Guardelle BENZALKONIUM CHLORIDE .13 g/100mL Aerosol, Foam, 52 mL
by Social Medical Supply LLC · 52 mL in 1 BOTTLE, PUMP (85754-000-02)
NDC 85754-0000-02
🏷️ FDA NDC (as labeled)
85754-000-02
billing pads the product segment with a zero
This package
Contains52 mL
Pack sizes3 compare ↓
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 →
⚠️
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
FDA NDC (as labeled)
85754-000-02
Product NDC
85754-000
11-digit billing NDC
85754000002
RxCUI
1020365
UNII
F5UM2KM3W7
Application #
M003
SPL Set ID
8793e3be-7409-4f71-9397-abbeacd27cf8
DEA schedule
Non-controlled
Marketing category
OTC MONOGRAPH DRUG
Marketing status
On market
FDA listing status
Listed (active directory)
Marketing start
2025-10-16
Route
TOPICAL
Dosage form
AEROSOL, FOAM
Substance
BENZALKONIUM CHLORIDE
Why two NDCs?
The FDA registers this code as 85754-000-02 — 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 → 85754-0000-02. 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
LabelerSocial Medical Supply LLC
FDA applicationM003 (OTC MONOGRAPH DRUG)
Labeler code85754
First marketedOct 2025
Product typeHuman Otc Drug
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?
Guardelle is a topical aerosol foam containing benzalkonium chloride, an antimicrobial and disinfectant agent. This product is marketed as an over-the-counter monograph drug, which means it follows FDA's established guidelines for its category rather than undergoing individual product review. Benzalkonium chloride is typically used in antiseptic and cleansing products applied to the skin. The aerosol foam formulation allows for convenient topical delivery to affected areas.
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.
💬 Questions about BENZALKONIUM CHLORIDE?
Ask a pharmacist →
Ask a licensed pharmacist directly — free, answered by our team.
🧪 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 H2KVQ74JM4
A compound derived from coconut oil that acts as a conditioning agent and surfactant. It helps stabilize and thicken liquid formulations while reducing static and improving texture in topical products.
-
UNII 7T1F30V5YH
A synthetic emulsifier derived from sorbitol and oleic acid. It helps mix oil and water-based ingredients together and keeps them from separating in liquid formulations.
-
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 3P5SU53360
Triethylene glycol is a synthetic liquid that acts as a solvent and humectant in medicines. It helps dissolve active ingredients and keeps liquid formulations from drying out.
-
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 statesWater, Cocamidolpropyl PG-Dimonium Chloride Phospate, Propylene glycol, Triethylene glycol, Polysorbate-20
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 system | Per g | 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
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
| Product | Labeler | Pack | NADAC/unit | TE | Status | Price vs. this |
|---|---|---|---|---|---|---|
| Instant Foam Non-alcohol PURE Hand Sanitizer .13 g/100mL 11084-0300-01 | SC | 47 ml | — | — | Discontinued | — |
| Foaming Hand 1.3 mg/mL 11344-0224-04 | Nice-Pak | 750 ml | — | — | Discontinued | — |
| Benzalkonium chloride 1.3 mg/mL 11673-0681-23 | Target | 68 ml | — | — | FDA listed | — |
| QS Plus Instant Hand Sanitizer 1.3 mg/mL 13302-0457-10 | Romaine | 1000 ml | — | — | Discontinued | — |
| X3 Clean 1.3 mg/mL 26550-0001-12 | X3 | 75 ml | — | — | FDA listed | — |
| Tork Hand Sanitizer Alcohol Free Foam .13 g/100mL 49351-0103-01 | Essity | 6 bottles | — | — | FDA listed | — |
| Tork Hand Sanitizing Alcohol-Free Foam 1.3 mg/mL 49351-0303-01 | Essity | 1000 ml | — | — | FDA listed | — |
| X3 Clean Foaming Hand Sanitizer 1.3 mg/mL 49354-0055-75 | HK | 75 ml | — | — | FDA listed | — |
| Ben E. Keith FIHS 1.3 mg/mL 50980-0207-12 | Ben | 1000 ml | — | — | FDA listed | — |
| American Red Cross Antiseptic Cleansing Foam .13 g/100mL 51628-4539-01 | MY | 177 ml | — | — | FDA listed | — |
| North Woods Derma Foam Hand Sanitizer 1.3 mg/mL 53125-0700-54 | Superior | 1000 ml | — | — | Discontinued | — |
| DermaCen Non-Alcohol Foaming Hand Sanitizer .13 g/100mL 62654-0141-14 | Central | 532 ml | — | — | FDA listed | — |
| Byotrol Hand Sanitizer 1.3 mg/mL 63002-0002-12 | Advanced | 1250 ml | — | — | FDA listed | — |
| Hand Sanitizer 1.3 g/mL 63002-0004-33 | Advanced | 9.76 ml | — | — | FDA listed | — |
| 99 Plus Hand Sanitizer 1.3 mg/mL 63533-0457-10 | Momar | 1000 ml | — | — | FDA listed | — |
| Lite nFoamy Eucalyptus Mint Sanitizing Handwash 1.3 g/L 64009-0332-72 | Spartan | 532 l | — | — | FDA listed | — |
| Lite nFoamy E2 Sanitizing Handwash 1.3 g/L 64009-0333-95 | Spartan | 3.79 l | — | — | FDA listed | — |
| Enriched Foam Alcohol-Free Hand Sanitizer 13 mg/100mL 65321-0039-01 | Rubbermaid | 4 pouches | — | — | FDA listed | — |
| Alcohol Free Foaming Hand Sanitizer 1.3 mg/mL 65601-0700-04 | Betco | 3780 ml | — | — | FDA listed | — |
| Band Aid Antiseptic Cleansing 1.3 mg/mL 69968-0728-01 | Kenvue | 68 ml | — | — | FDA listed | — |
| Blue Green Foam .13 g/100mL 70411-0100-07 | H2Ocean, | 207 ml | — | — | FDA listed | — |
| ElimiShield Hunt Core Body Foam for Hunters 1.3 mg/mL 71853-0010-00 | Bryson | 200 ml | — | — | FDA listed | — |
| Germ Free 24 Hand Sanitizer 1.3 mg/mL 71884-0006-01 | Enviro | 50 ml | — | — | FDA listed | — |
| Doctor Inks Hand Sanitizer 1.3 mg/mL 71884-0201-01 | Enviro | 58 ml | — | — | FDA listed | — |
| Mountain Air Scent FOAMING HAND SANITIZER 1.3 mg/mL 74177-0040-08 | K7 | 236 ml | — | — | FDA listed | — |
| Pine and Honey Scent FOAMING HAND SANITIZER 1.3 mg/mL 74177-0041-08 | K7 | 236 ml | — | — | FDA listed | — |
| Simply Lavender Scent FOAMING HAND SANITIZER 1.3 mg/mL 74177-0042-08 | K7 | 236 ml | — | — | FDA listed | — |
| Vanilla Coconut Scent FOAMING HAND SANITIZER 1.3 mg/mL 74177-0043-16 | K7 | 473 ml | — | — | FDA listed | — |
| Foaming Hand Sanitizer 1.3 g/1000mL 75044-0280-16 | American | 2 bottles | — | — | FDA listed | — |
| American Red Cross Antiseptic Cleansing Foam .13 g/100mL 75742-0082-01 | Zhejiang | 177 ml | — | — | FDA listed | — |
| Hand Sanitizer .13 g/100mL 76370-0006-05 | Tazza | 1000 ml | — | — | Discontinued | — |
| Gentlecare Hand And Skin Sanitizer 1.3 mg/mL 78181-0020-02 | PARAGON | 50 ml | — | — | FDA listed | — |
| KleenLine Essentials Alcohol Free Foaming Hand Sanitizer 1.3 mg/mL 79258-0700-29 | Brady | 1000 ml | — | — | FDA listed | — |
| Hygiene Clean Balsam Fir Hand Sanitizer Alcohol Free 1.3 mg/mL 80499-0004-01 | USA | 237 ml | — | — | FDA listed | — |
| Hygiene Clean Leather Oak Hand Sanitizer Alcohol Free 1.3 mg/mL 80499-0005-01 | USA | 237 ml | — | — | FDA listed | — |
| Hygiene Clean Mahogany Teakwood Hand Sanitizer Alcohol Free 1.3 mg/mL 80499-0006-01 | USA | 237 ml | — | — | FDA listed | — |
| Hygiene Clean Pumpkin Spice Hand Sanitizer Alcohol Free 1.3 mg/mL 80499-0007-01 | USA | 237 ml | — | — | FDA listed | — |
| Hygiene Clean Spring Bloom Hand Sanitizer Bottle Alcohol Free 1.3 mg/mL 80499-0025-08 | USA | 237 ml | — | — | FDA listed | — |
| Hygiene Clean Lilac Garden Hand Sanitizer Bottle Alcohol Free 1.3 mg/mL 80499-0026-08 | USA | 237 ml | — | — | FDA listed | — |
| Hygiene Clean Lavender Blossom Hand Sanitizer Bottle Alcohol Free 1.3 mg/mL 80499-0027-08 | USA | 237 ml | — | — | FDA listed | — |
| Hygiene Clean Clean Cotton Hand Sanitizer 1.3 mg/mL 80499-0100-01 | USA | 800 ml | — | — | FDA listed | — |
| Hygiene Clean Eucalyptus Hand Sanitizer 1.3 mg/mL 80499-0101-01 | USA | 800 ml | — | — | FDA listed | — |
| Hygiene Clean Luxury Clean Hand Sanitizer 1.3 mg/mL 80499-0102-01 | USA | 800 ml | — | — | FDA listed | — |
| Antiseptic Foaming Hand Sanitizer 1.3 mg/mL 82442-0812-20 | Target | 2 bottles | — | — | FDA listed | — |
| NOxyDERM .13 g/100mL 83823-0001-01 | NOxy | 100 ml | — | — | FDA listed | — |
| NOxyDERM .038 g/29.5mL 83823-0002-01 | NOxy | 29.5 ml | — | — | FDA listed | — |
| Foaming Hand Sanitizer 1.3 mg/mL 83986-0118-45 | UpLift | 1150 ml | — | — | FDA listed | — |
| Guardelle .13 g/100mLthis 85754-0000-02 | Social | 52 ml | — | — | FDA listed | — |
| GrowDefender Antibacterial Foam 1.3 mg/mL 87109-0013-01 | Grow | 50.68 ml | — | — | FDA listed | — |
| Betadine Foam Cleanser .13 g/100mL 67618-0184-08 | Atlantis | 237 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
🏛️
2025
On the market since
Oct 2025
📍
2026
Currently FDA-listed
1 year 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 Guardelle (this brand).
Top reported reactions
Age at onset
Reporter sex
Male · 28%
Female · 72%
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.
📦 Packaging — all sizes for this product
| Package NDC | Description | Marketing start | Status |
|---|---|---|---|
| 85754-0000-02 You're viewing this | 52 mL in 1 BOTTLE, PUMP (85754-000-02) | 2025-10-16 | Active |
| 85754-0000-07 | 207 mL in 1 BOTTLE, PUMP (85754-000-07) | 2025-10-16 | Active |
| 85754-0000-18 | 500 mL in 1 BOTTLE, PUMP (85754-000-18) | 2025-10-16 | Active |
You're viewing the smallest of 3 pack sizes for this product.
Pack size FAQ
What quantity is in NDC 85754-0000-02?
NDC 85754-0000-02 contains 52 mL — 52 ml in 1 bottle, pump.
What is the difference between NDC 85754-0000-02 and NDC 85754-0000-07?
Both are Guardelle BENZALKONIUM CHLORIDE .13 g/100mL Aerosol, Foam — the drug itself is identical. NDC 85754-0000-02 is the 52 mL package, while NDC 85754-0000-07 is the 207 ml package.
What NDC number is used to bill for this package of Guardelle BENZALKONIUM CHLORIDE .13 g/100mL Aerosol, Foam?
Bill NDC 85754-0000-02 — the 11-digit billing format is 85754000002. 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 | — Not published for this NDC No photo available yet for this listing. |
| 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 85754-000-02, 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: 85754-0000-02, written without dashes as 85754000002. 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 85754-0000-02, the first segment (85754) is the labeler code FDA assigned to Social Medical Supply LLC; the middle segment (0000) identifies this specific product — its ingredient, strength, and dosage form; and the last segment (02) 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 Social Medical Supply LLC. 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 2 other package presentations of this same product, including 207 ml (85754-0000-07), 500 ml (85754-0000-18). 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?
Social Medical Supply 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.
📄 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
🎯 Indications and Usage ▾
Uses To decrease bacteria on the skin
⏱️ Dosage and Administration ▾
Directions Liberally apply product to skin by gently massaging until absorbed. Supervise children in the use of the product.
⚠️ Warnings ▾
Warnings For external use only. Keep out of reach of children. If swallowed, get medical help or contact a Poison Control Center right away. Do not use in eyes. In case of contact, rinse eyes thoroughly with water. Stop use and ask a doctor if skin/eye irritation develops.
🧪 Active Ingredient ▾
Active Ingredient Benzalkonium chloride 0.13%
🧪 Inactive Ingredients ▾
Inactive Ingredients Water, Cocamidolpropyl PG-Dimonium Chloride Phospate, Propylene glycol, Triethylene glycol, Polysorbate-20
🎯 Purpose ▾
Purpose Antiseptic
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 ↗
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.