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XtraCare Foam Antibacterial Hand Wash Vanilla Passion Flower Benzalkonium Chloride .2 g/221g Soap, 221 g — NDC 57337-047-01 (Billing 57337-0047-01)

by Rejoice International · 221 g in 1 BOTTLE

This is a package of 221 g of XtraCare Foam Antibacterial Hand Wash Vanilla Passion Flower Benzalkonium Chloride .2 g/221g Soap from Rejoice International, marketed since Jan 2014 and currently FDA-listed. It is this product's only package size.

NDC 57337-0047-01
🏷️ FDA NDC (as labeled) 57337-047-01 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) 57337-047-01
Product NDC 57337-047
11-digit billing NDC 57337004701
RxCUI 1233282
UNII F5UM2KM3W7
UPC 0849607056184
Application # M003
SPL Set ID 4890f81e-7994-4ea2-9412-5614c405a2a3
DEA schedule Non-controlled
Marketing category OTC MONOGRAPH DRUG
Marketing status On market
FDA listing status Listed (active directory)
Marketing start 2014-01-29
Route TOPICAL
Dosage form SOAP
Substance BENZALKONIUM CHLORIDE
Quick answers
  • RxCUI (RxNorm): 1233282
Why two NDCs? The FDA registers this code as 57337-047-01 — 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 → 57337-0047-01. 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?

XtraCare Foam Antibacterial Hand Wash is a topical soap product containing benzalkonium chloride, an antimicrobial agent commonly used in over-the-counter hand-cleaning products. This product is marketed as an OTC monograph drug, meaning it follows FDA's established rules for antibacterial hand soaps rather than undergoing individual product review. Benzalkonium chloride is typically included in hand washes to reduce bacteria on the skin surface during washing. The product is formulated as a foam soap with vanilla passion flower fragrance.

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
57337-0047-01 You're viewing this Main listing 221 g in 1 BOTTLE 2014-01-29 — Active

Therapeutic equivalents

ProductLabelerPackNADAC/unitTEStatusPrice vs. this
g and h Protect Hand 1 mg/mL 10056-0026-00 Access 250 ml — — FDA listed —
Summit 367 Antibacterial Foam 1 mg/mL 23590-0200-10 R.L. 850 ml — — FDA listed —
Summit E2 1 mg/mL 23590-0300-10 R.L. 850 ml — — FDA listed —
Swisher 1 mg/mL 47593-0592-41 Ecolab 750 ml — — FDA listed —
Swisher TF 1 mg/mL 47593-0601-26 Ecolab 1000 ml — — FDA listed —
XtraCare Foam Antibacterial Hand Wash Refill Vanilla Passion Flower .5 g/444g 57337-0045-01 Rejoice 444 g — — FDA listed —
XtraCare Foam Antibacterial Hand Wash Refill Wild Berry Blast .5 g/444g 57337-0046-01 Rejoice 444 g — — FDA listed —
XtraCare Foam Antibacterial Hand Wash Vanilla Passion Flower .2 g/221gthis 57337-0047-01 Rejoice 221 g — — FDA listed —
XtraCare Foam Antibacterial Hand Wash Wild Berry Blast .2 g/221g 57337-0048-01 Rejoice 221 g — — FDA listed —
XtraCare Foam Antibacterial Hand Wash Pink Cherry Blossom .2 g/221g 57337-0049-01 Rejoice 221 g — — FDA listed —
XtraCare Foam Antibacterial Hand Wash Refill Pink Cherry Blossom .5 g/444g 57337-0050-01 Rejoice 444 g — — FDA listed —
SunDrops 87 1 mg/mL 63621-0387-14 Sunburst 3785 ml — — Discontinued —
WhiskCare 387 1 mg/mL 65585-0513-01 Whisk 50 ml — — FDA listed —
Algonquin HanClean Foam 1 mg/mL 65585-0520-01 Whisk 4000 ml — — FDA listed —
FOAM-BAC Antibacterial Hand 1 mg/mL 65585-0521-01 Whisk 1000 ml — — FDA listed —
Algonquin HanClean Foam 1 mg/mL 65585-0530-01 Whisk 4000 ml — — FDA listed —
WhiskCare 387 1 mg/mL 65585-0531-01 Whisk 50 ml — — FDA listed —
WhiskCare 357 1 mg/mL 65585-0557-01 Whisk 50 ml — — Discontinued —
WhiskCare 357 1 mg/mL 65585-0558-01 Whisk 50 ml — — FDA listed —
Jade Antibacterial Hand 1 mg/mL 65585-0586-01 Whisk 900 ml — — FDA listed —
Natural Extensions Antibacterial Foaming Hand 1 mg/mL 66975-0104-01 Benco 3785 ml — — FDA listed —
Aterra7 Antibacterial Foaming Hand 1 mg/mL 68306-0115-01 B4 530 ml — — FDA listed —
Aterra7 Antibacterial Foaming Hand Fragrance Free 1 mg/mL 68306-0117-01 B4 3785 ml — — FDA listed —
Germ-Free 24 Sanitizing 1 mg/mL 71884-0026-01 Enviro 245 ml — — FDA listed —
My-Shield Sanitizing 1 mg/mL 71884-0040-01 Enviro 244 ml — — FDA listed —
Doctor Inks Sanitizing 1 mg/mL 71884-0200-01 Enviro 118 ml — — FDA listed —
Hustle Butter Antibacterial Foaming .1 g/100mL 72014-0200-07 H.B.D. 207 ml — — Discontinued —
Lavex Foaming Antibacterial Hand 1 mg/mL 81551-0387-01 Clark 1000 ml — — FDA listed —
Foamy Blue 1 mg/mL 83188-0405-04 Pro 1000 ml — — FDA listed —
FloraMedis Hand Sanitizer .1 g/100mL 87215-0001-01 Sichuan 450 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

🏛️
2014
On the market since
Jan 2014
📍
2026
Currently FDA-listed
12 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

LabelerRejoice International
FDA applicationM003 (OTC MONOGRAPH DRUG)
Labeler code57337
First marketedJan 2014
Product typeHuman Otc Drug
Portfolio40 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.

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 📄 Keep Out of Reach of Children 📄 Other Information 📄 Package Label / Principal Display Panel
🎯 Indications and Usage 21 words ▾

XtraCare® Foam Antibacterial Hand Wash Kills 99.9% of bacteria Compare to Lysol® foam antibacterial hand wash

7.5 Fl Oz (221 mL)

⏱️ Dosage and Administration 15 words ▾

Directions pump into hands lather vigorously for at least 15 seconds rinse hands with water

⚠️ Warnings 32 words ▾

Warnings for external use only. When using this product avoid contact with eyes. In case of eye contact, flush with water, Stop use and ask a doctor if irritation and redness develops.

🧪 Active Ingredient 8 words ▾

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

🧪 Inactive Ingredients 27 words ▾

Inactive Ingredients water, glycerin, lauramine oxide, PET-150 distearate, cetrimonium chloride, propylene glycol, fragrance, citric acid, tetrasodium EDTA, cocamide MEA, methylchloroisothiazolinone, methylisothiazolinone, D&C red no.33, FD&C blue no.1

🎯 Purpose 10 words ▾

Uses for hand washing to decrease bacteria on the skin.

📄 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 40 words ▾

Other information : store at room temperature Questions/Comments? 1-855-345-5575 *this product is not manufactured or distributed by Reckitt Benckiser LLC, the distributor of Lysol® foam antibacterial hand wash. DISTRIBUTED BY: REJOICE INTERNATIONAL INC NORTHVILLE, MI 48168 USA MADE IN CHINA

📄 Package Label / Principal Display Panel 2 words ▾

label image

Source: FDA Structured Product Labeling, mirrored from DailyMed / openFDA. Prefer the government’s original formatting? View this label on DailyMed ↗

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) — 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 Rejoice International. Listing status can change — the directory data on this page refreshes weekly.
Who lists this product with the FDA?
Rejoice International 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.
← 57337-0046-01 · Rejoice 57337-0048-01 · Rejoice →
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.