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Durashield benzalkonium chloride .13 mg/mL Lotion, 473 mL — NDC 85131-0013-16 package photo
Label image from the product's FDA listing (DailyMed) — may show a different pack size or an older label revision.

Durashield benzalkonium chloride .13 mg/mL Lotion, 473 mL — NDC 85131-013-16 (Billing 85131-0013-16)

by Advanced Biomedical Incorporated · 473 mL in 1 BOTTLE, PUMP

This is a package of 473 mL of Durashield benzalkonium chloride .13 mg/mL Lotion from Advanced Biomedical Incorporated, marketed since Dec 2024 and currently FDA-listed.

NDC 85131-0013-16
🏷️ FDA NDC (as labeled) 85131-013-16 billing pads the product segment with a zero
This package
Contains473 mL Pack sizes6 compare ↓
Product page 85131-0013-00 Also comes in: 33 ml 85131-013-00 60 ml 85131-013-02 118 ml 85131-013-04 237 ml 85131-013-08 355 ml 85131-013-12
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 85131-013-16 alone.

Record
FDA NDC Directory package listing · Human OTC drug
Code segments
85131 labeler · 013 product · 16 package
Package marketed since
Dec 18, 2024
Sample package
No — commercial package
Listing certified through
Dec 31, 2026
Barcode (UPC)
0850027212098, 0850027212135, 0850027212142, 0850027212104 +2 more
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) 85131-013-16
Product NDC 85131-013
11-digit billing NDC 85131001316
UNII F5UM2KM3W7
UPC 0850027212098, 0850027212135, 0850027212142, 0850027212104 +2 more
Application # 505G(a)(3)
SPL Set ID b0723781-225a-46c6-907c-5c5c48f383b8
DEA schedule Non-controlled
Marketing category OTC MONOGRAPH DRUG
Marketing status On market
FDA listing status Listed (active directory)
Marketing start 2024-12-18
Route TOPICAL
Dosage form LOTION
Substance BENZALKONIUM CHLORIDE
Why two NDCs? The FDA registers this code as 85131-013-16 — 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 → 85131-0013-16. 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?

Durashield benzalkonium chloride.13 mg/mL lotion is a topical over-the-counter product marketed under FDA's monograph rules for skin care products. Benzalkonium chloride is a quaternary ammonium compound that functions as an antimicrobial agent and is commonly used in topical lotions for skin cleansing and disinfection purposes. This product is applied directly to the skin.

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 gPer 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: 33 ml 60 ml 118 ml 237 ml 355 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
85131-0013-00 85131-013-00 Main listing .33 mL in 1 BOTTLE 2024-12-18 — Active
85131-0013-02 85131-013-02 60 mL in 1 BOTTLE 2024-12-18 — Active
85131-0013-04 85131-013-04 118 mL in 1 BOTTLE 2024-12-18 — Active
85131-0013-08 85131-013-08 237 mL in 1 BOTTLE, PUMP 2024-12-18 — Active
85131-0013-12 85131-013-12 355 mL in 1 BOTTLE, PUMP 2024-12-18 — Active
85131-0013-16 You're viewing this 473 mL in 1 BOTTLE, PUMP 2024-12-18 — Active

Pack size FAQ

What quantity is in this package?
This package contains 473 mL — 473 ml in 1 bottle, pump.
How does this package differ from NDC 85131-0013-00?
Both are Durashield benzalkonium chloride .13 mg/mL Lotion — the drug itself is identical. This page's package is the 473 mL one, while NDC 85131-0013-00 is the 33 ml package.
What NDC number is used to bill for this package of Durashield benzalkonium chloride .13 mg/mL Lotion?
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
Durashield .13 mg/mLthis 85131-0013-16 Advanced 473 ml — — FDA listed —
Antibacterial Foaming Skin Cleanser .13 mg/mL 65601-0709-04 Betco 3780 ml — — FDA listed —
Benzalkonium chloride .13 mg/mL 83986-0912-20 UpLift 53 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

🏛️
2024
On the market since
Dec 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.

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.

Loading inactive ingredients from the official FDA label in the background. No external source is being called by this page request.
Where does this data come from?
Source: official FDA Structured Product Labeling (SPL) via DailyMed and the openFDA label index. Structured IACT rows and label-wide narrative are kept separate; availability and product-level specificity depend on the submitted label.

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

LabelerAdvanced Biomedical Incorporated
FDA application505G(a)(3) (OTC MONOGRAPH DRUG)
Labeler code85131
First marketedDec 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. Very long sections are excerpted here and marked; the full text is on DailyMed (linked in the sources below). 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 📄 Other Information 📄 Questions or Comments 📄 Package Label / Principal Display Panel
🎯 Indications and Usage 15 words ▾

Uses to decrease bacteria on the skin that could cause disease recommended for repeated use

⏱️ Dosage and Administration 31 words ▾

Directions Apply a small amount of lotion into palm of hand Rub hands together thoroughly until dry No towels or wiping required for children under 6, use only under adult supervision

⚠️ Warnings 69 words ▾

Warnings For external use only: hands When using this product keep out of eyes. In case of contact with eyes, flush thoroughly with water. avoid contact with broken skin do not ingest Stop use and ask a doctor if irritation and redness develop condition persists 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 5 words ▾

Active ingredient Benzalkonium chloride, 0.13%

🧪 Inactive Ingredients 35 words ▾

Inactive ingredients purified water (aqua), zea mays (corn) starch, persea gratissima (avocado) oil, pectin, petrolatum, phenoxyethanol, xanthan gum, potassium sorbate, tributyl phosphate, citrus paradisi (grapefruit) seed extract, ethylhexylglycerin, tocopherol, glycerin, ascorbic acid, bht, sodium hydroxide

🎯 Purpose 2 words ▾

Purpose Antimicrobial

📄 When Using This Product 26 words ▾

When using this product keep out of eyes. In case of contact with eyes, flush thoroughly with water. avoid contact with broken skin do not ingest

📄 Stop Use and Ask a Doctor If 18 words ▾

Stop use and ask a doctor if irritation and redness develop condition persists 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

📄 Other Information 5 words ▾

Other information Store between 35°-100°F

📄 Questions or Comments 8 words ▾

Questions or comments? www.DuraShieldProtects.com Tel: 1-855-NOT-ALC0 or 1-855-668-2520

📄 Package Label / Principal Display Panel ~3 min read ▾

Durashield Hand Sanitizing Lotion 0.011 Fl Oz - NDC 85131-013-00 DuraShield ® Advanced Hand Sanitizing Lotion Moisturizing Vitamin E & Avocado Oil Formula Dermatologically Tested Safe on Skin Prolonged Protection Kills 99.99% of Germs* Made in the USA 0.011 FL OZ (0.33mL) 100% Fragrance Free 100% Alcohol-Free 100% Paraben-Free Clinically Tested Safe for all glove types Latex Vinyl Nitrile *Kills 99.99% of most common germs that may cause illness. Puts The Power To Fight Germs In Your Hands™ Alcohol-Free Hand Sanitizing Lotion NDC: 85131-013-00 Distributed by: Advanced Biomedical, Inc.

Frisco, TX 75035 © 2025 Advanced Biomedical, Inc. All rights reserved. durashield-0-011oz

Durashield Hand Sanitizing Lotion 2 Fl Oz - NDC 85131-013-02 DuraShield ® Advanced Hand Sanitizing Lotion Moisturizing Vitamin E & Avocado Oil Formula Dermatologically Tested Safe on Skin Prolonged Protection Kills 99.99% of Germs* Made in the USA 2 FL OZ (59mL) 100% Fragrance Free 100% Alcohol-Free 100% Paraben-Free Clinically Tested Safe for all glove types Latex Vinyl Nitrile *Kills 99.99% of most common germs that may cause illness. Puts The Power To Fight Germs In Your Hands™ Alcohol-Free Hand Sanitizing Lotion NDC: 85131-013-02 Distributed by: Advanced Biomedical, Inc.

Frisco, TX 75035 © 2025 Advanced Biomedical, Inc. All rights reserved. durashield-2oz

Durashield Hand Sanitizing Lotion 4 Fl Oz - NDC 85131-013-04 DuraShield ® Advanced Hand Sanitizing Lotion Moisturizing Vitamin E & Avocado Oil Formula Dermatologically Tested Safe on Skin Prolonged Protection Kills 99.99% of Germs* Made in the USA 4 FL OZ (118mL) 100% Fragrance Free 100% Alcohol-Free 100% Paraben-Free Clinically Tested Safe for all glove types Latex Vinyl Nitrile *Kills 99.99% of most common germs that may cause illness. Puts The Power To Fight Germs In Your Hands™ Alcohol-Free Hand Sanitizing Lotion NDC: 85131-013-04 Distributed by: Advanced Biomedical, Inc.

Frisco, TX 75035 © 2025 Advanced Biomedical, Inc. All rights reserved. durashield-4oz

Durashield Hand Sanitizing Lotion 8 Fl Oz - NDC 85131-013-08 DuraShield ® Advanced Hand Sanitizing Lotion Moisturizing Vitamin E & Avocado Oil Formula Dermatologically Tested Safe on Skin Prolonged Protection Kills 99.99% of Germs* Made in the USA 8 FL OZ (237mL) 100% Fragrance Free 100% Alcohol-Free 100% Paraben-Free Clinically Tested Safe for all glove types Latex Vinyl Nitrile *Kills 99.99% of most common germs that may cause illness. Puts The Power To Fight Germs In Your Hands™ Alcohol-Free Hand Sanitizing Lotion NDC: 85131-013-08 Distributed by: Advanced Biomedical, Inc.

Frisco, TX 75035 © 2025 Advanced Biomedical, Inc. All rights reserved. durashield-8oz

Durashield Hand Sanitizing Lotion 12 Fl Oz - NDC 85131-013-12 DuraShield ® Advanced Hand Sanitizing Lotion Moisturizing Vitamin E & Avocado Oil Formula Dermatologically Tested Safe on Skin Prolonged Protection Kills 99.99% of Germs* Made in the USA 12 FL OZ (355mL) 100% Fragrance Free 100% Alcohol-Free 100% Paraben-Free Clinically Tested Safe for all glove types Latex Vinyl Nitrile *Kills 99.99% of most common germs that may cause illness. Puts The Power To Fight Germs In Your Hands™ Alcohol-Free Hand Sanitizing Lotion NDC: 85131-013-12 Distributed by: Advanced Biomedical, Inc.

Frisco, TX 75035 © 2025 Advanced Biomedical, Inc. All rights reserved. durashield-12oz

Durashield Hand Sanitizing Lotion 16 Fl Oz - NDC 85131-013-16 DuraShield ® Advanced Hand Sanitizing Lotion Moisturizing Vitamin E & Avocado Oil Formula Dermatologically Tested Safe on Skin Prolonged Protection Kills 99.99% of Germs* Made in the USA 16 FL OZ (473mL) 100% Fragrance Free 100% Alcohol-Free 100% Paraben-Free Clinically Tested Safe for all glove types Latex Vinyl Nitrile *Kills 99.99% of most common germs that may cause illness. Puts The Power To Fight Germs In Your Hands™ Alcohol-Free Hand Sanitizing Lotion NDC: 85131-013-16 Distributed by: Advanced Biomedical, Inc.

Frisco, TX 75035 © 2025 Advanced Biomedical, Inc.… [Excerpted — this section continues on DailyMed.]

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 Durashield (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
Life-threatening27
Disabling18
Reports over time (by year) — tap or hover for the count & year
2022 2023 2024 2026 77 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) — Not published for this NDC The labeler did not submit a structured excipient list, or no SPL is 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 Advanced Biomedical Incorporated. 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 5 other package presentations of this same product, including 33 ml (85131-0013-00), 60 ml (85131-0013-02), 118 ml (85131-0013-04). 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?
Advanced Biomedical Incorporated 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.
← 85130-0100-01 · B 85132-0001-30 · IKONIK →
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.