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Regenivade Hair Growth Foam Minoxidil 5 mg/mL Liquid — NDC 81653-0007-01 package photo

Regenivade Hair Growth Foam Minoxidil 5 mg/mL Liquid

by Guangzhou Jianyuan Biological Technology.Co.,Ltd · 1 BOTTLE in 1 PACKAGE (81653-007-01) / 60 mL in 1 BOTTLE
NDC 81653-0007-01
🏷️ FDA NDC (as labeled) 81653-007-01 billing pads the product segment with a zero
OTC 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) 81653-007-01
Product NDC 81653-007
11-digit billing NDC 81653000701
RxCUI 645146
UNII 5965120SH1
Application # 505G(a)(3)
SPL Set ID 085de93f-dae3-9964-e063-6394a90a5853
Established class (EPC) Arteriolar Vasodilator
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 2023-10-23
Route TOPICAL
Dosage form LIQUID
Substance MINOXIDIL
Why two NDCs? The FDA registers this code as 81653-007-01 — 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 → 81653-0007-01. 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

LabelerGuangzhou Jianyuan Biological Technology.Co.,Ltd
FDA application505G(a)(3) (OTC MONOGRAPH DRUG)
Labeler code81653
First marketedOct 2023
Product typeHuman Otc Drug
Portfolio4 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 H4N855PNZ1
    Alpha-tocopherol is a form of vitamin E, a fat-soluble antioxidant derived from natural or synthetic sources. In medicines, it prevents oils and fats from breaking down and becoming rancid, protecting the product's stability and shelf life.
  • UNII 344S277G0Z
    Allantoin is a naturally derived compound that helps soften and soothe skin. In medicines, it works as a skin-conditioning agent and may help support wound healing and reduce irritation in topical formulations.
  • UNII ZY81Z83H0X
    Aloe vera leaf is a plant extract derived from the aloe plant. It is used in medicines as a natural moisturizer and skin-soothing agent in topical formulations.
  • UNII 4V59G5UW9X
    Argan oil is a plant-derived oil from argan tree kernels. It's used in medicines as an emollient and skin-conditioning agent to help soften and moisturize the product's texture.
  • UNII 6SO6U10H04
    Biotin is a B-vitamin used as a nutritional supplement in some medications. It may also serve as a colorant or marker in formulations.
  • UNII 3G6A5W338E
    Caffeine is a natural stimulant compound commonly extracted from coffee beans and tea leaves. In medicines, it serves as an active booster in pain relievers and cold products to enhance alertness and improve the effectiveness of other ingredients.
  • UNII 5OCF3O11KX
    A plant-derived surfactant made from coconut oil. It helps mix oil and water ingredients together in the formulation and can improve how the medicine spreads or feels on the skin.
  • UNII 147D247K3P
    Ethylhexylglycerin is a synthetic preservative used to prevent bacteria and mold from growing in medicines and personal care products. It helps keep the product safe and stable throughout its shelf life.
  • 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 3K6008UJ5J
    A modified amino acid derivative used as a mucolytic agent in formulations. It helps thin and loosen mucus, making it easier to clear from airways, and may also serve as a stabilizer in the medicine.
  • UNII W2ZU1RY8B0
    A plant extract from green tea leaves. It's used as an antioxidant ingredient to help preserve the medicine and maintain its stability during storage.
  • UNII G46579QK1M
    A protein-derived ingredient made from keratin, the natural structural protein found in hair. It functions as a film-former and conditioner in topical products, helping to coat and soften the skin or hair.
  • UNII S270N0TRQY
    Hyaluronic acid is a naturally occurring substance found in skin and joints. In medicines, it acts as a moisturizer and thickening agent to improve texture and help the product spread smoothly.
  • UNII 724GKU717M
    Jojoba oil is a natural liquid wax extracted from jojoba plant seeds. It's used in medicines as an emollient and lubricant to soften and smooth the product, and sometimes as a carrier or penetration enhancer.
  • UNII 25X51I8RD4
    Niacinamide is a form of vitamin B3, a water-soluble nutrient. In medicines, it may be added as a nutritional supplement or to support skin health, though its primary role here is as an active ingredient rather than a traditional inactive filler.
  • UNII AV092KU4JH
    A natural oil extracted from peppermint plants. It's used as a flavoring agent to mask bitter tastes and add a refreshing mint flavor to medicines, making them easier to take.
  • 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 6E5QR5USSP
    Pumpkin seed oil is a plant-based oil extracted from pumpkin seeds. In medicines, it serves as an emollient and carrier to help dissolve or suspend active ingredients and improve how the product feels and absorbs.
  • UNII 2540B7G25G
    Reynoutria japonica leaf is an extract from Japanese knotweed plant. It's used in formulations as a natural preservative and antioxidant to help maintain product stability and prevent spoilage.
  • UNII 8LGU7VM393
    Rosemary leaf oil is a natural aromatic oil extracted from rosemary plants. It's used in medicines as a flavoring agent and preservative to help protect the product from spoilage.
  • UNII J7WWH9M8QS
    A plant-derived powder made from saw palmetto berries. It's included in some formulations as a natural ingredient and potential filler, though its primary role is typically as an active botanical rather than a structural excipient.
  • UNII VIF565UC2G
    Tea tree oil is an essential oil extracted from the leaves of the Australian tea tree plant. In medicines, it typically serves as a flavoring agent, fragrance, or antimicrobial component in topical formulations.
  • UNII 710FLW4U46
    Urtica dioica, commonly known as stinging nettle, is a plant extract used in medicines as a natural flavoring agent, colorant, or nutritional additive. It may also help improve tablet texture or serve as a botanical supplement ingredient.
  • UNII C34U15ICXA
    A plant extract from grape seeds that acts as an antioxidant and preservative in medications. It helps protect the active ingredients from degrading and extends the product's shelf life.
  • 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 TTV12P4NEE
    Xanthan gum is a thickening and stabilizing ingredient made from fermented corn or other sugars. It's added to medicines to improve texture, prevent separation of liquids and solids, and help the product stay consistent.

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

The official label also statesAqua, hyaluronic acid, cocamidopropyl betaine, keratin aminoacids, tocopherol(vitamin E), glycerol, xanthan gum, glyoxyloylallantoin, aloe barbadensis leaf extract, propylene glycol, vitasvinifera seed extract, polygonum cuspidatum extract,ethylhexlglycerin, biotin, argania spinosa kernel oil, simmondsiachinesis (jojoba) seed oil, castor oil, saw palmetto, peppermint oil.rosemary oil, pumpkin seed oil, caffeine, stinging nettle,niancinimide, green tea

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 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
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/g 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/mLthis 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 —
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

🏛️
2023
On the market since
Oct 2023
📍
2026
Currently FDA-listed
3 years listed
🔒
·
Generic approved (availability unconfirmed)
see note
🔒Generic approved by FDA, but pharmacy availability is not confirmed

The FDA lists approved generic versions of this medicine, but that does not always mean a pharmacy can get one today. Patent rules, launch agreements, supply and pricing can affect when generics actually arrive.

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 Regenivade Hair Growth 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
2019 2021 2023 2026 2,457 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
81653-0007-01 You're viewing this 1 BOTTLE in 1 PACKAGE (81653-007-01) / 60 mL in 1 BOTTLE 2023-10-23 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 81653-007-01, 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: 81653-0007-01, written without dashes as 81653000701. 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 81653-0007-01, the first segment (81653) is the labeler code FDA assigned to Guangzhou Jianyuan Biological Technology.Co.,Ltd; the middle segment (0007) 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 Guangzhou Jianyuan Biological Technology.Co.,Ltd. Listing status can change — the directory data on this page refreshes weekly.
Who lists this product with the FDA?
Guangzhou Jianyuan Biological Technology.Co.,Ltd 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 4 words ▾

Use to regrow hair

⏱️ Dosage and Administration 47 words ▾

Directions Men: Apply half a capful 2 times a day to the hair loss area. Women: Apply half a capful 1 time a day to the hair loss area. Massage to area with fingers, then wash hands well. Using more and more often will not improve results.

⚠️ Warnings ~1 min read ▾

Warnings For external use only. Do not use if: You are a pregnant woman Your amount of hair loss is different than that shown on the sideof this carton or your hair loss is on the front of the scalp. 5%minoxidil topical foam is not intended for frontal baldness orreceding hairline.

You suffer from metal allergies You have no family history of hair loss. You 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. You 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 withtwice a day usage.

For some people, you may need to use thisproduct for at least 4 months before you see results.The amount of hair regrowth is different for each person. Thisproduct will not work for all people. 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. lf swallowed, get medical help orcontact Poison Control Center right away.

🧪 Active Ingredient 5 words ▾

Active Ingredient Minoxidil 5% w/v

🧪 Inactive Ingredients 51 words ▾

Inactive Ingredient Aqua, hyaluronic acid, cocamidopropyl betaine, keratin aminoacids, tocopherol(vitamin E), glycerol, xanthan gum, glyoxyloylallantoin, aloe barbadensis leaf extract, propylene glycol, vitasvinifera seed extract, polygonum cuspidatum extract,ethylhexlglycerin, biotin, argania spinosa kernel oil, simmondsiachinesis (jojoba) seed oil, castor oil, saw palmetto, peppermint oil.rosemary oil, pumpkin seed oil, caffeine, stinging nettle,niancinimide, green tea

🎯 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 ↗
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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.