosage form; and the last segment (07) 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 Pharmaceutical Specialties, 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 1 other package presentation of this same product, including 237 ml (45334-0206-08). 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?

Pharmaceutical Specialties, 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 38 words ▾

Directions For best results use at least twice a week or as directed by a doctor Shake before use Wet hair and massage gently into scalp Leave lather on scalp for several minutes Rinse well, repeat if needed

⚠️ Warnings 80 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 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. 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 36 words ▾

Inactive ingredients water, lauryl glucoside, coco-glucoside, acrylates copolymer, panthenol, pentylene glycol, glycerin, sucrose cocoate, disodium cocoyl glutamate, sodium cocoyl glycinate, behenyl alcohol, sucrose stearate, cetyl palmitate, sodium cocoyl glutamate, 1,2-hexanediol, sodium hydroxide, caprylyl glycol, sodium chloride

🎯 Purpose 4 words ▾

Purposes Anti-dandruff, Anti-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 Pharmaceutical labeler NDCsLabeler code 45334

Vanicream Pyrithione Zinc 2 g/100mL Shampoo, 7.4 mL

🆔 Identity & classification

🏷️ RxNorm drug class

🏭 Manufacturer & labeler

🩺 Clinical

Patient education

Supplement & herbal interactions

🧪 Inactive Ingredients / Excipients

Inactive ingredient FAQ

💲 Pricing

🔁 Therapeutic equivalents

⏳ Availability & generic status

🔬 Reported adverse events (FAERS)

Top reported reactions

Age at onset

Reporter sex

Serious outcomes

📦 Packaging — all sizes for this product

Pack size FAQ

🧭 About this NDC listing & data coverage

Questions about this listing

📄 FDA label — Drug Facts FDA SPL

🔗 Related NDC lookups