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The Root Of Goodness Healthy Growth Hair Regrowth System For Women 3 Step System MINOXIDIL Kit — NDC 84828-0569-00 package photo

The Root Of Goodness Healthy Growth Hair Regrowth System For Women 3 Step System MINOXIDIL Kit

by Invest Strong, LLC · 1 KIT in 1 KIT (84828-569-00) * 1 BOTTLE, DROPPER in 1 KIT (84828-539-00) / 60 mL in 1 BOTTLE, DROPPER
NDC 84828-0569-00
🏷️ FDA NDC (as labeled) 84828-569-00 billing pads the product 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) 84828-569-00
Product NDC 84828-569
11-digit billing NDC 84828056900
RxCUI 311723
Application # ANDA078176
SPL Set ID 2e19bf51-1769-4bc1-9232-9aa4b8df5847
DEA schedule Non-controlled
Marketing category ANDA
Marketing status On market
FDA listing status Listed (active directory)
Marketing start 2024-09-11
Dosage form KIT
Why two NDCs? The FDA registers this code as 84828-569-00 — 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 → 84828-0569-00. 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

LabelerInvest Strong, LLC
Application holderPURE SOURCE LLC
FDA applicationANDA078176 (ANDA)
Labeler code84828
First marketedSep 2024
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.

From the label’s inactive-ingredient sectionalcohol, propylene glycol, purified water

This is label-wide narrative text, not a normalized exact-product ingredient list. A label can cover multiple strengths or packages.

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 eachPer 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 2 g/100mL 00113-6500-00 L. 3 bottles — — FDA listed —
hair regrowth treatment 2 g/100mL 00363-0703-16 Walgreen 1 bottle — — FDA listed —
Minoxidil 2 g/100mL 00363-9970-02 Walgreens 1 bottle — — FDA listed —
up and up hair regrowth treatment for women 2 g/100mL 11673-0919-30 Target 3 bottles — — FDA listed —
carols daughter hair regrowth treatment 2 g/100mL 49967-0988-01 L'Oreal 1 bottle — — FDA listed —
Womens Minoxidil Hair Growth System 20 mg/mL 51326-0161-01 Topiderm, 60 ml — — FDA listed —
Minoxidil Topical Solution 2% 20 mg/mL 51672-2152-04 SUN 1 bottle — — FDA listed —
minoxidil 2 g/100mL 56062-0070-16 Publix 1 bottle — — FDA listed —
minoxidil topical 2 g/100mL 59640-0000-16 H 1 bottle — — FDA listed —
BOSLEY Woman 2 Minoxidil Topical Solution 20 mg/mL 69113-0432-00 Scientific 1 bottle — — FDA listed —
BOSLEY Minoxidil Topical Solution 2 for Women 20 mg/mL 69113-0462-00 Scientific 1 bottle — — FDA listed —
Foligain Professional Series Extra Strength for Women Minoxidil Topical Hair Regrowth Treatment 20 mg/mL 69607-9530-00 WR 3 bottles — — FDA listed —
hair regrowth treatment 2 g/100mL 69842-0797-16 CVS 1 bottle — — FDA listed —
Womens Rogaine Unscented 20 mg/mL 69968-0090-01 Kenvue 1 bottle — — FDA listed —
Leader minoxidil 2 g/100mL 70000-0728-01 Cardinal 3 bottles — — FDA listed —
Keranique 2% Hair Regrowth Treatment for Women 20 mg/mL 70550-0576-01 PROFECTUS 1 bottle — — FDA listed —
hers hair regrowth treatment 2 g/100mL 71730-0023-16 Hims 1 bottle — — FDA listed —
MDhair hair regrowth treatment for women 2 g/100mL 71804-0711-02 MDalgorithms, 1 bottle — — FDA listed —
basic care hair regrowth treatment 2 g/100mL 72288-0202-30 Amazon.com 3 bottles — — FDA listed —
basic care hair regrowth treatment 2 g/100mL 72288-0701-16 Amazon.com 1 bottle — — FDA listed —
Gemachlich ZuHause Hair Growth Serum (Women) 2 g/100mL 76986-0012-01 Guangdong 8 bottles — — FDA listed —
hair regrowth treatment 2 g/100mL 79481-0070-01 Meijer, 3 bottles — — FDA listed —
equate hair regrowth treatment 2 g/100mL 79903-0072-30 WALMART 3 bottles — — FDA listed —
Santo Remedio Womens Hair Regrowth Treatment Minoxidil Unscented 20 mg/mL 81352-0561-00 SANTO 1 bottle — — FDA listed —
Remixdil Hair Regrowth Treatment For Women 2 g/100mL 83004-0009-01 Rida 4 bottles — — FDA listed —
Hair Regen Hair Regrowth Treatment 2 g/100mL 84232-0004-01 YIWUYIZHOUTRADINGCO.,LTD 60 ml — — FDA listed —
GROWELL Womens Hair Regrowth Treatment 2 Minoxidil 20 mg/mL 84329-0466-00 APIRA 1 bottle — — FDA listed —
The Root Of Goodness Healthy Growth Hair Regrowth System For Women 3 Step Systemthis 84828-0569-00 Invest 1 kit — — FDA listed —
eSalon Hair Regrowth Treatment Womens Minoxidil 20 mg/mL 84856-0604-00 ESALON.COM, 1 bottle — — FDA listed —
Happy Head Womens Hair Regrowth Treatment 20 mg/mL 87117-0880-00 Happy 3 bottles — — FDA listed —
Womens MinoGrow Hair Regrowth Treatment Minoxidil 20 mg/mL 87387-0980-00 Minogro 1 bottle — — FDA listed —
Fete Health Hair Regrowth Treatment for Women 20 mg/mL 87412-0981-00 Honest 1 bottle — — FDA listed —
Minoxidil Topical Solution USP, 2% .02 g/mL 87532-0001-01 Carol's 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

🏛️
2024
On the market since
Sep 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.

📊 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 The Root Of Goodness Healthy Growth Hair Regrowth System For Women 3 Step System (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

Reporter sex

32,801 reports

Serious outcomes

Death448
Disabling274
Life-threatening251
Reports over time (by year) — tap or hover for the count & year
2020 2022 2024 2026 4,838 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
84828-0569-00 You're viewing this 1 KIT in 1 KIT (84828-569-00) * 1 BOTTLE, DROPPER in 1 KIT (84828-539-00) / 60 mL in 1 BOTTLE, DROPPER 2024-09-11 Active

🧭 About this NDC listing & data coverage

Over-the-counter (OTC) product Kit / multi-component package

Kit / multi-component package

This NDC identifies a kit — a package containing more than one component. Structured data (pricing, ingredients, equivalents) is often reported per component rather than for the kit NDC itself, which can make this page look thinner than the components' own pages.

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 84828-569-00, 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: 84828-0569-00, written without dashes as 84828056900. 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 84828-0569-00, the first segment (84828) is the labeler code FDA assigned to Invest Strong, LLC; the middle segment (0569) identifies this specific product — its ingredient, strength, and dosage form; and the last segment (00) 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 Invest Strong, LLC. Listing status can change — the directory data on this page refreshes weekly.
Who lists this product with the FDA?
Invest Strong, LLC 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 7 words ▾

Use to regrow hair on the scalp

⏱️ Dosage and Administration 90 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

Directions apply one mL 2 times a day directly onto the scalp in the hair loss area see inner carton and enclosed boklet for complete directions using more or more often will not improve results continued use is necessary or hair loss will begin again

⚠️ Warnings ~2 min read ▾

Warnings For external use only Flammable: Keep away from fire or flame Do not use if your degree of hair loss is different than that shown on the side of this carton, because this product may not work for you you have no family history of hair loss your hair loss is sudden and/or patchy your hair loss is associated with childbirth 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. You may need to use this product 2 times a day 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 everyone.

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 right away.

Warnings For external use only Flammable: Keep away from fire or flame Do not use if you have no family history of hair loss your hair loss is sudden and/or patchy your hair loss is associated with childbirth 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 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 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 right away.

🧪 Active Ingredient 14 words ▾

Active ingredient Minoxidil 2% w/v Purpose Hair regrowth treatment

Active ingredient Minoxidil 2% w/v

🧪 Inactive Ingredients 14 words ▾

Inactive ingredients alcohol, propylene glycol, purified water

Inactive ingredients alcohol, propylene glycol, purified water

🎯 Purpose 4 words ▾

Purpose Hair regrowth treatment

Source: FDA Structured Product Labeling, mirrored from DailyMed / openFDA. Prefer the government’s original formatting? View this label on DailyMed ↗
← 84826-0002-01 · Ocuvex 84830-2107-02 · NewAlley →
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.