Dyna-Hex 4 Chlorhexidine Gluconate 4 g/100mL Liquid, 535 mL
by Xttrium Laboratories, Inc. · 535 mL in 1 BOTTLE, PLASTIC (0116-1060-18)
NDC 00116-1060-18
🏷️ FDA NDC (as labeled)
0116-1060-18
billing pads the labeler segment with a zero
This package
Contains535 mL
Pack sizes3 compare ↓
OTC
Brand
On market
Non-controlled
🗂️ Data synced Sep 24, 2026 · sources: openFDA · FDA label (DailyMed) · FDA Orange & Purple Book · First Databank · CMS NADAC, ASP, Medicare & Medicaid · RxNorm
📋 All sources & update times →
⚠️
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
FDA NDC (as labeled)
0116-1060-18
Product NDC
0116-1060
11-digit billing NDC
00116106018
NCPDP billing unit
ML — per mL (volume)
UNII
MOR84MUD8E
UPC
0301161060330
Application #
NDA019127
SPL Set ID
245c41e6-a0f6-0825-e054-00144ff8d46c
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
2023-11-15
Route
TOPICAL
Dosage form
LIQUID
Substance
CHLORHEXIDINE GLUCONATE
GPI-14
92100030102020
GCN Seq No
007254
GCN
30011
HICL code
004297
Ingredient (HICL)
Chlorhexidine Gluconate
HIC1 code
Q
Therapeutic class — broad (HIC1)
Ear/Eye/Nose/Rectum/Topical/Vagina/Other
HIC2 code
Q5
Therapeutic class — intermediate (HIC2)
Agents Acting Principally On The Skin
HIC3 code
Q5B
Therapeutic class — specific (HIC3)
Topical Preparations,Antibacterials
AHFS code
08:30.04.00
AHFS class
Amebicides
FDB label name
DYNA-HEX 4% LIQUID
FDB brand name
Dyna-Hex
Legend status
O — Over-the-counter (OTC) drug or device
Why two NDCs?
The FDA registers this code as 0116-1060-18 — 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 → 00116-1060-18. 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
LabelerXttrium Laboratories, Inc.
Application holderXTTRIUM LABORATORIES INC
FDA applicationNDA019127 (NDA)
Labeler code00116
First marketedNov 2023
Product typeHuman Otc Drug
Portfolio34 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
Label name DYNA-HEX 4% LIQUID Ingredient Chlorhexidine Gluconate
📗 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?
Patient education
Supplement & herbal interactions
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.
💬 Questions about Chlorhexidine Gluconate?
Ask a pharmacist →
Ask a licensed pharmacist directly — free, answered by our team.
🧪 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.
💲 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 system | Per mL | Per 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
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
| Product | Labeler | Pack | NADAC/unit | TE | Status | Price 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/100mLthis 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/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
🏛️
2023
On the market since
Nov 2023
📍
2026
Currently FDA-listed
3 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 Dyna-Hex 4 (this brand).
Top reported reactions
Reporter sex
Serious outcomes
Reports over time (by year) — tap or hover for the count & year
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 NDC | Description | Marketing start | Status |
|---|---|---|---|
| 00116-1060-18 You're viewing this | 535 mL in 1 BOTTLE, PLASTIC (0116-1060-18) | 2016-01-01 | Active |
| 00116-1060-32 | 946 mL in 1 BOTTLE, PLASTIC (0116-1060-32) | 2023-11-15 | Active |
| 00116-1060-33 | 946 mL in 1 BOTTLE, PLASTIC (0116-1060-33) | 2023-12-14 | Active |
Pack size FAQ
What quantity is in NDC 00116-1060-18?
NDC 00116-1060-18 contains 535 mL — 535 ml in 1 bottle, plastic.
What is the difference between NDC 00116-1060-18 and NDC 00116-1060-32?
Both are Dyna-Hex 4 Chlorhexidine Gluconate 4 g/100mL Liquid — the drug itself is identical. NDC 00116-1060-18 is the 535 mL package, while NDC 00116-1060-32 is the 946 ml package.
What NDC number is used to bill for this package of Dyna-Hex 4 Chlorhexidine Gluconate 4 g/100mL Liquid?
Bill NDC 00116-1060-18 — the 11-digit billing format is 00116106018. 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) | — 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 FDA registers it as 0116-1060-18, 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: 00116-1060-18, written without dashes as 00116106018. 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 00116-1060-18, the first segment (00116) is the labeler code FDA assigned to Xttrium Laboratories, Inc.; the middle segment (1060) identifies this specific product — its ingredient, strength, and dosage form; and the last segment (18) 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 Xttrium Laboratories, Inc.. 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 2 other package presentations of this same product, including 946 ml (00116-1060-32), 946 ml (00116-1060-33). 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?
Xttrium Laboratories, 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.
📄 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
🎯 Indications and Usage ▾
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 skin wound and general skin cleansing
⏱️ Dosage and Administration ▾
Directions use with care in premature infants or infants under 2 months of age. These products may cause irritation or chemical burns. Surgical hand scrub: wet hands and forearms with water scrub for 3 minutes with 3 full pumps (5 grams) of product and a wet brush paying close attention to the nails, cuticles, and interdigital spaces a seperate nail cleaner may be used rinse thoroughly wash for an additional 3 minutes with 3 full pumps (5 grams) of product and rinse under running water dry thoroughly Healthcare personnel handwash: wet hands with water dispense 3 full pumps (5 grams) of product into cupped hands and wash in a vigorous manner for 15 seconds rinse and dry thoroughly Skin wound and general skin cleansing: 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 ▾
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 ingredient in this product 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 do not use routinely if you have wounds which involve more than the superficial layers of the skin Stop use and ask a 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.
📦 Storage and Handling ▾
Other information store at 20-25°C (68-77°F) avoid excessive heat above 40°C (104°F)
🧪 Active Ingredient ▾
Active ingredient Chlorhexidine gluconate 4% solution
🧪 Inactive Ingredients ▾
Inactive ingredients cocamide DEA, fragrance, glucono-delta-lactone, isopropyl alcohol, lauramine oxide, PEG-75 lanolin, purified water, tridecyl alcohol
🎯 Purpose ▾
Purpose Antiseptic
No label section mentions that — try another word, or open the full label on DailyMed below.
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.