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HACCP Q E2 Sanitizing BENZALKONIUM CHLORIDE 1.2 mg/mL Liquid, 946352 mL — NDC 59900-0215-01 package photo

HACCP Q E2 Sanitizing BENZALKONIUM CHLORIDE 1.2 mg/mL Liquid, 946352 mL

by Best Sanitizers, Inc. · 946352 mL in 1 TANK (59900-215-01)
NDC 59900-0215-01
🏷️ FDA NDC (as labeled) 59900-215-01 billing pads the product segment with a zero
This package
Contains946352 mL Pack sizes4 compare ↓
Also comes in: 1250 ml 59900-0215-05 3785 ml 59900-0215-03 208197 ml 59900-0215-02
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

⚠️
Other active recalls for Benzalkonium Chloride (different manufacturers) — 6 · tap to view
These affect other manufacturers’ products for the same ingredient — not necessarily the exact NDC on this page.
Class II · Apr 8, 2026 — CGMP Deviations: product manufactured in the same facility under the same conditions as the product found to be contaminated (Blaine Labs Inc) · FDA recall D-0693-2026
Class II · Apr 8, 2026 — CGMP Deviations; product manufactured in the same facility under the same conditions as the product found to be contaminated (Blaine Labs Inc) · FDA recall D-0699-2026
Class II · Jan 20, 2026 — CGMP Deviations (ACME UNITED CORPORATION) · FDA recall D-0375-2026
Class II · Jan 20, 2026 — CGMP Deviations (ACME UNITED CORPORATION) · FDA recall D-0369-2026
Class II · Jan 20, 2026 — CGMP Deviations (ACME UNITED CORPORATION) · FDA recall D-0365-2026
Class II · Jan 20, 2026 — CGMP Deviations (ACME UNITED CORPORATION) · FDA recall D-0360-2026
Each entry is an official FDA enforcement report — look up any recall number in the FDA recall database ↗

🆔 Identity & classification

FDA NDC (as labeled) 59900-215-01
Product NDC 59900-215
11-digit billing NDC 59900021501
RxCUI 1053188
UNII F5UM2KM3W7
Application # 505G(a)(3)
SPL Set ID b5f48d59-8062-4b72-b87d-5825a519f5f9
DEA schedule Non-controlled
Marketing category OTC MONOGRAPH DRUG
Marketing status On market
FDA listing status Listed (active directory)
Marketing start 2019-05-03
Route TOPICAL
Dosage form LIQUID
Substance BENZALKONIUM CHLORIDE
Why two NDCs? The FDA registers this code as 59900-215-01 — 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 → 59900-0215-01. 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.

🏭 Manufacturer & labeler

LabelerBest Sanitizers, Inc.
FDA application505G(a)(3) (OTC MONOGRAPH DRUG)
Labeler code59900
First marketedMay 2019
Product typeHuman Otc Drug
Portfolio14 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.

🩺 Clinical

🧪 What is this product?

This is a topical liquid sanitizer containing benzalkonium chloride as its active ingredient. Benzalkonium chloride is a type of antimicrobial chemical commonly used in sanitizing products to reduce germs and bacteria on surfaces and skin. As an over-the-counter monograph drug, this product is marketed under FDA's established rules for sanitizer products rather than through individual approval. The 1.2 mg/mL concentration is typical for this class of sanitizing agents.

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.

💡 Tap an ingredient (hover on desktop) to see what it is and why it’s used.

  • 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.
  • 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 2KAG279R6R
    Dehydroacetic acid is a synthetic preservative that prevents mold, yeast, and bacterial growth in medicines. It extends shelf life by protecting the product from spoilage during storage and use.
  • UNII MP1J8420LU
    A salt derived from edetic acid that binds to trace metals in medicines. It serves as a chelating agent and preservative to prevent metal-catalyzed breakdown of the drug and extend shelf life.
  • 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.
  • UNII E89I1637KE
    Guar gum is a natural thickener made from guar bean seeds. It's used in medicines as a binder and thickening agent to hold ingredients together and create the right texture and consistency.
  • UNII 4F6FC4MI8W
    Lauramine oxide is a surfactant, a substance that helps mix oil and water together. It's used in medicines to improve how ingredients blend and to help the product dissolve or spread properly.
  • 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 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.
  • UNII TTV12P4NEE
    Xanthan gum is a thickening and stabilizing ingredient made from fermented corn or other sugars. It's added to medicines to improve texture, prevent separation of liquids and solids, and help the product stay consistent.

10 inactive ingredients listed in the exact product block matched to this NDC.

The official label also statesInactive ingredients Water, cocamipopropyl betaine, C12-C14 amine oxides, 1,2-propanediol, glycerol, guar gum, xatham gum, benzyl alcohol, dehydroacetic acid, tetra-sodium EDTA

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.

💲 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: 1250 ml 3785 ml 208197 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.

🔁 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/mLthis 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/100mL 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 —
Hygienic Ear Care Antiseptic 1.2 mg/mL 70094-0001-04 The 118 ml — — FDA listed —
Inverness Ear Care 1.2 mg/mL 70094-0007-01 The 118 ml — — FDA listed —
Ulta Beauty Ear Care 1.2 mg/mL 70094-0009-01 The 118 ml — — FDA listed —
Lovisa Piercing Care Solution 1.2 mg/mL 70094-0006-01 The 60 ml — — FDA listed —
Helzberg Diamonds Ear Care 1.2 mg/mL 70094-0008-01 The 60 ml — — FDA listed —
Inverness EAR CARE ANTISEPTIC 1.2 mg/mL 70094-0010-02 The 60 ml — — FDA listed —
Inverness Hygienic Ear Care Antiseptic 1.2 mg/mL 70094-0005-01 The 60 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

🏛️
2019
On the market since
May 2019
📍
2026
Currently FDA-listed
7 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.

🔬 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 HACCP Q E2 Sanitizing (this brand).

Top reported reactions

Drug Hypersensitivity118
Condition Aggravated114
Arthralgia112
Musculoskeletal Stiffness111
Pain In Extremity111
Infection110
Hepatotoxicity108

Age at onset

Infant1
Adolescent3
Adult36
Elderly10

Reporter sex

331 reports
Male · 28%
Female · 72%
Unknown · 0%

Serious outcomes

Hospitalization175
Life-threatening27
Disabling18
Reports over time (by year) — tap or hover for the count & year
2023 2024 2025 2026 24 5
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.

📦 Packaging — all sizes for this product

Package NDCDescription Marketing startStatus
59900-0215-01 You're viewing this 946352 mL in 1 TANK (59900-215-01) 2019-05-03 Active
59900-0215-02 208197 mL in 1 DRUM (59900-215-02) 2019-05-03 Active
59900-0215-03 3785 mL in 1 JUG (59900-215-03) 2019-05-03 Active
59900-0215-05 1250 mL in 1 BOTTLE (59900-215-05) 2019-05-03 Active

You're viewing the largest of 4 pack sizes for this product.

Pack size FAQ

What quantity is in NDC 59900-0215-01?
NDC 59900-0215-01 contains 946352 mL — 946352 ml in 1 tank.
What is the difference between NDC 59900-0215-01 and NDC 59900-0215-05?
Both are HACCP Q E2 Sanitizing BENZALKONIUM CHLORIDE 1.2 mg/mL Liquid — the drug itself is identical. NDC 59900-0215-01 is the 946352 mL package, while NDC 59900-0215-05 is the 1250 ml package.
What NDC number is used to bill for this package of HACCP Q E2 Sanitizing BENZALKONIUM CHLORIDE 1.2 mg/mL Liquid?
Bill NDC 59900-0215-01 — the 11-digit billing format is 59900021501. Pharmacy and medical claims use the 11-digit form; the FDA label may print a shorter form of the same code.

🧭 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 59900-215-01, 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: 59900-0215-01, written without dashes as 59900021501. 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 59900-0215-01, the first segment (59900) is the labeler code FDA assigned to Best Sanitizers, Inc.; the middle segment (0215) 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 Best Sanitizers, 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 3 other package presentations of this same product, including 1250 ml (59900-0215-05), 3785 ml (59900-0215-03), 208197 ml (59900-0215-02). 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?
Best Sanitizers, 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 29 words ▾

Uses handwash to help reduce bacteria that potentially can cause disease helps to prevent cross-contamination by hand contact helps to prevent drying of the skin recommended for repeated use

⏱️ Dosage and Administration 43 words ▾

Directions wet hands and wrists with clean, running water apply appropriate amount of product lather and scrub hands, fingers, fingernails, cuticles and wrists for at least 20 seconds rinse thoroughly with running water dry hands completely (incomplete drying may result in chapped skin)

⚠️ Warnings 44 words ▾

Warnings For external use only When using this product do not use in or near eyes Stop use and ask a doctor if irritation or redness develop. Keep out of reach of children. If swallowed, seek medical attention or contact Poison Control Center immediately.

📦 Storage and Handling 15 words ▾

Other information store in a cool, dry place below 104 o F (40 o C)

🧪 Active Ingredient 5 words ▾

Active ingredient Benzalkonium Chloride 0.12%

🧪 Inactive Ingredients 20 words ▾

Inactive ingredients Water, cocamipopropyl betaine, C12-C14 amine oxides, 1,2-propanediol, glycerol, guar gum, xatham gum, benzyl alcohol, dehydroacetic acid, tetra-sodium EDTA

🎯 Purpose 4 words ▾

Purpose Antiseptic Hand Cleanser

Source: FDA Structured Product Labeling, mirrored from DailyMed / openFDA. Prefer the government’s original formatting? View this label on DailyMed ↗
← 59900-0214-01 · Best 59900-0216-01 · Best →
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.