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Chlorhexidine Gluconate 1.2 mg/mL Rinse, 473 mL — NDC 00116-2001-16 package photo
Label image from the product's FDA listing (DailyMed) — may show a different pack size or an older label revision.

Chlorhexidine Gluconate 1.2 mg/mL Rinse, 473 mL — NDC 0116-2001-16 (Billing 00116-2001-16)

by Xttrium Laboratories, Inc. · 473 mL in 1 BOTTLE

This is a package of 473 mL of Chlorhexidine Gluconate 1.2 mg/mL Rinse from Xttrium Laboratories, Inc., marketed since Jun 2010 and currently FDA-listed; retail pharmacies pay about $0.0073 per mL (NADAC). It is the main listing for this product, which comes in 6 package sizes.

NDC 00116-2001-16
🏷️ FDA NDC (as labeled) 0116-2001-16 billing pads the labeler segment with a zero
This package
Contains473 mL Cost per mL$0.0073 NADAC Per package$3.45 / 473 ml Pack sizes6 compare ↓
Also priced by: Medicaid pays $0.0212/unit · Part D plans $0.0247/unit — full pricing hub ↓
Main listing for product 0116-2001 · Also comes in: 15 ml 0116-2001-05 15 ml 0116-2001-15 118 ml 0116-2001-04 600 ml 0116-2001-06 1500 ml 0116-2001-07
Rx only Generic 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 0116-2001-16 alone.

Record
FDA NDC Directory package listing · Human prescription drug
Code segments
0116 labeler · 2001 product · 16 package
Package marketed since
Jun 1, 2010
Sample package
No — commercial package
Listing certified through
Dec 31, 2026
Billing quantity
473 mL per package
Barcode (UPC)
0301162001158
Medicaid fills, this package
1,036,536 prescriptions in the last four reported quarters
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) 0116-2001-16
Product NDC 0116-2001
11-digit billing NDC 00116200116
NCPDP billing unit ML — per mL (volume)
RxCUI 834127
UNII MOR84MUD8E
UPC 0301162001158
Application # ANDA077789
SPL Set ID 34d15e72-8770-49dc-a514-d44ae4468a1e
Physiologic effect Decreased Cell Wall Integrity
DEA schedule Non-controlled
Marketing category ANDA
Marketing status On market
FDA listing status Listed (active directory)
Marketing start 2010-06-01
Route ORAL
Dosage form RINSE
Substance CHLORHEXIDINE GLUCONATE
TE code (Orange Book) AT · RLD · RS

Drug-database identifiers Medi-Span GPI and First Databank GCN / HICL / AHFS classification

GPI-14 88150020102012
GPI class Chlorhexidine Gluconate
GCN Seq No 057959
GCN 23248
HICL code 004297
Ingredient (HICL) Chlorhexidine Gluconate
HIC1 code D
Therapeutic class — broad (HIC1) Biliary System/Gastro-Intestinal System
HIC2 code D1
Therapeutic class — intermediate (HIC2) Dental Preparations
HIC3 code D1D
Therapeutic class — specific (HIC3) Dental Aids And Preparations
AHFS code 52:04.24.00
AHFS class Astringents (52:04)
FDB label name CHLORHEXIDINE 0.12% RINSE
FDB brand name Chlorhexidine Gluconate
Legend status F — Federal legend — prescription drug or device
Quick answers
  • GSN (GCN sequence number): 057959
  • GCN: 23248
  • GPI-14 (Medi-Span): 88150020102012
  • HICL (First Databank): 004297
  • AHFS class code: 52:04.24.00
  • RxCUI (RxNorm): 834127
Why two NDCs? The FDA registers this code as 0116-2001-16 — 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 → 00116-2001-16. 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

Label name CHLORHEXIDINE 0.12% RINSE Ingredient Chlorhexidine Gluconate
📖 What it is MedlinePlus · NLM

Chlorhexidine is used to treat gingivitis (redness and swelling of the gums). Chlorhexidine is in a class of medications called anti-infectant agents. It works by decreasing the amount of bacteria in the mouth.

Read the full MedlinePlus article ↗
📗 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 $0.007 $3.45 / 473 ml
Medicaid paysCMS SDUD · 12 mo $0.0212 $10.03 / 473 ml
Medicare drug plans payPart D · Q2 2026 $0.0247 $11.68 / 473 ml
NADAC price history (per mL) — tap or hover for the price & month
Jan 2022 Aug 2022 Jan 2026 Sep 2026 $0.007 $0.004
▲ Up 24% over the last 24 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.

Packaging — all sizes for this product

Package NDCDescription Per unit Per pack Marketing startMarketing endStatus
00116-2001-04 0116-2001-04 118 mL in 1 BOTTLE $0.0168 / mL $1.98 2010-06-01 — Active
00116-2001-05 0116-2001-05 15 mL in 1 CUP, UNIT-DOSE — — 2021-01-01 — Active
00116-2001-06 0116-2001-06 600 mL in 1 CASE — — 2021-01-01 — Active
00116-2001-07 0116-2001-07 1500 mL in 1 CASE — — 2021-01-01 — Active
00116-2001-15 0116-2001-15 15 mL in 1 BOTTLE — — 2010-06-01 — Active
00116-2001-16 You're viewing this Main listing 473 mL in 1 BOTTLE $0.0073 / mL $3.47 2010-06-01 — Active

This pack has the lowest per-mL cost of the 2 priced pack sizes ($0.0073 NADAC).

In Medicaid, this is the most-dispensed pack of this product — about 100% of fills over the last four reported quarters. See all packs ↓

Pack size FAQ

What quantity is in this package?
This package contains 473 mL — 473 ml in 1 bottle.
How does this package differ from NDC 00116-2001-05?
Both are Chlorhexidine Gluconate 1.2 mg/mL Rinse — the drug itself is identical. This page's package is the 473 mL one, while NDC 00116-2001-05 is the 15 ml package.
What NDC number is used to bill for this package of Chlorhexidine Gluconate 1.2 mg/mL Rinse?
Use the 11-digit billing form listed in the identifiers section of this page. 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.

Therapeutic equivalents

ProductLabelerPackNADAC/unitTEStatusPrice vs. this
Chlorhexidine Gluconate 1.2 mg/mLthis 00116-2001-16 Xttrium 473 ml $0.007 AT Availability likely —
Chlorhexidine Gluconate Oral Rinse 1.2 mg/mL 16571-0128-48 Rising 473 ml $0.007 AT Availability likely —
Chlorhexidine Gluconate 0.12% Oral Rinse 1.2 [iU]/mL 00116-0003-15 Xttrium 15 ml — AT FDA listed —
Chlorhexidine Gluconate 1.2 mg/mL 00116-0175-16 Xttrium 473 ml — AT FDA listed —
Chlorhexidine Gluconate 1.2 mg/mL 00116-0301-15 Xttrium 15 ml — AT FDA listed —
NUPRO Chlorhexidine Gluconate 1.2 mg/mL 00116-0800-16 Xttrium 473 ml — AT FDA listed —
Acclean Chlorhexidine Gluconate 0.12% Oral Rinse 1.2 mg/mL 00116-4075-01 Xttrium 473 ml — AT FDA listed —
Chlorhexidine Gluconate 1.2 mg/mL 00116-6000-04 Xttrium 118 ml — AT FDA listed —
Acclean Chlorhexidine Gluconate 0.12% Oral Rinse 1.2 mg/mL 00116-6720-04 Xttrium 118 ml — AT FDA listed —
Chlorhexidine Gluconate 1.2 mg/mL 00121-0893-00 PAI 10 cups — AT FDA listed —
Periogard Alcohol Free 1.2 mg/mL 00126-0272-16 Colgate 473 ml — AT FDA listed —
Periogard Alcohol Free 1.2 mg/mL 00126-0282-16 Colgate 473 ml — AT FDA listed —
Chlorhexidine Gluconate 1.2 mg/mL 00374-5080-01 Lyne 15 ml — AT FDA listed —
Acclean Chlorhexidine Gluconate 0.12% Oral Rinse 1.2 mg/mL 00404-4075-01 Henry 473 ml — AT Discontinued —
Chlorhexidine Gluconate 1.2 mg/mL 00904-7035-80 Major 1500 ml — AT FDA listed —
Periogard Alcohol Free 1.2 mg/mL 17856-0272-01 ATLANTIC 72 cups — AT FDA listed —
Chlorhexidine Gluconate 1.2 mg/mL 17856-2001-03 Atlantic 10 ml — AT FDA listed —
Chlorhexidine Gluconate 1.2 mg/mL 17856-2002-03 ATLANTIC 15 ml — AT Discontinued —
Peridex 1.2 mg/mL 48878-0620-01 Solventum 473 ml — AT FDA listed —
Chlorhexidine Gluconate 1.2 mg/mL 50090-0722-00 A-S 473 ml — AT FDA listed —
Chlorhexidine Gluconate 1.2 mg/mL 53329-0301-24 Medline 15 ml — AT FDA listed —
Chlorhexidine Gluconate 0.12% Oral Rinse 1.2 mg/mL 53462-0003-15 Sage 15 ml — AT FDA listed —
DASH Chlorhexidine Gluconate 0.12% Oral Rinse 1.2 mg/mL 55154-1980-05 Cardinal 5 cups — AT FDA listed —
DASH Chlorhexidine Gluconate 0.12% Oral Rinse 1.2 mg/mL 55154-1981-05 Cardinal 5 cups — AT FDA listed —
Major Oral Rinse 1.2 mg/mL 55154-3573-05 Cardinal 5 cups — AT FDA listed —
Major Oral Rinse 1.2 mg/mL 55154-3574-05 Cardinal 5 cups — AT FDA listed —
Chlorhexidine Gluconate 1.2 mg/mL 59883-0175-16 Den-mat 473 ml — AT FDA listed —
Chlorhexidine Gluconate, 0.12% Oral Rinse 1.2 mg/mL 60687-0714-16 American 10 cups — AT FDA listed —
Chlorhexidine Gluconate, 0.12% Oral Rinse Solution 1.2 mg/mL 61037-0469-02 Bajaj 118 ml — AT FDA listed —
Chlorhexidine Gluconate 0.12% Oral Rinse 1.2 mg/mL 62135-0649-41 Chartwell 120 ml — AT FDA listed —
Chlorhexidine Gluconate 0.12% Oral Rinse 1.2 mg/mL 62135-0650-24 Chartwell 10 cups — AT FDA listed —
Chlorhexidine Gluconate 1.2 mg/mL 63187-0685-16 Proficient 473 ml — AT FDA listed —
Sky Oral Rinse 1.2 mg/mL 63739-0052-57 McKesson 600 ml — AT FDA listed —
NUPRO Chlorhexidine Gluconate 1.2 mg/mL 65222-0800-16 Dentsply 473 ml — AT FDA listed —
Chlorhexidine Gluconate 1.2 mg/mL 66467-2560-01 Darby 473 ml — AT FDA listed —
Chlorhexidine Gluconate 1.2 mg/mL 66689-0106-50 VistaPharm, 50 cups — AT FDA listed —
Chlorhexidine Gluconate 1.2 mg/mL 66975-0600-04 Benco 118 ml — AT FDA listed —
CleanCare Chlorhexidine Gluconate 0.12% Oral Rinse 1.2 mg/mL 67239-0225-00 Safco 118 ml — AT FDA listed —
Chlorhexidine Gluconate 1.2 mg/mL 68071-1837-06 NuCare 473 ml — AT FDA listed —
Chlorhexidine Gluconate Oral Rinse 1.2 mg/mL 68071-3630-06 NuCare 473 ml — AT FDA listed —
Chlorhexidine Gluconate 1.2 mg/mL 68788-9546-04 Preferred 473 ml — AT FDA listed —
Chlorhexidine Gluconate 0.12% Oral Rinse 1.2 mg/mL 68999-0650-24 Chartwell 10 cups — AT FDA listed —
DASH Chlorhexidine Gluconate 0.12% Oral Rinse 1.2 mg/mL 69339-0138-15 Natco 15 ml — AT FDA listed —
Chlorhexidine Gluconate 1.2 mg/mL 70518-4494-00 REMEDYREPACK 473 ml — AT FDA listed —
Chlorhexidine Gluconate, 0.12% Oral Rinse Solution 1.2 mg/mL 73141-0512-50 A2A 100 cups — AT FDA listed —
Chlorhexidine Gluconate Oral Rinse 1.2 mg/mL 73614-0203-01 Brisk 118 ml — AT FDA listed —
Chlorhexidine Gluconate, 0.12% Oral Rinse Solution 1.2 mg/mL 81033-0512-50 Kesin 100 cups — AT FDA listed —
Chlorhexidine Gluconate 1.2 mg/mL 00121-1786-16 PAI 473 ml — AT FDA listed —
Chlorhexidine Gluconate 1.2 mg/mL 00116-1999-16 Xttrium 473 ml — AT FDA listed —
About this product: this is a generic version of the medicine. FDA equivalence ratings are shown when available, and other versions are listed above, least expensive first.
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

🏛️
2010
On the market since
Jun 2010
📍
2026
Currently FDA-listed
16 years listed
🔓
·
Generic on the market
this product is a generic
✅This is a generic drug

This product is an FDA-approved generic. Other versions of the same drug are listed under Therapeutic equivalents, least expensive first.

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.

🧪 Avoiding an ingredient? See Chlorhexidine inactive ingredients by manufacturer: every current product's list side by side, so you can ask your pharmacy for the version that does not list it.

💡 Tap an ingredient (hover on desktop) to see what it is and why it’s used.

  • UNII 3K9958V90M
    A liquid solvent derived from fermentation or chemical synthesis. In medicines, alcohol dissolves active ingredients, helps preserve the product, and improves how the body absorbs certain drugs.
  • UNII H3R47K3TBD
    FD&C Blue No. 1 is a synthetic blue dye approved for use in foods and medicines. It serves as a colorant to give the medication its distinctive appearance and help with product identification.
  • UNII PDC6A3C0OX
    Glycerin is a clear, thick liquid derived from plant oils or fats. It acts as a humectant to retain moisture, a sweetener, and a solvent in medications.
  • UNII JL4CCU7I1G
    A synthetic emulsifier made from polyethylene glycol and sorbitan, combined with fatty acids. It helps mix oil and water-based ingredients together and improves the texture and spreadability of topical and oral medicines.
  • UNII SB8ZUX40TY
    Saccharin sodium is an artificial sweetener made from saccharin salt. It's added to medicines to improve taste, especially in liquid formulations for children or bitter drugs.
  • 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.

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.

Manufacturer & labeler

LabelerXttrium Laboratories, Inc.
Application holderPHARMOBEDIENT CONSULTING LLC
FDA applicationANDA077789 (ANDA)
Labeler code00116
First marketedJun 2010
Product typeHuman Prescription Drug
Portfolio35 products on file

More NDCs from Xttrium Laboratories, Inc. labeler code 00116

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.

Full prescribing information FDA SPL

The complete FDA label for this product — the official prescribing information, verbatim, section by section. Very long sections are excerpted here and marked; the full text is on DailyMed (linked in the sources below). Jump with a chip, search within the label, or expand everything.
🎯 Indications and Usage ⏱️ Dosage and Administration ⛔ Contraindications ⚠️ Warnings 🤒 Adverse Reactions 🤰 Pregnancy 🧒 Pediatric Use 🆘 Overdosage 🧬 Clinical Pharmacology 📦 How Supplied / Storage and Handling 📋 Description ⚠️ Precautions 🍼 Nursing Mothers 📄 Carcinogenesis, Mutagenesis, Impairment of Fertility 📄 Package Label / Principal Display Panel
🎯 Indications and Usage 63 words ▾

INDICATION Chlorhexidine gluconate oral rinse is indicated for use between dental visits as part of a professional program for the treatment of gingivitis as characterized by redness and swelling of the gingivae, including gingival bleeding upon probing. Chlorhexidine gluconate oral rinse has not been tested among patients with acute necrotizing ulcerative gingivitis (ANUG). For patients having coexisting gingivitis and periodontitis, see PRECAUTIONS .

⏱️ Dosage and Administration 105 words ▾

DOSAGE AND ADMINISTRATION Chlorhexidine gluconate oral rinse therapy should be initiated directly following a dental prophylaxis. Patients using chlorhexidine gluconate oral rinse should be reevaluated and given a thorough prophylaxis at intervals no longer than six months. Recommended use is twice daily oral rinsing for 30 seconds, morning and evening after tooth brushing.

Usual dosage is 15 ml (marked in cap) of undiluted chlorhexidine gluconate oral rinse. Patients should be instructed to not rinse with water, or other mouthwashes, brush teeth, or eat immediately after using chlorhexidine gluconate oral rinse. Chlorhexidine gluconate oral rinse is not intended for ingestion and should be expectorated after rinsing.

⛔ Contraindications 24 words ▾

CONTRAINDICATIONS Chlorhexidine gluconate oral rinse should not be used by persons who are known to be hypersensitive to chlorhexidine gluconate or other formula ingredients.

⚠️ Warnings 87 words ▾

WARNINGS The effect of chlorhexidine gluconate oral rinse on periodontitis has not been determined. An increase in supragingival calculus was noted in clinical testing in chlorhexidine gluconate oral rinse users compared with control users. It is not known if chlorhexidine gluconate oral rinse use results in an increase in subgingival calculus.

Calculus deposits should be removed by a dental prophylaxis at intervals not greater than six months. Anaphylaxis, as well serious allergic reactions, have been reported during postmarketing use with dental products containing chlorhexidine. SEE CONTRAINDICATIONS .

🤒 Adverse Reactions 175 words ▾

ADVERSE REACTIONS The most common side effects associated with chlorhexidine gluconate oral rinses are; 1) an increase in staining of teeth and other oral surfaces; 2) an increase in calculus formation; and 3) an alteration in taste perception; see WARNINGS and PRECAUTIONS . Oral irritation and local allergy-type symptoms have been spontaneously reported as side effects associated with the use of chlorhexidine gluconate rinse. The following oral mucosal side effects were reported during placebo-controlled adult clinical trials: aphthous ulcer, grossly obvious gingivitis, trauma, ulceration, erythema, desquamation, coated tongue, keratinization, geographic tongue, mucocele, and short frenum.

Each occurred at a frequency of less than 1%. Among post marketing reports, the most frequently reported oral mucosal symptoms associated with chlorhexidine gluconate oral rinse are stomatitis, gingivitis, glossitis, ulcer, dry mouth, hypesthesia, glossal edema, and paresthesia. Minor irritation and superficial desquamation of the oral mucosa have been noted in patients using chlorhexidine gluconate oral rinse.

There have been cases of parotid gland swelling and inflammation of the salivary glands (sialadenitis) reported in patients using chlorhexidine gluconate oral rinse.

🤰 Pregnancy 68 words ▾

Pregnancy: Teratogenic Effects Reproduction studies have been performed in rats and rabbits at chlorhexidine gluconate doses up to 300 mg/kg/day and 40 mg/kg/day, respectively, and have not revealed evidence of harm to the fetus. However, adequate and well-controlled studies in pregnant women have not been done. Because animal reproduction studies are not always predictive of human response, this drug should be used during pregnancy only if clearly needed.

🧒 Pediatric Use 22 words ▾

Pediatric Use Clinical effectiveness and safety of chlorhexidine gluconate oral rinse have not been established in children under the age of 18.

🆘 Overdosage 60 words ▾

OVERDOSAGE Ingestion of 1 or 2 ounces of chlorhexidine gluconate oral rinse by a small child (~10 kg body weight) might result in gastric distress, including nausea, or signs of alcohol intoxication. Medical attention should be sought if more than 4 ounces of chlorhexidine gluconate oral rinse is ingested by a small child or if signs of alcohol intoxication develop.

🧬 Clinical Pharmacology ~1 min read ▾

CLINICAL PHARMACOLOGY Chlorhexidine gluconate oral rinse provides antimicrobial activity during oral rinsing. The clinical significance of chlorhexidine gluconate oral rinse’s antimicrobial activities is not clear. Microbiological sampling of plaque has shown a general reduction of counts of certain assayed bacteria, both aerobic and anaerobic, ranging from 54–97% through six-months use.

Use of chlorhexidine gluconate oral rinse in a six-month clinical study did not result in any significant changes in bacterial resistance, overgrowth of potentially opportunistic organisms or other adverse changes in the oral microbial ecosystem. Three months after chlorhexidine gluconate oral rinse use was discontinued, the number of bacteria in plaque had returned to baseline levels and resistance of plaque bacteria to chlorhexidine gluconate was equal to that at baseline. Pharmacokinetics: Pharmacokinetic studies with chlorhexidine gluconate oral rinse indicate approximately 30% of the active ingredient, chlorhexidine gluconate, is retained in the oral cavity following rinsing.

This retained drug is slowly released into the oral fluids. Studies conducted on human subjects and animals demonstrate chlorhexidine gluconate is poorly absorbed from the gastrointestinal tract. The mean plasma level of chlorhexidine gluconate reached a peak of 0 .

206 mcg/g in humans 30 minutes after they ingested a 300-mg dose of the drug. Detectable levels of chlorhexidine gluconate were not present in the plasma of these subjects 12 hours after the compound was administered. Excretion of chlorhexidine gluconate occurred primarily through the feces (~90%).

Less than 1% of the chlorhexidine gluconate ingested by these subjects was excreted in the urine.

📦 How Supplied / Storage and Handling 98 words ▾

HOW SUPPLIED Chlorhexidine gluconate oral rinse is supplied as a blue liquid in 0.5-ounce (15 ml) (NDC 0116-2001-05) white plastic unit dose cups 0.5-ounce (15 ml) (NDC 0116-2001-15) amber plastic bottles with child-resistant dispensing closures 4-ounce (118 ml) (NDC 0116-2001-04) amber plastic bottles with child-resistant dispensing closures 1-pint (473 ml) (NDC 0116-2001-16) amber plastic bottles with child-resistant dispensing closures Store at 20°C to 25°C (68°F-77°F), excursions permitted to 15°C to 30°C (59°F to 86°F) [See USP controlled Room Temperature].

Rx Only. Revised: April 2022 Distributed by: Xttrium Laboratories, Inc. 1200 E.

Business Center Dr. Mount Prospect, IL 60056

📋 Description 62 words ▾

DESCRIPTION 0.12% chlorhexidine gluconate (CHG) is an oral rinse containing (1,1'-hexamethylene bis [5-(p-chlorophenyl) biguanide]di-D-gluconate) in a base containing water, 11 . 6% alcohol, glycerin, PEG-40 sorbitan diisostearate, flavor, sodium saccharin, and FD&C Blue No.1. Chlorhexidine gluconate product is a near neutral solution (pH range 5-7).

Chlorhexidine gluconate is a salt of chlorhexidine and gluconic acid. Its chemical structure is: XT logo.jpg 1

⚠️ Precautions ~2 min read ▾

PRECAUTIONS General Precautions 1. For patients having coexisting gingivitis and periodontitis, the presence or absence of gingival inflammation following treatment with chlorhexidine gluconate oral rinse should not be used as a major indicator of underlying periodontitis. 2.

Chlorhexidine gluconate oral rinse can cause staining of oral surfaces, such as tooth surfaces, restorations, and the dorsum of the tongue. Not all patients will experience a visually significant increase in toothstaining. In clinical testing, 56% of chlorhexidine gluconate oral rinse users exhibited a measurable increase in facial anterior stain, compared to 35% of control users after six months; 15% of chlorhexidine gluconate oral rinse users developed what was judged to be heavy stain, compared to 1% of control users after six months.

Stain will be more pronounced in patients who have heavier accumulations of unremoved plaque. Stain resulting from use of chlorhexidine gluconate oral rinse does not adversely affect health of the gingivae or other oral tissues. Stain can be removed from most tooth surfaces by conventional professional prophylactic techniques.

Additional time may be required to complete the prophylaxis. Discretion should be used when prescribing to patients with anterior facial restorations with rough surfaces or margins. If natural stain cannot be removed from these surfaces by a dental prophylaxis, patients should be excluded from chlorhexidine gluconate oral rinse treatment if permanent discoloration is unacceptable.

Stain in these areas may be difficult to remove by dental prophylaxis and on rare occasions may necessitate replacement of these restorations. 3. Some patients may experience an alteration in taste perception while undergoing treatment with chlorhexidine gluconate oral rinse.

Rare instances of permanent taste alteration following chlorhexidine gluconate oral rinse use have been reported via post-marketing product surveillance. Nursing Mothers It is not known whether this drug is excreted in human milk. Because many drugs are excreted in human milk, caution should be exercised when chlorhexidine gluconate oral rinse is administered to nursing women.

In parturition and lactation studies with rats, no evidence of impaired parturition or of toxic effects to suckling pups was observed when chlorhexidine gluconate was administered to dams at doses that were over 100 times greater than that which would result from a person's ingesting 30 ml (2 capfuls) of chlorhexidine gluconate oral rinse per day. Pediatric Use Clinical effectiveness and safety of chlorhexidine gluconate oral rinse have not been established in children under the age of 18. Carcinogenesis, Mutagenesis, and Impairment of Fertility In a drinking water study in rats, carcinogenic effects were not observed at doses up to 38 mg/kg/day.

Mutagenic effects were not observed in two mammalian in vivo mutagenesis studies with chlorhexidine gluconate. The highest doses of chlorhexidine used in a mouse dominant-lethal assay and a hamster cytogenetics test were 1000 mg/kg/day and 250 mg/kg/day, respectively. No evidence of impaired fertility was observed in rats at doses up to 100 mg/kg/day.

Pregnancy: Teratogenic Effects Reproduction studies have been performed in rats and rabbits at chlorhexidine gluconate doses up to 300 mg/kg/day and 40 mg/kg/day, respectively, and have not revealed evidence of harm to the fetus. However, adequate and well-controlled studies in pregnant women have not been done. Because animal reproduction studies are not always predictive of human response, this drug should be used during pregnancy only if clearly needed.

🍼 Nursing Mothers 92 words ▾

Nursing Mothers It is not known whether this drug is excreted in human milk. Because many drugs are excreted in human milk, caution should be exercised when chlorhexidine gluconate oral rinse is administered to nursing women. In parturition and lactation studies with rats, no evidence of impaired parturition or of toxic effects to suckling pups was observed when chlorhexidine gluconate was administered to dams at doses that were over 100 times greater than that which would result from a person's ingesting 30 ml (2 capfuls) of chlorhexidine gluconate oral rinse per day.

📄 Carcinogenesis, Mutagenesis, Impairment of Fertility 77 words ▾

Carcinogenesis, Mutagenesis, and Impairment of Fertility In a drinking water study in rats, carcinogenic effects were not observed at doses up to 38 mg/kg/day. Mutagenic effects were not observed in two mammalian in vivo mutagenesis studies with chlorhexidine gluconate. The highest doses of chlorhexidine used in a mouse dominant-lethal assay and a hamster cytogenetics test were 1000 mg/kg/day and 250 mg/kg/day, respectively.

No evidence of impaired fertility was observed in rats at doses up to 100 mg/kg/day.

📄 Package Label / Principal Display Panel ~3 min read ▾

PRINCIPAL DISPLAY PANEL NDC 0116-2001-16 CHLORHEXIDINE GLUCONATE 0.12% ORAL RINSE, USP Direction for Use: Fill cap to the "fill line" (15ml). Swish in mouth undiluted for 30 seconds, then spit out. Use after breakfast and before bedtime.

Or, use as prescribed. Note: to minimize medicinal taste, do not rinse with water immediately after use. Rx Only KEEP OUT OF REACH OF CHILDREN I PINT (473 ml) INGREDIENTS: 0.12% chlorhexidine gluconate in a base containing water, 11.6% alcohol, glycerin, PEG-40 sorbitan diisostearate, flavor, sodium saccharin and FD&C Blue No.1.

To open, press in flat pannels while turning cap. To reseal, turn cap past "clicks" until tightly locked. WHAT TO EXPECT WHEN USING CHLORHEXIDINE GLUCONATE ORAL RINSE Your dentist has prescribed chlorhexidine gluconate oral rinse to treat your gingivitis, to help reduce the redness and swelling of your gums, and also to help you control any gum bleeding.

Use chlorhexidine gluconate oral rinse regularly, as directed by your dentist, in addition to daily brushing. Spit out after use, chlorhexidine gluconate oral rinse should not be swallowed. If you develop allergic symptoms such as skin rash, itch, generalized swelling, breathing difficulties, light headedness, rapid heart rate, upset stomach or diarrhea, seek medical attention immediately.

Chlorhexidine gluconate oral rinse should not be used by persons who have a sensitivity to it or its components. Chlorhexidine gluconate oral rinse may cause some tooth discoloration, or increase in tartar (calculus) formation, particularly in areas where stain and tartar usually form. It is important to see your dentist for removal of any stain or tartar at least every six months or more frequently if your dentist advises.

Both stain and tartar can be removed by your dentist or hygienist. Chlorhexidine gluconate oral rinse may cause permanent discoloration of some front-tooth fillings. To minimize discoloration, you should brush and floss daily, emphasizing areas which begin to discolor.

Chlorhexidine gluconate oral rinse may taste bitter to some patients and can affect how food and beverages taste. This will become less noticeable in most cases with continued use of chlorhexidine gluconate oral rinse. To avoid taste interference, rinse with chlorhexidine gluconate oral rinse after meals.

Do not rinse with water or other mouthwashes immediately after rinsing with chlorhexidine gluconate oral rinse. If you have any questions or comments about Chlorhexidine gluconate oral rinse, contact your dentist, pharmacist, or Xttrium Laboratories, Inc. toll free at 1-800-587-3721. Call your health care provider for medical advice about side effects.

You may report side effects to FDA at 1-800-FDA-1088. STORE at 20°C to 25°C (68°F to 77°F), excursions permitted to 15°C to 30°C (59°F to 86°F) [See USP controlled Room Temperature]. 16-oz PDP 16-oz 1 PET 16oz 16-oz 3

PRINCIPLE DISPLAY PANEL NDC 0116-2001-04 CHLORHEXIDINE GLUCONATE 0.12% ORAL RINSE, USP Direction for Use: Fill cap to the "fill line" (15ml). Swish in mouth undiluted for 30 seconds, then spit out. Use after breakfast and before bedtime.

Or, use as prescribed. Note: to minimize medicinal taste, do not rinse with water immediately after use. Rx Only KEEP OUT OF REACH OF CHILDREN 4 oz.

(118 mL) INGREDIENTS: 0.12% chlorhexidine gluconate in a base containing water, 11.6% alcohol, glycerin, PEG-40 sorbitan diisostearate, flavor, sodium saccharin and FD&C Blue No.1. To open, press in flat pannels while turning cap. To reseal, turn cap past "clicks" until tightly locked.

WHAT TO EXPECT WHEN USING CHLORHEXIDINE GLUCONATE ORAL RINSE Your dentist has prescribed chlorhexidine gluconate oral rinse to treat your gingivitis, to help reduce the redness and swelling of your gums, and also to help you control any gum bleeding. Use chlorhexidine gluconate oral rinse regularly, as directed by your dentist, in addition to daily brushing. Spit out after use, chlorhexidine gluconate oral rinse should not b… [Excerpted — this section continues on DailyMed.]

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

Medicaid utilization & spend

📍 This exact package only: Medicaid data is reported per full 11-digit NDC — labeler, product and pack size — so every number here is for this package alone, not the drug overall. Other pack sizes report separately.
💊 Pharmacy benefit only: These are Medicaid outpatient pharmacy claims, billed by NDC. They exclude the medical benefit — clinic- or hospital-administered drugs billed under HCPCS J-codes — so drugs used mostly that way (e.g. Avastin, Lucentis, Keytruda) can look low or missing here. That’s expected, not an error.
📅 Q1 2025 – Q1 2026 · 5 quarters of data
ⓘ The newest quarter is usually incomplete when first published; states restate recent quarters in later CMS releases, so the latest figures typically revise upward. State coverage-policy changes can also shift quarter-to-quarter totals.
Prescriptions last 4 qtrs
1M
Units reimbursed last 4 qtrs
504.3M
Gross reimbursed last 4 qtrs
$10.72M
Avg / prescription
$10.34
Avg / unit
$0.0212
Latest quarter Q1 2026
226.4KRx
Medicaid pays / mL
$0.0212
gross reimbursed
vs
NADAC / mL
$0.0073
acquisition cost
=
Spread
+$0.0139
+190% vs cost
What Medicaid paid per mL (before rebates; includes the pharmacy’s dispensing fee) compared with NADAC — the average price pharmacies pay to buy the drug. A positive spread means Medicaid reimbursed more than the purchase price, before manufacturer rebates.
Fee-for-service vs managed care ⓘ
43% FFS 57% MCO
Fee-for-service · 443,182 Rx Managed care · 593,354 Rx
State Medicaid map
Alaska: 1,045,971 units · 142,697 per 100k residents AK Maine: 1,688,840 units · 121,064 per 100k residents ME Washington: 13,689,816 units · 175,241 per 100k residents WA Idaho: 2,587,923 units · 131,768 per 100k residents ID Montana: 1,743,898 units · 154,055 per 100k residents MT North Dakota: 449,350 units · 57,388 per 100k residents ND Minnesota: 8,509,098 units · 148,320 per 100k residents MN Wisconsin: 7,124,071 units · 120,543 per 100k residents WI Michigan: 24,795,511 units · 247,041 per 100k residents MI New York: 92,775,220 units · 474,044 per 100k residents NY Vermont: 865,327 units · 133,745 per 100k residents VT New Hampshire: 974,448 units · 69,504 per 100k residents NH Oregon: 9,832,691 units · 232,287 per 100k residents OR Nevada: 5,314,372 units · 166,386 per 100k residents NV Wyoming: 231,477 units · 39,636 per 100k residents WY South Dakota: 1,590,356 units · 173,053 per 100k residents SD Iowa: 5,654,972 units · 176,332 per 100k residents IA Illinois: 16,089,873 units · 128,216 per 100k residents IL Indiana: 11,618,654 units · 169,319 per 100k residents IN Ohio: 31,112,361 units · 264,000 per 100k residents OH Pennsylvania: 27,581,736 units · 212,806 per 100k residents PA New Jersey: 14,798,616 units · 159,296 per 100k residents NJ Massachusetts: 4,871,479 units · 69,583 per 100k residents MA California: 54,222,858 units · 139,158 per 100k residents CA Utah: 3,409,941 units · 99,793 per 100k residents UT Colorado: 12,381,910 units · 210,648 per 100k residents CO Nebraska: 2,639,035 units · 133,419 per 100k residents NE Missouri: no data reported MO Kentucky: 9,815,269 units · 216,864 per 100k residents KY West Virginia: 6,613,959 units · 373,670 per 100k residents WV Virginia: 9,853,966 units · 113,056 per 100k residents VA Maryland: 13,357,297 units · 216,137 per 100k residents MD Connecticut: 4,506,919 units · 124,604 per 100k residents CT Rhode Island: 621,324 units · 56,742 per 100k residents RI Arizona: 7,039,220 units · 94,728 per 100k residents AZ New Mexico: 7,081,360 units · 334,974 per 100k residents NM Kansas: 1,563,461 units · 53,179 per 100k residents KS Arkansas: 2,281,115 units · 74,376 per 100k residents AR Tennessee: 7,332,052 units · 102,892 per 100k residents TN North Carolina: 15,948,220 units · 147,192 per 100k residents NC South Carolina: 2,541,825 units · 47,307 per 100k residents SC Delaware: 1,891,153 units · 183,429 per 100k residents DE Oklahoma: 4,623,526 units · 114,077 per 100k residents OK Louisiana: 10,559,795 units · 230,866 per 100k residents LA Mississippi: 2,962,047 units · 100,750 per 100k residents MS Alabama: 2,713,305 units · 53,119 per 100k residents AL Georgia: 4,739,465 units · 42,973 per 100k residents GA D.C.: 1,603,679 units · 236,182 per 100k residents DC Hawaii: 688,179 units · 47,957 per 100k residents HI Texas: 17,298,677 units · 56,711 per 100k residents TX Florida: 8,675,294 units · 38,369 per 100k residents FL
Units reimbursed · per 100k residents
38,369474,044
gray = no data reported ⓘ
Colors are per 100,000 residents, so big states don’t automatically dominate. Tap or hover a state for its actual totals.
Tap or hover a state
…for its Medicaid breakdown
🏆 Top states by units · per 100k residents
1 New York 474,044 /100k
2 West Virginia 373,670 /100k
3 New Mexico 334,974 /100k
4 Ohio 264,000 /100k
5 Michigan 247,041 /100k
6 D.C. 236,182 /100k
7 Oregon 232,287 /100k
8 Louisiana 230,866 /100k
National units — by quarter
💵 About the dollar figures: “reimbursed” is what Medicaid paid pharmacies before confidential manufacturer rebates, so the program’s real net cost is lower than these numbers. Fee-for-service and managed-care claims are combined unless split above. Source: CMS State Drug Utilization Data; per-100k rates use 2023 Census population estimates.

Medicaid utilization by pack size

Medicaid (SDUD) totals over the four most recent reported quarters for every package size of this drug — handy when a specific package (e.g. a starter/titration pack) carries little or no Medicaid volume on its own.
473 ml this page00116-2001-16 1,036,536 Rx · $10,716,407
118 ml00116-2001-04 905 Rx · $41,885
15 ml00116-2001-05 24 Rx · $4,403
600 ml00116-2001-06 No Medicaid data
1500 ml00116-2001-07 No Medicaid data
15 ml00116-2001-15 No Medicaid data
Drug total (last 4 qtrs): 1,037,465 Rx · 504,554,811 units · $10,762,695 gross reimbursed
Tap a pack size to open its page. Source: CMS State Drug Utilization Data, last 4 quarters.

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

Medicare Part D (outpatient prescription) spending for Chlorhexidine Gluconate — 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. 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.
← 00116-1999-16 · Xttrium 00116-3678-07 · 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.