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Escudo Ultra-Protect Original Benzalkonium Chloride .1 g/100g Soap, 115 g — NDC 84529-001-01 (Billing 84529-0001-01)

by Indelpa, Inc · 115 g in 1 CELLO PACK

This is a package of 115 g of Escudo Ultra-Protect Original Benzalkonium Chloride .1 g/100g Soap from Indelpa, Inc, marketed since Jul 2024 and currently FDA-listed. It is this product's only package size.

NDC 84529-0001-01
🏷️ FDA NDC (as labeled) 84529-001-01 billing pads the product segment with a zero
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

⚠️
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) 84529-001-01
Product NDC 84529-001
11-digit billing NDC 84529000101
RxCUI 1926450
UNII F5UM2KM3W7
Application # M003
SPL Set ID 1cd4c38f-8156-bd74-e063-6394a90a9f56
DEA schedule Non-controlled
Marketing category OTC MONOGRAPH DRUG
Marketing status On market
FDA listing status Listed (active directory)
Marketing start 2024-07-09
Route TOPICAL
Dosage form SOAP
Substance BENZALKONIUM CHLORIDE
Quick answers
  • RxCUI (RxNorm): 1926450
Why two NDCs? The FDA registers this code as 84529-001-01 — 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 → 84529-0001-01. 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.

Clinical

🧪 What is this product?

Escudo Ultra-Protect Original is a topical soap containing benzalkonium chloride, an antimicrobial ingredient. This product is marketed as an over-the-counter monograph drug, meaning it follows FDA's established rules for antiseptic soaps rather than being individually reviewed. Benzalkonium chloride is commonly used in cleansing products for its antimicrobial properties. This soap is applied to the skin during routine cleansing.

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
84529-0001-01 You're viewing this Main listing 115 g in 1 CELLO PACK 2024-07-09 — Active

Therapeutic equivalents

ProductLabelerPackNADAC/unitTEStatusPrice vs. this
Dial refresh and renew Antibacterial Mountain Fresh .1 g/100g 54340-0017-03 Henkel 3 packets — — FDA listed —
Dial Antibacterial with Vitamins .1 g/100g 54340-0020-01 Henkel 113 g — — FDA listed —
Dial refresh and renew Antibacterial white .1 g/100g 54340-0260-01 Henkel 113 g — — FDA listed —
Dial advanced clean Antibacterial gold .1 g/100g 54340-0262-01 Henkel 113 g — — FDA listed —
Dial Antibacterial Calm and Soothe .1 g/100g 54340-0266-03 Henkel 3 packets — — FDA listed —
Dial Antibacterial and Sensitive Aloe .1 g/100g 54340-0267-03 Henkel 16 cellos — — FDA listed —
Dial Complete Antibacterial Bar Spring Water .1 g/100g 54340-0270-08 Henkel 8 packets — — FDA listed —
Dial Antibacterial Bar .1 g/100g 54340-0272-20 Henkel 99 g — — FDA listed —
Dial Antibacterial Bar .1 g/100g 54340-0274-01 Henkel 180 g — — Discontinued —
Dial Antibacterial Bar .1 g/100g 54340-0278-04 Henkel 678 g — — Discontinued —
Dial antibacterial and sensitive hypoallergenic bar .1 g/100g 54340-0283-30 Henkel 1 cello — — FDA listed —
Dial Antibacterial Vitamin Bar .1 g/100g 54340-0286-02 Henkel 72 cellos — — FDA listed —
Dial refresh and renew Antibacterial Bar Spring Water .1 g/100g 54340-0300-01 Henkel 113 g — — FDA listed —
DK12 Oatmeal Antibacterial and Moisturizing .1 g/110g 62476-0104-15 Industria 140 g — — FDA listed —
DK12 Creamy Antibacterial and Moisturizing .1 g/110g 62476-0105-15 Industria 140 g — — FDA listed —
DK12 Fresh Energy Antibacterial and Moisturizing .1 g/110g 62476-0106-15 Industria 140 g — — FDA listed —
Escudo Ultra-Protect Original .1 g/100gthis 84529-0001-01 Indelpa, 115 g — — FDA listed —
Escudo Ultra-Protect Soft Care .1 g/100g 84529-0002-01 Indelpa, 115 g — — FDA listed —
Gelle-N-Detox Ice Mint And Eucalyptus Massage .1 g/100g 49283-0014-07 CHEMCO 20 g — — Discontinued —
Gelle-N-Detox - Lavender And Rosemary Massage .1 g/100g 49283-0001-07 CHEMCO 20 g — — FDA listed —
Gelle-N-Detox Ice Mint And Eucalyptus Massage .1 g/100g 49283-0110-07 CHEMCO 20 g — — FDA listed —
Klean-Them Hand Sanitizing Towels .1 g/100g 73943-0953-01 Rite-Kem, 400 g — — FDA listed —
5EWA5 Antibacterial Hand Sanitizer Wipes .1 g/100g 40096-1909-01 W.W. 6 canisters — — Discontinued —
Gelle-N-Detox - Lavender And Rosemary Massage .1 g/100g 49283-0015-07 CHEMCO 20 g — — Discontinued —
SCRUBS Hand Sanitizer Wipes .1 g/100g 51239-2909-01 ITW 400 g — — 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

🏛️
2024
On the market since
Jul 2024
📍
2026
Currently FDA-listed
2 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.

What it looks like

Color blue
ShapeFreeform
ImprintEscudo;ULTRA;PROTECT
Size96 mm
ScoringNot scored
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 3K9958V90M
    A liquid solvent derived from fermentation or chemical synthesis. In medicines, alcohol dissolves active ingredients, helps preserve the product, and improves how the body absorbs certain drugs.
  • UNII 9DBA0SBB0L
    A synthetic red dye derived from coal tar used as a colorant in medicines and cosmetics. It gives tablets, capsules, and liquids their red or pink appearance for identification and visual appeal.
  • UNII MP1J8420LU
    A salt derived from edetic acid that binds to trace metals in medicines. It serves as a chelating agent and preservative to prevent metal-catalyzed breakdown of the drug and extend shelf life.
  • UNII M2F465ROXU
    A phosphorus-containing compound used as a chelating agent and water softener in pharmaceutical formulations. It helps prevent mineral buildup and stabilizes the medicine by binding to metal ions that could otherwise degrade the product.
  • UNII 3P3ONR6O1S
    A synthetic green dye approved by the FDA for use in medicines and foods. It serves as a colorant to make the pill or liquid visually distinctive and help with product identification.
  • UNII 5EM498GW35
    A mixture of aromatic compounds used to add pleasant smell to the medicine. Fragrance helps mask unpleasant tastes or odors, making the medication easier to take.
  • 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.

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

The official label also statesAlcohol, D&C Red 33, Etidronic Acid, FD&C Green 3, Glycerin, Sodium Chloride, Sodium Palmate, Sodium Palm Kernelate, Tetrasodium EDTA, Titanium Dioxide, Water, Fragance.

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

LabelerIndelpa, Inc
FDA applicationM003 (OTC MONOGRAPH DRUG)
Labeler code84529
First marketedJul 2024
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.

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 📄 Do Not Use 📄 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 ▾

Use for washing to decrease becateria on the skin.

⏱️ Dosage and Administration 16 words ▾

Directions Wet bar with water. Lather vigorously and wash skin. Rinse with water and dry thoroughly.

⚠️ Warnings 87 words ▾

Warnings For external use only. Do not use if you are allergic to any of the ingredients Directions Wet bar with water. Lather vigorously and wash skin.

Rinse with water and dry thoroughly. When using this product avoid contact with eyes. In case of eye contact, rinse thoroughly with water.

Stop use and ask a doctor if irritation or redness develop and persist for more than 72 hours. Keep out of reach of children If swallowed, get medical help or contact a Poison Control Center right away.

🧪 Active Ingredient 20 words ▾

Active Ingredient Active Ingredient ------------------------------- Purpose Benzalkonium Chloride 0.1% ----------------- Antibacterial Active Ingredient ------------------------------- Purpose Benzalkonium Chloride 0.1% ----------------- Antibacterial

🧪 Inactive Ingredients 25 words ▾

Inactive Ingredients Alcohol, D&C Red 33, Etidronic Acid, FD&C Green 3, Glycerin, Sodium Chloride, Sodium Palmate, Sodium Palm Kernelate, Tetrasodium EDTA, Titanium Dioxide, Water, Fragance.

🎯 Purpose 9 words ▾

Active Ingredient ------------------------------- Purpose Benzalkonium Chloride 0.1% ----------------- Antibacterial

📄 Do Not Use 12 words ▾

Do not use if you are allergic to any of the ingredients

📄 When Using This Product 17 words ▾

When using this product avoid contact with eyes. In case of eye contact, rinse thoroughly with water.

📄 Stop Use and Ask a Doctor If 18 words ▾

Stop use and ask a doctor if irritation or redness develop and persist for more than 72 hours.

📄 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 5 words ▾

Questions or Comments? 1-800-678-5082 [email protected]

📄 Package Label / Principal Display Panel 28 words ▾

Package Label principal display panel Eliminates 99.9% of Bacteria Fresh clean scent Deep cleansing Escudo® ULTRA-PROTECT ORIGINAL ANTIBACTERIAL BAR SOAP NET WT

4.05 Z (115g) Escudo Ultra-Protect Original

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

Age at onset

Infant1
Child1
Adolescent3
Adult41
Elderly17

Reporter sex

479 reports
Male · 32%
Female · 68%
Unknown · 0%

Serious outcomes

Hospitalization211
Disabling23
Reports over time (by year) — tap or hover for the count & year
2020 2022 2024 2026 81 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 — 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 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 Indelpa, Inc. Listing status can change — the directory data on this page refreshes weekly.
Who lists this product with the FDA?
Indelpa, Inc 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.
← 84528-0682-30 · Kindra 84529-0002-01 · Indelpa, →
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.