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Hair Regrowth Treatment Extra Strength for Men Minoxidil 50 mg/mL Solution

by Seiseidou America, Inc. · 1 BOTTLE, DROPPER in 1 CARTON (82269-607-02) / 60 mL in 1 BOTTLE, DROPPER
NDC 82269-0607-02
🏷️ FDA NDC (as labeled) 82269-607-02 billing pads the product segment with a zero
OTC Generic Discontinued Non-controlled ⚠ Discontinued by firm
🗂️ 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

⚠️
Excluded from the active FDA NDC Directory. The labeler reported this product as discontinued, so it is excluded from the active NDC Directory. The listing was last certified through Mar 2024. A label may still appear on DailyMed, but the NDC is no longer in the current FDA NDC Directory. Search the FDA NDC Directory ↗

🆔 Identity & classification

FDA NDC (as labeled) 82269-607-02
Product NDC 82269-607
11-digit billing NDC 82269060702
RxCUI 311724
UNII 5965120SH1
UPC 0860003894606
Application # ANDA075518
SPL Set ID 1bcb9934-861c-405a-948a-3e4cdd13246d
Established class (EPC) Arteriolar Vasodilator
Physiologic effect Arteriolar Vasodilation
DEA schedule Non-controlled
Marketing category ANDA
Marketing status Discontinued
FDA listing status Discontinued by firm (certified through Mar 2024)
Marketing start 2021-10-15
Route TOPICAL
Dosage form SOLUTION
Substance MINOXIDIL
Why two NDCs? The FDA registers this code as 82269-607-02 — 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 → 82269-0607-02. 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

LabelerSeiseidou America, Inc.
Application holderP AND L DEVELOPMENT LLC
FDA applicationANDA075518 (ANDA)
Labeler code82269
First marketedOct 2021
Product typeHuman Otc Drug
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.

We could not link this NDC to a current FDA Structured Product Label. An inactive-ingredient list is therefore not available from this source.
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 systemPer mLPer 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
Good Sense Hair Regrowth Treatment 5 g/100mL 00113-1032-30 L. 3 bottles — — FDA listed —
hair regrowth treatment 5 g/100mL 00363-0032-16 Walgreen 1 bottle — — FDA listed —
Minoxidil 50 mg/mL 00363-9971-02 Walgreens 1 bottle — — FDA listed —
Minoxidil 50 mg/mL 00363-9973-06 Walgreens 3 bottles — — FDA listed —
up and up hair regrowth treatment for men 5 g/100mL 11673-0317-30 Target 3 bottles — — FDA listed —
hair regrowth treatment 5 g/100mL 11822-1260-00 Rite 1 bottle — — FDA listed —
hair regrowth treatment 5 g/100mL 21130-0611-16 Safeway 1 bottle — — FDA listed —
signature care hair regrowth treatment 5 g/100mL 21130-0819-16 Safeway 1 bottle — — Discontinued —
Loesch Hair Regrowth Formula Unscented Topical Solution Extra-Strength for Men 3 g/60mL 25280-0006-42 Loesch 1 bottle — — FDA listed —
hair regrowth treatment 5 g/100mL 30142-0632-30 Kroger 3 bottles — — FDA listed —
minoxidil 5 g/100mL 37808-0833-16 H 1 bottle — — FDA listed —
hair regrowth treatment 5 g/100mL 41250-0428-30 Meijer, 3 bottles — — FDA listed —
equate hair regrowth treatment 5 g/100mL 49035-0746-16 Wal-Mart 1 bottle — — FDA listed —
Minoxidil Topical Solution, 5% 50 mg/mL 51672-2151-04 Sun 1 bottle — — FDA listed —
minoxidil 5 g/100mL 56062-0322-16 Publix 1 bottle — — FDA listed —
LILIVERA Hair Regrowth Kit 5 g/100mL 60771-0012-01 Guangzhou 60 ml — — FDA listed —
Psalmonica Hair Growth Serum 5 g/100mL 60771-0013-01 Guangzhou 60 ml — — FDA listed —
kirkland signature minoxidil 5 g/100mL 63981-0032-40 Costco 6 bottles — — FDA listed —
kirkland signature minoxidil 3 g/60mL 63981-0798-40 Costco 6 bottles — — FDA listed —
members mark hair regrowth treatment 5 g/100mL 68196-0032-40 Sam's 6 bottles — — FDA listed —
BOSLEY Man 5 Minoxidil Topical Solution 50 mg/mL 69113-0431-00 Scientific 1 bottle — — FDA listed —
Dr. Bosley Minoxidil (For Men) Hair Regrowth Treatment 50 mg/mL 69113-0913-00 Scientific 1 bottle — — FDA listed —
Foligain Professional Series Extra Strength For Men Minoxidil Hair Regrowth Treatment 50 mg/mL 69607-9540-00 WR 3 bottles — — FDA listed —
Hair Regrowth Treatment 5 g/100mL 69842-0598-16 CVS 1 bottle — — FDA listed —
Mens Rogaine Extra Strength Unscented 50 mg/mL 69968-0089-01 Kenvue 1 bottle — — FDA listed —
Leader Minoxidil 5 g/100mL 70000-0653-01 Cardinal 3 bottles — — FDA listed —
Regenpure Precision 50 mg/mL 71290-0813-02 Salonceuticals, 1 bottle — — FDA listed —
minoxidil 5 g/100mL 71713-0094-16 THIRTY 1 bottle — — FDA listed —
Keeps Minoxidil Topical Solution, 5% 50 mg/mL 71713-0102-09 Keeps 3 bottles — — FDA listed —
hims hair regrowth treatment 5 g/100mL 71730-0000-16 Hims 1 bottle — — FDA listed —
MDhair Extra Strength hair regrowth treatment for Men 5 g/100mL 71804-0704-05 MDalgorithms, 1 bottle — — FDA listed —
basic care hair regrowth treatment 5 g/100mL 72288-0798-16 Amazon.com 60 ml — — FDA listed —
Minoxidil Extra Strength for Men 5 g/100mL 72484-0095-03 Roman 1 bottle — — FDA listed —
SUAVECITO 5% Minoxidil Solution 50 mg/mL 74866-0414-01 SUAVECITO, 1 bottle — — FDA listed —
Gemachlich ZuHause Hair Growth Serum (Men) 5 g/100mL 76986-0011-01 Guangdong 8 bottles — — FDA listed —
Verdibliss 5% Minoxidil Topical Hair Regrowth Treatment For Men .05 g/mL 76986-0029-01 Guangdong 2 bottles — — FDA listed —
equate hair regrowth treatment 5 g/100mL 79903-0222-01 WALMART 1 bottle — — FDA listed —
Santo Remedio Mens Hair Regrowth Treatment Minoxidil Topical Solution Extra Strength Unscented 50 mg/mL 81352-0560-00 SANTO 1 bottle — — FDA listed —
INTELLIGENT Mens Minoxidil Extra Strength 5 Minoxidil 50 mg/mL 81632-0408-00 INTELLIGENT 1 bottle — — FDA listed —
Elevate Hair Growth Serum 5 g/100mL 81653-0010-01 Guangzhou 60 ml — — FDA listed —
Soti Hair Growth Serum 5 g/100mL 81653-0013-01 Guangzhou 60 ml — — FDA listed —
Hair Regrowth Treatment Extra Strength for Men 50 mg/mLthis 82269-0607-02 Seiseidou 1 bottle — — Discontinued —
DAVV Minoxidil Topical Solution Mens Hair Regrowth Treatment 50 mg/mL 82372-0482-00 Good 1 bottle — — FDA listed —
Remixdil Extra Strength hair regrowth treatment for Men 5 g/100mL 83004-0008-01 Rida 2 bottles — — FDA listed —
Hair Serum .05 g/mL 83804-0003-01 Shenzhen 60 ml — — FDA listed —
OLIVITA 5% Minoxidil 5 g/100mL 83818-0028-01 Shenzhen 2 bottles — — FDA listed —
VENANOCI Minoxidil 5 g/100mL 83818-0029-01 Shenzhen 60 ml — — FDA listed —
OLIVITA Minoxidil 5 g/100mL 83818-0031-01 Shenzhen 60 ml — — FDA listed —
VeraRoot Minoxidil Topical Solution 5 g/100mL 83818-0033-01 Shenzhen 60 ml — — FDA listed —
Etaderm Mens Minoxidil Hair Regrowth Treatment Extra Strength 50 mg/mL 84180-0878-00 NUEPHASE 1 bottle — — FDA listed —
5% Minoxidil Beard Growth Serum 5 g/100mL 84183-0101-01 Shenzhen 4 bottles — — Discontinued —
Hair Regen Hair Growth Treatment 5 g/100mL 84232-0001-01 YIWUYIZHOUTRADINGCO.,LTD 60 ml — — FDA listed —
Hair Regen Hair Regrowth Treatment 5 g/100mL 84232-0002-01 YIWUYIZHOUTRADINGCO.,LTD 60 ml — — FDA listed —
Hair-Regen Hair Growth Treatment 5 g/100mL 84232-0011-26 Yiwu 6 bottles — — FDA listed —
Hair-Regen Hair Growth Treatment Derma Roller Included 5 g/100mL 84232-0021-26 Yiwu 6 bottles — — FDA listed —
GROWELL Mens Hair Regrowth Treatment 5 Minoxidil 50 mg/mL 84329-0465-00 APIRA 1 bottle — — FDA listed —
Ollm 5% MINOXIDIL Growth Serum 5 g/100mL 84558-0011-01 GUANGZHOU 60 ml — — FDA listed —
Elevate Hair Regrowth Treatment 5 Minoxidil Solution 50 mg/mL 84561-0514-00 VAPOR 1 bottle — — FDA listed —
5% MINOXIDIL HAIR GROWTH SERUM liquid 5 g/100mL 84735-0012-01 Hengyang 1 bottle — — Discontinued —
Colorsmith Hair Regrowth Treatment Mens Minoxidil Topical Solution Extra Strength 50 mg/mL 84856-0603-00 ESALON.COM, 1 bottle — — FDA listed —
Tomum Hair Growth Treatment For Men Minoxidil Unscented 50 mg/mL 85003-0546-00 BELLEKA 1 bottle — — FDA listed —
Stafenit Hair Regrowth Treatment Topical Minoxidil 50 mg/mL 85097-0576-00 Cozesmo 1 bottle — — FDA listed —
5% Minoxidil Hair Growth Serum .05 g/mL 85158-0001-01 Shenzhen 60 ml — — FDA listed —
5% MINOXIDIL TOPICAL Solution 5 g/100mL 85174-0001-02 Nanhong 2 bottles — — Discontinued —
Hair Regrowth Treatment 5 g/100mL 85407-0001-01 Dongguan 100 ml — — Discontinued —
ProBliva Mens Extra Strength Minoxidil 50 mg/mL 85464-0595-00 CAVTECH 1 bottle — — FDA listed —
Hair Growth Serum Roll-ON 5 g/100mL 85524-2625-02 FlexiGo 1 bottle — — FDA listed —
Minoxidil Hair Growth Serum 5 g/100mL 85741-0004-01 Shenzhen 1 bottle — — FDA listed —
Happy Head Mens Extra Strength Minoxidil 50 mg/mL 87117-0882-00 Happy 3 bottles — — FDA listed —
RegrowthX Hair Regrowth Treatment Minoxidil 50 mg/mL 87148-0881-00 Nimex 1 bottle — — FDA listed —
OpusMeds Extra Strength Minoxidil 50 mg/mL 87338-0983-00 Opus 1 bottle — — FDA listed —
5% Minoxidil Hair Care Solution 5 g/100mL 87376-0001-02 Shenzhen 4 bottles — — FDA listed —
5% MINOXIDIL HAIR REGROWTH SERUM With Biotin .05 g/mL 87394-0001-01 Shenzhen 2 bottles — — FDA listed —
Mens Extra Strength Minoxidil Hair Growth Treatment 50 mg/mL 87616-0969-00 Hairmax 1 bottle — — FDA listed —
RootVive Mens Hair Regrowth Treatment Extra Strength Minoxidil 50 mg/mL 87663-0962-00 TrueRoot 1 bottle — — FDA listed —
Gemachlich ZuHause Beard Growth Treatment Serum .05 g/mL 87681-0005-01 Guangzhou 3 bottles — — FDA listed —
Mens Jivexa Extra Strength Minoxidil 50 mg/mL 87688-0955-00 SMC 1 bottle — — FDA listed —
Nuvarra Mens Minoxidil Hair Regrowth Treatment 50 mg/mL 87779-0966-00 Bionetics 1 bottle — — FDA listed —
Yabercha Hair Growth Serum 5 g/100mL 87793-0001-01 Yiwu 60 ml — — FDA listed —
Minoxidil Hair Regrowth Kit .05 g/mL 87813-0001-01 Guangzhou 4 bottles — — FDA listed —
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 —
Elevate Hair Regrowth Treatment 5 50 mg/mL 84561-0524-00 VAPOR 1 bottle — — FDA listed —
Follicly Minoxidil Hair Regrowth Treatment 50 mg/mL 87884-0006-00 Follicly 1 bottle — — FDA listed —
Olivita Extra Strength Minoxidil 50 mg/mL 87695-0008-00 Olivita 1 bottle — — 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

🏛️
2021
On the market since
Oct 2021
📍
2026
Currently FDA-listed
5 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.

📊 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 Hair Regrowth Treatment Extra Strength for Men (this brand).

Top reported reactions

Adverse Drug Reaction8,573
Application Site Pruritus2,535
Application Site Irritation1,229
Application Site Pain1,091
Headache1,080
Alopecia885
Application Site Dryness738

Reporter sex

32,806 reports

Serious outcomes

Hospitalization2,047
Death448
Disabling274
Life-threatening252
Reports over time (by year) — tap or hover for the count & year
2019 2021 2023 2026 7,986 0
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
82269-0607-02 You're viewing this 1 BOTTLE, DROPPER in 1 CARTON (82269-607-02) / 60 mL in 1 BOTTLE, DROPPER 2021-10-15 Discontinued by firm

🧭 About this NDC listing & data coverage

Over-the-counter (OTC) product No longer marketed (per FDA listing data)
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 — Not published for this NDC No photo available yet for this listing.
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

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.
What does the discontinued status mean for this NDC?
The labeler reported a marketing end date (or the listing was delisted), so this specific package is no longer actively marketed. Remaining stock may still be dispensed for a time, and the NDC stays valid for historical records and claims — but data feeds (pricing, labeling) typically stop updating for it. Other package sizes or other manufacturers' versions of the same medication may still be marketed — see the equivalents section where available.
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 82269-607-02, 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: 82269-0607-02, written without dashes as 82269060702. 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 82269-0607-02, the first segment (82269) is the labeler code FDA assigned to Seiseidou America, Inc.; the middle segment (0607) identifies this specific product — its ingredient, strength, and dosage form; and the last segment (02) identifies this exact package size and type. Together they name one specific package of one specific product.
Who lists this product with the FDA?
Seiseidou America, 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 🧪 Active Ingredient 🧪 Inactive Ingredients 🎯 Purpose
🎯 Indications and Usage 18 words ▾

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

⏱️ Dosage and Administration 45 words ▾

Directions apply one mL with dropper 2 times a day directly onto the scalp in the hair loss area 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 ~1 min read ▾

Warnings For external use only. For use by men only. Flammable: Keep away from fire or flame Do not use if you are a woman your amount of hair loss is different than that shown on the side of this carton or your hair loss is on the front of the scalp.

Minoxidil topical solution 5% is not intended for frontal baldness or receding hairline. you have no family history of hair loss your hair loss is sudden and/or patchy you do not know the reason for your hair loss you are under 18 years of age. Do not use on babies and children. your scalp is red, inflamed, infected, irritated, or painful you use other medicines on the scalp Ask a doctor before use if you have heart disease When using this product do not apply on other parts of the body avoid contact with the eyes. In case of accidental contact, rinse eyes with large amounts of cool tap water. some people have experienced changes in hair color and/or texture it takes time to regrow hair.

Results may occur at 2 months with twice a day usage. For some men, you may need to use this product for at least 4 months before you see results. the amount of hair regrowth is different for each person. This product will not work for all men.

Stop use and ask a doctor if chest pain, rapid heartbeat, faintness, or dizziness occurs sudden, unexplained weight gain occurs your hands or feet swell scalp irritation or redness occurs unwanted facial hair growth occurs you do not see hair regrowth in 4 months May be harmful if used when pregnant or breast-feeding. Keep out of reach of children. If swallowed, get medical help or contact a Poison Control Center (1-800-222-1222) right away.

🧪 Active Ingredient 6 words ▾

Active ingredient Minoxidil, USP 5% w/v

🧪 Inactive Ingredients 11 words ▾

Inactive ingredients alcohol (30% v/v), propylene glycol (50% v/v), purified water

🎯 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 ↗
← 82266-0238-00 · BALBOA 82274-0001-04 · Chr. →
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.