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COASTWIDE PROFESSIONAL Antibacterial Hand Sp Chloroxylenol .3 mg/100mL Liquid, 3780 mL — NDC 80434-051-01 (Billing 80434-0051-01)

by Worklifebrands LLC · 3780 mL in 1 PACKAGE

This is a package of 3,780 mL of COASTWIDE PROFESSIONAL Antibacterial Hand Sp Chloroxylenol .3 mg/100mL Liquid from Worklifebrands LLC, marketed since Aug 2021 and currently FDA-listed, this package's marketing is listed to end Jul 2028. It is this product's only package size.

NDC 80434-0051-01
🏷️ FDA NDC (as labeled) 80434-051-01 billing pads the product segment with a zero
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) 80434-051-01
Product NDC 80434-051
11-digit billing NDC 80434005101
UNII 0F32U78V2Q
UPC 0718103389310
Application # 505G(a)(3)
SPL Set ID dfefa541-4868-41de-b440-8dd0da415dbc
DEA schedule Non-controlled
Marketing category OTC MONOGRAPH DRUG
Marketing status On market
FDA listing status Listed (active directory)
Marketing start 2021-08-01
Marketing end 2028-07-02
Route TOPICAL
Dosage form LIQUID
Substance CHLOROXYLENOL
Why two NDCs? The FDA registers this code as 80434-051-01 — 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 → 80434-0051-01. 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.

Clinical

🧪 What is this product?

Coastwide Professional Antibacterial Hand Soap is a liquid topical cleanser containing chloroxylenol, an antimicrobial agent typically used in hand soaps to reduce bacteria on skin. This product is an over-the-counter monograph drug, meaning it is marketed under FDA's established rules for antibacterial soaps rather than through individual product approval. Chloroxylenol is commonly found in consumer hand-washing products and functions as a broad-spectrum antimicrobial agent intended for routine hand hygiene.

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.
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
80434-0051-01 You're viewing this Main listing 3780 mL in 1 PACKAGE 2021-08-01 Jul 2, 2028 Active

Therapeutic equivalents

ProductLabelerPackNADAC/unitTEStatusPrice vs. this
COASTWIDE PROFESSIONAL Antibacterial Hand Sp .3 mg/100mLthis 80434-0051-01 Worklifebrands 3780 ml — — FDA listed —
RENOWN Antibacterial Foam Cleanser .3 mg/100mL 42584-0081-02 Home 2000 ml — — Discontinued —
Antimicrobial Hand SP .3 mg/100mL 83919-0600-42 Envoy 1250 ml — — FDA listed —
PURELL Healthy Sp Antibacterial Ltn Sp with PCMX .3 mg/100mL 21749-0423-33 GOJO 1000 ml — — FDA listed —
RENOWN Antibacterial Foam .3 mg/100mL 42584-0080-01 Home 1200 ml — — FDA listed —
PRO-LINK ProFormance Foaming Antimicrobial SP .3 mg/100mL 66908-0083-42 Pro-Link, 1250 ml — — FDA listed —
DAYCON Antibacterial Foaming Hand So ap .3 mg/100mL 71874-0080-40 Daycon 1200 ml — — Discontinued —
PURELL Antimicrobial Ltn Sp with PCMX .3 mg/100mL 21749-0753-12 GOJO 354 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

🏛️
2021
On the market since
Aug 2021
📍
2026
Currently FDA-listed
5 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.

Loading inactive ingredients from the official FDA label in the background. No external source is being called by this page request.
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.

Manufacturer & labeler

LabelerWorklifebrands LLC
FDA application505G(a)(3) (OTC MONOGRAPH DRUG)
Labeler code80434
First marketedAug 2021
Product typeHuman Otc Drug
Portfolio3 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 15 words ▾

Use • Handwash to help decrease bacteria on the skin • Recommended for repeated use

⏱️ Dosage and Administration 23 words ▾

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

⚠️ Warnings 58 words ▾

Warnings For external use only When using this product do not use in or near the eyes. In case of contact, rinse eyes thoroughly 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.

🧪 Active Ingredient 4 words ▾

Active ingredient Chloroxylenol 0.3%

🧪 Inactive Ingredients 30 words ▾

Inactive ingredients Water (Aqua), Coconut Acid, Oleic Acid, Sodium Sulfate, Ethanolamine, Cocamide MEA, Coco-Betaine, Propylene Glycol, Retinyl Palmitate, Tetrasodium EDTA, Tocopheryl Acetate, Zea Mays (Corn) Oil, Hydroxypropyl Methylcellulose, Fragrance (Parfum)

🎯 Purpose 2 words ▾

Purpose Antimicrobial

📄 When Using This Product 21 words ▾

When using this product do not use in or near the eyes. In case of contact, rinse eyes thoroughly with water.

📄 Stop Use and Ask a Doctor If 13 words ▾

Stop use and ask a doctor if irritation or rash appears and 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 2 words ▾

Product Label

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

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 COASTWIDE PROFESSIONAL Antibacterial Hand Sp (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

Hospitalization3
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.

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 — Not published for this NDC No photo available yet for this listing.
Inactive ingredients (structured) — Not published for this NDC The labeler did not submit a structured excipient list, or no SPL is 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 it is currently marketed — but Worklifebrands LLC has reported a marketing end date of 2028-07-02, after which this package is expected to stop being marketed. The directory data on this page refreshes weekly.
Who lists this product with the FDA?
Worklifebrands 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.
← 80426-0047-01 · PPL 80434-0280-08 · Worklifebrands →
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.