Label image from the product's FDA listing (DailyMed) — may show a different pack size or an older label revision.
GenRx Hand Sanitizing Benzalkonium Chloride 1.3 mg/mL Spray, 237 mL — NDC 59088-315-16 (Billing 59088-0315-16)
by PureTek Corporation · 237 mL in 1 BOTTLE, SPRAY
This is a package of 237 mL of GenRx Hand Sanitizing Benzalkonium Chloride 1.3 mg/mL Spray from PureTek Corporation, marketed since Mar 2020 and currently FDA-listed. It is this product's only package size.
NDC 59088-0315-16
🏷️ FDA NDC (as labeled)
59088-315-16
billing pads the product segment with a zero
🗂️ 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 →
NDC database record
One package, one record: these facts belong to NDC 59088-315-16 alone.
- Record
- FDA NDC Directory package listing · Human OTC drug
- Code segments
- 59088 labeler · 315 product · 16 package
- Package marketed since
- Mar 18, 2020
- Sample package
- No — commercial package
- Listing certified through
- Dec 31, 2026
- Barcode (UPC)
- 0731477352193
- FDA record last changed
- Jul 24, 2026
⚠️
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-0374-2026
Each entry is an official FDA enforcement report — look up any recall number in the FDA recall database ↗
Identity & classification
Regulatory identifiers FDA, NLM and CMS codes for this package
FDA NDC (as labeled)
59088-315-16
Product NDC
59088-315
11-digit billing NDC
59088031516
RxCUI
1039012
UNII
F5UM2KM3W7
UPC
0731477352193
Application #
M003
SPL Set ID
a12715c0-77f2-7716-e053-2995a90a06d3
DEA schedule
Non-controlled
Marketing category
OTC MONOGRAPH DRUG
Marketing status
On market
FDA listing status
Listed (active directory)
Marketing start
2020-03-18
Route
TOPICAL
Dosage form
SPRAY
Substance
BENZALKONIUM CHLORIDE
Quick answers
- RxCUI (RxNorm): 1039012
Why two NDCs?
The FDA registers this code as 59088-315-16 — 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 → 59088-0315-16. 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.
- FDA openFDA NDC Directory · synced Oct 1, 2026
- FDA label on DailyMed · label index refreshed Oct 5, 2026
- RxNorm (NLM RxNav) · catalog refreshed Oct 1, 2026
- Medi-Span GPI (licensed)
- First Databank (licensed) · refreshed Oct 1, 2026
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.
- RxClass (NLM) · catalog refreshed Oct 1, 2026
Clinical
🧪 What is this product?
GenRx Hand Sanitizing Benzalkonium Chloride is a topical spray containing benzalkonium chloride, an antimicrobial agent commonly used in hand sanitizers and disinfectants. This product is marketed as an over-the-counter monograph drug, meaning it follows FDA's established rules for antiseptic hand-sanitizing products rather than being individually approved. Benzalkonium chloride is typically used to reduce bacteria and other microorganisms on the skin. The spray form allows direct application to the hands for sanitizing purposes.
Patient education
Supplement & herbal interactions
Some supplements/herbs that may interact with Benzalkonium Chloride — tap one for details:
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.
- MedlinePlus (NLM) · refreshed Oct 1, 2026
- FDA label on DailyMed · label index refreshed Oct 5, 2026
💬 Questions about Benzalkonium Chloride?
Ask a pharmacist →
Ask a licensed pharmacist directly — free, answered by our team.
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 system | Per mL | Per 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.
- CMS NADAC weekly file
- CMS ASP pricing files · refreshed Sep 20, 2026
- CMS Medicaid State Drug Utilization Data · refreshed Oct 5, 2026
- CMS Part D plan pricing files · refreshed Sep 24, 2026
- VA National Acquisition Center price file
Packaging — all sizes for this product
| Package NDC | Description | Marketing start | Marketing end | Status |
|---|---|---|---|---|
| 59088-0315-16 You're viewing this Main listing | 237 mL in 1 BOTTLE, SPRAY | 2020-03-18 | — | Active |
Therapeutic equivalents
| Product | Labeler | Pack | NADAC/unit | TE | Status | Price vs. this |
|---|---|---|---|---|---|---|
| Wound Wash Antiseptic Saline with Benzalkonium Chloride 1.3 mg/mL 13709-0235-11 | NeilMed | 75 ml | — | — | FDA listed | — |
| X3 Clean 1.3 mg/mL 26550-0002-10 | X3 | 8 ml | — | — | FDA listed | — |
| Lightning X Antiseptic 1.3 mg/100mL 43473-0303-01 | Nantong | 59.1 ml | — | — | FDA listed | — |
| Antiseptic 1.3 g/L 47682-0245-02 | Unifirst | 0591 l | — | — | FDA listed | — |
| Medi-First Antiseptic 1.3 g/L 47682-0254-02 | Unifirst | 0591 l | — | — | FDA listed | — |
| Antiseptic 1.3 g/L 47682-0316-02 | Unifirst | 0591 l | — | — | FDA listed | — |
| Green Guard Antiseptic 1.3 g/L 47682-0317-02 | Unifirst | 0591 l | — | — | FDA listed | — |
| Green Guard Antiseptic 1.3 g/L 47682-0333-02 | Unifirst | 0591 l | — | — | FDA listed | — |
| American Red Cross Antiseptic Cleansing 1.3 mg/mL 51628-0035-01 | MY | 177 ml | — | — | FDA listed | — |
| American Red Cross Antiseptic Cleansing .13 g/100mL 51628-4440-01 | MY | 177 ml | — | — | FDA listed | — |
| GenRx Hand Sanitizing 1.3 mg/mLthis 59088-0315-16 | PureTek | 237 ml | — | — | FDA listed | — |
| DiaSinc 1.3 mg/mL 59088-0596-16 | PureTek | 237 ml | — | — | FDA listed | — |
| First Aid Antiseptic .13 g/100mL 59898-0401-10 | Water-Jel | 59 ml | — | — | FDA listed | — |
| X3 Clean Hand Sanitizer 1.3 mg/mL 66902-0038-02 | Natural | 59 ml | — | — | FDA listed | — |
| Zoono Wound Cleanser .13 g/100mL 69221-0204-01 | Zoono | 50 ml | — | — | FDA listed | — |
| Antiseptic 1.3 g/L 69396-0153-02 | Trifecta | 0591 l | — | — | FDA listed | — |
| TOUCH Sanitizing Germ Block, Unscented, 1oz (28.35g) .13 g/100g 69744-0201-01 | Relevo, | 43 g | — | — | FDA listed | — |
| TOUCH Sanitizing Germ Block, Mint Green Tea Aloe, 1oz (28.35g) .13 g/100g 69744-0202-01 | Relevo, | 43 g | — | — | FDA listed | — |
| TOUCH Sanitizing Germ Block, Tropical Breeze, 1oz (28.35g) .13 g/100g 69744-0203-01 | Relevo, | 43 g | — | — | FDA listed | — |
| TOUCH Sanitizing Germ Block, Ocean Mist, 1oz (28.35g) .13 g/100g 69744-0204-01 | Relevo, | 43 g | — | — | FDA listed | — |
| ECOLAB Antiseptic 1.3 g/L 71338-0122-02 | ECOLAB | 059 l | — | — | FDA listed | — |
| My-Shield Hand Sanitizer .13 g/100mL 71884-0012-00 | Enviro | 10 ml | — | — | FDA listed | — |
| Germfree24 Hand Sanitizer .13 g/100mL 71884-0016-01 | Enviro | 10 ml | — | — | FDA listed | — |
| FIRST SHIELD First Aid Antiseptic .13 g/100mL 72976-0003-01 | Ever | 60 ml | — | — | FDA listed | — |
| American Red Cross Antiseptic Cleansing .13 g/100mL 75742-0037-01 | Zhejiang | 177 ml | — | — | FDA listed | — |
| MEDI-FIRST First Aid Antiseptic 1.3 mg/mL 78495-0122-01 | Ultra | 59.1 ml | — | — | FDA listed | — |
| Snugell .13 g/100mL 80671-0005-33 | QUANZHOU | 473 ml | — | — | Discontinued | — |
| Aeroaid 1.3 mg/mL 55305-0144-01 | Aero | 59.1 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.
- FDA openFDA NDC Directory · synced Oct 1, 2026
- FDA Orange Book · refreshed Oct 3, 2026
- CMS NADAC weekly file
Availability & generic status
🏛️
2020
On the market since
Mar 2020
📍
2026
Currently FDA-listed
6 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.
- FDA Orange Book · refreshed Oct 3, 2026
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 ZY81Z83H0X
Aloe vera leaf is a plant extract derived from the aloe plant. It is used in medicines as a natural moisturizer and skin-soothing agent in topical formulations.
-
UNII 3XUS85K0RA
Butylene glycol is a clear liquid derived from petroleum or plants that acts as a humectant, solvent, and preservative booster in medicines. It helps keep formulations stable, dissolve active ingredients, and maintain moisture in topical products.
-
UNII 7FLD91C86K
Edetate disodium is a chemical compound that binds and removes certain metal ions. In medicines, it acts as a preservative and stabilizer by preventing metals like calcium from interfering with the product's shelf life and consistency.
-
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 YSE9PPT4TH
Hyaluronate sodium is a natural carbohydrate that holds moisture. It's used in medicines as a lubricant, thickener, and moisture-retaining agent to improve texture and delivery of the active ingredient.
-
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.
-
UNII 55X04QC32I
A strong alkaline chemical used to adjust and maintain the pH balance of liquid medicines. It helps keep the medicine stable and ensures it stays effective during storage.
-
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.
8 inactive ingredients listed in the exact product block matched to this NDC.
The official label also statesAloe barbadensis (Aloe vera) leaf juice, butylene glycol, disodium EDTA, glycerin, phenoxyethanol, purified water, sodium hyaluronate.
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.- FDA label on DailyMed · label index refreshed Oct 5, 2026
- FDA openFDA NDC Directory · synced Oct 1, 2026
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
LabelerPureTek Corporation
FDA applicationM003 (OTC MONOGRAPH DRUG)
Labeler code59088
First marketedMar 2020
Product typeHuman Otc Drug
Portfolio178 products on file
More NDCs from PureTek Corporation labeler code 59088
- GenRx Anti-Bacterial Gel Alcohol 62 mL/100mL Liquid NDC 59088-299-08
- Folixate Folate, Vitamin D3 1000 ug; 125 ug Tablet NDC 59088-301-54
- Lidotral Two Percent Lidocaine Hydrochloride 20 mg/mL Spray NDC 59088-304-03
- Lidotral 3.88% Roll on Lidocaine HCI 38.8 mg/g Gel NDC 59088-307-07
- Lidotral Five Percent with Menthol Lidocaine Hydrochloride, 30 mg/mL; 50 mg/mL Liquid NDC 59088-308-03
- DermacinRx Penetral Cream Capsaicin .25 mg/mL Cream NDC 59088-310-08
- Lidotral 3.88 Percent Plus Hydrocortisone 1 Percent Cream Lidocaine HCl, Hydrocortisone Acetate 38.8 mg/g; 10 mg/g Cream NDC 59088-317-07
- Lidotral 5 Percent and Hydrocortisone 1 Percent with Peptides and Arnica Lidocaine HCl 5 % , Hydrocortisone Acetate 1% 50 mg/g; 10 mg/g Cream NDC 59088-319-07
- Neurozyl Lidocaine HCl 4.12 % 41.2 mg/g Cream NDC 59088-321-07
- Lidotral 5 Percent Roll On Gel Lidocaine Hydrochloride 50 mg/g Gel NDC 59088-327-07
- Hydroxate Gel HYDROCORTISONE 2% 20 mg/g Gel NDC 59088-328-03
- Penetral Roll-on Capsaicin 0.025% .25 mg/g Gel NDC 59088-329-07
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 openFDA NDC Directory · synced Oct 1, 2026
- Drugs@FDA
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
📄 Do Not Use
📄 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 ▾
Uses ■ a topical antiseptic that protects against germs
⏱️ Dosage and Administration ▾
Directions ■ wet hands thoroughly with product ■ allow to dry without wiping ■ repeat as necessary
⚠️ Warnings ▾
Warnings For external use only
📦 Storage and Handling ▾
Other information ■ protect from freezing ■ avoid excessive heat
🧪 Active Ingredient ▾
Active ingredient Benzalkonium Chloride 0.13% Purpose Antiseptic
🧪 Inactive Ingredients ▾
Inactive ingredients Aloe barbadensis (Aloe vera) leaf juice, butylene glycol, disodium EDTA, glycerin, phenoxyethanol, purified water, sodium hyaluronate.
🎯 Purpose ▾
Purpose Antiseptic
📄 Do Not Use ▾
Do not use on ■ deep or puncture wounds ■ animal bites ■ serious burns
📄 When Using This Product ▾
When using this product ■ do not get into eyes
📄 Stop Use and Ask a Doctor If ▾
Stop use and ask a doctor if ■ Irritation and redness develop ■ condition persists for more than 72 hours
📄 Keep Out of Reach of Children ▾
Keep out of reach of children. If swallowed, get medical help or contact a Poison Control Center right away.
📄 Package Label / Principal Display Panel ▾
GenRx Hand Sanitizing Spray (8 oz label) Label
No label section mentions that — try another word, or open the full label on DailyMed below.
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 Benzalkonium Chloride — the ingredient across all brands.
Top reported reactions
Age at onset
Reporter sex
Male · 32%
Female · 68%
Unknown · 0%
Serious outcomes
Reports over time (by year) — tap or hover for the count & year
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 | ✓ 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 PureTek Corporation. Listing status can change — the directory data on this page refreshes weekly.
Who lists this product with the FDA?
PureTek Corporation 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.
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.