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HAIRFX HAIR GROWTH FOAM Minoxidil 5 g/100g Aerosol, Foam, 60 g — NDC 81653-0003-01 package photo
Label image from the product's FDA listing (DailyMed) — may show a different pack size or an older label revision.

HAIRFX HAIR GROWTH FOAM Minoxidil 5 g/100g Aerosol, Foam, 60 g — NDC 81653-003-01 (Billing 81653-0003-01)

by Guangzhou Jianyuan Biological Technology.Co.,Ltd · 60 g in 1 BOTTLE

This is a package of 60 g of HAIRFX HAIR GROWTH FOAM Minoxidil 5 g/100g Aerosol, Foam from Guangzhou Jianyuan Biological Technology.Co.,Ltd, marketed since Mar 2022 and currently FDA-listed. It is this product's only package size.

NDC 81653-0003-01
🏷️ FDA NDC (as labeled) 81653-003-01 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 Jul 24, 2026 · sources: openFDA · FDA label (DailyMed) · FDA Orange & Purple Book · First Databank · CMS NADAC, ASP, Medicare & Medicaid · RxNorm
📋 All sources & update times →

NDC database record

One package, one record: these facts belong to NDC 81653-003-01 alone.

Record
FDA NDC Directory package listing · Human OTC drug
Code segments
81653 labeler · 003 product · 01 package
Package marketed since
Mar 27, 2022
Sample package
No — commercial package
Listing certified through
Dec 31, 2027
Barcode (UPC-A, from the NDC)
3 8165300301 4
FDA record last changed
Jul 24, 2026

Identity & classification

Regulatory identifiers FDA, NLM and CMS codes for this package

FDA NDC (as labeled) 81653-003-01
Product NDC 81653-003
11-digit billing NDC 81653000301
RxCUI 645146
UNII 5965120SH1
Application # 505G(a)(3)
SPL Set ID dec7249c-e1f9-b5eb-e053-2995a90acf37
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 2022-03-23
Route TOPICAL
Dosage form AEROSOL, FOAM
Substance MINOXIDIL
Quick answers
  • RxCUI (RxNorm): 645146
Why two NDCs? The FDA registers this code as 81653-003-01 — 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 → 81653-0003-01. 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
81653-0003-01 You're viewing this Main listing 60 g in 1 BOTTLE 2022-03-27 — 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/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/100gthis 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 —
5% Minoxidil(For Men) 5 g/100g 87815-0004-01 Guangzhou 60 g — — FDA listed —
5%Minoxidil Topical Aerosol(For Men) 5 g/100g 84355-0005-01 Guangzhou 1 canister — — FDA listed —
Kirkland Signature Minoxidil 5 g/100g 63981-0098-06 Costco 6 cans — — FDA listed —
Hair Regrowth Treatment 5 g/100g 72288-0674-03 Amazon.com 3 cans — — 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

🏛️
2022
On the market since
Mar 2022
📍
2026
Currently FDA-listed
4 years listed
🔓
·
Generic versions listed
see equivalents
✅Generic appears available

FDA-approved generic versions are listed, and recent pricing/market data suggests they may be available — see Therapeutic equivalents.

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 B66F4574UG
    A plant-derived ingredient from Chinese angelica root, used as a natural flavoring and fragrance agent in medicines. It may also serve as a traditional ingredient to support formulation stability.
  • 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 S07O44R1ZM
    Capsaicin is a pungent compound from chili peppers. In topical medicines, it acts as an active warming or heat-producing agent rather than a traditional inactive ingredient, creating localized skin sensation.
  • UNII S2D77IH61R
    A plant extract from the bark of the alder buckthorn shrub. It's used as a natural colorant and may also provide mild laxative properties to support the medication's intended effect in digestive formulations.
  • UNII 42B5YD8F0K
    A plant extract from licorice root used in traditional medicine. In formulations, it may serve as a flavoring agent, sweetener, or soothing ingredient to improve taste and texture.
  • UNII RR83T99U97
    A plant-derived substance from Asian lovage root used in traditional formulations. It may serve as a flavoring agent, fragrance component, or natural additive to support product stability and palatability.
  • UNII M9G2U96DUT
    A plant extract from the glossy privet fruit, used as a natural coloring agent or botanical ingredient in some formulations. It may help provide color and support the product's stability.
  • UNII E35T4MOI3E
    A plant extract from ginseng fruit used as a flavor ingredient and botanical additive in medicines. It may enhance taste and provide traditional plant-based components to the formulation.
  • UNII 835370K47L
    A plant extract from the oriental arborvitae tree, used as a natural flavoring agent, fragrance component, or botanical additive in medicines to enhance taste or aroma.
  • UNII I8442U2G7J
    A protein derived from pork skin or bones that acts as a binder and thickening agent. It helps hold tablet ingredients together and can improve the texture and stability of capsules and other formulations.
  • UNII AUZ3VD75MC
    A plant extract from Japanese knotweed root used as a natural colorant and antioxidant in medications. It helps preserve the product and may contribute to the pill's appearance or stability.
  • UNII 4VBL71TY4Y
    Safflower is a plant-derived ingredient used as a natural colorant and flavoring agent in medicines. It may also serve as a filler to add bulk to the formulation.
  • 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.

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

The official label also statesWater, Vitamin H (Biotin), Pork Collagen. Panax Ginseng Berry Extract, Carthamus Tinctorius (Safflower) Flower Extract, Frangula Alnus Bark Extract, Ligustrum Lucidum Fruit Extract, Ligusticum Chuanxiong Root Extract, Glycyrrhiza Uralensis (Licorice) Root Extract, Angelica Sinensis Root Extract, Platycladus Orientalis, Polygonum Multiflorum Root Extract, Capsaicin

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 Jianyuan Biological Technology.Co.,Ltd
FDA application505G(a)(3) (OTC MONOGRAPH DRUG)
Labeler code81653
First marketedMar 2022
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.

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 53 words ▾

for hair loss Apply half a capful once daily to 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

⏱️ Dosage and Administration 35 words ▾

THIS PACKAGE CONTAINS. One 60g (2.11 fl oz) cans of Foam (one month supply) Apply half a capful once daily to directly to the scalp in the hair loss area massage into scalp with fingers

⚠️ Warnings and Cautions 38 words ▾

When using this product keep out of eyes, ears, andmouth. In case of contact with eyes, rinse eyes thoroughlywith water. Stop use and ask a doctor if irritation or rash occurs.These may be signs of a serious condition.

⚠️ Warnings 22 words ▾

For adult external use only. Flammable. Keep away fromheat or flame. Do not use ·Pregnant women and children. ·on open skin wounds

📦 Storage and Handling 37 words ▾

other information Store at Controlled Room Temperature 20 °C to25 °C(68°Fto 77°F) Contents under pressure.Do not puncture or incinerate container. Do not expose to heat or store at temperatures above 120°F(49 °C). Don't hold straight upside down

🧪 Active Ingredient 4 words ▾

Active ingredient Minoxidil 5%

🧪 Inactive Ingredients 45 words ▾

lnactive ingredients Water, Vitamin H (Biotin), Pork Collagen. Panax Ginseng Berry Extract, Carthamus Tinctorius (Safflower) Flower Extract, Frangula Alnus Bark Extract, Ligustrum Lucidum Fruit Extract, Ligusticum Chuanxiong Root Extract, Glycyrrhiza Uralensis (Licorice) Root Extract, Angelica Sinensis Root Extract, Platycladus Orientalis, Polygonum Multiflorum Root Extract, Capsaicin

🎯 Purpose 76 words ▾

STRONGER THICKER LONGER HAIR REDUCE HAIR LOSS RESTORE THINNING HAIR The Foam is for somepeople who have a general thinning of hair on the top of the scalp(vertex only, asshown below). Not intendedfor frontal baldness or areceding hairline. The Foamhas been shown to regrowhair in some people with thefollowing degrees of thinninghair or hair loss. lf you have more hair loss or hair loss in a place different than shown above, Foam may not work. 1122

📄 Stop Use and Ask a Doctor If 69 words ▾

Do not use - Pregnant women and children. - on open skin wounds when using this product keep out of eyes,ears, and mouth. ln case of contact with eyes, rinse eyes thoroughly with water. Stop use and ask a doctor if irritation or rashoccurs.These may be signs of a serious condition. Keep out of reach of children. If swallowed, get medical help or contact a Poison ControlCenter right away.

📄 Keep Out of Reach of Children 24 words ▾

KEEP OUT OF REACH OF CHILDREN Keep out of reach of children.lf swallowed, get medical help or contact a Poison Control Center right away.

📄 Package Label / Principal Display Panel 1 words ▾

60g

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 ✓ 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 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.
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.