HomeNDC LookupIngredientsChloroxylenol › 59900-0217-01
SoftenSure Antimicrobial Liquid Chloroxylenol .75 mg/100mL Liquid, 500 mL — NDC 59900-0217-01 package photo

SoftenSure Antimicrobial Liquid Chloroxylenol .75 mg/100mL Liquid, 500 mL

by Best Sanitizers, Inc · 500 mL in 1 BOTTLE (59900-217-01)
NDC 59900-0217-01
🏷️ FDA NDC (as labeled) 59900-217-01 billing pads the product segment with a zero
This package
Contains500 mL Pack sizes4 compare ↓
OTC On market Non-controlled
🗂️ Data synced 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

FDA NDC (as labeled) 59900-217-01
Product NDC 59900-217
11-digit billing NDC 59900021701
UNII 0F32U78V2Q
Application # 505G(a)(3)
SPL Set ID 2929d297-4263-0d9a-e063-6294a90a762e
DEA schedule Non-controlled
Marketing category OTC MONOGRAPH DRUG
Marketing status On market
FDA listing status Listed (active directory)
Marketing start 2023-12-26
Route TOPICAL
Dosage form LIQUID
Substance CHLOROXYLENOL
Why two NDCs? The FDA registers this code as 59900-217-01 — 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 → 59900-0217-01. 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.

🏭 Manufacturer & labeler

LabelerBest Sanitizers, Inc
FDA application505G(a)(3) (OTC MONOGRAPH DRUG)
Labeler code59900
First marketedDec 2023
Product typeHuman Otc Drug
Portfolio5 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.

🩺 Clinical

🧪 What is this product?

SoftenSure Antimicrobial Liquid is a topical OTC product containing chloroxylenol, an antimicrobial agent commonly found in skin cleansing and disinfectant products. Chloroxylenol is typically used to reduce bacteria and other microorganisms on the skin surface. This product is an OTC monograph drug, meaning it is marketed under established FDA guidelines for antimicrobial skin cleansers rather than as an individually reviewed application.

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.

🧪 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 5KV86114PT
    A chemical compound used in medicines as a pH buffer and neutralizing agent. It helps maintain the proper acidity level in liquid formulations to improve stability and make the medicine easier to take.
  • UNII C80684146D
    A foaming agent and thickener derived from coconut oil. It helps create a smooth texture and stable foam in liquid or semi-solid medicines, improving how the product feels and applies.
  • UNII 03DH2IZ3FY
    A mild cleansing agent derived from coconut oil. It's used in medicines as a surfactant to help dissolve or distribute other ingredients evenly throughout the formulation.
  • UNII 40U37V505D
    A fatty acid derived from coconut oil. It acts as an emulsifier to help mix water and oil-based ingredients, and may also serve as a surfactant or lubricant in tablet and capsule formulations.
  • UNII I2W85YOX9L
    D&C Green No. 8 is a synthetic colorant approved for use in medicines. It adds green color to tablets, capsules, and other drug products for identification and appearance purposes.
  • UNII H3R47K3TBD
    FD&C Blue No. 1 is a synthetic blue dye approved for use in foods and medicines. It serves as a colorant to give the medication its distinctive appearance and help with product identification.
  • UNII I753WB2F1M
    FD&C Yellow No. 5 is a synthetic yellow colorant approved by the FDA. It is added to medicines to make pills, tablets, or liquids visually distinct and easier to identify.
  • 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 3NXW29V3WO
    Hypromellose is a plant-based thickener made from cellulose. It's used in medicines as a binder to hold ingredients together, a coating for tablets, and a thickener for liquids.
  • UNII 2UMI9U37CP
    Oleic acid is a naturally occurring fatty acid derived from plant or animal oils. It functions as an emulsifier and solvent in medicines, helping blend water and oil-based ingredients together and dissolving other components.
  • 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 0YPR65R21J
    Sodium sulfate is a mineral salt used in pharmaceuticals as a filler and diluent. It helps provide bulk and stability to tablets and capsules while remaining inert in the body.
  • UNII MP1J8420LU
    A salt derived from edetic acid that binds to trace metals in medicines. It serves as a chelating agent and preservative to prevent metal-catalyzed breakdown of the drug and extend shelf life.
  • 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.

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

The official label also statesCocamide MEA, Coco-Betaine, Coconut Fatty Acid, D&C Green No. 8, FD&C Blue No. 1, FD&C Yellow No. 5, Fragrance, Glycerin, Hydroxypropyl Methylcellulose, Monoethanolamine, Oleic Acid, Propylene Glycol, Sodium Sulfate, Tetrasodium EDTA, Water.

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 DailyMedingredient 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.

💲 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.
Try another pack size: 4 bottles 12 bottles 1200 ml
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.

🔁 Therapeutic equivalents

ProductLabelerPackNADAC/unitTEStatusPrice vs. this
SoftenSure Antimicrobial Liquid .75 mg/100mLthis 59900-0217-01 Best 500 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

🏛️
2023
On the market since
Dec 2023
📍
2026
Currently FDA-listed
3 years listed
🔒
·
No generic listed yet
brand only
ℹ️No FDA-approved generic found

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

Where does this data come from?
Patents and exclusivity from the FDA Orange Book (small-molecule drugs), refreshed from public FDA data. Generic launch timing is an estimate, not a guarantee.

🔬 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 SoftenSure Antimicrobial Liquid (this brand).

Top reported reactions

Vomiting2
Abdominal Pain Lower1
Abdominal Pain Upper1
Anaemia1
Cholecystitis1
Cystitis1
Drug Effect Decreased1

Age at onset

Elderly1

Reporter sex

7 reports
Male · 14%
Female · 86%

Serious outcomes

Life-threatening1
Death1
Reports over time (by year) — tap or hover for the count & year
2025 2026 2 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.

📦 Packaging — all sizes for this product

Package NDCDescription Marketing startStatus
59900-0217-01 You're viewing this 500 mL in 1 BOTTLE (59900-217-01) 2023-12-26 Active
59900-0217-02 12 BOTTLE in 1 CASE (59900-217-02) / 500 mL in 1 BOTTLE 2023-12-26 Active
59900-0217-03 1200 mL in 1 BOTTLE (59900-217-03) 2023-12-26 Active
59900-0217-04 4 BOTTLE in 1 CASE (59900-217-04) / 1200 mL in 1 BOTTLE 2023-12-26 Active

Pack size FAQ

What quantity is in NDC 59900-0217-01?
NDC 59900-0217-01 contains 500 mL — 500 ml in 1 bottle.
What is the difference between NDC 59900-0217-01 and NDC 59900-0217-03?
Both are SoftenSure Antimicrobial Liquid Chloroxylenol .75 mg/100mL Liquid — the drug itself is identical. NDC 59900-0217-01 is the 500 mL package, while NDC 59900-0217-03 is the 1200 ml package.
What NDC number is used to bill for this package of SoftenSure Antimicrobial Liquid Chloroxylenol .75 mg/100mL Liquid?
Bill NDC 59900-0217-01 — the 11-digit billing format is 59900021701. Pharmacy and medical claims use the 11-digit form; the FDA label may print a shorter form of the same code.

🧭 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 FDA registers it as 59900-217-01, 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: 59900-0217-01, written without dashes as 59900021701. 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 59900-0217-01, the first segment (59900) is the labeler code FDA assigned to Best Sanitizers, Inc; the middle segment (0217) 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 Best Sanitizers, Inc. Listing status can change — the directory data on this page refreshes weekly.
Does this product come in other package sizes?
Yes — the FDA directory lists 3 other package presentations of this same product, including 4 bottles (59900-0217-04), 12 bottles (59900-0217-02), 1200 ml (59900-0217-03). Each has its own NDC and its own page — see the package list near the top of this page.
Who lists this product with the FDA?
Best Sanitizers, Inc 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.

📄 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 33 words

Uses • handwash to help reduce bacteria that potentially can cause disease • helps to prevent cross-contamination by hand contact • helps to prevent drying of the skin • recommended for repeated use

⏱️ Dosage and Administration 50 words

Directions • wet hands and wrists with potable water • apply appropriate amounts of product • lather and scrub hands, fingers, fingernails, cuticles, and wrists for at least 20 seconds • rinse thoroughly with potable water before handling food • dry hands completely (incomplete drying may result in chapped skin)

⚠️ Warnings 44 words

Warnings For external use only When using this product do not use in or near eyes. Stop use and ask a doctor if irritation or redness develop. Keep out of reach of children. If swallowed, seek medical attention or contact Poison Control Center immediately.

🧪 Active Ingredient 4 words

Active ingredient Chloroxylenol 0.75%

🧪 Inactive Ingredients 34 words

Inactive ingredients Cocamide MEA, Coco-Betaine, Coconut Fatty Acid, D&C Green No. 8, FD&C Blue No. 1, FD&C Yellow No. 5, Fragrance, Glycerin, Hydroxypropyl Methylcellulose, Monoethanolamine, Oleic Acid, Propylene Glycol, Sodium Sulfate, Tetrasodium EDTA, Water.

🎯 Purpose 4 words

Purpose Antiseptic Hand Cleanser

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