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AMERIWASH PARACHLOROMETAXYLENOL .003 mg/mL Liquid, 800 mL — NDC 52410-8038-03 package photo
Label image from the product's FDA listing (DailyMed) — may show a different pack size or an older label revision.

AMERIWASH PARACHLOROMETAXYLENOL .003 mg/mL Liquid, 800 mL — NDC 52410-8038-3 (Billing 52410-8038-03)

by SHIELD LINE LLC · 800 mL in 1 POUCH

This is a package of 800 mL of AMERIWASH PARACHLOROMETAXYLENOL .003 mg/mL Liquid from SHIELD LINE LLC, marketed since Aug 2017 and currently FDA-listed. It is the main listing for this product, which comes in 3 package sizes.

NDC 52410-8038-03
🏷️ FDA NDC (as labeled) 52410-8038-3 billing pads the package segment with a zero
This package
Contains800 mL Pack sizes3 compare ↓
Main listing for product 52410-8038 · Also comes in: 1000 ml 52410-8038-4 3780 ml 52410-8038-5
OTC On market Non-controlled ⇄ Compare with another NDC
🗂️ FDA directory synced Oct 1, 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 →

This page is curated, coded, and maintained by

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

Identity & classification

Regulatory identifiers FDA, NLM and CMS codes for this package

FDA NDC (as labeled) 52410-8038-3
Product NDC 52410-8038
11-digit billing NDC 52410803803
UNII 0F32U78V2Q
Application # M003
SPL Set ID 6d5ed0f9-fb48-7855-e053-2991aa0a18a8
DEA schedule Non-controlled
Marketing category OTC MONOGRAPH DRUG
Marketing status On market
FDA listing status Listed (active directory)
Marketing start 2017-08-01
Route TOPICAL
Dosage form LIQUID
Substance CHLOROXYLENOL
Why two NDCs? The FDA registers this code as 52410-8038-3 — a 5-4-1 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 package segment → 52410-8038-03. 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.

Clinical

🧪 What is this product?

Ameriwash Parachlorometaxylenol is a topical liquid cleanser containing chloroxylenol, an antimicrobial agent typically used in skin cleansing products. This product is marketed as an over-the-counter monograph drug, meaning it follows FDA's established safety and effectiveness rules for antiseptic cleansers rather than requiring individual approval. Chloroxylenol is commonly found in antibacterial soaps and washes meant for general skin hygiene and cleansing.

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.

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: 1000 ml 3780 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.

Packaging — all sizes for this product

Package NDCDescription Marketing startMarketing endStatus
52410-8038-03 You're viewing this Main listing 800 mL in 1 POUCH 2017-08-01 — Active
52410-8038-04 52410-8038-4 1000 mL in 1 POUCH 2017-08-01 — Active
52410-8038-05 52410-8038-5 3780 mL in 1 BOTTLE 2017-08-01 — Active

You're viewing the smallest of 3 pack sizes for this product.

Pack size FAQ

What quantity is in this package?
This package contains 800 mL — 800 ml in 1 pouch.
How does this package differ from NDC 52410-8038-04?
Both are AMERIWASH PARACHLOROMETAXYLENOL .003 mg/mL Liquid — the drug itself is identical. This page's package is the 800 mL one, while NDC 52410-8038-04 is the 1000 ml package.
What NDC number is used to bill for this package of AMERIWASH PARACHLOROMETAXYLENOL .003 mg/mL Liquid?
Use the 11-digit billing form listed in the identifiers section of this page. Pharmacy and medical claims use the 11-digit form; the FDA label may print a shorter form of the same code.

Therapeutic equivalents

ProductLabelerPackNADAC/unitTEStatusPrice vs. this
AmeriDerm Antibacterial Wash .003 mg/mL 52410-8073-02 SHIELD 1000 ml — — FDA listed —
Ameriwash .003 mg/mLthis 52410-8038-03 SHIELD 800 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

🏛️
2017
On the market since
Aug 2017
📍
2026
Currently FDA-listed
9 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.

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 7X6O37OK2I
    A synthetic fragrance compound used as a flavoring agent or aromatic component in medicines. It adds pleasant taste or smell to make the medication more acceptable to patients.
  • UNII 2968PHW8QP
    A weak organic acid derived from citrus fruits or made through fermentation. It works as a buffer to control pH, a preservative to extend shelf life, and a flavoring agent in medications.
  • UNII 5OCF3O11KX
    A plant-derived surfactant made from coconut oil. It helps mix oil and water ingredients together in the formulation and can improve how the medicine spreads or feels on the skin.
  • UNII 92005F972D
    A foaming and thickening agent derived from coconut oil. It's used in liquid medicines to improve texture, help distribute active ingredients evenly, and create a pleasant consistency for easier swallowing or application.
  • UNII 9DBA0SBB0L
    A synthetic red dye derived from coal tar used as a colorant in medicines and cosmetics. It gives tablets, capsules, and liquids their red or pink appearance for identification and visual appeal.
  • UNII BYR0546TOW
    DMDM hydantoin is a preservative chemical used to prevent the growth of bacteria and fungi in medicines. It helps keep the product safe and stable throughout its shelf life.
  • UNII 8NLQ36F6MM
    Edetate disodium anhydrous is a chemical compound that binds to metal ions in a medicine. It's used as a stabilizer to prevent unwanted chemical reactions and help keep the drug product effective during storage.
  • 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 H77VEI93A8
    A synthetic yellow dye used to color medications. It helps identify the drug and make it visually distinctive, with no effect on how the medicine works.
  • UNII VNX7251543
    A plant-derived emulsifier made from coconut oil and polyethylene glycol. It helps mix oil and water-based ingredients together and improves how the medicine spreads or absorbs.
  • 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 BPV390UAP0
    Sodium laureth sulfate is a mild detergent and surfactant derived from coconut oil or petroleum. It helps mix oil and water in formulations and is often used as a cleaning or foaming agent in topical products like shampoos and cleansers.
  • UNII 1W6L629B4K
    Sulisobenzone is a chemical UV filter used in some topical products to help protect against sun damage. It works as a sunscreen ingredient that absorbs ultraviolet light before it reaches the skin.
  • 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 statesAlpha Hexylcinnamaldehyde, Citric Acid Monohydrate, Cocamidopropyl Betaine, Coco Diethanolamide, D&C Red No. 33, DMDM Hydantoin, Edetate Disodium Anhydrous, FD&C Yellow No.5, FD&C Yellow No.6, PEG-7 Glyceryl Cocoate, Sodium Chloride, Sodium, Laureth Sulfate, Sulisobenzone, 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 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

LabelerSHIELD LINE LLC
FDA applicationM003 (OTC MONOGRAPH DRUG)
Labeler code52410
First marketedAug 2017
Product typeHuman Otc Drug
Portfolio38 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 ⏱️ Dosage and Administration ⚠️ Warnings 🧪 Active Ingredient 🧪 Inactive Ingredients 🎯 Purpose 📄 When Using This Product 📄 Stop Use and Ask a Doctor If 📄 Keep Out of Reach of Children 📄 Package Label / Principal Display Panel
🎯 Indications and Usage 18 words ▾

Uses Handwash to help reduce bacteria on the skin that potentially can cause disease Recommended for repeat use

⏱️ Dosage and Administration 19 words ▾

Directions Wet hands Apply a small amount of product and work into lather Rinse well and dry hands completely

⚠️ Warnings 5 words ▾

Warnings FOR EXTERNAL USE ONLY

🧪 Active Ingredient 7 words ▾

Drug Facts Active Ingredient Parachlorometaxylenol 0.3% w/w

🧪 Inactive Ingredients 36 words ▾

Inactive Ingredients Alpha Hexylcinnamaldehyde, Citric Acid Monohydrate, Cocamidopropyl Betaine, Coco Diethanolamide, D&C Red No. 33, DMDM Hydantoin, Edetate Disodium Anhydrous, FD&C Yellow No.5, FD&C Yellow No.6, PEG-7 Glyceryl Cocoate, Sodium Chloride, Sodium, Laureth Sulfate, Sulisobenzone, Water

🎯 Purpose 2 words ▾

Purpose Antimicrobial

📄 When Using This Product 22 words ▾

When using this product Do not use in or near the eyes Incase of eye contact rinse the eyes thoroughly with water

📄 Stop Use and Ask a Doctor If 13 words ▾

Stop use and ask a doctor if Irritation or rash appears or lasts

📄 Keep Out of Reach of Children 19 words ▾

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

📄 Package Label / Principal Display Panel 10 words ▾

AMERIWASH DRUG FACT PANEL Principal Display & Drug Fact Panel

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

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 SHIELD LINE LLC. 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 2 other package presentations of this same product, including 1000 ml (52410-8038-04), 3780 ml (52410-8038-05). 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?
SHIELD LINE LLC 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.
← 52410-8037-02 · Shield 52410-8042-06 · SHIELD →
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.