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Maxiclens Chlorhexidine Gluconate Liquid Solution, 4% 40 mg/mL Solution, 118 mL — NDC 00404-0219-01 package photo
Label image from the product's FDA listing (DailyMed) — may show a different pack size or an older label revision.

Maxiclens Chlorhexidine Gluconate Liquid Solution, 4% 40 mg/mL Solution, 118 mL — NDC 0404-0219-01 (Billing 00404-0219-01)

by Henry Schein, Inc. · 118 mL in 1 BOTTLE

This is a package of 118 mL of Maxiclens Chlorhexidine Gluconate Liquid Solution, 4% 40 mg/mL Solution from Henry Schein, Inc., marketed since Nov 2021 and currently FDA-listed. It is this product's only package size.

NDC 00404-0219-01
🏷️ FDA NDC (as labeled) 0404-0219-01 billing pads the labeler segment with a zero
OTC Brand 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 0404-0219-01 alone.

Record
FDA NDC Directory package listing · Human OTC drug
Code segments
0404 labeler · 0219 product · 01 package
Package marketed since
Nov 17, 2021
Sample package
No — commercial package
Listing certified through
Dec 31, 2027
Barcode (UPC-A, from the NDC)
3 0404021901 0
FDA record last changed
Jul 24, 2026
⚠️
Other active recalls for Chlorhexidine Gluconate (different manufacturers) — 1 · tap to view
These affect other manufacturers’ products for the same ingredient — not necessarily the exact NDC on this page.
Class II · Aug 18, 2026 — Cross Contamination with Other Products (Sage Products, LLC) · FDA recall D-0837-2026
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) 0404-0219-01
Product NDC 0404-0219
11-digit billing NDC 00404021901
RxCUI 211365, 2630838
UNII MOR84MUD8E
Application # NDA019258
SPL Set ID 4b0c6bcd-2242-f734-e063-6294a90a8fbf
Physiologic effect Decreased Cell Wall Integrity
DEA schedule Non-controlled
Marketing category NDA
Marketing status On market
FDA listing status Listed (active directory)
Marketing start 2021-11-17
Route TOPICAL
Dosage form SOLUTION
Substance CHLORHEXIDINE GLUCONATE
Quick answers
  • RxCUI (RxNorm): 211365
Why two NDCs? The FDA registers this code as 0404-0219-01 — a 4-4-2 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 labeler segment → 00404-0219-01. 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 Antiinfectives and antiseptics for local oral treatment class.

Drug family (ATC) Antiinfectives and antiseptics for local oral treatment, Antiinfectives, Biguanides and amidines
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

📗 Our plain-language guide HelloPharmacist
  • It treats gingivitis, which means red, swollen gums that may bleed. You use it between dental visits as part of a program with your dentist. It has not been tested in people with A...
  • It can. Staining of teeth and other mouth surfaces is one of the most common side effects. You may also notice more tartar and changes in taste. Your dentist should remove tartar a...
  • Anyone allergic to chlorhexidine gluconate or any ingredient in the product should avoid it. Serious allergic reactions, including anaphylaxis, have been reported with dental produ...
  • Keep it out of reach of children. A small child who swallows 1 or 2 ounces may have stomach upset, nausea or signs of alcohol intoxication. Get medical help if more than 4 ounces i...
📖 Read our full Chlorhexidine guide →

Supplement & herbal interactions

🌿 Drug–supplement interaction checker →
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 mLPer 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
00404-0219-01 You're viewing this Main listing 118 mL in 1 BOTTLE 2021-11-17 — Active

Therapeutic equivalents

ProductLabelerPackNADAC/unitTEStatusPrice vs. this
Antiseptic Skin Cleanser 4 g/100mL 70000-0407-01 Cardinal 237 ml $0.025 — FDA listed —
Antiseptic Skin Cleanser 4 g/100mL 00116-1061-04 Xttrium 118 ml $0.034 — Availability likely —
Antiseptic Skin Cleanser 4 mg/100mL 46122-0137-34 AmerisourceBergen 237 ml $0.037 — Availability likely —
Foster and Thrive 4 g/100mL 70677-1221-01 McKesson 237 ml $0.037 — Availability likely —
Chlorhexidine Gluconate 40 mg/mL 16571-0111-12 Rising 118 ml $0.040 — Availability likely —
Betasept .04 mg/mL 67618-0200-04 Atlantis 118 ml $0.040 — Availability likely —
Cardinal Health 4 g/100mL 00116-0061-04 Xttrium 118 ml — — Discontinued —
Antiseptic Skin Cleanser 4 mg/100mL 00116-0137-34 Xttrium 237 ml — — FDA listed —
Antiseptic Skin Cleanser 4 mg/100mL 00116-0161-08 Xttrium 237 ml — — FDA listed —
Betasept .04 mg/mL 00116-0200-01 Xttrium 3785 ml — — FDA listed —
Antiseptic Skin Cleanser 4 mg/100mL 00116-0401-50 Xttrium 237 ml — — FDA listed —
Antiseptic Skin Cleanser 4 g/100mL 00116-0407-01 Xttrium 237 ml — — FDA listed —
Antiseptic Skin Cleanser 4 g/100mL 00116-0767-08 Xttrium 237 ml — — FDA listed —
CliniClean 4 g/100mL 00116-0901-05 Xttrium 118 ml — — Discontinued —
Dyna-Hex 4 4 g/100mL 00116-1060-18 Xttrium 535 ml — — FDA listed —
Foster and Thrive 4 g/100mL 00116-1221-01 Xttrium 237 ml — — FDA listed —
Bactoshield CHG 40 mg/mL 00116-1344-08 Xttrium 3780 ml — — FDA listed —
Antiseptic Skin Cleanser 4 mg/100mL 00116-3678-07 Xttrium 473 ml — — FDA listed —
Hibiclens 4 g/100mL 00234-0575-40 Molnlycke 118 ml — — FDA listed —
Antiseptic Skin Cleanser 4 mg/100mL 00363-1061-08 Walgreen 237 ml — — FDA listed —
Maxiclens Chlorhexidine Gluconate Liquid Solution, 4% 40 mg/mLthis 00404-0219-01 Henry 118 ml — — FDA listed —
Maxiclens Chlorhexidine Gluconate Liquid Solution, 4% 40 mg/mL 00404-0220-03 Henry 236 ml — — FDA listed —
Maxiclens Chlorhexidine Gluconate Liquid Solution, 4% 40 mg/mL 00404-0221-04 Henry 473 ml — — FDA listed —
Bactoshield CHG 40 mg/mL 11084-0039-03 SC 118 ml — — FDA listed —
Bactoshield CHG 40 mg/mL 11084-0128-03 SC 118 ml — — FDA listed —
Antiseptic Skin Cleanser 4 g/100mL 11822-0116-05 Rite 237 ml — — FDA listed —
Antiseptic Skin Cleanser 4 g/100mL 11822-0891-02 Rite 532 ml — — FDA listed —
Antiseptic Skin Cleanser 4 mg/100mL 11822-3678-07 Rite 473 ml — — FDA listed —
BD E-Z Scrub 107 40 g/1000mL 17271-0107-03 Becton 18 ml — — FDA listed —
Antiseptic Skin Cleanser 4 mg/100mL 36800-0401-50 Topco 237 ml — — FDA listed —
Halyard Chlorhexidine Gluconate 40 mg/mL 39892-0960-01 Owens 118 ml — — FDA listed —
Halyard Chlorhexidine Gluconate 40 mg/mL 39892-0961-01 Owens 118 ml — — FDA listed —
Antiseptic Skin Cleanser 4 mg/100mL 41250-0162-08 Meijer 237 ml — — Discontinued —
Scrub, Scrub-Stat, Foam Safe, Micro-Guard 40 mg/mL 42939-0125-19 AVA, 946 ml — — FDA listed —
Scrub, Scrub-Stat, Foam Safe, Micro-Guard 40 mg/mL 42939-0128-01 AVA, 118 ml — — FDA listed —
Scrub-Stat 40 mg/mL 47593-0464-11 Ecolab 3780 ml — — FDA listed —
Scrub-Stat 40 mg/mL 47593-0468-21 Ecolab 208000 ml — — Discontinued —
Antiseptic Skin Cleanser 4 g/100mL 59779-0767-08 CVS 237 ml — — FDA listed —
Antiseptic Skin Cleanser 4 mg/100mL 63868-0940-08 Chain 237 ml — — FDA listed —
Antiseptic Skin Cleanser 4 g/100mL 68599-5401-00 McKesson 4 bottles — — FDA listed —
CliniClean 4 g/100mL 69464-0901-05 HR 118 ml — — Discontinued —
Hibiclens 4 g/100mL 76420-0535-08 Asclemed 236 ml — — FDA listed —
Surgical Scrub Brush/Sponge With Nail Cleaner 4% CHG 4 g/100mL 84128-0003-01 Xinxiang 30 patches — — FDA listed —
About this product: this is the brand-name version. Some generic versions are approved by the FDA, but we could not confirm current pharmacy availability from our pricing/market data.
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

🏛️
2021
On the market since
Nov 2021
📍
2026
Currently FDA-listed
5 years listed
🔒
·
Generic approved (availability unconfirmed)
see note
🔒Generic approved by FDA, but pharmacy availability is not confirmed

The FDA lists approved generic versions of this medicine, but that does not always mean a pharmacy can get one today. Patent rules, launch agreements, supply and pricing can affect when generics actually arrive.

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

LabelerHenry Schein, Inc.
Application holderECOLAB INC
FDA applicationNDA019258 (NDA)
Labeler code00404
First marketedNov 2021
Product typeHuman Otc Drug
Portfolio172 products on file

More NDCs from Henry Schein, Inc. labeler code 00404

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 📦 Storage and Handling 🧪 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 46 words ▾

Uses surgical hand scrub: significantly reduces the number of microorganisms on the hands and forearms prior to surgery or patient care healthcare personnel handwash: handwash to help reduce bacteria that potentially can cause disease skin wound and general skin cleanser: helps reduce bacteria on the skin

⏱️ Dosage and Administration 154 words ▾

Directions use with care in premature infants or infants under 2 months of age. These products may cause irritation or chemical burns. use full strength do not dilute Surgical hand scrub: remove jewelry wet hands and forearms with water and apply 5 mL of the product wash/scrub hands and forearms for 3 minutes paying particular attention to the nails, cuticles, and interdigital spaces rinse thoroughly with water wash for an additional 3 minutes with 5 mL of the product and rinse under running water dry thoroughly Healthcare personnel handwash: wet hands with water dispense about 5 mL of product into cupped hands and wash in a vigorous manner for 30 seconds rinse and dry thoroughly Skin wound and general skin cleanser: thoroughly rinse the area to be cleansed with water apply the minimum amount of product necessary to cover the skin or wound area and wash gently.

Rinse thoroughly with water. rinse again thoroughly

⚠️ Warnings 38 words ▾

Warnings For external use only Allergy alert This product may cause a severe allergic reaction. Symptoms may include: wheezing/difficulty breathing shock facial swelling hives rash If an allergic reaction occurs, stop use and seek medical help right away.

📦 Storage and Handling 31 words ▾

Other information store between 20-25°C (68-77°F) avoid excessive heat (above 104°F/40°C) for additional information, see Safety Data Sheet (SDS) if swallowed get medical help or contact a Poison Control Center immediately

🧪 Active Ingredient 6 words ▾

Active ingredient Chlorhexidine gluconate solution, 4%

🧪 Inactive Ingredients 30 words ▾

Inactive ingredients cocamide DEA, cocamine oxide, fragrance, gluconic acid*, gluconolactone*, hydroxyethyl cellulose, isopropyl alcohol 4%, PEG-75 lanolin, PEG-150 distearate, propylene glycol, quaternium-60, water *contains one or more of these ingredients

🎯 Purpose 13 words ▾

Purposes Surgical hand scrub Healthcare personnel handwash Skin wound and general skin cleanser

📄 Do Not Use 37 words ▾

Do not use if you are allergic to chlorhexidine gluconate or any other ingredient in this preparation as a patient preoperative skin preparation (especially on the head or face) in contact with meninges in the genital area

📄 When Using This Product 94 words ▾

When using this product keep out of eyes, ears, and mouth. May cause serious and permanent eye injury if placed or kept in the eye during surgical procedures or may cause deafness when instilled in the middle ear through perforated eardrums. if contact occurs, rinse with cold water right away wounds which involve more than the superficial layers of the skin should not be routinely treated repeated general skin cleansing of large body areas should not be done except when an underlying condition makes it necessary to reduce the bacterial population of the skin

📄 Stop Use and Ask a Doctor If 26 words ▾

Stop use and ask a doctor if irritation, sensitization or allergic reaction occurs and lasts for 72 hours. These may be signs of a serious condition.

📄 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 14 words ▾

Questions or comments? Call 1-800-472-4346 Monday through Friday 8:00 AM to 5:00 PM EST

📄 Package Label / Principal Display Panel 99 words ▾

NDC 0404-0219-01 Maxiclens TM Antiseptic Skin Cleanser (Chlorhexidine Gluconate 4%) NON-STERILE FOR EXTERNAL USE ONLY Distributed By HENRY SCHEIN INC . 135 Duryea Road Melville, NY 11747 USA Net Contents: 4 fl oz (118 mL) Made in U.S.A. Laundering/Cleaning Instructions: Chlorhexidine gluconate skin cleansers will cause stains if used with chlorine releasing products, such as chlorine bleach.

Rinse completely and use only non-chlorine detergents. WARNING: This product can expose you to coconut oil diethanolamine condensate (cocamide diethanolamine), which is known to the State of California to cause cancer. For more information go to www.P65Warnings.ca.gov Keep from freezing. a 4oz

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

Medicare Part D spend CMS · PART D · 2026 (Q1)

Medicare Part D (outpatient prescription) spending for Chlorhexidine Gluconate (matched by generic name) — the program that covers self-administered drugs. 7 manufacturers.
⚠️ Drug-level data: CMS publishes Part D spending by drug, not by NDC — these figures combine every manufacturer, strength and package size sold under the name Chlorhexidine Gluconate. CMS lists 2 products for this generic; we show the highest-spend one. That’s a different level of aggregation than the Medicaid card above, which is specific to this exact 11-digit NDC (pack size included), so the two aren’t directly comparable.
Period
Total Part D spend
$3.96M
Claims incl. refills
658.9K
Beneficiaries
540.1K
Spend / beneficiary
$7.34
Spend / claim
$6.02
Trend by period
💵 About the dollar figures: spending is what Part D plans paid before confidential manufacturer rebates, so the program’s real net cost is lower. A blank patient count means fewer than 11 people — CMS hides counts that small to protect privacy. Source: CMS Medicare Quarterly Part D Spending by Drug (data.cms.gov), updated quarterly.

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 Maxiclens Chlorhexidine Gluconate Liquid Solution, 4% (this brand).

Top reported reactions

Fatigue1,850
Joint Swelling1,685
Rash1,667
Hypersensitivity1,614
Folliculitis1,602
Impaired Healing1,593
Weight Increased1,576

Age at onset

Neonate42
Infant7
Child12
Adolescent23
Adult1,023
Elderly300

Reporter sex

7,498 reports
Male · 25%
Female · 75%
Unknown · 0%

Serious outcomes

Hospitalization3,671
Disabling2,644
Death2,593
Life-threatening2,502
Reports over time (by year) — tap or hover for the count & year
2019 2021 2023 2026 1,536 306
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

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 Henry Schein, Inc.. Listing status can change — the directory data on this page refreshes weekly.
Who lists this product with the FDA?
Henry Schein, 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.
← 00404-0174-04 · Henry 00404-0220-03 · Henry →
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.