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Total Solutions Hygien Hand Benzalkonium .12 g/100mL Soap, 3785 mL — NDC 62819-0268-01 package photo
Label image from the product's FDA listing (DailyMed) — may show a different pack size or an older label revision.

Total Solutions Hygien Hand Benzalkonium .12 g/100mL Soap, 3785 mL — NDC 62819-268-01 (Billing 62819-0268-01)

by Athea Laboratories, Inc. · 3785 mL in 1 BOTTLE, PLASTIC

This is a package of 3,785 mL of Total Solutions Hygien Hand Benzalkonium .12 g/100mL Soap from Athea Laboratories, Inc., marketed since Jan 2013 and currently FDA-listed. It is the main listing for this product, which comes in 2 package sizes.

NDC 62819-0268-01
🏷️ FDA NDC (as labeled) 62819-268-01 billing pads the product segment with a zero
This package
Contains3785 mL Pack sizes2 compare ↓
Main listing for product 62819-268 · Also comes in: 473 ml 62819-268-02
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

NDC database record

One package, one record: these facts belong to NDC 62819-268-01 alone.

Record
FDA NDC Directory package listing · Human OTC drug
Code segments
62819 labeler · 268 product · 01 package
Package marketed since
Jan 18, 2013
Sample package
No — commercial package
Listing certified through
Dec 31, 2026
Barcode (UPC-A, from the NDC)
3 6281926801 0
FDA record last changed
Jul 24, 2026

Identity & classification

Regulatory identifiers FDA, NLM and CMS codes for this package

FDA NDC (as labeled) 62819-268-01
Product NDC 62819-268
11-digit billing NDC 62819026801
RxCUI 1053188
UNII F5UM2KM3W7
Application # 505G(a)(3)
SPL Set ID fcd63fe4-a357-4432-a738-ae1bccbb8bae
DEA schedule Non-controlled
Marketing category OTC MONOGRAPH DRUG
Marketing status On market
FDA listing status Listed (active directory)
Marketing start 2013-01-18
Route TOPICAL
Dosage form SOAP
Substance BENZALKONIUM CHLORIDE
Quick answers
  • RxCUI (RxNorm): 1053188
Why two NDCs? The FDA registers this code as 62819-268-01 — 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 → 62819-0268-01. 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 Quaternary ammonium compounds class.

Drug family (ATC) Quaternary ammonium compounds, Medicated dressings with antiinfectives, Antiseptics
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.

Clinical

🧪 What is this product?

Total Solutions Hygien Hand is a topical soap containing benzalkonium chloride, an antimicrobial agent. It is marketed as an over-the-counter hand hygiene product under FDA's OTC monograph rules, meaning it follows established safety and effectiveness standards for its category rather than undergoing individual review. Benzalkonium chloride is commonly used in hand soaps and sanitizing products for its antibacterial properties. This product is intended for routine hand washing and cleaning.

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 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.
Try another pack size: 473 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
62819-0268-01 You're viewing this Main listing 3785 mL in 1 BOTTLE, PLASTIC 2013-01-18 — Active
62819-0268-02 62819-268-02 473 mL in 1 BOTTLE, PLASTIC 2013-01-18 — Active

You're viewing the largest of 2 pack sizes for this product.

Pack size FAQ

What quantity is in this package?
This package contains 3785 mL — 3785 ml in 1 bottle, plastic.
How does this package differ from NDC 62819-0268-02?
Both are Total Solutions Hygien Hand Benzalkonium .12 g/100mL Soap — the drug itself is identical. This page's package is the 3785 mL one, while NDC 62819-0268-02 is the 473 ml package.
What NDC number is used to bill for this package of Total Solutions Hygien Hand Benzalkonium .12 g/100mL Soap?
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
Safeguard Antibacterial Foaming .12 g/100mL 37000-0601-40 The 1200 ml — — FDA listed —
Safeguard Antibacterial E2 Foaming .12 g/100mL 37000-0602-40 The 1200 ml — — FDA listed —
Alpet Q E2 1.2 g/1000mL 59900-0130-01 Best 1250 ml — — FDA listed —
Alpet Qe2 Sanitizing Foam 1.2 mg/mL 59900-0214-01 Best 946352 ml — — FDA listed —
HACCP Q E2 Sanitizing 1.2 mg/mL 59900-0215-01 Best 946352 ml — — FDA listed —
Haccp Qe2 1200 ug/mL 59900-0718-01 Best 1200 ml — — FDA listed —
Total Solutions Hygien Hand .12 g/100mLthis 62819-0268-01 Athea 3785 ml — — FDA listed —
Alpha E2 Pro-Q Sanitizing Foam 1.2 g/1000mL 69335-0004-02 Alpha 1250 ml — — FDA listed —
San X E2 .12 g/100mL 69884-0706-06 Amerisan, 1250 ml — — FDA listed —
Avance Incontinence Care .12 g/100g 70936-0112-08 SMART 237 g — — FDA listed —
Chemstation HACCP Q E2 1.2 g/L 71212-0101-00 ChemStation 208.198 l — — FDA listed —
Chemstation Q E2 1.2 g/L 71212-0102-00 Chemstation 208.198 l — — 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

🏛️
2013
On the market since
Jan 2013
📍
2026
Currently FDA-listed
13 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.

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.

  • 0.05 g / 100 mL UNII XF417D3PSL
    Anhydrous citric acid is a sour, crystalline powder derived from citric acid with water removed. In medicines, it acts as a buffer to control pH, adds tartness to improve taste, and helps tablets disintegrate.
  • 0.4 mL / 100 mL UNII LKG8494WBH
    Benzyl alcohol is a clear liquid used as a preservative and solvent in medicines. It helps prevent bacterial and fungal growth and dissolves other ingredients to create uniform liquid formulations.
  • 0.0003 g / 100 mL 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.
  • 0.0006 g / 100 mL 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.
  • 0.8 mL / 100 mL 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.
  • 1 mL / 100 mL UNII X70SE62ZAR
    Hydroxyethyl cellulose is a plant-derived thickener made from cellulose. It's used in medicines as a binder to hold ingredients together, a thickener for gels or liquids, and sometimes as a coating agent.
  • 2.1 mL / 100 mL UNII I6KX160QTV
    A cleaning agent and surfactant derived from coconut oil. It helps reduce foam and improves the flow and mixing of powder ingredients in the formulation.
  • 0.7 mL / 100 mL UNII 3HSF539C9T
    A surfactant and foaming agent derived from myristic acid. It helps mix oil and water-based ingredients, improves product texture, and aids in even distribution of active ingredients throughout the formulation.
  • 1.5 mL / 100 mL UNII YZ6NLA4O1E
    A plant-derived emulsifier made from coconut oil and polyethylene glycol. It helps blend oil and water ingredients together and improves how the medicine spreads or absorbs.
  • 0.072 mL / 100 mL UNII HIE492ZZ3T
    Phenoxyethanol is a synthetic preservative and antimicrobial agent used to prevent bacterial and fungal growth in medicines and cosmetic products, extending shelf life and maintaining product safety.
  • 4 mL / 100 mL UNII 1S66E28KXA
    Poloxamer 124 is a synthetic polymer that acts as a surfactant and solubilizer in medicines. It helps dissolve and stabilize active ingredients, particularly in liquid formulations and gels.
  • 89.26 mL / 100 mL 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, Poloxamer 124, Lauramidopropylamine Oxide; PEG-3 Cocamide, Hydroxyethylcellulose, Glycerin, Myristamidopropylamine oxide, Benzyl Alcohol, Fragrance, Phenoxyethanol, Citric Acid, FD&C Yellow Number 5, FD&C Red Number 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 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

LabelerAthea Laboratories, Inc.
FDA application505G(a)(3) (OTC MONOGRAPH DRUG)
Labeler code62819
First marketedJan 2013
Product typeHuman Otc Drug
Portfolio4 products on file

More NDCs from Athea Laboratories, Inc. labeler code 62819

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 📄 Do Not Use 📄 When Using This Product 📄 Stop Use and Ask a Doctor If 📄 Keep Out of Reach of Children 📄 Other Information 📄 Package Label / Principal Display Panel
🎯 Indications and Usage 35 words ▾

Uses ■ For handwashing to help reduce bacteria on skin. ■ After changing diapers. ■ After assisting ill persons. ■ Before contact with a person under medical care or treatment. ■ Recommended for repeat use.

⏱️ Dosage and Administration 24 words ▾

Directions ■ Wet hands and forearms. Apply 5 milliliters (teaspoonful) or palmful to hands and forearms. Scrub hands thoroughly. Rinse with water and repeat.

⚠️ Warnings 5 words ▾

Warnings For external use only

🧪 Active Ingredient 5 words ▾

Active ingredient Benzalkonium Chloride 0.12%

🧪 Inactive Ingredients 27 words ▾

Inactive ingredients Water, Poloxamer 124, Lauramidopropylamine Oxide; PEG-3 Cocamide, Hydroxyethylcellulose, Glycerin, Myristamidopropylamine oxide, Benzyl Alcohol, Fragrance, Phenoxyethanol, Citric Acid, FD&C Yellow Number 5, FD&C Red Number 40.

🎯 Purpose 2 words ▾

Purpose Antiseptic

📄 Do Not Use 6 words ▾

Do not use in the eyes

📄 When Using This Product 16 words ▾

When using this product do not get into eyes. If contact occurs, rinse thoroughly with water.

📄 Stop Use and Ask a Doctor If 22 words ▾

Stop use and ask a doctor if irritation and redness develop. If condition persists for more than 72 hours consult a doctor.

📄 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.

📄 Other Information 9 words ▾

Other information ■ Store in a cool, dry place.

📄 Package Label / Principal Display Panel 4 words ▾

62819-268-01.jpg 62819-260-01.jpg

62819-268-02.jpg 62819-268-02

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 Athea Laboratories, 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 1 other package presentation of this same product, including 473 ml (62819-0268-02). 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?
Athea Laboratories, 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.
← 62795-9488-02 · MediNatura 62819-0282-00 · Athea →
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.