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DYNA-HEX 2 Chlorhexidine gluconate 2 g/100mL Liquid, 118 mL — NDC 00116-1021-04 package photo

DYNA-HEX 2 Chlorhexidine gluconate 2 g/100mL Liquid, 118 mL

by Xttrium Laboratories, Inc. · 118 mL in 1 BOTTLE, PLASTIC (0116-1021-04)
NDC 00116-1021-04
🏷️ FDA NDC (as labeled) 0116-1021-04 billing pads the labeler segment with a zero
This package
Contains118 mL Cost per mL$0.0240 NADAC Per package$2.83 / 118 ml Pack sizes7 compare ↓
Also comes in: 237 ml 00116-1021-08 250 ml 00116-1021-85 473 ml 00116-1021-16 473 ml 00116-1021-17 946 ml 00116-1021-32 15142 ml 00116-1021-01
OTC Brand On market Non-controlled
🗂️ Data synced 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

🆔 Identity & classification

FDA NDC (as labeled) 0116-1021-04
Product NDC 0116-1021
11-digit billing NDC 00116102104
NCPDP billing unit ML — per mL (volume)
RxCUI 834160, 1245230
UNII MOR84MUD8E
UPC 0011610211601, 0301161021089, 0011610211700
Application # NDA019422
SPL Set ID 6cc89ac1-baef-40bb-85a3-d9ae9e3e7a63
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 2014-01-01
Marketing end 2027-02-28
Route TOPICAL
Dosage form LIQUID
Substance CHLORHEXIDINE GLUCONATE
GPI-14 92100030102015
GPI class Dyna-Hex 2
GCN Seq No 013248
GCN 30012
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 2% SOLUTION
FDB brand name Dyna-Hex
Legend status O — Over-the-counter (OTC) drug or device
Why two NDCs? The FDA registers this code as 0116-1021-04 — 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 → 00116-1021-04. 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 applicationNDA019422 (NDA)
Labeler code00116
First marketedJan 2014
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 2% SOLUTION 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?
📖 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.

🧪 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 2968PHW8QP
    A weak organic acid derived from citrus fruits or made through fermentation. It works as a buffer to control pH, a preservative to extend shelf life, and a flavoring agent in medications.
  • 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 S38J6RZN16
    Hydroxyethyl cellulose is a plant-derived thickening agent made from cellulose. In medicines, it acts as a binder to hold ingredients together, a thickener to adjust product texture, and a film-former to create smooth coatings on tablets.
  • 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 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.

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

The official label also statescitric add. cocamide DEA, hydroxyethylcellulose, isopropyl alcohol, lauramine oxide, purified water

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 DailyMed — ingredient 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 $0.024 $2.83 / 118 ml
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.
NADAC price history (per mL) — tap or hover for the price & month
Apr 2026 Jun 2026 Jul 2026 Aug 2026 $0.025 $0.024
▼ Down 2% over the last 4 months.
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
Dyna-Hex 2 2 g/100mLthis 00116-1021-04 Xttrium 118 ml $0.024 — Availability likely —
Dyna-Hex 2 20 mg/mL 00116-1022-18 Xttrium 535 ml — — FDA listed —
Provon Antimicrobial Foam Handwash 20 mg/mL 00116-8500-89 Xttrium 1200 ml — — FDA listed —
Bactoshield CHG Chlorhexidine Gluconate 20 mg/mL 11084-0038-03 SC 118 ml — — FDA listed —
Bactoshield CHG 20 mg/mL 11084-0126-03 SC 118 ml — — FDA listed —
Antimicrobial Skin Cleanser 20 mg/mL 21749-0106-32 Gojo 946 ml — — FDA listed —
Purell Antimicrobial Foam 20 mg/mL 21749-0225-53 GOJO 535 ml — — FDA listed —
Antimicrobial Foam Handwash 20 mg/mL 21749-0416-89 GOJO 1200 ml — — FDA listed —
Antiseptic Foam Handwash 20 mg/mL 21749-0461-89 GOJO 1200 ml — — FDA listed —
Provon Antimicrobial Foam Handwash 20 mg/mL 21749-0850-53 Gojo 535 ml — — FDA listed —
Scrub, Scrub-Stat, Foam Safe, Micro-Guard 20 mg/mL 42939-0124-19 AVA, 946 ml — — FDA listed —
Scrub, Scrub-Stat, Foam Safe, Micro-Guard 20 mg/mL 42939-0127-01 AVA, 118 ml — — FDA listed —
Scrub-Stat 20 mg/mL 47593-0463-11 Ecolab 3780 ml — — FDA listed —
Scrub-Stat 20 mg/mL 47593-0467-21 Ecolab 208000 ml — — Discontinued —
foaming hand wash 20 mg/mL 53329-0994-84 Medline 1000 ml — — 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

🏛️
2014
On the market since
Jan 2014
📍
2026
Currently FDA-listed
12 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 2 (this brand).

Top reported reactions

Fatigue1,852
Joint Swelling1,686
Rash1,672
Hypersensitivity1,616
Folliculitis1,603
Impaired Healing1,594
Weight Increased1,576

Reporter sex

7,526 reports
Reports over time (by year) — tap or hover for the count & year
2021 2022 2024 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.

📦 Packaging — all sizes for this product

Package NDCDescription Per unit Per pack Marketing startStatus
00116-1021-01 15142 mL in 1 JUG (0116-1021-01) — — 2014-01-01 Discontinued by firm
00116-1021-08 237 mL in 1 BOTTLE, PLASTIC (0116-1021-08) — — 2014-01-01 Discontinued by firm
00116-1021-16 473 mL in 1 BOTTLE, PLASTIC (0116-1021-16) — — 2014-01-01 Discontinued by firm
00116-1021-17 473 mL in 1 BOTTLE, PLASTIC (0116-1021-17) — — 2014-01-01 Discontinued by firm
00116-1021-32 946 mL in 1 BOTTLE, PLASTIC (0116-1021-32) — — 2014-01-01 Active
00116-1021-85 250 mL in 1 BOTTLE, PUMP (0116-1021-85) — — 2020-10-01 Discontinued by firm
00116-1021-04 You're viewing this 118 mL in 1 BOTTLE, PLASTIC (0116-1021-04) $0.0240 / mL $2.83 2014-01-01 Active

Pack size FAQ

What quantity is in NDC 00116-1021-04?
NDC 00116-1021-04 contains 118 mL — 118 ml in 1 bottle, plastic.
What is the difference between NDC 00116-1021-04 and NDC 00116-1021-08?
Both are DYNA-HEX 2 Chlorhexidine gluconate 2 g/100mL Liquid — the drug itself is identical. NDC 00116-1021-04 is the 118 mL package, while NDC 00116-1021-08 is the 237 ml package.
What NDC number is used to bill for this package of DYNA-HEX 2 Chlorhexidine gluconate 2 g/100mL Liquid?
Bill NDC 00116-1021-04 — the 11-digit billing format is 00116102104. Pharmacy and medical claims use the 11-digit form; the FDA label may print a shorter form of the same code.

Prices are the latest CMS NADAC pharmacy acquisition cost per NDC; per-pack figures are per-unit × pack quantity, shown only when the pack is denominated in the same measure NADAC prices.

📄 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
🎯 Indications and Usage 38 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 skin wound and general skin cleansing

⏱️ Dosage and Administration 164 words ▾

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 under running water for 30 seconds.

Clean fingernails using a nailstick or similar cleaner. scrub for 1.5 minutes with about 8 mL of product with or without a wet brush paying close attention to the nails, cuticles, and skin between the fingers rinse thoroughly under running water for 30 seconds wash for an additional 1.5 minutes with 8 mL of product and rinse under running water for 30 seconds 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 15 seconds rinse and dry thoroughly 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 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.

🧪 Active Ingredient 6 words ▾

Active ingredient chlorhexidine gluconate 2% solution

🧪 Inactive Ingredients 13 words ▾

Inactive ingredients citric add. cocamide DEA, hydroxyethylcellulose, isopropyl alcohol, lauramine oxide, purified water

🎯 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 ↗
← 00116-0901-05 · Xttrium 00116-1022-18 · Xttrium →
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.