MAXIM Assure PCMX, Dishwashing and Hand Soap 1 g/L Soap, 4 bottles — NDC 69050-0800-01 package photo

MAXIM Assure PCMX, Dishwashing and Hand Soap 1 g/L Soap, 4 bottles

by Cyan Labs, S.A. de C.V. · 4 BOTTLE, PLASTIC in 1 BOX (69050-800-01) / 3.78 L in 1 BOTTLE, PLASTIC
NDC 69050-0800-01
🏷️ FDA NDC (as labeled) 69050-800-01 billing pads the product segment with a zero
OTC On market Non-controlled
🗂️ Data synced Sep 3, 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) 69050-800-01
Product NDC 69050-800
11-digit billing NDC 69050080001
RxCUI 1941461
UNII 0F32U78V2Q
Application # 505G(a)(3)
SPL Set ID 596b43ae-30a0-db33-e063-6294a90ae697
DEA schedule Non-controlled
Marketing category OTC MONOGRAPH DRUG
Marketing status On market
FDA listing status Listed (active directory)
Marketing start 2026-08-18
Route TOPICAL
Dosage form SOAP
Substance CHLOROXYLENOL
Why two NDCs? The FDA registers this code as 69050-800-01 — 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 → 69050-0800-01. 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 Phenol and derivatives class.

Drug family (ATC) Phenol and derivatives
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.

🏭 Manufacturer & labeler

LabelerCyan Labs, S.A. de C.V.
FDA application505G(a)(3) (OTC MONOGRAPH DRUG)
Labeler code69050
First marketedAug 2026
Product typeHuman Otc Drug
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?

This is an over-the-counter monograph soap containing chloroxylenol, an antimicrobial agent. It is a topical liquid soap intended for hand washing and dishwashing and functions as an antibacterial cleanser. Chloroxylenol is commonly used in consumer soaps to reduce bacteria on the skin and surfaces during routine washing. This product is marketed under FDA's established rules for nonprescription antimicrobial soaps rather than as an individually reviewed drug 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.

💊 What it looks like

Color orange
One label can cover several strengths, so colors may be combined — always confirm a loose pill against the dispensed prescription label or a pharmacist.
Where does this data come from?
Physical description (imprint, shape, color, scoring, coating) from this product’s FDA Structured Product Labeling (SPL), mirrored from DailyMed / openFDA.

🧪 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 6PU1E16C9W
    Bronopol is a synthetic antimicrobial preservative used in liquid and semi-solid medicines to prevent the growth of bacteria and fungi, helping keep the product safe and stable throughout its shelf life.
  • UNII 62V75NI93W
    A surfactant derived from coconut oil that helps cleanse and remove oils from skin or hair. In medicines and personal care products, it acts as a cleanser and foaming agent.
  • UNII WZB9127XOA
    A synthetic red dye used to color medications and make them easier to identify. It serves as a colorant in tablets, capsules, and liquid formulations.
  • 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 DEL7T5QRPN
    A synthetic preservative that kills bacteria and fungi. It's added to medications to prevent microbial growth and extend shelf life, especially in liquid or topical formulations.
  • UNII 229D0E1QFA
    Methylisothiazolinone is a synthetic chemical preservative that prevents bacterial and fungal growth in liquid medicines and topical products. It helps keep the medication safe and extends shelf life during storage.
  • UNII 5965N8W85T
    Propanediol is a clear liquid organic compound derived from vegetable sources or synthesized chemically. It acts as a humectant to retain moisture, a solvent to dissolve active ingredients, and a preservative booster in liquid medications and supplements.
  • 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 O9W3D3YF5U
    A synthetic surfactant derived from petroleum-based olefins. It helps dissolve or suspend active ingredients and other substances in liquid formulations, improving how the medicine mixes and flows.
  • UNII 451W47IQ8X
    Sodium chloride is common table salt. It's used in medicines as a buffer to maintain proper pH, as a filler to add bulk, or to adjust the osmotic balance in liquid formulations.
  • UNII G7SW5QN7TT
    Sodium polyitaconate is a synthetic polymer derived from itaconic acid. In medicines, it acts as a binder and film-former to help hold tablet ingredients together and create protective coatings on solid dosage forms.
  • 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 statesWater (Aqua), Sodium C14-16 Olefin Sulfonate, Cocamidopropyl Hydroxysultaine, Sodium Choride, Propanediol, Propylene Glycol, Sodium Polyitaconate, Fragrance (Proprietar Nitropropane-1,3-Diol), Methylisothiazolinone, Methylchloroisothiazolinone, Yellow 5, Red 40.

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 eachPer 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.

🔁 Therapeutic equivalents

ProductLabelerPackNADAC/unitTEStatusPrice vs. this
MAXIM Assure 1 g/L 70542-0701-41 Midlab 3.78 l FDA listed
MAXIM Assure 1 g/Lthis 69050-0800-01 Cyan 4 bottles 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

🏛️
2026
On the market since
Aug 2026
📍
2026
Currently FDA-listed
listed with the FDA
🔒
·
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.

📦 Packaging — all sizes for this product

Package NDCDescription Marketing startStatus
69050-0800-01 You're viewing this 4 BOTTLE, PLASTIC in 1 BOX (69050-800-01) / 3.78 L in 1 BOTTLE, PLASTIC 2026-08-18 Active

🧭 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 69050-800-01, 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: 69050-0800-01, written without dashes as 69050080001. 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 69050-0800-01, the first segment (69050) is the labeler code FDA assigned to Cyan Labs, S.A. de C.V.; the middle segment (0800) 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 Cyan Labs, S.A. de C.V.. Listing status can change — the directory data on this page refreshes weekly.
Who lists this product with the FDA?
Cyan Labs, S.A. de C.V. 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 9 words

Uses Handwash to help decrease bacteria on the skin.

⏱️ Dosage and Administration 32 words

Directions Apply a small amount of product to wet hands, work into lather for 30 seconds, and rinse thoroughly. Children under 6 years of age should be supervised when using this product.

⚠️ Warnings 80 words

Warnings For external use only. Do Not Use in the eyes. In case of contact, immediately flush eyes with water. Stop use and ask a doctor if irritation or rash appears and lasts. Keep out of reach of children. If swallowed, get medical help or contact a Poison Control Center right away.

Do Not Use in the eyes. In case of contact, immediately flush eyes with water.

Stop use and ask a doctor if irritation or rash appears and lasts.

🧪 Active Ingredient 5 words

Active Ingredient Chloroxylenol 0.1 %

🧪 Inactive Ingredients 26 words

Inactive Ingredients Water (Aqua), Sodium C14-16 Olefin Sulfonate, Cocamidopropyl Hydroxysultaine, Sodium Choride, Propanediol, Propylene Glycol, Sodium Polyitaconate, Fragrance (Proprietar Nitropropane-1,3-Diol), Methylisothiazolinone, Methylchloroisothiazolinone, Yellow 5, Red 40.

🎯 Purpose 2 words

Purpose Antiseptic

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.