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MINOXIDIL FOR MEN 50 mg/g Aerosol, Foam — NDC 70000-0754-01 package photo

MINOXIDIL FOR MEN 50 mg/g Aerosol, Foam

by CARDINAL HEALTH 110, LLC. DBA LEADER · 3 CAN in 1 CARTON (70000-0754-1) / 60 g in 1 CAN
NDC 70000-0754-01
🏷️ FDA NDC (as labeled) 70000-0754-1 billing pads the package segment with a zero
OTC Generic 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) 70000-0754-1
Product NDC 70000-0754
11-digit billing NDC 70000075401
RxCUI 645146
UNII 5965120SH1
Application # ANDA218616
SPL Set ID a592317d-bc7c-4c69-a3bf-74d57cd36e3a
Established class (EPC) Arteriolar Vasodilator
Physiologic effect Arteriolar Vasodilation
DEA schedule Non-controlled
Marketing category ANDA
Marketing status On market
FDA listing status Listed (active directory)
Marketing start 2026-03-16
Route TOPICAL
Dosage form AEROSOL, FOAM
Substance MINOXIDIL
Why two NDCs? The FDA registers this code as 70000-0754-1 — 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 → 70000-0754-01. 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 Arteriolar Vasodilator class.

Pharmacologic class Arteriolar Vasodilator
Drug family (ATC) Pyrimidine derivatives, 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

LabelerCARDINAL HEALTH 110, LLC. DBA LEADER
Application holderAUROBINDO PHARMA LTD
FDA applicationANDA218616 (ANDA)
Labeler code70000
First marketedMar 2026
Product typeHuman Otc Drug
Portfolio162 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 it is MedlinePlus · NLM

Minoxidil is used with other medications to treat high blood pressure. It is in a class of medications called vasodilators. It works by relaxing the blood vessels so that blood can flow more easily through the body. High blood pressure is a common condition and when not treated, can cause damage to the brain, heart, blood vessels, kidneys and other parts of the body. Damage to these organs may cause heart disease, a heart attack, heart failure, stroke, kidney failure, loss of vision, and other problems. In addition to taking medication, making lifestyle changes will also help to control your b...

Read the full MedlinePlus article ↗
📗 Our plain-language guide HelloPharmacist
  • That's a really common question. Minoxidil tablets are very effective at lowering blood pressure, but they cause two side effects that need to be managed: your heart speeds up, and...
  • I've been prescribed minoxidil tablets for blood pressure — why do I need to take other pills with it?
  • It takes patience — most people need at least 2 to 4 months of twice-daily use before they notice any regrowth. Some products note that results can start appearing around the 2-mon...
  • I'm using a topical minoxidil solution for hair loss. How long before I see results?
📖 Read our full Minoxidil guide →
1
Nutrient depletion considerations

Minoxidil may be associated with lower levels of 1 nutrient — worth a chat with your pharmacist, not a cause for alarm.

🧪 Full Minoxidil nutrient depletion report →
An association is not a deficiency. Educational only — don't start or stop anything without professional guidance.
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 3K9958V90M
    A liquid solvent derived from fermentation or chemical synthesis. In medicines, alcohol dissolves active ingredients, helps preserve the product, and improves how the body absorbs certain drugs.
  • UNII XF417D3PSL
    Anhydrous citric acid is a sour, crystalline powder derived from citric acid with water removed. In medicines, it acts as a buffer to control pH, adds tartness to improve taste, and helps tablets disintegrate.
  • UNII 6LV4FOR43R
    Butane is a colorless gas derived from petroleum. In medicines, it serves as a propellant in inhalers and aerosol sprays, helping deliver the active drug to the lungs or skin.
  • UNII 1P9D0Z171K
    BHT is a synthetic antioxidant that prevents fats and oils in medicines from breaking down and becoming rancid. It helps keep the product stable and effective during storage.
  • UNII 936JST6JCN
    Cetyl alcohol is a waxy, fatty substance derived from plant or animal sources. It acts as an emulsifier and thickener in medicines, helping blend oil and water components and giving products a smooth, creamy texture.
  • 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 BXR49TP611
    Isobutane is a liquefied gas used as a propellant in aerosol inhalers and sprays. It helps push the medicine out of the container so you can breathe or spray it as directed.
  • UNII 33X04XA5AT
    Lactic acid is a naturally occurring organic acid derived from milk or plant sources. It lowers and maintains pH in formulations, helps preserve the product, and can enhance ingredient stability and absorption.
  • UNII CAL22UVI4M
    A synthetic emulsifier derived from sorbitol and fatty acids. It helps mix oil and water-based ingredients together and improves the texture and stability of the medicine.
  • UNII T75W9911L6
    A flammable gas used as a propellant in aerosol formulations. It helps dispense the medicine as a fine mist or spray when you activate the inhaler or pump.
  • UNII 2KR89I4H1Y
    Stearyl alcohol is a waxy, fatty substance derived from natural oils or made synthetically. It acts as an emulsifier and thickener in medicines, helping mix ingredients together and give the product the right texture.
  • 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 statesAlcohol, anhydrous citric acid, butane, butylated hydroxy toluene, cetyl alcohol, glycerin, isobutane, lactic acid, polysorbate 60, propane, purified water, stearyl alcohol Questions? Call toll-free 1-855-274-4122 (Monday – Friday 8:30 AM to 5:00 PM EST) *This product is not manufactured or distributed by Johnson & Johnson Consumer Inc., distributor of Men’s Rogaine ®. Cardinal Health™ DISTRIBUTED BY CARDINAL HEALTH DUBLIN, OHIO 43017 www.myleader.com      1-800-200-6313 Essential to Care™ since 1979 Made in India Code: TS/DRUGS/58039/2020 CIN 6103964      REV. 02/26

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
Minoxidil 5% (For Men) 50 mg/g 51672-2128-04 Sun 1 can $0.300 — Availability likely —
Minoxidil For Women 50 mg/g 51672-2129-04 Sun 1 can $0.300 — Availability likely —
good sense hair regrowth treatment 5 g/100g 00113-0294-06 L. 6 cans — — Discontinued —
Good Sense Hair Regrowth Treatment 50 mg/g 00113-1129-06 L. 6 cans — — FDA listed —
minoxidil 50 mg/g 00113-5129-01 L. 60 g — — FDA listed —
Good Sense Hair Regrowth Treatment 5 g/100g 00113-7080-01 L. 3 cans — — FDA listed —
Minoxidil (For Men) 50 mg/g 00363-9090-01 Walgreen 1 can — — FDA listed —
Minoxidil (For Women) 50 mg/g 00363-9091-01 Walgreen 1 can — — FDA listed —
Minoxidil (For Men) 50 mg/g 11673-0157-03 TARGET 3 cans — — FDA listed —
Minoxidil (For Women) 50 mg/g 11673-0158-04 TARGET 1 can — — FDA listed —
Signature Care Hair Regrowth Treatment for men 5 g/100g 21130-0750-01 Safeway 60 g — — Discontinued —
hair regrowth treatment for men 5 g/100g 30142-0294-01 Kroger 1 can — — Discontinued —
hair regrowth treatment 50 mg/g 30142-0719-02 Kroger 2 cans — — Discontinued —
hair regrowth treatment 5 g/100g 41250-0294-01 Meijer 1 can — — FDA listed —
hair regrowth treatment 50 mg/g 41250-0749-01 Meijer 1 can — — FDA listed —
equate hair regrowth treatment 5 g/100g 49035-0294-01 Wal-Mart 1 can — — FDA listed —
equate hair regrowth treatment 50 mg/g 49035-0905-01 Wal-Mart 1 can — — FDA listed —
Minoxidil (For Men) 50 mg/g 51316-0212-01 CVS 1 can — — Discontinued —
Minoxidil (For Women) 50 mg/g 51316-0213-01 CVS 1 can — — Discontinued —
Regoxidine (For Men) 50 mg/g 57483-0165-11 INNOVUS 1 can — — FDA listed —
Regoxidine (For Women) 50 mg/g 57483-0175-11 INNOVUS 1 can — — FDA listed —
Regoxidine (For Men) 50 mg/g 57483-0530-31 Innovus 3 cans — — FDA listed —
Regoxidine (For Women) 50 mg/g 57483-0540-31 Innovus 2 cans — — FDA listed —
Minoxidil 5% (For Women) 50 mg/g 58602-0607-01 Aurohealth 1 can — — FDA listed —
Minoxidil 5% (For Men) 50 mg/g 58602-0608-01 Aurohealth 1 can — — FDA listed —
Minoxidil 5% (For Men) 50 mg/g 59450-0210-01 Kroger 1 can — — FDA listed —
Minoxidil (For Women) 50 mg/g 59450-0211-02 Kroger 2 cans — — FDA listed —
Minoxidil 50 mg/g 59726-0115-60 P 60 g — — FDA listed —
Minoxidil 50 mg/g 59726-0116-60 P 60 g — — FDA listed —
Minoxidil 50 mg/g 59726-0122-60 P 1 can — — FDA listed —
Minoxidil 50 mg/mL 59726-0125-60 P 1 can — — FDA listed —
Minoxidil 50 mg/g 59726-0151-60 P 1 can — — FDA listed —
hair regrowth treatment for men 5 g/100g 59779-0294-01 CVS 1 can — — Discontinued —
kirkland signature Minoxidil 5 g/100g 63981-0294-06 Costco 6 cans — — FDA listed —
members mark hair regrowth treatment 5 g/100g 68196-0469-04 Sam's 4 cans — — FDA listed —
berkley and jensen minoxidil 5 g/100g 68391-0294-04 BJWC 4 cans — — FDA listed —
Minoxidil (for Men) 50 mg/g 69113-0128-01 SCIENTIFIC 1 can — — FDA listed —
Minoxidil (for Women) 50 mg/g 69113-0129-01 SCIENTIFIC 1 can — — FDA listed —
Minoxidil For Men 50 mg/g 69113-0501-01 BosleyMD 1 can — — FDA listed —
Minoxidil For Women 50 mg/g 69113-0502-01 BosleyMD 1 can — — FDA listed —
hair regrowth treatment 50 mg/g 69842-0599-01 CVS 1 can — — Discontinued —
Womens Rogaine Unscented 50 mg/g 69968-0030-01 Kenvue 1 can — — FDA listed —
Mens rogaine Minoxidil Unscented Formula 50 mg/g 69968-0031-01 Kenvue 1 can — — FDA listed —
Minoxidil For Women 50 mg/g 70000-0753-01 CARDINAL 1 can — — FDA listed —
Minoxidil For Men 50 mg/gthis 70000-0754-01 CARDINAL 3 cans — — FDA listed —
Minoxidil 50 mg/g 70550-0116-02 Keranique 1 can — — FDA listed —
Minoxidil 5 Percent (For Women) 50 mg/g 70550-0605-04 PROFECTUS 1 can — — FDA listed —
Minoxidil 5% (For Men) 50 mg/g 71713-0091-30 Thirty 3 cans — — FDA listed —
keeps minoxidil topical 5 g/100g 71713-0092-30 THIRTY 3 cans — — FDA listed —
Keeps Minoxidil Topical 5 g/100g 71713-0123-03 THIRTY 3 cans — — FDA listed —
hers hair regrowth treatment 50 mg/g 71730-0129-01 Hims 1 can — — FDA listed —
hims hair regrowth treatment 5 g/100g 71730-0294-01 Hims 1 can — — FDA listed —
hims hair regrowth treatment 5 g/100g 71730-0700-01 Hims 1 can — — FDA listed —
hers hair regrowth treatment 5 g/100g 71730-0813-01 Hims 1 can — — FDA listed —
basic care hair regrowth treatment 50 mg/g 72288-0129-01 Amazon.com 1 can — — FDA listed —
Basic Care Hair Regrowth Treatment 5 g/100g 72288-0294-03 Amazon.com 3 cans — — FDA listed —
Gemachlich ZuHause Hair Growth Foam (Men) 5 g/100mL 76986-0008-01 Guangdong 60 ml — — FDA listed —
Minoxidil (for Women) 50 mg/g 80855-0201-05 Virtue 1 can — — FDA listed —
Hairfx Hair Growth Foam 5 g/100g 81653-0003-01 Guangzhou 60 g — — FDA listed —
Hair regrowth treatment 5 g/100mL 81653-0005-01 Guangzhou 3 bottles — — FDA listed —
Regenivade Hair Growth Foam 5 mg/mL 81653-0007-01 Guangzhou 1 bottle — — FDA listed —
Minoxidil (For Men) 50 mg/g 82376-6006-03 SPAZI 3 cans — — FDA listed —
Minoxidil (For Women) 50 mg/g 82376-6007-02 SPAZI 2 cans — — FDA listed —
Minoxidil (for Men) 50 mg/g 82796-0100-01 RESTORATION 60 g — — FDA listed —
Hair Growth Foam 5 g/100mL 83804-0008-01 Shenzhen 60 ml — — FDA listed —
5% Minoxidil Hair Regrowth Foam 5 g/100g 84148-0025-01 Guangzhou 60 g — — FDA listed —
Hair Regen - Hair Regrowth Treatment 5 g/100g 84232-0012-21 Yiwu 1 bottle — — FDA listed —
Hair Regen - Hair Regrowth Treatment 5 g/100g 84232-0014-26 Yiwu 6 bottles — — FDA listed —
Hair Regen - Hair Regrowth Treatment 5 g/100g 84232-0016-21 Yiwu 1 bottle — — FDA listed —
Hair Regen - Hair Regrowth Treatment 5 g/100g 84232-0018-26 Yiwu 6 bottles — — FDA listed —
Minoxidil 50 mg/g 84382-0001-04 Clarity 1 can — — FDA listed —
Hair Beardgrowth Foam 5 g/100mL 85173-0001-01 Shenzhen 60 ml — — FDA listed —
Minoxidil (For Men) 5 g/100g 85524-2611-02 FlexiGo 3 bottles — — FDA listed —
Minoxidil (For Men) 5 g/100g 85524-2612-02 FlexiGo 1 bottle — — FDA listed —
Gainxtra Hair Regrowth Treatment for Men and Women Minoxidil 5% Form with Biotin 50 mg/g 85929-0101-18 GAINXTRA 3 cans — — Discontinued —
Carenice 5% Minoxidil HAIR REGROWTH TREATMENT 5 g/100g 87086-0001-01 Shenzhen 1 bottle — — FDA listed —
Nizoral Hair Regrowth Treatment for Men 50 mg/g 55505-0237-86 Kramer 3 cans — — FDA listed —
Minoxidil 5% (For Men) 50 mg/g 21130-0208-03 Better 3 cans — — FDA listed —
About this product: this is a generic version of the medicine. FDA equivalence ratings are shown when available, and other versions are listed above, least expensive first.
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
Mar 2026
📍
2026
Currently FDA-listed
listed with the FDA
🔓
·
Generic on the market
this product is a generic
✅This is a generic drug

This product is an FDA-approved generic. Other versions of the same drug are listed under Therapeutic equivalents, least expensive first.

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.

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

Medicare Part D (outpatient prescription) spending for Minoxidil (matched by generic name) — the program that covers self-administered drugs. 3 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 Minoxidil. 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
$3.5M
Claims incl. refills
260.9K
Beneficiaries
202.1K
Spend / beneficiary
$17.33
Spend / claim
$13.42
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.

🔬 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 MINOXIDIL — the ingredient across all brands.

Top reported reactions

Adverse Drug Reaction8,585
Alopecia3,803
Application Site Pruritus2,926
Overdose1,461
Application Site Irritation1,420
Application Site Pain1,413
Hair Texture Abnormal1,409

Age at onset

Neonate3
Infant14
Child18
Adolescent35
Adult4,531
Elderly2,902

Reporter sex

44,697 reports
Male · 58%
Female · 42%
Unknown · 0%

Serious outcomes

Hospitalization2,096
Disabling297
Life-threatening261
Reports over time (by year) — tap or hover for the count & year
2021 2022 2024 2026 8,466 973
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
70000-0754-01 You're viewing this 3 CAN in 1 CARTON (70000-0754-1) / 60 g in 1 CAN 2026-03-16 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

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 70000-0754-1, 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: 70000-0754-01, written without dashes as 70000075401. 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 70000-0754-01, the first segment (70000) is the labeler code FDA assigned to CARDINAL HEALTH 110, LLC. DBA LEADER; the middle segment (0754) identifies this specific product — its ingredient, strength, and dosage form; and the last segment (01) 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 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.

📄 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 19 words ▾

Use to regrow hair on the top of the scalp (vertex only, see pictures on side of this carton)

⏱️ Dosage and Administration 62 words ▾

Directions apply half a capful 2 times a day to the scalp in the hair loss area massage into scalp with fingers, then wash hands well see enclosed leaflet for complete directions on how to use using more or more often will not improve results continued use is necessary to increase and keep your hair regrowth or hair loss will begin again

⚠️ Warnings 22 words ▾

Warnings For external use only. For use by men only. Extremely Flammable: Avoid fire, flame, or smoking during and immediately following application.

📦 Storage and Handling 86 words ▾

Other information hair growth has been shown in a clinical study of men (mostly white) aged 18 to 49 years who used it for 4 months see hair loss pictures on side of this carton before use, read all information on package and enclosed leaflet keep the package. It contains important information store at 20° to 25°C (68° to 77°F) [See USP Controlled Room Temperature] contents under pressure. Do not puncture or incinerate container.

Do not expose to heat or store at temperatures above 120°F (49°C).

🧪 Active Ingredient 8 words ▾

Active ingredient Minoxidil USP 5% w/w (without propellant)

🧪 Inactive Ingredients 80 words ▾

Inactive ingredients Alcohol, anhydrous citric acid, butane, butylated hydroxy toluene, cetyl alcohol, glycerin, isobutane, lactic acid, polysorbate 60, propane, purified water, stearyl alcohol Questions? Call toll-free 1-855-274-4122 (Monday – Friday 8:30 AM to 5:00 PM EST) *This product is not manufactured or distributed by Johnson & Johnson Consumer Inc., distributor of Men’s Rogaine ® . Cardinal Health™ DISTRIBUTED BY CARDINAL HEALTH DUBLIN, OHIO 43017 www.myleader.com 1-800-200-6313 Essential to Care™ since 1979 Made in India Code: TS/DRUGS/58039/2020 CIN 6103964 REV.

02/26

🎯 Purpose 6 words ▾

Purpose Hair regrowth treatment for men

Source: FDA Structured Product Labeling, mirrored from DailyMed / openFDA. Prefer the government’s original formatting? View this label on DailyMed ↗
← 70000-0753-01 · CARDINAL 70000-0755-01 · 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.