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JOHNSON FOAM MINOXIDIL .1 g/100g; 5 g/100g Aerosol, Foam, 90 g — NDC 84539-0001-01 package photo

JOHNSON FOAM MINOXIDIL .1 g/100g; 5 g/100g Aerosol, Foam, 90 g

by JOHNSON BIOPHARMACEUTICAL INC. · 90 g in 1 BOTTLE (84539-001-01)
NDC 84539-0001-01
🏷️ FDA NDC (as labeled) 84539-001-01 billing pads the product segment with a zero
OTC On market Non-controlled
🗂️ Data synced Aug 6, 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) 84539-001-01
Product NDC 84539-001
11-digit billing NDC 84539000101
UNII 57GNO57U7G, 5965120SH1
Application # M032
SPL Set ID 1d44a75c-c940-680c-e063-6394a90a5839
Established class (EPC) 5-alpha Reductase Inhibitor; Arteriolar Vasodilator
Mechanism of action 5-alpha Reductase Inhibitors
Physiologic effect Arteriolar Vasodilation
DEA schedule Non-controlled
Marketing category OTC MONOGRAPH DRUG
Marketing status On market
FDA listing status Listed (active directory)
Marketing start 2024-07-15
Route TOPICAL
Dosage form AEROSOL, FOAM
Substance FINASTERIDE; MINOXIDIL
Why two NDCs? The FDA registers this code as 84539-001-01 — 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 → 84539-0001-01. 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.

🏭 Manufacturer & labeler

LabelerJOHNSON BIOPHARMACEUTICAL INC.
FDA applicationM032 (OTC MONOGRAPH DRUG)
Labeler code84539
First marketedJul 2024
Product typeHuman Otc Drug
Portfolio2 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

📗 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 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 035JKJ76MT
    A silicone-based ingredient that helps oil and water mix together in formulations. It works as an emulsifier to create smooth, stable textures in topical medicines and creams.
  • 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 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 BZ1R15MTK7
    Levomenthol is the left-handed form of menthol, a natural cooling compound from mint plants. It's used in medicines as a flavoring agent and to provide a cooling sensation on the skin or mucous membranes.
  • UNII TUF2IVW3M2
    Poloxamer 407 is a synthetic polymer made from ethylene oxide and propylene oxide. In medicines, it acts as a thickener, emulsifier, and solubilizer to help mix ingredients and create the right texture.
  • UNII 6OZP39ZG8H
    Polysorbate 80 is a synthetic emulsifier derived from sorbitol and oleic acid. It helps mix oil and water-based ingredients together in medications and improves how the product disperses in the body.
  • UNII M9NL0C577Y
    Ubiquinol is a fat-soluble compound found naturally in cells that acts as an antioxidant. In medicines, it serves as an active nutritional ingredient to support formulation stability and bioavailability.
  • 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.
  • UNII C32PQ86DH4
    Zinc PCA is a zinc salt of pyroglutamic acid, a naturally occurring amino acid derivative. It's used in medications as a skin-conditioning agent and to help maintain product stability and texture in topical formulations.

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

The official label also statesALCOHOL GLYCERIN WHATER CETYL PEG/PPG-10/1 DIMETHICONE (HLB 5) UBIQUINOL ZINC PIDOLATE BUTYLATED HYDROXYTOLUENE EDETATE DISODIUM LEVOMENTHOL Poloxzam POLYSORBATE 80

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
Johnson Foam .1 g/100g; 5 g/100gthis 84539-0001-01 JOHNSON 90 g — — 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
Jul 2024
📍
2026
Currently FDA-listed
2 years listed
🔓
·
Generic versions listed
see equivalents
✅Generic appears available

FDA-approved generic versions are listed, and recent pricing/market data suggests they may be available — see Therapeutic equivalents.

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 JOHNSON FOAM (this brand).

Top reported reactions

Adverse Drug Reaction8,573
Application Site Pruritus2,535
Application Site Irritation1,229
Application Site Pain1,091
Headache1,080
Alopecia884
Application Site Dryness738

Age at onset

Neonate3
Infant14
Child12
Adolescent16
Adult1,717
Elderly377

Reporter sex

32,801 reports
Male · 77%
Female · 23%
Unknown · 0%

Serious outcomes

Hospitalization2,047
Death448
Disabling274
Life-threatening251
Reports over time (by year) — tap or hover for the count & year
2022 2023 2024 2026 7,986 809
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
84539-0001-01 You're viewing this 90 g in 1 BOTTLE (84539-001-01) 2024-07-15 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 84539-001-01, 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: 84539-0001-01, written without dashes as 84539000101. 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 84539-0001-01, the first segment (84539) is the labeler code FDA assigned to JOHNSON BIOPHARMACEUTICAL INC.; the middle segment (0001) 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 JOHNSON BIOPHARMACEUTICAL INC.. Listing status can change — the directory data on this page refreshes weekly.
Who lists this product with the FDA?
JOHNSON BIOPHARMACEUTICAL 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 49 words ▾

Fight primary cause of hair loss in men.Anti hair lossto help increase hair density and volume do not apply on other parts of the body. avoid contactwith eyes.In case of accidental contactrinse eyes with large amounts of cool tap water. some people have experienced changes in hair colorand/or texture

⏱️ Dosage and Administration 104 words ▾

1.PREP HANDSWITH COLD WATERRinse Your Fingers In Cold WaterAnd DryThem.note:Foam Will MeltOn Contact With Warm Surfaces. 2.OPEN CHILDRESISTANT CAP Be Sure To Align Arrow On The capWith Arrow On Blue Ring. Tilt CapBack And Pull Off.

3.DISPENSEVERTICALLYONTOACOLD SURFACE Hold The Can Straight UpsideDown.lf You Hold Thecan At AnAngle, Foam May Not DispenseProperly.Press Nozzle To DispenseHalfACapful Of Foam Onto ColdSurface(e.g.dish.or Cold Hands). 4.APPLYTOSCALP.NOT HAIR Part Your Hair To Expose Hair LossArea.Massage Foam Into ScalpNot Hair, Repeat UntilAll HairLossAreas Have Been Covered. 5.CLOSE CAP AND WASHHANDSsnap cap back into place be surearrows do not line up, so cap remainschild resistant, wash hands and anysurface thoroughly afteruse

⚠️ Warnings 20 words ▾

For external use only For use by men only. Extremely Flammable Avoid fire, flame, or smoking during and immediatelyfollowing application.

📦 Storage and Handling 24 words ▾

Store at controlledroom temperature20 ℃ to 25 ℃68°to 77 F).Contentsunder pressure.Do not puncture orincinerate container. Do not expose toheat or store at temperatures above120F(49℃)

🧪 Active Ingredient 4 words ▾

MINOXIDIL 5% FINASTERIDE 0.1%

🧪 Inactive Ingredients 19 words ▾

ALCOHOL GLYCERIN WHATER CETYL PEG/PPG-10/1 DIMETHICONE (HLB 5) UBIQUINOL ZINC PIDOLATE BUTYLATED HYDROXYTOLUENE EDETATE DISODIUM LEVOMENTHOL Poloxzam POLYSORBATE 80

🎯 Purpose 17 words ▾

Fight primary cause of hair loss in men. Anti hair loss to help increase hair densityand volume.

Source: FDA Structured Product Labeling, mirrored from DailyMed / openFDA. Prefer the government’s original formatting? View this label on DailyMed ↗
← 84536-0378-01 · Allsino 84539-0002-01 · JOHNSON →
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.