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American Red Cross Antiseptic Cleansing BENZALKONIUM CHLORIDE 1.3 mg/mL Spray, 177 mL

by MY IMPORTS USA, LLC · 177 mL in 1 BOTTLE, PUMP (51628-0035-1)
NDC 51628-0035-01
🏷️ FDA NDC (as labeled) 51628-0035-1 billing pads the package segment with a zero
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-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) 51628-0035-1
Product NDC 51628-0035
11-digit billing NDC 51628003501
RxCUI 1039012
UNII F5UM2KM3W7
Application # M003
SPL Set ID 716da1e6-d0f5-4cc1-ad78-517d5ca809a5
DEA schedule Non-controlled
Marketing category OTC MONOGRAPH DRUG
Marketing status On market
FDA listing status Listed (active directory)
Marketing start 2025-11-01
Route TOPICAL
Dosage form SPRAY
Substance BENZALKONIUM CHLORIDE
Why two NDCs? The FDA registers this code as 51628-0035-1 — a 5-4-1 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 package segment → 51628-0035-01. 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

LabelerMY IMPORTS USA, LLC
FDA applicationM003 (OTC MONOGRAPH DRUG)
Labeler code51628
First marketedNov 2025
Product typeHuman Otc Drug
Portfolio25 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 an over-the-counter antiseptic spray marketed under FDA's OTC monograph rules for topical wound cleansing products. The active ingredient, benzalkonium chloride, is a quaternary ammonium antimicrobial agent that functions as a broad-spectrum germicide, commonly used to reduce bacteria and other germs on minor cuts, scrapes, and irritated skin. Applied directly to the affected area via spray, it is typically part of first-aid wound care routines.

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 33X04XA5AT
    Lactic acid is a naturally occurring organic acid derived from milk or plant sources. It lowers and maintains pH in formulations, helps preserve the product, and can enhance ingredient stability and absorption.
  • 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.

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

The official label also statesWater (Aqua), Propylene Glycol, Lactic acid

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.
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
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/mLthis 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/mL 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.

⏳ Availability & generic status

🏛️
2025
On the market since
Nov 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.

📦 Packaging — all sizes for this product

Package NDCDescription Marketing startStatus
51628-0035-01 You're viewing this 177 mL in 1 BOTTLE, PUMP (51628-0035-1) 2025-11-01 Active

🧭 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 51628-0035-1, 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: 51628-0035-01, written without dashes as 51628003501. 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 51628-0035-01, the first segment (51628) is the labeler code FDA assigned to MY IMPORTS USA, LLC; the middle segment (0035) 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 MY IMPORTS USA, LLC. Listing status can change — the directory data on this page refreshes weekly.
Who lists this product with the FDA?
MY IMPORTS USA, 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 23 words ▾

Uses First aid to help prevent the risk of bacterial contamination or skin infection associated with minor: • cuts • scrapes • burns.

⏱️ Dosage and Administration 55 words ▾

Directions Adults and children 2 years of age and older • clean the affected area • spray a small amount of this product on the area 1 to 3 times daily • may be covered with a sterile bandage • if bandaged, let dry first • children under 2 years of age: consult a doctor

⚠️ Warnings 104 words ▾

Warnings For external use only. Do not use • in or near the eyes • over large areas of the body or in large quantities • longer than I week • over raw surfaces or blistered areas. Ask a doctor before use if you have • deep or puncture wounds •animal bites • serious burns.

Stop use and ask a doctor if • condition or symptoms get worse or last more than I week • symptoms clear up and occur again within a few days. Keep out of reach of children. If swallowed, get medical help or contact a Poison Control Center right away.

🧪 Active Ingredient 10 words ▾

Active ingredient Benzalkonium Cl 0.13% w/v Purpose First aid antiseptic

🧪 Inactive Ingredients 8 words ▾

Inactive ingredients Water (Aqua), Propylene Glycol, Lactic acid

🎯 Purpose 4 words ▾

Purpose First aid antiseptic

Source: FDA Structured Product Labeling, mirrored from DailyMed / openFDA. Prefer the government’s original formatting? View this label on DailyMed ↗
← 51628-0034-00 · My 51628-0036-01 · My →
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.