Label image from the product's FDA listing (DailyMed) — may show a different pack size or an older label revision.
Minoxidil Extra Strength for Men 5 g/100mL Spray — NDC 72484-097-01 (Billing 72484-0097-01)
by Roman Health Ventures Inc. · 3 BOTTLE, SPRAY in 1 CARTON / 60 mL in 1 BOTTLE, SPRAY
This is a package of Minoxidil Extra Strength for Men 5 g/100mL Spray from Roman Health Ventures Inc., marketed since Jan 2024 and currently FDA-listed. It is the main listing for this product, which comes in 2 package sizes.
NDC 72484-0097-01
🏷️ FDA NDC (as labeled)
72484-097-01
billing pads the product segment with a zero
This package
Contains60 mL in 1 bottle, spray
Pack sizes2 compare ↓
Main listing for product 72484-097 · Also comes in:
60 mL 72484-097-02
🗂️ FDA directory synced Oct 1, 2026 · this listing last changed Jul 24, 2026 · sources: openFDA · FDA label (DailyMed) · FDA Orange & Purple Book · First Databank · CMS NADAC, ASP, Medicare & Medicaid · RxNorm
📋 All sources & update times →
Identity & classification
Regulatory identifiers FDA, NLM and CMS codes for this package
FDA NDC (as labeled)
72484-097-01
Product NDC
72484-097
11-digit billing NDC
72484009701
RxCUI
1537948
UNII
5965120SH1
UPC
0810058746580, 0810058746573
Application #
ANDA076239
SPL Set ID
03738dd6-a42c-0986-e063-6294a90a1cc0
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
2024-01-01
Route
TOPICAL
Dosage form
SPRAY
Substance
MINOXIDIL
Quick answers
- RxCUI (RxNorm): 1537948
Why two NDCs?
The FDA registers this code as 72484-097-01 — 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 → 72484-0097-01. 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.
- FDA openFDA NDC Directory · synced Oct 1, 2026
- FDA label on DailyMed · label index refreshed Oct 1, 2026
- RxNorm (NLM RxNav) · catalog refreshed Oct 1, 2026
- Medi-Span GPI (licensed)
- First Databank (licensed) · refreshed Oct 1, 2026
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.
- RxClass (NLM) · catalog refreshed Oct 1, 2026
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
- The topical products in the label are specifically approved for hair regrowth on the top of the scalp only — not for use on other parts of the body. Applying it elsewhere isn't rec...
- Can I use the topical minoxidil solution on my beard or other areas, not just my scalp?
- Hair regrowth takes time and patience. Some people start to see results after about 2 months of twice-daily use, but for others it may take 4 months or more. Not everyone responds...
- How long does it take to see results with topical minoxidil?
Patient education
Supplement & herbal interactions
Some supplements/herbs that may interact with Minoxidil — tap one for details:
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.
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.
- MedlinePlus (NLM) · refreshed Oct 1, 2026
- FDA label on DailyMed · label index refreshed Oct 1, 2026
💬 Questions about Minoxidil?
Ask a pharmacist →
Ask a licensed pharmacist directly — free, answered by our team.
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 mL | 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:
60 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.
- CMS NADAC weekly file
- CMS ASP pricing files · refreshed Sep 20, 2026
- CMS Medicaid State Drug Utilization Data · refreshed Oct 2, 2026
- CMS Part D plan pricing files · refreshed Sep 24, 2026
- VA National Acquisition Center price file
Packaging — all sizes for this product
| Package NDC | Description | Marketing start | Marketing end | Status |
|---|---|---|---|---|
| 72484-0097-01 You're viewing this Main listing | 3 BOTTLE, SPRAY in 1 CARTON / 60 mL in 1 BOTTLE, SPRAY | 2024-01-01 | — | Active |
| 72484-0097-02 72484-097-02 | 1 BOTTLE, SPRAY in 1 CARTON / 60 mL in 1 BOTTLE, SPRAY | 2024-01-01 | — | Active |
Pack size FAQ
What quantity is in this package?
This package is listed by the FDA — 3 bottle, spray in 1 carton / 60 ml in 1 bottle, spray.
What NDC number is used to bill for this package of Minoxidil Extra Strength for Men 5 g/100mL Spray?
Use the 11-digit billing form listed in the identifiers section of this page. Pharmacy and medical claims use the 11-digit form; the FDA label may print a shorter form of the same code.
Therapeutic equivalents
| Product | Labeler | Pack | NADAC/unit | TE | Status | Price vs. this |
|---|---|---|---|---|---|---|
| BOSLEY Minoxidil Topical Solution 5 (for men) 50 mg/mL 69113-0483-00 | Scientific | 1 bottle | — | — | FDA listed | — |
| DS Labs Spectral UHP Men s Extra Strength Hair Regrowth Treatment 50 mg/mL 69188-0593-00 | DS | 1 bottle | — | — | FDA listed | — |
| Minoxidil Extra Strength for Men 5 g/100mLthis 72484-0097-01 | Roman | 3 bottles | — | — | FDA listed | — |
| Elevate Hair Regrowth Treatment 5 50 mg/mL 84561-0524-00 | VAPOR | 1 bottle | — | — | FDA listed | — |
| 5% Minoxidil HAIR GROWTH SPARY 5 g/100mL 84778-0099-01 | Guangzhou | 1 bottle | — | — | Discontinued | — |
| 5%Minoxidilhairgrowthspray 5 g/100mL 84778-0105-01 | Guangzhou | 1 bottle | — | — | Discontinued | — |
| Minoxidil hair growth serum 50 mg/100mL 84867-0005-01 | Jiashen | 100 ml | — | — | FDA listed | — |
| Minoxidil Hair Growth Serum 5 g/100mL 85092-0001-01 | Shenzhen | 1 bottle | — | — | Discontinued | — |
| iBeaLee 5-in-1 5% Minoxidil Hair Regrowth Solution 5 g/100mL 85636-0010-01 | Shenzhen | 60 ml | — | — | FDA listed | — |
| iBeaLee 5% Minoxidil Hair Regrowth Treatment 5 g/100mL 85636-0018-01 | Shenzhen | 60 ml | — | — | FDA listed | — |
| 5% Minoxidil Hair Regrowth Treatment 5 g/100mL 85636-0023-01 | Shenzhen | 60 ml | — | — | FDA listed | — |
| Minoxidil Hair Regrowth Treatment 5 g/100mL 85636-0024-01 | Shenzhen | 60 ml | — | — | FDA listed | — |
| Gainxtra Hair Regrowth Treatment for Men and Women Minoxidil 5% Sprays with Biotin 50 mg/mL 85929-0100-01 | GAINXTRA | 1 bottle | — | — | Discontinued | — |
| DAAZZS 5% Minoxidil Hair and Beard Regrowth Kit with Biotin 5 g/100mL 87408-0008-01 | Guangzhou | 2 bottles | — | — | FDA listed | — |
| FUZYAT 5% Minoxidil Hair Growth for Men and Women 5 g/100mL 87408-0015-01 | Guangzhou | 2 bottles | — | — | FDA listed | — |
| Hair Growth Serum 5 g/100mL 87540-0001-01 | Shenzhen | 60 ml | — | — | 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.
- FDA openFDA NDC Directory · synced Oct 1, 2026
- FDA Orange Book · refreshed Sep 3, 2026
- CMS NADAC weekly file
Availability & generic status
🏛️
2024
On the market since
Jan 2024
📍
2026
Currently FDA-listed
2 years listed
🔓
·
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.
- FDA Orange Book · refreshed Sep 3, 2026
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 6DC9Q167V3
Propylene glycol is a clear liquid derived from petroleum or vegetable sources. It acts as a solvent, humectant, and preservative in medicines, helping dissolve active ingredients and maintain product stability.
-
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.
3 inactive ingredients listed in the exact product block matched to this NDC.
The official label also statesInactive ingredients Alcohol, propylene glycol, purified water
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.- FDA label on DailyMed · label index refreshed Oct 1, 2026
- FDA openFDA NDC Directory · synced Oct 1, 2026
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
LabelerRoman Health Ventures Inc.
Application holderPURE SOURCE LLC
FDA applicationANDA076239 (ANDA)
Labeler code72484
First marketedJan 2024
Product typeHuman Otc Drug
Portfolio3 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 openFDA NDC Directory · synced Oct 1, 2026
- Drugs@FDA
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
🧪 Active Ingredient
🧪 Inactive Ingredients
🎯 Purpose
🎯 Indications and Usage ▾
1 Bottle Carton Use to regrow hair on the scalp (vertex only, see picture on side of carton) 3 Bottle Carton Use to regrow hair on the scalp (vertex only, see picture on side of carton)
⏱️ Dosage and Administration ▾
Directions Prime the sprayer by holding the bottle the bottle upright and pump the sprayer 5 times to ensure delivery of full spray. Do not inhale mist Apply one mL with spray (6 sprays) 2 times a day directly onto the scalp in the hair loss area Using more or more often will not improve restuls Continued use is necessary to increase and keep your hair regrowth, or hair loss will begind again.
⚠️ Warnings ▾
Warnings For external use only. For use by men only. Flammable: Keep away from fire or flame
🧪 Active Ingredient ▾
1 Bottle Carton Active Ingredient Minoxidil, USP 5% w/v 3 Bottle Carton Active Ingredient Minoxidil 5% w/v
🧪 Inactive Ingredients ▾
Inactive ingredients Alcohol, propylene glycol, purified water
🎯 Purpose ▾
1 Bottle Carton Purpose Hair regrowth treatment for men 3 Bottle Carton Purpose Hair regrowth treatment
No label section mentions that — try another word, or open the full label on DailyMed below.
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 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 Extra Strength for Men (this brand).
Top reported reactions
Age at onset
Reporter sex
Serious outcomes
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.
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 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 Roman Health Ventures 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 1 bottle (72484-0097-02). 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?
Roman Health Ventures 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.
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.