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Minoxidil for Women 50 mg/g Aerosol, Foam — NDC 70000-0753-1 (Billing 70000-0753-01)

by CARDINAL HEALTH 110, LLC. DBA LEADER · 1 CAN in 1 CARTON (70000-0753-1) / 60 g in 1 CAN

NDC 70000-0753-1 (billing 70000-0753-01) is a package of Minoxidil for Women 50 mg/g Aerosol, Foam from CARDINAL HEALTH 110, LLC. DBA LEADER, marketed since Mar 2026 and currently FDA-listed. It is this product's only package size.

NDC 70000-0753-01
🏷️ FDA NDC (as labeled) 70000-0753-1 billing pads the package segment with a zero
OTC Generic On market Non-controlled ⇄ 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 →

Identity & classification

Regulatory identifiers FDA, NLM and CMS codes for this package

FDA NDC (as labeled) 70000-0753-1
Product NDC 70000-0753
11-digit billing NDC 70000075301
RxCUI 645146
UNII 5965120SH1
Application # ANDA218616
SPL Set ID 33f9e0de-dff1-4a14-8aec-8c842bf34c31
Established class (EPC) Arteriolar Vasodilator
Physiologic effect Arteriolar Vasodilation
DEA schedule Non-controlled
Marketing category ANDA
Marketing status On market
FDA listing status Listed (active directory)
Marketing start 2026-03-16
Route TOPICAL
Dosage form AEROSOL, FOAM
Substance MINOXIDIL
Quick answers for NDC 70000-0753-1
  • RxCUI (RxNorm): 645146
  • 11-digit billing NDC: 70000075301
Why two NDCs? The FDA registers this code as 70000-0753-1 — a 5-4-1 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 package segment → 70000-0753-01. 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.

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 gPer 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
70000-0753-01 70000-0753-1 You're viewing this Main listing 1 CAN in 1 CARTON (70000-0753-1) / 60 g in 1 CAN 2026-03-16 — Active

Therapeutic equivalents

ProductLabelerPackNADAC/unitTEStatusPrice vs. this
Minoxidil 5% (For Men) 50 mg/g 51672-2128-04 Sun 1 can $0.275 — Availability likely —
Minoxidil For Women 50 mg/g 51672-2129-04 Sun 1 can $0.275 — 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/gthis 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/mL 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 — — Discontinued —
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 —
Nizoral Hair Regrowth Treatment for Men 50 mg/g 55505-0237-86 Kramer 3 cans — — FDA listed —
Minoxidil 5% (For Men) 50 mg/g 21130-0208-03 Better 3 cans — — FDA listed —
Minoxidil 5% (For Women) 50 mg/g 58602-0104-23 Aurohealth 3 cans — — FDA listed —
Minoxidil 5% (For Men) 50 mg/g 58602-0614-23 Aurohealth 3 cans — — 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

🏛️
2026
On the market since
Mar 2026
📍
2026
Currently FDA-listed
listed with the FDA
🔓
·
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.

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.

Loading inactive ingredients from the official FDA label in the background. No external source is being called by this page request.
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.

Manufacturer & labeler

LabelerCARDINAL HEALTH 110, LLC. DBA LEADER
Application holderAUROBINDO PHARMA LTD
FDA applicationANDA218616 (ANDA)
Labeler code70000
First marketedMar 2026
Product typeHuman Otc Drug
Portfolio163 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.

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 17 words ▾

Use to regrow hair on the top of the scalp (see pictures on side of this carton)

⏱️ Dosage and Administration 61 words ▾

Directions see enclosed leaflet for complete directions on how to use apply half a capful once daily directly to the scalp in the hair loss area massage into scalp with fingers, then wash hands well using more or more often will not improve results continued use is necessary to increase and keep your hair regrowth, or hair loss will begin again

⚠️ Warnings 17 words ▾

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

📦 Storage and Handling 62 words ▾

Other information see hair loss pictures on side of this carton before use, read all information on carton and enclosed leaflet keep the carton. It contains important information. Store at 20°C to 25°C (68°F to 77°F) [See USP Controlled Room Temperature]. contents under pressure. Do not puncture or incinerate container. Do not expose to heat or store at temperatures above 120°F (49°C).

🧪 Active Ingredient 8 words ▾

Active ingredient Minoxidil USP 5% w/w (without propellant)

🧪 Inactive Ingredients 81 words ▾

Inactive ingredients Alcohol, anhydrous citric acid, butane, butylated hydroxy toluene, cetyl alcohol, glycerin, isobutane, lactic acid, polysorbate 60, propane, purified water, stearyl alcohol Questions? Call toll-free 1-855-274-4122 (Monday – Friday 8:30 AM to 5:00 PM EST) *This product is not manufactured or distributed by Johnson & Johnson Consumer Inc., distributor of Women’s Rogaine ® . Cardinal Health ™ DISTRIBUTED BY CARDINAL HEALTH DUBLIN, OHIO 43017 www.myleader.com 1-800-200-6313 Essential to Care™ since 1979 Made in India Code: TS/DRUGS/58039/2020 CIN 6103956 REV.

02/26

🎯 Purpose 6 words ▾

Purpose Hair regrowth treatment for women

📄 Do Not Use 89 words ▾

Do not use if your degree of hair loss is different than that shown on 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 10 words ▾

Ask a doctor before use if you have heart disease

📄 When Using This Product 103 words ▾

When using this product do not use more than directed 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 3 months with once-daily use.

For some women, you may need to use this product once a day for at least 6 months before you see results. the amount of hair regrowth is different for each person. This product will not work for all 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 in 6 months

🤰 If Pregnant or Breast-Feeding 9 words ▾

May be harmful if used when pregnant or breast-feeding.

📄 Keep Out of Reach of Children 22 words ▾

Keep out of reach of children and pets. If swallowed, get medical help or contact a Poison Control Center (1-800-222-1222) right away.

📄 Package Label / Principal Display Panel 70 words ▾

PRINCIPAL DISPLAY PANEL - One 60 g Can Carton LEADER™ NDC 70000-0753-1 For Women Minoxidil Topical Aerosol, 5% Hair Regrowth Treatment Hair Regrowth Treatment for Women Reactivates Hair Follicles to Stimulate Regrowth Clinically Proven to Regrow Hair Once-a-Day Foam For Women COMPARE TO WOMEN'S ROGAINE ® active ingredient* 100% Money Back Guarantee Unscented 2 MONTH SUPPLY 1-60 g (2.11 OZ) CAN PRINCIPAL DISPLAY PANEL - One 60 g Can Carton

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.

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 — Not published for this NDC No photo available yet for this listing.
Inactive ingredients (structured) — Not published for this NDC The labeler did not submit a structured excipient list, or no SPL is available.
NADAC pharmacy acquisition price (CMS) — Not published for this NDC CMS publishes NADAC only for NDCs reported in its retail-pharmacy survey.
Orange Book / therapeutic-equivalence data — Not published for this NDC Applies only to products approved under an NDA/ANDA; many listings are out of scope.
HCPCS J-code billing crosswalk — Not published for this NDC Most self-administered / retail products have no J-code — that is normal.
Medicaid utilization (CMS SDUD) — Not published for this NDC CMS reports utilization only for NDCs with Medicaid claims above its privacy threshold.
“Not published” reflects what the public FDA / CMS / NLM sources provide for this exact package code — it is a property of the data feeds, not a judgment about the product.

Questions about this listing

Why is there no price listed?
The pricing shown on our NDC pages comes from CMS NADAC, a voluntary survey of retail community pharmacy invoices. CMS does not publish a NADAC for every NDC — packages outside the retail survey (institutional and hospital products, bulk packages, discontinued items, and many OTC items) may never receive one. A missing price reflects the survey's scope, not this product's actual cost, and does not mean the product is free or unavailable.
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 70000-0753-1, 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: 70000-0753-01, written without dashes as 70000075301. 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 70000-0753-01, the first segment (70000) is the labeler code FDA assigned to CARDINAL HEALTH 110, LLC. DBA LEADER; the middle segment (0753) 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 CARDINAL HEALTH 110, LLC. DBA LEADER. Listing status can change — the directory data on this page refreshes weekly.
Who lists this product with the FDA?
CARDINAL HEALTH 110, LLC. DBA LEADER 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.
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.