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5% MINOXIDIL SERUM 5 g/100mL Liquid, 60 mL — NDC 84558-0031-01 package photo
Label image from the product's FDA listing (DailyMed) — may show a different pack size or an older label revision.

5% MINOXIDIL SERUM 5 g/100mL Liquid, 60 mL — NDC 84558-031-01 (Billing 84558-0031-01)

by GUANGZHOU YUSONG FINE CHEMICLS Co., Ltd · 60 mL in 1 BOTTLE

This is a package of 60 mL of 5% MINOXIDIL SERUM 5 g/100mL Liquid from GUANGZHOU YUSONG FINE CHEMICLS Co., Ltd, marketed since Aug 2026 and currently FDA-listed. It is this product's only package size.

NDC 84558-0031-01
🏷️ FDA NDC (as labeled) 84558-031-01 billing pads the product segment with a zero
OTC On market Non-controlled ⇄ Compare with another NDC
🗂️ FDA directory synced Oct 8, 2026 · this listing last changed Sep 3, 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

NDC database record

One package, one record: these facts belong to NDC 84558-031-01 alone.

Record
FDA NDC Directory package listing · Human OTC drug
Code segments
84558 labeler · 031 product · 01 package
Package marketed since
Aug 20, 2026
Sample package
No — commercial package
Listing certified through
Dec 31, 2027
Barcode (UPC-A, from the NDC)
3 8455803101 4
FDA record last changed
Sep 3, 2026

Identity & classification

Regulatory identifiers FDA, NLM and CMS codes for this package

FDA NDC (as labeled) 84558-031-01
Product NDC 84558-031
11-digit billing NDC 84558003101
RxCUI 311724
UNII 5965120SH1
Application # 505G(a)(3)
SPL Set ID 595d2e2f-ce05-3a42-e063-6294a90ab0d2
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 2026-08-20
Route TOPICAL
Dosage form LIQUID
Substance MINOXIDIL
Quick answers
  • RxCUI (RxNorm): 311724
Why two NDCs? The FDA registers this code as 84558-031-01 — 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 → 84558-0031-01. 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.

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?
📖 Read our full Minoxidil guide →

Supplement & herbal interactions

🌿 Drug–supplement interaction checker →
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.

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.

Packaging — all sizes for this product

Package NDCDescription Marketing startMarketing endStatus
84558-0031-01 You're viewing this Main listing 60 mL in 1 BOTTLE 2026-08-20 — Active

Therapeutic equivalents

ProductLabelerPackNADAC/unitTEStatusPrice vs. this
5% Minoxidil Serum 5 g/100mLthis 84558-0031-01 GUANGZHOU 60 ml — — 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

🏛️
2026
On the market since
Aug 2026
📍
2026
Currently FDA-listed
listed with the FDA
🔒
·
No generic listed yet
brand only
ℹ️No FDA-approved generic found

We did not find an FDA-approved generic match for this exact strength, form and route.

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.

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.

🧪 Avoiding an ingredient? See Minoxidil inactive ingredients by manufacturer: every current product's list side by side, so you can ask your pharmacy for the version that does not list it.

💡 Tap an ingredient (hover on desktop) to see what it is and why it’s used.

  • UNII TMS4MGA0H4
    A synthetic liquid derived from petroleum-based chemistry. It acts as a solvent and humectant in medicines, helping dissolve active ingredients and retain moisture in topical or liquid formulations.
  • 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 TE7660XO1C
    Glycine is an amino acid used in medicines as a buffer to help stabilize pH and improve taste. It may also serve as a filler or binder to give the product proper form and consistency.
  • UNII 7YC686GQ8F
    A synthetic oily substance made from castor oil. It works as a solubilizer and emulsifier to help mix oily and water-based ingredients together in the medicine.
  • 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.
  • 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.

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

The official label also statesWater, Propylene Glycol, Glycerin, Butanediol, Glycine, Xanthan Gum, PEG-40 Hydrogenated Castor Oil.

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.

Manufacturer & labeler

LabelerGUANGZHOU YUSONG FINE CHEMICLS Co., Ltd
FDA application505G(a)(3) (OTC MONOGRAPH DRUG)
Labeler code84558
First marketedAug 2026
Product typeHuman Otc Drug
Portfolio26 products on file

More NDCs from GUANGZHOU YUSONG FINE CHEMICLS Co., Ltd labeler code 84558

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 label — Drug Facts FDA SPL

The complete FDA label for this product — the official Drug Facts labeling, verbatim, section by section. Jump with a chip, search within the label, or expand everything.
🎯 Indications and Usage ⏱️ Dosage and Administration ⚠️ Warnings 📦 Storage and Handling 🧪 Active Ingredient 🧪 Inactive Ingredients 🎯 Purpose 📄 Do Not Use 📄 When Using This Product 📄 Stop Use and Ask a Doctor If 📄 Keep Out of Reach of Children 📄 Package Label / Principal Display Panel
🎯 Indications and Usage 16 words ▾

Use Use to regrow hair on the vertex (top of scalp) in men with androgenetic alopecia.

⏱️ Dosage and Administration 53 words ▾

Directions Apply 1 mL twice a day directly onto the scalp in the hair loss area for men only. Using more or more often will not improve results. Loss will begin again if use is stopped. Continued use is necessary to increase and keep your hair regrowth, or hair loss will begin again.

⚠️ Warnings 5 words ▾

Warnings For external use only.

📦 Storage and Handling 23 words ▾

Other information Store at 20-25°C (68-77°F). Keep tightly closed. Before use, read all information on carton. Keep the carton. It contains important information.

🧪 Active Ingredient 5 words ▾

Active Ingredient(s) Minoxidil 5% w/v

🧪 Inactive Ingredients 14 words ▾

Inactive ingredients Water, Propylene Glycol, Glycerin, Butanediol, Glycine, Xanthan Gum, PEG-40 Hydrogenated Castor Oil.

🎯 Purpose 4 words ▾

Purpose Hair Regrowth Treatment

📄 Do Not Use 86 words ▾

Do not use ▪ you are a woman ▪ your hair loss pattern is different from the examples shown on the carton ▪ 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 ▪ 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 97 words ▾

▪ 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 people, 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 people.

📄 Stop Use and Ask a Doctor If 54 words ▾

▪ 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 ▪ If pregnant or breast-feeding, ask a health professional before use.

📄 Keep Out of Reach of Children 15 words ▾

If swallowed, get medical help or contact a Poison Control Center right away at 1-800-222-1222.

📄 Package Label / Principal Display Panel 8 words ▾

Package Label - Principal Display Panel label undefined

Source: FDA Structured Product Labeling, mirrored from DailyMed / openFDA. Prefer the government’s original formatting? View this label on DailyMed ↗

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 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 GUANGZHOU YUSONG FINE CHEMICLS Co., Ltd. Listing status can change — the directory data on this page refreshes weekly.
Who lists this product with the FDA?
GUANGZHOU YUSONG FINE CHEMICLS 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.
← 84558-0030-01 · GUANGZHOU 84558-0032-01 · GUANGZHOU →
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.