HomeNDC LookupIngredientsChlorhexidine Gluconate › 68599-5401-08
Antiseptic Skin Cleanser CHLORHEXIDINE GLUCONATE 4 g/100mL Solution — NDC 68599-5401-08 package photo

Antiseptic Skin Cleanser CHLORHEXIDINE GLUCONATE 4 g/100mL Solution

by McKesson Medical-Surgical · 12 BOTTLE in 1 CASE (68599-5401-8) / 473 mL in 1 BOTTLE (68599-5401-4)
NDC 68599-5401-08
🏷️ FDA NDC (as labeled) 68599-5401-8 billing pads the package segment with a zero
This package
Contains473 mL in 1 bottle Pack sizes5 compare ↓
OTC Brand On market Non-controlled
🗂️ Data synced Sep 3, 2026 · sources: openFDA · FDA label (DailyMed) · FDA Orange & Purple Book · First Databank · CMS NADAC, ASP, Medicare & Medicaid · RxNorm
📋 All sources & update times →

🆔 Identity & classification

FDA NDC (as labeled) 68599-5401-8
Product NDC 68599-5401
11-digit billing NDC 68599540108
RxCUI 211365
UNII MOR84MUD8E
UPC 0612479223592, 0612479223530, 0612479223554, 0612479223578
Application # NDA019125
SPL Set ID 626d7aa9-b8da-4254-9c57-9007ed4290d4
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 2017-06-01
Route TOPICAL
Dosage form SOLUTION
Substance CHLORHEXIDINE GLUCONATE
Why two NDCs? The FDA registers this code as 68599-5401-8 — a 5-4-1 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 package segment → 68599-5401-08. 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.

🏭 Manufacturer & labeler

LabelerMcKesson Medical-Surgical
Application holderXTTRIUM LABORATORIES INC
FDA applicationNDA019125 (NDA)
Labeler code68599
First marketedJun 2017
Product typeHuman Otc Drug
Portfolio18 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.

🩺 Clinical

📗 Our plain-language guide HelloPharmacist
  • It's actually a prescription-strength antimicrobial rinse, which is different from over-the-counter mouthwash. Your dentist prescribes it specifically to treat gingivitis — that's...
  • What exactly is chlorhexidine rinse for — is it just like a regular mouthwash?
  • Yes, tooth and surface staining is one of the most common side effects of chlorhexidine oral rinse. It can also increase tartar buildup on your teeth. The good news is that this is...
  • My teeth look like they're staining — is that from the rinse?
📖 Read our full Chlorhexidine guide →
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.

🧪 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 92005F972D
    A foaming and thickening agent derived from coconut oil. It's used in liquid medicines to improve texture, help distribute active ingredients evenly, and create a pleasant consistency for easier swallowing or application.
  • UNII WQ29KQ9POT
    Gluconolactone is a mild organic acid derived from glucose. It functions as a buffer and pH regulator in medicines, helping maintain stable acidity levels and improve product stability.
  • UNII R33S7TK2EP
    Hydroxyethyl cellulose is a thickening agent made from processed plant cellulose. It's used in medicines to increase viscosity, improve texture, and help distribute active ingredients evenly throughout liquid or semi-solid formulations.
  • UNII ND2M416302
    Isopropyl alcohol is a clear liquid solvent derived from petroleum. In medicines, it dissolves active ingredients and other components, helps the product flow smoothly, and aids in sterilization during manufacturing.
  • UNII 4F6FC4MI8W
    Lauramine oxide is a surfactant, a substance that helps mix oil and water together. It's used in medicines to improve how ingredients blend and to help the product dissolve or spread properly.
  • UNII 09179OX7TB
    PEG-75 Lanolin is a waxy substance derived from sheep's wool that has been chemically modified to mix easily with water and oil. It acts as an emulsifier and moisturizer in topical formulations, helping blend different ingredients and soften the skin.
  • UNII 8I9428H868
    Tridecyl alcohol is a fatty alcohol derived from natural oils or made synthetically. In medicines, it works as an emulsifier and surfactant to help mix oil and water-based ingredients together smoothly.
  • 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.

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

The official label also statescocamide DEA, fragrance, glucono-delta-lactone, hydroxyethylcellulose, isopropyl alcohol, lauramine oxide, PEG-75 lanolin, purified water, tridecyl alcohol

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 DailyMedingredient 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.

💲 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.
Try another pack size: 4 bottles 12 bottles 24 bottles 48 bottles
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.

🔁 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 $0.041 Availability likely
Betasept .04 mg/mL 67618-0200-04 Atlantis 118 ml $0.041 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/mL 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/100mLthis 68599-5401-08 McKesson 12 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

🏛️
2017
On the market since
Jun 2017
📍
2026
Currently FDA-listed
9 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.

📊 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 Antiseptic Skin Cleanser (this brand).

Top reported reactions

Fatigue1,851
Joint Swelling1,686
Rash1,669
Hypersensitivity1,617
Folliculitis1,603
Impaired Healing1,594
Weight Increased1,576

Age at onset

Neonate42
Infant7
Child12
Adolescent23
Adult1,024
Elderly302

Reporter sex

7,520 reports
Male · 25%
Female · 75%
Unknown · 0%

Serious outcomes

Hospitalization3,677
Disabling2,647
Life-threatening2,504
Reports over time (by year) — tap or hover for the count & year
2022 2023 2024 2026 1,536 305
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.

📦 Packaging — all sizes for this product

Package NDCDescription Marketing startStatus
68599-5401-00 4 BOTTLE in 1 CASE (68599-5401-0) / 3800 mL in 1 BOTTLE (68599-5401-6) 2017-06-01 Active
68599-5401-01 48 BOTTLE in 1 CASE (68599-5401-1) / 118 mL in 1 BOTTLE (68599-5401-2) 2017-06-01 Discontinued by firm
68599-5401-07 24 BOTTLE in 1 CASE (68599-5401-7) / 237 mL in 1 BOTTLE (68599-5401-3) 2017-06-01 Active
68599-5401-08 You're viewing this 12 BOTTLE in 1 CASE (68599-5401-8) / 473 mL in 1 BOTTLE (68599-5401-4) 2017-06-01 Active
68599-5401-09 12 BOTTLE in 1 CASE (68599-5401-9) / 946 mL in 1 BOTTLE (68599-5401-5) 2017-06-01 Discontinued by firm

Pack size FAQ

What quantity is in NDC 68599-5401-08?
NDC 68599-5401-08 is listed by the FDA — 12 bottle in 1 case / 473 ml in 1 bottle.
What NDC number is used to bill for this package of Antiseptic Skin Cleanser CHLORHEXIDINE GLUCONATE 4 g/100mL Solution?
Bill NDC 68599-5401-08 — the 11-digit billing format is 68599540108. Pharmacy and medical claims use the 11-digit form; the FDA label may print a shorter form of the same code.

🧭 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) ✓ 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 FDA registers it as 68599-5401-8, which is what is printed on the packaging and shown on DailyMed. Insurance claims use a fixed 11-digit 5-4-2 format, so the short segment is padded with a leading zero: 68599-5401-08, written without dashes as 68599540108. The Identity section at the top of this page lists every form of this code.
What do the three segments of this NDC mean?
In 68599-5401-08, the first segment (68599) is the labeler code FDA assigned to McKesson Medical-Surgical; the middle segment (5401) identifies this specific product — its ingredient, strength, and dosage form; and the last segment (08) identifies this exact package size and type. Together they name one specific package of one specific product.
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 McKesson Medical-Surgical. 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 4 other package presentations of this same product, including 4 bottles (68599-5401-00), 12 bottles (68599-5401-09), 24 bottles (68599-5401-07). 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?
McKesson Medical-Surgical 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.

📄 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 53 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: helps reduce bacteria that potentially can cause disease patient preoperative skin preparation: for the preparation of the patient's skin prior to surgery skin wound and general skin cleansing

⏱️ Dosage and Administration 122 words

Directions use with care in premature infants or infants under 2 months of age. These products may cause irritation or chemical burns. Healthcare personnel handwash: wet hands with water dispense about 5 mL of product into cupped hands and wash in a vigorous manner for 15 seconds rinse and dry thoroughly Patient preoperative skin preparation: apply product liberally to surgical site and swab for at least 2 minutes and dry with a sterile towel repeat procedure for an additional 2 minutes and dry with a sterile towel Skin wound and general skin cleaning: thoroughly rinse the area to be cleaned with water apply the minimum amount of product necessary to cover the skin or wound area and wash gently rinse again thoroughly

⚠️ Warnings 210 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. Do not use if you are allergic to chlorhexidine gluconate or any other ingredients in this product in contact with meninges in the genital area as a preoperative skin preparation of the head or face 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 solution should contact these areas, rinse out promptly and thoroughly with water 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 the underlying condition makes it necessary to reduce the bacterial population of the skin Stop use and ask doctor if irritation, sensitization or allergic reaction occurs.

These may be signs of a serious condition. Keep out of reach of children. If swallowed, get medical help or contact a Poison Control Center right away.

🧪 Active Ingredient 6 words

Active ingredient Chlorhexidine gluconate 4% solution

🧪 Inactive Ingredients 17 words

Inactive ingredients cocamide DEA, fragrance, glucono-delta-lactone, hydroxyethylcellulose, isopropyl alcohol, lauramine oxide, PEG-75 lanolin, purified water, tridecyl alcohol

🎯 Purpose 2 words

Purpose Antiseptic

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