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Wasted Benzalkonium Chloride .13 g/100mL; .75 g/100mL Liquid, 250 mL — NDC 52305-0802-25 package photo
Label image from the product's FDA listing (DailyMed) — may show a different pack size or an older label revision.

Wasted Benzalkonium Chloride .13 g/100mL; .75 g/100mL Liquid, 250 mL — NDC 52305-802-25 (Billing 52305-0802-25)

by Freshorize Ltd · 250 mL in 1 BOTTLE, PUMP

This is a package of 250 mL of Wasted Benzalkonium Chloride .13 g/100mL; .75 g/100mL Liquid from Freshorize Ltd, marketed since Dec 2023 and currently FDA-listed. It is the main listing for this product, which comes in 2 package sizes.

NDC 52305-0802-25
🏷️ FDA NDC (as labeled) 52305-802-25 billing pads the product segment with a zero
This package
Contains250 mL Pack sizes2 compare ↓
Main listing for product 52305-802 · Also comes in: 270 ml 52305-802-27
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 52305-802-25 alone.

Record
FDA NDC Directory package listing · Human OTC drug
Code segments
52305 labeler · 802 product · 25 package
Package marketed since
Dec 18, 2023
Sample package
No — commercial package
Listing certified through
Dec 31, 2026
Barcode (UPC-A, from the NDC)
3 5230580225 5
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) 52305-802-25
Product NDC 52305-802
11-digit billing NDC 52305080225
UNII F5UM2KM3W7, ZF94AP8MEY
Application # 505G(a)(3)
SPL Set ID 0c43b516-7608-c826-e063-6294a90ae4e3
DEA schedule Non-controlled
Marketing category OTC MONOGRAPH DRUG
Marketing status On market
FDA listing status Listed (active directory)
Marketing start 2023-12-18
Route TOPICAL
Dosage form LIQUID
Substance BENZALKONIUM CHLORIDE; HYDROGENATED CASTOR OIL
Why two NDCs? The FDA registers this code as 52305-802-25 — 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 → 52305-0802-25. 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?

This is a topical liquid product sold over the counter under FDA's OTC monograph rules. It contains benzalkonium chloride, which is commonly used as an antimicrobial and skin cleanser in topical products. The formulation also includes hydrogenated castor oil, which functions as an emollient to help condition and soften skin. Products of this type are typically applied to the skin for cleansing or mild antimicrobial purposes.

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: 270 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
52305-0802-25 You're viewing this Main listing 250 mL in 1 BOTTLE, PUMP 2023-12-18 — Active
52305-0802-27 52305-802-27 270 mL in 1 BOTTLE, PUMP 2023-12-18 — Active

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

Pack size FAQ

What quantity is in this package?
This package contains 250 mL — 250 ml in 1 bottle, pump.
How does this package differ from NDC 52305-0802-27?
Both are Wasted Benzalkonium Chloride .13 g/100mL; .75 g/100mL Liquid — the drug itself is identical. This page's package is the 250 mL one, while NDC 52305-0802-27 is the 270 ml package.
What NDC number is used to bill for this package of Wasted Benzalkonium Chloride .13 g/100mL; .75 g/100mL 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
Wasted .13 g/100mL; .75 g/100mLthis 52305-0802-25 Freshorize 250 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

🏛️
2023
On the market since
Dec 2023
📍
2026
Currently FDA-listed
3 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.

  • 0.1 g / 100 mL 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.
  • 0.2 g / 100 mL 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.
  • 5 g / 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.
  • 0.5 g / 100 mL UNII AUG1H506LY
    Propylene is a simple hydrocarbon gas used in medicines as a solvent and carrier. It helps dissolve or suspend active ingredients and improves how the medicine flows and mixes during manufacturing.
  • 93.07 g / 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.

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

The official label also statesInactive Ingredients: Aqua, Glycerin, PEG-40, Hydrogenated Castor Oil, Propylene Glycol, DMDM Hydantoin, Aloe Barbadensis Leaf Extract.

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

LabelerFreshorize Ltd
FDA application505G(a)(3) (OTC MONOGRAPH DRUG)
Labeler code52305
First marketedDec 2023
Product typeHuman Otc Drug
Portfolio2 products on file

More NDCs from Freshorize Ltd labeler code 52305

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 📄 Keep Out of Reach of Children 📄 Other Information 📖 Instructions for Use 📄 Package Label / Principal Display Panel
🎯 Indications and Usage 7 words ▾

Uses: Uses: To decrease bacteria on skin.

⏱️ Dosage and Administration 17 words ▾

Happy Hands Sanitizer This is a pump item with no dosage information. Most customers use 1-2 pumps.

⚠️ Warnings 55 words ▾

Warnings: Warnings: For external use only. Do no use in eyes, in case of contact, rinse eyes thoroughly with water. Stop use and ask a doctor if contact a skin irritation develops. Keep out of children. If swallowed,get medical help or contact a Poison Control Centre right away Warnings: Keep out of reach of children.

🧪 Active Ingredient 9 words ▾

Drug facts: Drug Facts: Active Ingredients: Benzalkonium Chloride 0.13%.

🧪 Inactive Ingredients 18 words ▾

Inactive Ingredients: Inactive Ingredients: Aqua, Glycerin, PEG-40, Hydrogenated Castor Oil, Propylene Glycol, DMDM Hydantoin, Aloe Barbadensis Leaf Extract.

🎯 Purpose 3 words ▾

Purpose: Purpose: Antibacterial.

📄 Keep Out of Reach of Children 7 words ▾

Warnings: Keep out of reach of children.

📄 Other Information 7 words ▾

Other Information: Other Information: Avoid extreme temperatures.

📖 Instructions for Use 20 words ▾

Directions: Directions: Liberally apply product to skin by gently massaging until absorbed. Supervise children in the use of the product.

📄 Package Label / Principal Display Panel 23 words ▾

Happy Hands Safety Sanitizer 270 ml Happy Hands Sanitizer This is a pump item with no dosage information. Most customers use 1-2 pumps.

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 Wasted (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
Death25
Reports over time (by year) — tap or hover for the count & year
2019 2021 2023 2026 35 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 ✓ 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 Freshorize Ltd. 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 270 ml (52305-0802-27). 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?
Freshorize Ltd 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.
← 52305-0602-30 · Freshorize 52311-0686-01 · Ironwood →
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.