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Leader Maximum Strength Therapeutic Dandruff Salicylic Acid 3 g/100mL Shampoo — NDC 70000-0776-01 package photo
Label image from the product's FDA listing (DailyMed) — may show a different pack size or an older label revision.

Leader Maximum Strength Therapeutic Dandruff Salicylic Acid 3 g/100mL Shampoo — NDC 70000-0776-1 (Billing 70000-0776-01)

by CARDINAL HEALTH 110, LLC. DBA LEADER · 1 BOTTLE in 1 CARTON / 133 mL in 1 BOTTLE

This is a package of Leader Maximum Strength Therapeutic Dandruff Salicylic Acid 3 g/100mL Shampoo from CARDINAL HEALTH 110, LLC. DBA LEADER, marketed since Sep 2026 and currently FDA-listed. It is this product's only package size.

NDC 70000-0776-01
🏷️ FDA NDC (as labeled) 70000-0776-1 billing pads the package segment with a zero
OTC On market Non-controlled ⇄ Compare with another NDC
🗂️ FDA directory synced Oct 1, 2026 · this listing last changed Sep 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

Regulatory identifiers FDA, NLM and CMS codes for this package

FDA NDC (as labeled) 70000-0776-1
Product NDC 70000-0776
11-digit billing NDC 70000077601
RxCUI 205023
UNII O414PZ4LPZ
Application # M032
SPL Set ID 5afb2260-5b50-de95-e063-6394a90a5a47
DEA schedule Non-controlled
Marketing category OTC MONOGRAPH DRUG
Marketing status On market
FDA listing status Listed (active directory)
Marketing start 2026-09-02
Route TOPICAL
Dosage form SHAMPOO
Substance SALICYLIC ACID
Quick answers
  • RxCUI (RxNorm): 205023
Why two NDCs? The FDA registers this code as 70000-0776-1 — a 5-4-1 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 package segment → 70000-0776-01. 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 Salicylic acid and derivatives class.

Drug family (ATC) Salicylic acid and derivatives, Other antifungals for topical use, Antiinflammatory agents, non-steroids
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.

Clinical

🧪 What is this product?

Leader Maximum Strength Therapeutic Dandruff is a medicated shampoo containing 3% salicylic acid, an over-the-counter product marketed under FDA's monograph rules for dandruff shampoos. Salicylic acid is commonly used in scalp treatments to help soften and remove flaky, dead skin cells. This shampoo is applied topically to the scalp and hair during washing.

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.

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.

Packaging — all sizes for this product

Package NDCDescription Marketing startMarketing endStatus
70000-0776-01 You're viewing this Main listing 1 BOTTLE in 1 CARTON / 133 mL in 1 BOTTLE 2026-09-02 — Active

Therapeutic equivalents

ProductLabelerPackNADAC/unitTEStatusPrice vs. this
Quality Choice Therapeutic 3 g/100mL 83324-0295-45 Chain 1 bottle — — FDA listed —
Kenkoderm Psoriasis 3 g/100mL 73632-0003-01 Olympus 118 ml — — FDA listed —
Nizoral Psoriasis 3 g/100mL 55505-0202-64 Kramer 1 bottle — — FDA listed —
Quality Choice Psoriasis 3 g/100mL 85161-0342-11 Longway 1 bottle — — FDA listed —
Pert 2 in 1 Extra Strength 3 g/100mL 81277-0803-12 Sodalis 355 ml — — FDA listed —
Kenkoderm Psoriasis 3 g/100mL 85286-0003-01 Nexgel,Inc. 118 ml — — FDA listed —
TRIDERMA Psoriasis Control 3 g/100mL 10738-0980-50 Genuine 1 tube — — FDA listed —
Quality Choice Psoriasis 3 g/100mL 83324-0342-11 Chain 1 bottle — — FDA listed —
Quality Choice Therapeutic 3 g/100mL 85161-0295-45 Longway 1 bottle — — FDA listed —
Leader Maximum Strength Therapeutic Dandruff 3 g/100mLthis 70000-0776-01 CARDINAL 1 bottle — — 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

🏛️
2026
On the market since
Sep 2026
📍
2026
Currently FDA-listed
listed with the FDA
🔒
·
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.

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 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 KEH0A3F75J
    Hexylene glycol is a clear liquid alcohol used as a solvent and preservative in medicines. It helps dissolve other ingredients and keeps the product stable during storage.
  • UNII GMR4PEN8PK
    A synthetic polymer used as a thickener and film-former in liquid formulations. It increases viscosity to improve texture and help the medicine spread or adhere evenly on the skin or mucous membranes.
  • UNII H3W1D31JAR
    A synthetic polymer that acts as a thickener and film-former in liquid medications. It increases viscosity to improve texture and help the medicine coat or adhere to surfaces where applied.
  • UNII O9W3D3YF5U
    A synthetic surfactant derived from petroleum-based olefins. It helps dissolve or suspend active ingredients and other substances in liquid formulations, improving how the medicine mixes and flows.
  • UNII 1Q73Q2JULR
    Sodium citrate is a salt derived from citric acid. It works as a buffer to maintain the medicine's pH level and may also help improve taste or act as a preservative in the formulation.
  • 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.

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

The official label also statesWater, Sodium C14-16 Olefin Sulfonate, Cocamidopropyl Betaine, Hexylene Glycol, Sodium Citrate, Polyquaternium-22, Polyquaternium-10, Citric Acid

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.

Manufacturer & labeler

LabelerCARDINAL HEALTH 110, LLC. DBA LEADER
FDA applicationM032 (OTC MONOGRAPH DRUG)
Labeler code70000
First marketedSep 2026
Product typeHuman Otc Drug
Portfolio163 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.

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 📄 Ask a Doctor Before Use If 📄 When Using This Product 📄 Stop Use and Ask a Doctor If 📄 Keep Out of Reach of Children 📄 Questions or Comments 📄 Package Label / Principal Display Panel
🎯 Indications and Usage 22 words ▾

Uses helps to stop the symptoms of these conditions and their recurrence: ▪ irritation ▪ itching ▪ redness ▪ flaking ▪ scaling

⏱️ Dosage and Administration 41 words ▾

Directions ▪ wet hair, massage onto scalp, rinse and repeat if desired ▪ for best results use at least twice a week or as directed by a doctor ▪ for maximum dandruff control, use every time when you want to shampoo

⚠️ Warnings 5 words ▾

Warnings For external use only

📦 Storage and Handling 12 words ▾

Other information store away from direct sunlight, excessive heat, and freezing conditions

🧪 Active Ingredient 11 words ▾

Active Ingredient Salicylic Acid 3% Purpose Anti-dandruff, Anti-psoriasis, and Anti-seborrheic dermatitis

🧪 Inactive Ingredients 17 words ▾

Inactive ingredients Water, Sodium C14-16 Olefin Sulfonate, Cocamidopropyl Betaine, Hexylene Glycol, Sodium Citrate, Polyquaternium-22, Polyquaternium-10, Citric Acid

🎯 Purpose 6 words ▾

Purpose Anti-dandruff, Anti-psoriasis, and Anti-seborrheic dermatitis

📄 Ask a Doctor Before Use If 18 words ▾

Ask a doctor before use if you have a condition that covers a large area of the body

📄 When Using This Product 17 words ▾

When using this product avoid contact with the eyes. If contact occurs, rinse eyes thoroughly with water.

📄 Stop Use and Ask a Doctor If 20 words ▾

Stop use and ask doctor if condition worsens or does not improve after regular use of this product as directed.

📄 Keep Out of Reach of Children 21 words ▾

Keep out of the reach of children. If swallowed, get medical help or contact a Poison Control Center (1-800-222-1222) right away.

📄 Questions or Comments 20 words ▾

Questions? 866-306-9136 You may also report serious side effects to this phone number. Monday-Friday 9 AM - 5 PM EST

📄 Package Label / Principal Display Panel 1 words ▾

Shampoo

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

Medicare Part D spend CMS · PART D · 2026 (Q1)

Medicare Part D (outpatient prescription) spending for Salicylic Acid (matched by generic name) — the program that covers self-administered drugs. 2 manufacturers.
⚠️ Drug-level data: CMS publishes Part D spending by drug, not by NDC — these figures combine every manufacturer, strength and package size sold under the name Salicylic Acid. That’s a different level of aggregation than the Medicaid card above, which is specific to this exact 11-digit NDC (pack size included), so the two aren’t directly comparable.
Period
Total Part D spend
$11.2K
Claims incl. refills
43
Beneficiaries
35
Spend / beneficiary
$319.01
Spend / claim
$259.66
Trend by period
💵 About the dollar figures: spending is what Part D plans paid before confidential manufacturer rebates, so the program’s real net cost is lower. A blank patient count means fewer than 11 people — CMS hides counts that small to protect privacy. Source: CMS Medicare Quarterly Part D Spending by Drug (data.cms.gov), updated quarterly.

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 form printed on the packaging and shown on DailyMed is the one the FDA registered. Insurance claims use a fixed 11-digit 5-4-2 format, so the short segment is padded with a leading zero and the dashes are dropped. The Identity section at the top of this page lists each form of this code.
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 CARDINAL HEALTH 110, LLC. DBA LEADER. Listing status can change — the directory data on this page refreshes weekly.
Who lists this product with the FDA?
CARDINAL HEALTH 110, LLC. DBA LEADER 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.
← 70000-0775-01 · CARDINAL 70000-1543-01 · Cardinal →
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.