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Gainxtra Hair Regrowth Treatment for Men and Women Minoxidil 5% Sprays with Biotin 50 mg/mL Spray — NDC 85929-100-01 (Billing 85929-0100-01)

by GAINXTRA LLC · 1 BOTTLE, SPRAY in 1 BOX / 60 mL in 1 BOTTLE, SPRAY

This is a package of Gainxtra Hair Regrowth Treatment for Men and Women Minoxidil 5% Sprays with Biotin 50 mg/mL Spray from GAINXTRA LLC, no longer marketed (first marketed Nov 2025), no longer in the FDA NDC Directory. It is this product's only package size.

NDC 85929-0100-01
🏷️ FDA NDC (as labeled) 85929-100-01 billing pads the product segment with a zero
OTC Discontinued Non-controlled ⚠ Inactivated by FDA ⇄ Compare with another NDC
🗂️ FDA directory synced Oct 1, 2026 · this listing last changed Jul 24, 2026 · sources: openFDA · FDA label (DailyMed) · FDA Orange & Purple Book · First Databank · CMS NADAC, ASP, Medicare & Medicaid · RxNorm
📋 All sources & update times →

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 85929-100-01 alone.

Record
FDA NDC Directory package listing · Human OTC drug
Code segments
85929 labeler · 100 product · 01 package
Package marketed since
Nov 7, 2025
Sample package
No — commercial package
Listing certified through
Dec 31, 2026
Barcode (UPC)
0385929100018
FDA record last changed
Jul 24, 2026
⚠️
Excluded from the active FDA NDC Directory. FDA inactivated this product’s listing record, so it is excluded from the active NDC Directory. The listing was last certified through Dec 2026. 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

Regulatory identifiers FDA, NLM and CMS codes for this package

FDA NDC (as labeled) 85929-100-01
Product NDC 85929-100
11-digit billing NDC 85929010001
RxCUI 1537948
UNII 5965120SH1
UPC 0385929100018
Application # 505G(a)(3)
SPL Set ID c9b57d68-9aba-471b-b07a-9ba41b38c762
Established class (EPC) Arteriolar Vasodilator
Physiologic effect Arteriolar Vasodilation
DEA schedule Non-controlled
Marketing category OTC MONOGRAPH DRUG
Marketing status Discontinued
FDA listing status Inactivated by FDA (certified through Dec 2026)
Marketing start 2025-11-07
Route TOPICAL
Dosage form SPRAY
Substance MINOXIDIL
Quick answers
  • RxCUI (RxNorm): 1537948
Why two NDCs? The FDA registers this code as 85929-100-01 — 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 → 85929-0100-01. 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

📗 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 →
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.

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
85929-0100-01 You're viewing this Main listing 1 BOTTLE, SPRAY in 1 BOX / 60 mL in 1 BOTTLE, SPRAY 2025-11-07 — Inactivated by FDA

Therapeutic equivalents

ProductLabelerPackNADAC/unitTEStatusPrice vs. this
BOSLEY Minoxidil Topical Solution 5 (for men) 50 mg/mL 69113-0483-00 Scientific 1 bottle — — FDA listed —
DS Labs Spectral UHP Men s Extra Strength Hair Regrowth Treatment 50 mg/mL 69188-0593-00 DS 1 bottle — — FDA listed —
Minoxidil Extra Strength for Men 5 g/100mL 72484-0097-01 Roman 3 bottles — — FDA listed —
Elevate Hair Regrowth Treatment 5 50 mg/mL 84561-0524-00 VAPOR 1 bottle — — FDA listed —
5% Minoxidil HAIR GROWTH SPARY 5 g/100mL 84778-0099-01 Guangzhou 1 bottle — — Discontinued —
5%Minoxidilhairgrowthspray 5 g/100mL 84778-0105-01 Guangzhou 1 bottle — — Discontinued —
Minoxidil hair growth serum 50 mg/100mL 84867-0005-01 Jiashen 100 ml — — FDA listed —
Minoxidil Hair Growth Serum 5 g/100mL 85092-0001-01 Shenzhen 1 bottle — — Discontinued —
iBeaLee 5-in-1 5% Minoxidil Hair Regrowth Solution 5 g/100mL 85636-0010-01 Shenzhen 60 ml — — FDA listed —
iBeaLee 5% Minoxidil Hair Regrowth Treatment 5 g/100mL 85636-0018-01 Shenzhen 60 ml — — FDA listed —
5% Minoxidil Hair Regrowth Treatment 5 g/100mL 85636-0023-01 Shenzhen 60 ml — — FDA listed —
Minoxidil Hair Regrowth Treatment 5 g/100mL 85636-0024-01 Shenzhen 60 ml — — FDA listed —
Gainxtra Hair Regrowth Treatment for Men and Women Minoxidil 5% Sprays with Biotin 50 mg/mLthis 85929-0100-01 GAINXTRA 1 bottle — — Discontinued —
DAAZZS 5% Minoxidil Hair and Beard Regrowth Kit with Biotin 5 g/100mL 87408-0008-01 Guangzhou 2 bottles — — FDA listed —
FUZYAT 5% Minoxidil Hair Growth for Men and Women 5 g/100mL 87408-0015-01 Guangzhou 2 bottles — — FDA listed —
Hair Growth Serum 5 g/100mL 87540-0001-01 Shenzhen 60 ml — — FDA listed —
About this product: 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

🏛️
2025
On the market since
Nov 2025
📍
2026
Currently FDA-listed
1 year 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.

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 94ZLA3W45F
    Arginine is an amino acid used in medicines as a buffer and pH adjuster. It helps maintain the proper acidity level and stability of liquid formulations.
  • UNII E4M09UY5BL
    A dried plant material from sweet wormwood. It's used in some formulations as a natural filler or ingredient to add bulk to the product.
  • UNII 2JYC99Q0WZ
    A plant extract from Artemisia argyi, commonly known as mugwort. It may be used as a flavoring agent, fragrance, or traditional botanical ingredient in some formulations.
  • 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 UPY805K99W
    A synthetic compound derived from caprylic acid that works as a preservative and antimicrobial agent to help prevent bacterial and fungal growth in the medicine.
  • UNII 6BJQ43T1I9
    A synthetic peptide made from copper and amino acids. It's used in topical formulations as an active conditioning or skin-support ingredient, though classified as an excipient in some product listings.
  • UNII CA2Y0FE3FX
    A salt derived from licorice root extract, used as a flavoring agent and sweetener. It may also help soothe and protect mucous membranes in throat lozenges and cough products.
  • 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 GXZ33VNT92
    Gentiana scabra root is a plant extract used in some formulations as a flavoring agent and natural colorant. It may also serve to support the product's stability and shelf life.
  • UNII C5529G5JPQ
    Ginger is a plant-derived ingredient used as a flavoring agent to add taste and aroma to medicines. It may also provide mild soothing properties to support product palatability.
  • UNII 1DI56QDM62
    A natural fatty substance from soybeans that helps mix oil and water-based ingredients together. It acts as an emulsifier and lubricant in medicines to improve texture and help the product break down properly in your body.
  • UNII WV9CM0O67Z
    Panthenol is a humectant and skin-conditioning agent derived from pantothenic acid. It's added to medicines to help retain moisture and soothe skin irritation.
  • UNII 32E5V7G32B
    A plant extract from Oriental arborvitae leaves, used in formulations as a natural flavoring agent, fragrance component, or preservative to enhance taste, aroma, or shelf stability.
  • 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 IYR6K8KQ5K
    A plant extract from sophora flavescens root used as a natural colorant and flavoring agent in medicines. It may also help preserve the product and provide texture.
  • 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.

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

The official label also statesPurified Water, Dipotassium Glycyrrhizinate, Propylene Glycol, Biotin, Panthenol, Tripeptide-1 Copper, Arginine, Platycladus Orientalis Leaf Extract, Zingiber Officinale Root Extract, Mugwort (Artemisia Argyi) Leaf Extract, Artemisia Annua (Artemisia Annua) Extract, Gentiana (Gentiana Scabra) Root Extract, Sophora Angustifolia (Sophora Angustifolia) Root Extract, Lecithin, Ethylhexylglycerin, Caprylyl Hydroxamic Acid.

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

LabelerGAINXTRA LLC
FDA application505G(a)(3) (OTC MONOGRAPH DRUG)
Labeler code85929
First marketedNov 2025
Product typeHuman Otc Drug
Portfolio2 products on file

More NDCs from GAINXTRA LLC labeler code 85929

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 🧪 Active Ingredient 🧪 Inactive Ingredients 🎯 Purpose 📄 Do Not Use 📄 Ask a Doctor Before Use If 📄 When Using This Product 📄 Stop Use and Ask a Doctor If 📄 Keep Out of Reach of Children 📄 Other Information 📄 Questions or Comments 📄 Package Label / Principal Display Panel
🎯 Indications and Usage 6 words ▾

USE To regrow hair the scalp

⏱️ Dosage and Administration 42 words ▾

Directions Apply 5 sprays twice daily directly onto the scalp in the area of hair loss massage into scalp with fingers, then wash hands well continued use is necessary to increase and maintain your hair regrowth or hair loss will begin again

⚠️ Warnings 17 words ▾

WARNINGS For external use only. Extremely Flammable: Avoid Fire, flame, or smoking during and immediately following application.

🧪 Active Ingredient 5 words ▾

ACTIVE INGREDIENT Minoxidil 5% W/V

🧪 Inactive Ingredients 47 words ▾

Inactive ingredients Purified Water, Dipotassium Glycyrrhizinate, Propylene Glycol, Biotin, Panthenol, Tripeptide-1 Copper, Arginine, Platycladus Orientalis Leaf Extract, Zingiber Officinale Root Extract, Mugwort (Artemisia Argyi) Leaf Extract, Artemisia Annua (Artemisia Annua) Extract, Gentiana (Gentiana Scabra) Root Extract, Sophora Angustifolia (Sophora Angustifolia) Root Extract, Lecithin, Ethylhexylglycerin, Caprylyl Hydroxamic Acid.

🎯 Purpose 8 words ▾

PURPOSE Hair regrowth treatment for men and women

📄 Do Not Use 95 words ▾

Do not use if: the amount of hair loss is different the amount that is shown on the carton or your hair loss is on the front of the scalp. 5% Minoxidil Spray is not intended for frontal baldness of receding hairline. you have no family history of hair loss your hair is sudden and/or patchy you do not know the reason for your hair loss you are 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 10 words ▾

Ask a doctor before use if you have heart disease.

📄 When Using This Product 84 words ▾

When using this product do not apply to other body parts 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. Some men and women may need to use this product for up to 4 months before seeing results the amount of hair regrowth is different for each person. This product will not work for all men and women

📄 Stop Use and Ask a Doctor If 44 words ▾

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 within 4 months

📄 Keep Out of Reach of Children 29 words ▾

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. (1-800-222-1222)

📄 Other Information 69 words ▾

Other information hair growth has been shown in a clinical study of men and women aged 18-49 years who used it for 4 months read all information and the enclosed leaflet before use store at this controlled room temperature 20° to 25°C (68° to 77°F) do not expose to hear or store in temperatures above 120°F (49°C) increasing the dose or frequency of use will not accelerate hair growth

📄 Questions or Comments 19 words ▾

Questions? Call (1-248-923-5024) or gainxtra.com Manufactured for and distributed by: Gainxtra LLC 3162 Martin Road Commerce Township, MI 48390

📄 Package Label / Principal Display Panel 9 words ▾

Save this leaflet for future reference. 1 2 3

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

Medicare Part D spend CMS · PART D · 2026 (Q1)

Medicare Part D (outpatient prescription) spending for Minoxidil (matched by generic name) — the program that covers self-administered drugs. 3 manufacturers.
⚠️ Drug-level data: CMS publishes Part D spending by drug, not by NDC — these figures combine every manufacturer, strength and package size sold under the name Minoxidil. That’s a different level of aggregation than the Medicaid card above, which is specific to this exact 11-digit NDC (pack size included), so the two aren’t directly comparable.
Period
Total Part D spend
$3.5M
Claims incl. refills
260.9K
Beneficiaries
202.1K
Spend / beneficiary
$17.33
Spend / claim
$13.42
Trend by period
💵 About the dollar figures: spending is what Part D plans paid before confidential manufacturer rebates, so the program’s real net cost is lower. A blank patient count means fewer than 11 people — CMS hides counts that small to protect privacy. Source: CMS Medicare Quarterly Part D Spending by Drug (data.cms.gov), updated quarterly.

Reported adverse events (FAERS)

Read carefully: FAERS reports are voluntary and unverified. Counts are not incidence, do not establish causation, are subject to reporting bias, and cannot be used to compare one drug to another. Shown for signal context only. Reports for Minoxidil — the ingredient across all brands.

Top reported reactions

Adverse Drug Reaction8,585
Alopecia3,803
Application Site Pruritus2,926
Overdose1,461
Application Site Irritation1,420
Application Site Pain1,413
Hair Texture Abnormal1,409

Age at onset

Neonate3
Infant14
Child18
Adolescent35
Adult4,531
Elderly2,902

Reporter sex

44,695 reports
Male · 58%
Female · 42%
Unknown · 0%
Reports over time (by year) — tap or hover for the count & year
2019 2021 2023 2026 8,466 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.

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) ✓ 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.
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 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.
Who lists this product with the FDA?
GAINXTRA 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.
← 85928-0625-00 · KLARINA 85929-0101-18 · GAINXTRA →
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.