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D-COL Personal Hygiene Convenience kit Pyrithione Zinc and Chloroxylenol Kit

by D-COL Inc · 1 KIT in 1 CARTON (53205-001-01) * 15 mL in 1 PACKET * 1 mL in 1 PACKET * 7.4 mL in 1 PACKET
NDC 53205-0001-01
🏷️ FDA NDC (as labeled) 53205-001-01 billing pads the product segment with a zero
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 →

This page is curated, coded, and maintained by

Compiled from public FDA, CMS, DailyMed, NADAC, and related drug data sources. Editorial policy

🆔 Identity & classification

FDA NDC (as labeled) 53205-001-01
Product NDC 53205-001
11-digit billing NDC 53205000101
Application # M032
SPL Set ID 273fcc6f-9c54-42b0-aa0c-9051457b1341
DEA schedule Non-controlled
Marketing category OTC MONOGRAPH DRUG
Marketing status On market
FDA listing status Listed (active directory)
Marketing start 2018-05-30
Dosage form KIT
Why two NDCs? The FDA registers this code as 53205-001-01 — 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 → 53205-0001-01. 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

LabelerD-COL Inc
FDA applicationM032 (OTC MONOGRAPH DRUG)
Labeler code53205
First marketedMay 2018
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?

D-COL Personal Hygiene Convenience Kit is an over-the-counter drug product sold as a kit containing pyrithione zinc and chloroxylenol. These are antimicrobial agents typically used in personal care products to reduce or inhibit the growth of bacteria and fungi on skin. This kit appears intended for routine hygiene use and is marketed under FDA's OTC monograph rules for this class of antimicrobial products.

Supplement & herbal interactions

🌿 Drug–supplement interaction checker →
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.

From the label’s inactive-ingredient sectionpropylene glycol, cocamide dea, ammonium lauryl sulfate, sodium laureth sulfate, citric acid, edta, ammonium chloride, propylparaben, imidazolidinyl urea, fragrance, deionized water benzalkonium chloride, polysorbate 20, peach kernel oil glycereth-8 esters, sodium chloride, potassium sorbate, sodium citrate, xylitol, disodium edta, lavandula angustifolia (lavender) oil, mentha viridis (spearmint leaf) oil, melaleuca alternifolia (tea tree leaf) oil, citric acid deionized water, acrylates/C10-30 alkyl acrylate crosspolymer, sodium lauryl ether sulfate, PEG-90 diisostearate, cocamidopropyl betaine, cocamide dea, cyclomethicone 5, edta sodium, caprylyl glycol, sodium hydroxide

This is label-wide narrative text, not a normalized exact-product ingredient list. A label can cover multiple strengths or packages.

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.

💲 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
D-COL Personal Hygiene Convenience kitthis 53205-0001-01 D-COL 1 kit — — 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

🏛️
2018
On the market since
May 2018
📍
2026
Currently FDA-listed
8 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.

📦 Packaging — all sizes for this product

Package NDCDescription Marketing startStatus
53205-0001-01 You're viewing this 1 KIT in 1 CARTON (53205-001-01) * 15 mL in 1 PACKET * 1 mL in 1 PACKET * 7.4 mL in 1 PACKET 2018-05-30 Active

🧭 About this NDC listing & data coverage

Over-the-counter (OTC) product Kit / multi-component package

Kit / multi-component package

This NDC identifies a kit — a package containing more than one component. Structured data (pricing, ingredients, equivalents) is often reported per component rather than for the kit NDC itself, which can make this page look thinner than the components' own pages.

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) ✓ 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 53205-001-01, 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: 53205-0001-01, written without dashes as 53205000101. 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 53205-0001-01, the first segment (53205) is the labeler code FDA assigned to D-COL Inc; the middle segment (0001) 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 D-COL Inc. Listing status can change — the directory data on this page refreshes weekly.
Who lists this product with the FDA?
D-COL 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 ⏱️ Dosage and Administration ⚠️ Warnings 📦 Storage and Handling 🧪 Active Ingredient 🧪 Inactive Ingredients 🎯 Purpose
🎯 Indications and Usage 46 words ▾

Uses Antiseptic skin cleansers help reduce bacteria that potentially causes disease. For patient antiseptic skin preparation (15 mL packets only). For healthcare personnel hand wash. For surgical hand scrub.

Uses For nasal inner rim cleanser.

Uses helps prevent recurrence of flaking and itching associated with dandruff.

⏱️ Dosage and Administration ~1 min read ▾

Directions Patient antiseptic skin preparation . Thoroughly rinse the area to be cleansed with water. Apply the minimum amount of the product necessary to cover the skin area and wash gently.

Rinse thoroughly with water. Surgical hand scrub . Wet hands and forearms with water.

Scrub for 3 minutes with about 5 mL of the product with a brush. Rinse thoroughly under running water. Healthcare personnel handwash .

Wet hands with water. Dispense about 5 mL of the product into cupped hands and wash in a vigorous manner for 15 seconds. Rinse and dry thoroughly.

Directions Apply a reasonable amount of the product to the end of your index finger for a single nasal inner rim application. Save a reasonable amount to apply to the opposite nasal inner rim. Insert your index finger into one nostril no further than the inner rim, and cover the inner rim of the nasal passage with the product.

Do not apply the product beyond the inner rim of the nasal passage. Repeat the application of the product to the untreated nasal inner rim. Wait 30 seconds after you complete the application, and thoroughly wipe the inner rim of each nostril with a cloth wet with water.

Children under 6 years of age should be supervised when using this product.

Directions Place enough product in your palm to thoroughly cover the scalp area. Rub hands together until product covers entire surface of your palms. Apply product to the scalp and thoroughly massage and cover the scalp. Rinse with water until the product is completely removed from the application area. Use one packet as directed. Children under 6 years of age should be supervised when using this product.

⚠️ Warnings ~1 min read ▾

Do not use If you or the patient is allergic to Chloroxylenol or any other ingredient in this product. When using this product Keep out of eyes, ears, and mouth. May cause serious and permanent eye injury if permitted to enter and remain in the eye or may cause deafness when instilled in the middle ear through perforated eardrums.

If contact occurs in any of these areas, rinse with cold water right away. Repeated general cleansing of large body areas should not be done except when advised by a health care provider. Stop use and ask doctor if irritation, sensitization, or allergic reaction occurs.

Keep out of reach of children. If swallowed, get medical help or contact a Poison Control Center right away.

Warnings For use only in the inner rim of each nostril. When using this product Avoid contact with eyes. In case of eye contact, flush with water. Stop use and ask doctor if irritation, discomfort, or redness develops. Keep out of reach of children. If swallowed, get medical help or contact a Poison Control Center right away.

Warnings For external use only. When using this product Avoid contact with eyes. If contact occurs, rinse eyes thoroughly with water. Stop use and ask doctor if condition worsens or does not improve after regular use of this product as directed. Keep out of reach of children. If swallowed, get medical help or contact a Poison Control Center right away.

📦 Storage and Handling 12 words ▾

Other Information Store between 20-25°C (68-77°F). Avoid excessive heat above 40°C (104°F).

🧪 Active Ingredient 9 words ▾

Active Ingredient Chloroxylenol 0.24%

Active Ingredient Zinc Pyrithione 1.0%

🧪 Inactive Ingredients 86 words ▾

Inactive Ingredient propylene glycol, cocamide dea, ammonium lauryl sulfate, sodium laureth sulfate, citric acid, edta, ammonium chloride, propylparaben, imidazolidinyl urea, fragrance, deionized water

Inactive Ingredient benzalkonium chloride, polysorbate 20, peach kernel oil glycereth-8 esters, sodium chloride, potassium sorbate, sodium citrate, xylitol, disodium edta, lavandula angustifolia (lavender) oil, mentha viridis (spearmint leaf) oil, melaleuca alternifolia (tea tree leaf) oil, citric acid

Inactive Ingredient deionized water, acrylates/C10-30 alkyl acrylate crosspolymer, sodium lauryl ether sulfate, PEG-90 diisostearate, cocamidopropyl betaine, cocamide dea, cyclomethicone 5, edta sodium, caprylyl glycol, sodium hydroxide

🎯 Purpose 4 words ▾

Purpose Antiseptic

Purpose Anti-dandruff

Source: FDA Structured Product Labeling, mirrored from DailyMed / openFDA. Prefer the government’s original formatting? View this label on DailyMed ↗
← 53194-0003-00 · IOI 53208-0000-00 · LG →
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.