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Nizoral Hair Regrowth Treatment for Men Minoxidil 50 mg/g Aerosol, Foam — NDC 55505-0237-86 package photo
Label image from the product's FDA listing (DailyMed) — may show a different pack size or an older label revision.

Nizoral Hair Regrowth Treatment for Men Minoxidil 50 mg/g Aerosol, Foam — NDC 55505-237-86 (Billing 55505-0237-86)

by Kramer Laboratories · 3 CAN in 1 PACKAGE / 60 g in 1 CAN

This is a package of Nizoral Hair Regrowth Treatment for Men Minoxidil 50 mg/g Aerosol, Foam from Kramer Laboratories, marketed since Aug 2026 and currently FDA-listed. It is this product's only package size.

NDC 55505-0237-86
🏷️ FDA NDC (as labeled) 55505-237-86 billing pads the product segment with a zero
OTC Generic On market Non-controlled ⇄ Compare with another NDC
🗂️ FDA directory synced Oct 8, 2026 · this listing last changed Aug 20, 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 55505-237-86 alone.

Record
FDA NDC Directory package listing · Human OTC drug
Code segments
55505 labeler · 237 product · 86 package
Package marketed since
Aug 1, 2026
Sample package
No — commercial package
Listing certified through
Dec 31, 2027
Barcode (UPC-A, from the NDC)
3 5550523786 5
FDA record last changed
Aug 20, 2026

Identity & classification

Regulatory identifiers FDA, NLM and CMS codes for this package

FDA NDC (as labeled) 55505-237-86
Product NDC 55505-237
11-digit billing NDC 55505023786
RxCUI 645146
UNII 5965120SH1
Application # ANDA218616
SPL Set ID d3260777-d56a-4a35-ac82-b0e8e8021517
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 2026-08-01
Route TOPICAL
Dosage form AEROSOL, FOAM
Substance MINOXIDIL
Quick answers
  • RxCUI (RxNorm): 645146
Why two NDCs? The FDA registers this code as 55505-237-86 — 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 → 55505-0237-86. 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 →
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
55505-0237-86 You're viewing this Main listing 3 CAN in 1 PACKAGE / 60 g in 1 CAN 2026-08-01 — Active

Therapeutic equivalents

ProductLabelerPackNADAC/unitTEStatusPrice vs. this
Minoxidil For Women 50 mg/g 51672-2129-04 Sun 1 can $0.275 — Availability likely —
Minoxidil 5% (For Men) 50 mg/g 51672-2128-04 Sun 1 can $0.275 — Availability likely —
Good Sense Hair Regrowth Treatment 50 mg/g 00113-1129-06 L. 6 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 —
hair regrowth treatment 50 mg/g 30142-0719-02 Kroger 2 cans — — Discontinued —
equate hair regrowth treatment 50 mg/g 49035-0905-01 Wal-Mart 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 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 —
hers hair regrowth treatment 50 mg/g 71730-0129-01 Hims 1 can — — FDA listed —
basic care hair regrowth treatment 50 mg/g 72288-0129-01 Amazon.com 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 (For Men) 50 mg/g 11673-0157-03 TARGET 3 cans — — FDA listed —
Minoxidil For Women 50 mg/g 70000-0753-01 CARDINAL 1 can — — FDA listed —
Minoxidil (For Men) 50 mg/g 82376-6006-03 SPAZI 3 cans — — FDA listed —
Minoxidil (for Men) 50 mg/g 82796-0100-01 RESTORATION 60 g — — FDA listed —
Gainxtra Hair Regrowth Treatment for Men and Women Minoxidil 5% Form with Biotin 50 mg/g 85929-0101-18 GAINXTRA 3 cans — — Discontinued —
Regoxidine (For Women) 50 mg/g 57483-0175-11 INNOVUS 1 can — — FDA listed —
Minoxidil 50 mg/g 59726-0115-60 P 60 g — — FDA listed —
Minoxidil 50 mg/g 59726-0151-60 P 1 can — — FDA listed —
Minoxidil For Women 50 mg/g 69113-0502-01 BosleyMD 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 —
hair regrowth treatment 50 mg/g 41250-0749-01 Meijer 1 can — — FDA listed —
Minoxidil 50 mg/g 59726-0116-60 P 60 g — — FDA listed —
Minoxidil For Men 50 mg/g 69113-0501-01 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 —
Minoxidil (For Women) 50 mg/g 11673-0158-04 TARGET 1 can — — FDA listed —
Regoxidine (For Men) 50 mg/g 57483-0165-11 INNOVUS 1 can — — FDA listed —
Minoxidil (For Men) 50 mg/g 51316-0212-01 CVS 1 can — — Discontinued —
Minoxidil 5% (For Men) 50 mg/g 58602-0608-01 Aurohealth 1 can — — FDA listed —
Minoxidil (for Men) 50 mg/g 69113-0128-01 SCIENTIFIC 1 can — — FDA listed —
minoxidil 50 mg/g 00113-5129-01 L. 60 g — — FDA listed —
Minoxidil 5% (For Women) 50 mg/g 58602-0607-01 Aurohealth 1 can — — FDA listed —
Minoxidil (For Women) 50 mg/g 51316-0213-01 CVS 1 can — — Discontinued —
Mens rogaine Minoxidil Unscented Formula 50 mg/g 69968-0031-01 Kenvue 1 can — — FDA listed —
Minoxidil (For Women) 50 mg/g 82376-6007-02 SPAZI 2 cans — — FDA listed —
Minoxidil (for Women) 50 mg/g 80855-0201-05 Virtue 1 can — — FDA listed —
Minoxidil 50 mg/g 59726-0122-60 P 1 can — — FDA listed —
Minoxidil (for Women) 50 mg/g 69113-0129-01 SCIENTIFIC 1 can — — FDA listed —
Nizoral Hair Regrowth Treatment for Men 50 mg/gthis 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
Aug 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.

🧪 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 3K9958V90M
    A liquid solvent derived from fermentation or chemical synthesis. In medicines, alcohol dissolves active ingredients, helps preserve the product, and improves how the body absorbs certain drugs.
  • UNII XF417D3PSL
    Anhydrous citric acid is a sour, crystalline powder derived from citric acid with water removed. In medicines, it acts as a buffer to control pH, adds tartness to improve taste, and helps tablets disintegrate.
  • UNII 6LV4FOR43R
    Butane is a colorless gas derived from petroleum. In medicines, it serves as a propellant in inhalers and aerosol sprays, helping deliver the active drug to the lungs or skin.
  • UNII 1P9D0Z171K
    BHT is a synthetic antioxidant that prevents fats and oils in medicines from breaking down and becoming rancid. It helps keep the product stable and effective during storage.
  • UNII 936JST6JCN
    Cetyl alcohol is a waxy, fatty substance derived from plant or animal sources. It acts as an emulsifier and thickener in medicines, helping blend oil and water components and giving products a smooth, creamy texture.
  • 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 BXR49TP611
    Isobutane is a liquefied gas used as a propellant in aerosol inhalers and sprays. It helps push the medicine out of the container so you can breathe or spray it as directed.
  • UNII 33X04XA5AT
    Lactic acid is a naturally occurring organic acid derived from milk or plant sources. It lowers and maintains pH in formulations, helps preserve the product, and can enhance ingredient stability and absorption.
  • UNII CAL22UVI4M
    A synthetic emulsifier derived from sorbitol and fatty acids. It helps mix oil and water-based ingredients together and improves the texture and stability of the medicine.
  • UNII T75W9911L6
    A flammable gas used as a propellant in aerosol formulations. It helps dispense the medicine as a fine mist or spray when you activate the inhaler or pump.
  • UNII 2KR89I4H1Y
    Stearyl alcohol is a waxy, fatty substance derived from natural oils or made synthetically. It acts as an emulsifier and thickener in medicines, helping mix ingredients together and give the product the right 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.

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

The official label also statesalcohol, anhydrous citric acid, butane, butylated hydroxy toluene, cetyl alcohol, glycerin, isobutane, lactic acid, polysorbate 60, propane, purified water, stearyl alcohol

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

LabelerKramer Laboratories
Application holderAUROBINDO PHARMA LTD
FDA applicationANDA218616 (ANDA)
Labeler code55505
First marketedAug 2026
Product typeHuman Otc Drug
Portfolio26 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 19 words ▾

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

⏱️ Dosage and Administration 62 words ▾

Directions apply half a capful 2 times a day to the scalp in the hair loss area massage into scalp with fingers, then wash hands well see enclosed leaflet for complete directions on how to use 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 22 words ▾

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

🧪 Active Ingredient 8 words ▾

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

🧪 Inactive Ingredients 23 words ▾

Inactive ingredients alcohol, anhydrous citric acid, butane, butylated hydroxy toluene, cetyl alcohol, glycerin, isobutane, lactic acid, polysorbate 60, propane, purified water, stearyl alcohol

🎯 Purpose 6 words ▾

Purpose Hair regrowth treatment for men

📄 Do Not Use 102 words ▾

Do not use if you are a woman your amount of hair loss is different than that shown on side of this carton or your hair loss is on the front of the scalp. 5% minoxidil topical foam is not intended for frontal baldness or receding hairline. 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. 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 96 words ▾

When using this product do not apply on other parts of the body avoid contact with the eyes. In case of accidental contact, rinse eyes with large amounts of cool tap water. some people have experienced changes in hair color and/or texture it takes time to regrow hair. Results may occur at 2 months with twice a day usage.

For some men, 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 men.

📄 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 4 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.

📄 Other Information 86 words ▾

Other information hair growth has been shown in a clinical study of men (mostly white) aged 18 to 49 years who used it for 4 months see hair loss pictures on side of this carton before use, read all information on package and enclosed leaflet keep the package. It contains important information store at 20° to 25°C (68° 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).

📄 Questions or Comments 4 words ▾

Questions? Call toll-free 1-800-824-4894

📄 Package Label / Principal Display Panel ~2 min read ▾

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL NOT FOR DANDRUFF Nizoral ® Hair Regrowth Treatment For Men MINOXIDIL TOPICAL AEROSOL 5% REACTIVATES HAIR FOLLICLES to stimulate regrowth CLINICALLY PROVEN to help regrow hair UNSCENTED EASY-TO-USE FOAM NOT FOR USE BY WOMEN THREE MONTH SUPPLY CONTAINS: THREE ● 60 g(2.11 oz) CANS P1062483 FOR BEST RESULTS USE TWICE DAILY APPLY DIRECTLY TO SCALP Minoxidil Topical Aerosol, 5% (For Men) is for men who have a general thinning of hair on the top of the scalp (vertex only, as shown below).

Not intended for frontal baldness or a receding hairline. Minoxidil Topical Aerosol, 5% (For Men) has been shown to regrow hair in men with the following degrees of thinning hair or hair loss. If men have more hair loss or hair loss in a place different than shown above, Minoxidil Topical Aerosol, 5% (For Men) may not work.

THIS PACKAGE CONTAINS Three 60 g (2.11 oz) cans of Minoxidil Foam (For Men) (Three month supply) DIRECTIONS FOR USE See information leaflet with complete directions on how to use and obtain best results. 1: PREP HANDS WITH COLD WATER Rinse your fingers in cold water and dry them. Note: foam will melt on contact with warm surfaces.

2: OPEN CHILD RESISTANT CAP Be sure to align arrow on the cap with arrow on white ring. Tilt cap back and pull off. 3: DISPENSE VERTICALLY ONTO A COLD SURFACE Hold the can straight upside down.

If you hold the can at an angle, foam may not dispense properly. Press nozzle to dispense half a capful of foam onto cold surface (e.g. dish, or cold hands). 4: APPLY TO SCALP, NOT HAIR Part your hair to expose hair loss area.

Massage foam into scalp, not hair. Repeat until all hair loss areas have been covered. 5: CLOSE CAP AND WASH HANDS Snap cap back into place.

Be sure arrows do not line up, so cap remains child resistant. Wash hands and any surface thoroughly after use. Distributed by: Kamer Laboratories, Inc.

Bridgewater, NJ 08807 USA Made in India © 2026 KRAMER LABORATORIES, INC. Code: TS/DRUGS/58039/2020 Before use, read all label information. If you have a drug reaction, contact a doctor and report it by calling: 1.800.824.4894 K0126

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

44,697 reports
Male · 58%
Female · 42%
Unknown · 0%

Serious outcomes

Hospitalization2,096
Death450
Disabling297
Life-threatening261
Reports over time (by year) — tap or hover for the count & year
2019 2021 2023 2026 5,601 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
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

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 Kramer Laboratories. Listing status can change — the directory data on this page refreshes weekly.
Who lists this product with the FDA?
Kramer Laboratories 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.