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American Red Cross Antibacterial Bar BENZALKONIUM CHLORIDE 1.3 mg/g Soap, 85 g — NDC 51628-0034-00 package photo
Label image from the product's FDA listing (DailyMed) — may show a different pack size or an older label revision.

American Red Cross Antibacterial Bar BENZALKONIUM CHLORIDE 1.3 mg/g Soap, 85 g — NDC 51628-0034-0 (Billing 51628-0034-00)

by My Imports Usa, LLC · 85 g in 1 BOX

This is a package of 85 g of American Red Cross Antibacterial Bar BENZALKONIUM CHLORIDE 1.3 mg/g Soap from My Imports Usa, LLC, marketed since May 2025 and currently FDA-listed. It is this product's only package size.

NDC 51628-0034-00
🏷️ FDA NDC (as labeled) 51628-0034-0 billing pads the package segment with a zero
OTC On market Non-controlled ⇄ Compare with another NDC
🗂️ FDA directory synced Oct 8, 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 51628-0034-0 alone.

Record
FDA NDC Directory package listing · Human OTC drug
Code segments
51628 labeler · 0034 product · 0 package
Package marketed since
May 10, 2025
Sample package
No — commercial package
Listing certified through
Dec 31, 2027
Barcode (UPC)
0850065393926
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) 51628-0034-0
Product NDC 51628-0034
11-digit billing NDC 51628003400
RxCUI 2057666
UNII F5UM2KM3W7
UPC 0850065393926
Application # 505G(a)(3)
SPL Set ID eab6bee4-e780-4f0d-aa9c-a0111f033b32
DEA schedule Non-controlled
Marketing category OTC MONOGRAPH DRUG
Marketing status On market
FDA listing status Listed (active directory)
Marketing start 2025-05-10
Route TOPICAL
Dosage form SOAP
Substance BENZALKONIUM CHLORIDE
Quick answers
  • RxCUI (RxNorm): 2057666
Why two NDCs? The FDA registers this code as 51628-0034-0 — 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 → 51628-0034-00. 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.

Clinical

🧪 What is this product?

This is an antibacterial bar soap made with benzalkonium chloride, an antimicrobial ingredient applied topically to the skin. Benzalkonium chloride is commonly used in over-the-counter soap products to reduce bacteria on the skin surface. This product is marketed under FDA's OTC soap monograph, meaning it follows the agency's established rules for this category rather than undergoing individual product review.

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 eachPer 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.

Packaging — all sizes for this product

Package NDCDescription Marketing startMarketing endStatus
51628-0034-00 You're viewing this Main listing 85 g in 1 BOX 2025-05-10 — Active

Therapeutic equivalents

ProductLabelerPackNADAC/unitTEStatusPrice vs. this
Covex Antibacterial Bar Active Protection 1.3 mg/g 51209-0017-00 DALAN 115 g — — FDA listed —
Covex Antibacterial Bar Cool Protection 1.3 mg/g 51209-0018-00 DALAN 115 g — — FDA listed —
Covex Antibacterial Bar Fresh Protection 1.3 mg/g 51209-0020-27 DALAN 270 g — — FDA listed —
Covex Antibacterial Bar Active Protection 1.3 mg/g 51209-0021-27 DALAN 270 g — — FDA listed —
Covex Antibacterial Bar Cool Protection 1.3 mg/g 51209-0022-27 DALAN 270 g — — FDA listed —
American Red Cross Antibacterial Bar 1.3 mg/gthis 51628-0034-00 My 85 g — — FDA listed —
Dove .13 g/100g 64942-1846-01 Conopco 212 g — — FDA listed —
Dove .13 g/100g 64942-2455-01 Conopco 106 g — — FDA listed —
Dove .13 g/100g 64942-2468-01 Conopco 850 g — — FDA listed —
Terramed Just Think Comfort Armor Antibacterial Cleansing Bar .13 g/100g 83004-0033-01 Rida 120 g — — FDA listed —
Obstetrical Towelette 1.3 mg/g 34645-0015-01 Jianerkang 1 patch — — FDA listed —
BZK Antiseptic Towelette Non-Sterile 1.3 mg/g 34645-0017-01 Jianerkang 1 patch — — FDA listed —
BZK Antiseptic Towelette Sterile 1.3 mg/g 34645-0018-01 Jianerkang 1 patch — — FDA listed —
Cleansing Towelette 1.3 mg/g 34645-0019-01 Jianerkang 1 patch — — FDA listed —
BZK Antiseptic Wipe 1.3 mg/g 59050-0264-01 Changzhou 1 patch — — FDA listed —
Antiseptic BZK Towelette 1.3 mg/g 63517-0501-83 Cardinal 100 pouches — — FDA listed —
Antiseptic Towelette TOALLITAS ANTISEPTICAS 1.3 mg/g 84219-0004-00 M-star 1 patch — — FDA listed —
MyMedic Antiseptic Towelette 1.3 mg/g 59050-0273-01 Changzhou 1 patch — — FDA listed —
BZK Antiseptic Wipe 1.3 mg/g 59050-0262-01 Changzhou 1 patch — — FDA listed —
Club Wipes Sanitizing Wipes Lemon Scent 1.3 mg/g 78940-0010-12 Golden 1200 patches — — Discontinued —
CLUB Wipes Sanitizing Wipes for Hands 1.3 mg/g 42326-0099-00 Petra 1500 patches — — FDA listed —
Health E Wipes, Lemon Scent 1.3 mg/g 78940-0011-10 Golden 1000 patches — — Discontinued —
Antiseptic Towelette 1.3 mg/g 82264-0008-00 UNCHARTED 10 applicators — — FDA listed —
Genuine First Aid Antiseptic Towelette 1.3 mg/g 50814-0081-00 GFA 25 g — — FDA listed —
Antiseptic Towelette 1.3 mg/g 82996-0004-01 Hubei 1 pouch — — FDA listed —
My-Shield Sanitizing Hand Wipes 1.3 mg/g 71884-0010-20 ENVIRO 960 patches — — FDA listed —
Urgent First Aid BZK Antiseptic Wipe 1.3 mg/g 59050-0275-01 Changzhou 1 patch — — 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
May 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.

What it looks like

Color white
ShapeOval
ImprintAMERICAN;RED;CROSS
One label can cover several strengths, so colors may be combined — always confirm a loose pill against the dispensed prescription label or a pharmacist.
Where does this data come from?
Physical description (imprint, shape, color, scoring, coating) from this product’s FDA Structured Product Labeling (SPL), mirrored from DailyMed / openFDA.

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 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 451W47IQ8X
    Sodium chloride is common table salt. It's used in medicines as a buffer to maintain proper pH, as a filler to add bulk, or to adjust the osmotic balance in liquid formulations.
  • UNII 6H91L1NXTW
    A processed palm kernel oil derivative used as an emulsifier and surfactant in medications. It helps mix oil and water-based ingredients together and improves how the medicine spreads and dissolves in the body.
  • UNII S0A6004K3Z
    Sodium palmate is a salt made from palm oil. It acts as an emulsifier and surfactant in medicines, helping mix ingredients that normally don't blend well together and improving product texture and consistency.
  • UNII 15FIX9V2JP
    Titanium dioxide is a bright white mineral powder commonly used as a colorant and opacifying agent. It makes pills and tablets white or lighter in color and helps make coatings non-transparent.
  • 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.

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

The official label also statesSodium Palmate, Aqua, Sodium Palm Kernelate, Glycerin, Fragrance, Sodium Chloride, Titanium Dioxide.

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

LabelerMy Imports Usa, LLC
FDA application505G(a)(3) (OTC MONOGRAPH DRUG)
Labeler code51628
First marketedMay 2025
Product typeHuman Otc Drug
Portfolio25 products on file

More NDCs from My Imports Usa, LLC labeler code 51628

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 📄 When Using This Product 📄 Stop Use and Ask a Doctor If 📄 Keep Out of Reach of Children 📄 Questions or Comments 📄 Package Label / Principal Display Panel
🎯 Indications and Usage 9 words ▾

Uses for washing to decrease bacteria on the skin

⏱️ Dosage and Administration 14 words ▾

Directions Wet bar with water, lather vigorously and use all over body. Rinse clean.

⚠️ Warnings 55 words ▾

Warnings For external use only. When using this product do not use in or near the eyes. In case of contact, rinse eyes thoroughly with water. Stop use and ask doctor if irritation or redness develop. Keep out of reach of children. If swallowed, get medical help or contact a Poison Control Center right away.

🧪 Active Ingredient 7 words ▾

Active ingredient Benzalkonium Chloride 0.13% Purpose Antibacterial

🧪 Inactive Ingredients 14 words ▾

Inacive ingredients Sodium Palmate, Aqua, Sodium Palm Kernelate, Glycerin, Fragrance, Sodium Chloride, Titanium Dioxide.

🎯 Purpose 2 words ▾

Purpose Antibacterial

📄 When Using This Product 21 words ▾

When using this product do not use in or near the eyes. In case of contact, rinse eyes thoroughly with water.

📄 Stop Use and Ask a Doctor If 10 words ▾

Stop use and ask doctor if irritation or redness develop.

📄 Keep Out of Reach of Children 19 words ▾

Keep out of reach of children. If swallowed, get medical help or contact a Poison Control Center right away.

📄 Questions or Comments 4 words ▾

Questions or comments? 1-877-879-6999

📄 Package Label / Principal Display Panel 3 words ▾

Package Labeling: Label

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

Drug Hypersensitivity124
Arthralgia117
Condition Aggravated115
Pain In Extremity114
Infection111
Musculoskeletal Stiffness111
Joint Swelling109

Reporter sex

479 reports

Serious outcomes

Death31
Disabling23
Reports over time (by year) — tap or hover for the count & year
2020 2022 2024 2026 51 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 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.
← 51628-0033-00 · MY 51628-0035-01 · 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.