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Theraplus Antibacterial Wipes Fresh Scent with Aloe and Vitamin E BENZALKONIUM CHLORIDE 1 mg/mL Cloth, 20 patches — NDC 80684-007-20 (Billing 80684-0007-20)

by Fourstar Group USA, Inc. · 20 PATCH in 1 BAG / 3.5 mL in 1 PATCH

This is a package of 20 patches of Theraplus Antibacterial Wipes Fresh Scent with Aloe and Vitamin E BENZALKONIUM CHLORIDE 1 mg/mL Cloth from Fourstar Group USA, Inc., no longer marketed (first marketed Nov 2020), no longer in the FDA NDC Directory. It is this product's only package size.

NDC 80684-0007-20
🏷️ FDA NDC (as labeled) 80684-007-20 billing pads the product segment with a zero
OTC Discontinued Non-controlled ⚠ Discontinued by firm ⇄ 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 80684-007-20 alone.

Record
FDA NDC Directory package listing · Human OTC drug
Code segments
80684 labeler · 007 product · 20 package
Package marketed since
Nov 10, 2020
Sample package
No — commercial package
Listing certified through
Dec 31, 2026
Barcode (UPC)
0049696504010
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 ↗
⚠️
Excluded from the active FDA NDC Directory. The labeler reported this product as discontinued, so it is excluded from the active NDC Directory. The listing was last certified through Mar 2026. A label may still appear on DailyMed, but the NDC is no longer in the current FDA NDC Directory. Search the FDA NDC Directory ↗

Identity & classification

Regulatory identifiers FDA, NLM and CMS codes for this package

FDA NDC (as labeled) 80684-007-20
Product NDC 80684-007
11-digit billing NDC 80684000720
RxCUI 1038856
UNII F5UM2KM3W7
UPC 0049696504010
Application # 505G(a)(3)
SPL Set ID b3ece54b-6e1e-08a7-e053-2a95a90a363e
DEA schedule Non-controlled
Marketing category OTC MONOGRAPH DRUG
Marketing status Discontinued
FDA listing status Discontinued by firm (certified through Mar 2026)
Marketing start 2020-11-10
Route TOPICAL
Dosage form CLOTH
Substance BENZALKONIUM CHLORIDE
Quick answers
  • RxCUI (RxNorm): 1038856
Why two NDCs? The FDA registers this code as 80684-007-20 — 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 → 80684-0007-20. 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?

Theraplus Antibacterial Wipes are pre-moistened cloth wipes containing benzalkonium chloride, an antimicrobial agent typically used to reduce bacteria on skin surfaces. This is an over-the-counter monograph product applied topically by wiping on the skin. The wipes are formulated with aloe and vitamin E, which are commonly added to skin care products for their moisturizing and soothing properties. These wipes are typically used for general skin cleansing and sanitizing purposes.

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
80684-0007-20 You're viewing this Main listing 20 PATCH in 1 BAG / 3.5 mL in 1 PATCH 2020-11-10 — Discontinued by firm

Therapeutic equivalents

ProductLabelerPackNADAC/unitTEStatusPrice vs. this
5EWA5 Antibacterial Hand Sanitizer Wipes .1 g/100g 40096-1909-01 W.W. 6 canisters — — Discontinued —
SCRUBS Hand Sanitizer Wipes .1 g/100g 51239-2909-01 ITW 400 g — — FDA listed —
Aerowipe .1 g/100g 55305-0118-10 Aero 1.5 g — — FDA listed —
Hand Sanitizing Wipes 1 mg/g 69446-0220-00 Ez 1500 patches — — FDA listed —
GERMisept Antibacterial Hand Sanitizing Wipes 1 mg/mL 70335-0012-01 Innovent 200 patches — — FDA listed —
Redicare Antiseptic Towelettes 1 mg/1000mg 71105-0800-02 Redicare 50 packets — — FDA listed —
Klean-Them Hand Sanitizing Towels .1 g/100g 73943-0953-01 Rite-Kem, 400 g — — FDA listed —
Nuvik Large Roll in Bucket Antibacterial Hand Wipes .1 g/100mL 74602-0900-80 Nuvik 1 pail — — FDA listed —
Germ-Away 1 mg/g 74680-0107-46 Unico 80 g — — FDA listed —
Germ-Away 1 mg/g 74680-0110-23 Unico 72 g — — FDA listed —
Germ-Away 1 mg/g 74680-0111-45 Unico 80 g — — FDA listed —
Germ-Away 1 mg/g 74680-0112-88 Unico 1200 g — — FDA listed —
Pet wipes 1 g 79539-0801-01 Shandong 1 cloth — — FDA listed —
CleanCom .01 mg 80436-0005-01 RMT 200 cloths — — Discontinued —
Theraplus Antibacterial Wipes Fresh Scent with Aloe and Vitamin E 1 mg/mLthis 80684-0007-20 Fourstar 20 patches — — Discontinued —
wet wipes 01 .1 g/1001 82953-0048-01 Cosmuses 10 cloths — — FDA listed —
fomin mini Hand Sanitizer Wipes COCO-NILLA BLISS .1 g/100mL 85755-0001-08 Fomin 6 packets — — FDA listed —
fomin mini Hand Sanitizer Wipes MELON POP .1 g/100mL 85755-0002-08 Fomin 6 packets — — FDA listed —
fomin mini Hand Sanitizer Wipes FRAGRANCE FREE .1 g/100mL 85755-0003-08 Fomin 6 packets — — FDA listed —
fomin mini Hand Sanitizer Wipes - 6 - VARIETY PACK 85755-0004-06 Fomin 1 kit — — FDA listed —
g and h Protect Hand 1 mg/mL 10056-0026-00 Access 250 ml — — FDA listed —
New Wave Cleaning Solutions Foaming Hand Sanitizer 1 mg/mL 80042-0003-00 NEW 3785 ml — — FDA listed —
Summit E2 1 mg/mL 23590-0300-10 R.L. 850 ml — — FDA listed —
SunDrops 87 1 mg/mL 63621-0387-14 Sunburst 3785 ml — — Discontinued —
My-Shield Sanitizing 1 mg/mL 71884-0040-01 Enviro 244 ml — — FDA listed —
Algonquin HanClean Foam 1 mg/mL 65585-0520-01 Whisk 4000 ml — — FDA listed —
Doctor Inks Sanitizing 1 mg/mL 71884-0200-01 Enviro 118 ml — — FDA listed —
SunDrops 77 1 mg/mL 63621-0354-70 Sunburst 6 bottles — — Discontinued —
Aterra7 Antibacterial Foaming Hand 1 mg/mL 68306-0115-01 B4 530 ml — — FDA listed —
Jade Antibacterial Hand 1 mg/mL 65585-0586-01 Whisk 900 ml — — FDA listed —
WhiskCare 357 1 mg/mL 65585-0557-01 Whisk 50 ml — — Discontinued —
MyTerra Hand Sanitizer Foam NA 1 mg/mL 70780-0151-13 PortionPac 1000 ml — — FDA listed —
WhiskCare 387 1 mg/mL 65585-0513-01 Whisk 50 ml — — FDA listed —
FOAM-BAC Antibacterial Hand 1 mg/mL 65585-0521-01 Whisk 1000 ml — — FDA listed —
Natural Extensions Antibacterial Foaming Hand 1 mg/mL 66975-0104-01 Benco 3785 ml — — FDA listed —
Germ-Free 24 Sanitizing 1 mg/mL 71884-0026-01 Enviro 245 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

🏛️
2020
On the market since
Nov 2020
📍
2026
Currently FDA-listed
6 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.

We could not link this NDC to a current FDA Structured Product Label. An inactive-ingredient list is therefore not available from this source.
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

LabelerFourstar Group USA, Inc.
FDA application505G(a)(3) (OTC MONOGRAPH DRUG)
Labeler code80684
First marketedNov 2020
Product typeHuman Otc Drug
Portfolio151 products on file

More NDCs from Fourstar Group USA, Inc. labeler code 80684

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 📄 Package Label / Principal Display Panel
🎯 Indications and Usage 5 words ▾

Use decreases bacteria on skin

⏱️ Dosage and Administration 24 words ▾

Directions for adults and children of 2 years and over children under 2 year ask a doctor before use allow to dry without wiping

⚠️ Warnings 75 words ▾

Warnings For external use only. Do not use over large areas of the body if you are allergic to any of the ingredients When using this product avoid contact with eyes. If contact occurs, flush thoroughly with water. Stop use and ask a doctor if irritation or rash develops and continues 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 7 words ▾

Active ingredient Benzalkonium chloride 0.1% Purpose Antibacterial

🧪 Inactive Ingredients 19 words ▾

Inactive ingredients Water, Glycerin, Phenoxyethanol, Polysorbate 20, Aloe Barbadensis Leaf Extract, Polyaminopropyl Biguanide, Disodium EDTA, Fragrance, 2-Bromo-2-Nitropropane-1,3-Diol, Tocopheryl Acetate

🎯 Purpose 2 words ▾

Purpose Antibacterial

📄 Do Not Use 18 words ▾

Do not use over large areas of the body if you are allergic to any of the ingredients

📄 When Using This Product 15 words ▾

When using this product avoid contact with eyes. If contact occurs, flush thoroughly with water.

📄 Stop Use and Ask a Doctor If 18 words ▾

Stop use and ask a doctor if irritation or rash develops and continues 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.

📄 Package Label / Principal Display Panel 3 words ▾

Package Labeling: Bottle

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 Theraplus Antibacterial Wipes Fresh Scent with Aloe and Vitamin E (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
2019 2021 2023 2026 35 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 No longer marketed (per FDA listing data)
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) — 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.
What does the discontinued status mean for this NDC?
The labeler reported a marketing end date (or the listing was delisted), so this specific package is no longer actively marketed. Remaining stock may still be dispensed for a time, and the NDC stays valid for historical records and claims — but data feeds (pricing, labeling) typically stop updating for it. Other package sizes or other manufacturers' versions of the same medication may still be marketed — see the equivalents section where available.
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.
Who lists this product with the FDA?
Fourstar Group USA, 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.
← 80684-0006-01 · Fourstar 80684-0030-01 · FOURSTAR →
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.