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Chlorhexidine Gluconate 1.2 mg/mL Rinse — NDC 66689-106-50 (Billing 66689-0106-50)

by VistaPharm, LLC · 50 CUP, UNIT-DOSE in 1 CASE / 15 mL in 1 CUP, UNIT-DOSE

This is a package of Chlorhexidine Gluconate 1.2 mg/mL Rinse from VistaPharm, LLC, marketed since Jan 2022 and currently FDA-listed. It is the main listing for this product, which comes in 2 package sizes.

NDC 66689-0106-50
🏷️ FDA NDC (as labeled) 66689-106-50 billing pads the product segment with a zero
This package
Contains15 mL in 1 cup, unit-dose Pack sizes2 compare ↓
Also priced by: Part D plans $0.0247/unit — full pricing hub ↓
Main listing for product 66689-106 · Also comes in: 100 cups 66689-106-99
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

⚠️
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) 66689-106-50
Product NDC 66689-106
11-digit billing NDC 66689010650
NCPDP billing unit ML — per mL (volume)
RxCUI 834127
UNII MOR84MUD8E
Application # ANDA203212
SPL Set ID 7fb18b56-a76d-4f15-9438-c941def76fdb
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 2022-01-24
Route BUCCAL
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% 15 ML CUP
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 66689-106-50 — a 5-3-2 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 product segment → 66689-0106-50. 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% 15 ML CUP Ingredient Chlorhexidine Gluconate
📗 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 eachPer 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 · Q2 2026 $0.0247 $1.24 / 50 cups
Where does this data come from?
NADAC (National Average Drug Acquisition Cost) is the CMS weekly pharmacy-acquisition-cost survey — what pharmacies pay. ASP (Average Sales Price) is the CMS Medicare Part B drug-payment file, published quarterly. Medicaid pays is computed by us from CMS State Drug Utilization Data (total reimbursed ÷ units, trailing 12 months) — gross of rebates and inclusive of dispensing fees, so it reflects what Medicaid paid, not an acquisition cost. Medicare drug plans pay is the median negotiated point-of-sale unit cost across plans listing this NDC in the CMS quarterly Prescription Drug Plan pricing files, before rebates. The VA pays is the federal contract price (FSS, and the statutory Big 4 ceiling where listed) from the VA National Acquisition Center pharmaceutical price file. All are free public government data; each measures a different payer, so the figures are not directly comparable.

Packaging — all sizes for this product

Package NDCDescription Marketing startMarketing endStatus
66689-0106-50 You're viewing this Main listing 50 CUP, UNIT-DOSE in 1 CASE / 15 mL in 1 CUP, UNIT-DOSE 2022-01-24 — Active
66689-0106-99 66689-106-99 100 CUP, UNIT-DOSE in 1 CASE / 15 mL in 1 CUP, UNIT-DOSE 2022-01-24 — Active

Pack size FAQ

What quantity is in this package?
This package is listed by the FDA — 50 cup, unit-dose in 1 case / 15 ml in 1 cup, unit-dose.
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.

Therapeutic equivalents

ProductLabelerPackNADAC/unitTEStatusPrice vs. this
Chlorhexidine Gluconate Oral Rinse 1.2 mg/mL 16571-0128-48 Rising 473 ml $0.007 AT Availability likely —
Chlorhexidine Gluconate 1.2 mg/mL 00116-2001-04 Xttrium 118 ml $0.017 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/mLthis 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 —
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

🏛️
2022
On the market since
Jan 2022
📍
2026
Currently FDA-listed
4 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.

Loading inactive ingredients from the official FDA label in the background. No external source is being called by this page request.
Where does this data come from?
Source: official FDA Structured Product Labeling (SPL) via DailyMed and the openFDA label index. Structured IACT rows and label-wide narrative are kept separate; availability and product-level specificity depend on the submitted label.

Inactive ingredient FAQ

Are inactive ingredients the same for every manufacturer?
No. Inactive ingredients can differ by manufacturer, dosage form, strength, and package / product version.
Why might an inactive ingredient be missing?
Some SPLs do not provide a complete structured inactive-ingredient list, and older or unusual labels may only include the information in narrative text.
Can inactive ingredients matter?
Yes. They can matter for allergies, intolerances, dyes, gluten / lactose concerns, preservatives, and formulation differences — but confirm with a pharmacist or the manufacturer when it’s clinically important.

Manufacturer & labeler

LabelerVistaPharm, LLC
Application holderCOLGATE-PALMOLIVE CO
FDA applicationANDA203212 (ANDA)
Labeler code66689
First marketedJan 2022
Product typeHuman Prescription Drug
Portfolio19 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.

Full prescribing information FDA SPL

The complete FDA label for this product — the official prescribing information, verbatim, section by section. 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 🧬 Pharmacokinetics 📄 Carcinogenesis, Mutagenesis, Impairment of Fertility 📄 Package Label / Principal Display Panel
🎯 Indications and Usage 69 words ▾

INDICATIONS AND USAGE: Chlorhexidine gluconate oral rinse USP, 0.12% 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 USP, 0.12% has not been tested among patients with acute necrotizing ulcerative gingivitis (ANUG). For patients having coexisting gingivitis and periodontitis, see PRECAUTIONS .

⏱️ Dosage and Administration 117 words ▾

DOSAGE AND ADMINISTRATION: Chlorhexidine gluconate oral rinse USP, 0.12% therapy should be initiated directly following a dental prophylaxis. Patients using chlorhexidine gluconate oral rinse USP, 0.12% 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 toothbrushing.

Usual dosage is 1/2 fl. oz. (one 15 mL unit-dose cup) of undiluted chlorhexidine gluconate oral Rinse USP, 0.12%. Patients should be instructed not to rinse with water or other mouthwashes, brush teeth, or eat immediately after using chlorhexidine gluconate oral rinse USP, 0.12%.

Chlorhexidine gluconate oral rinse USP, 0.12% is not intended for ingestion and should be expectorated after rinsing.

⛔ Contraindications 26 words ▾

CONTRAINDICATIONS: Chlorhexidine gluconate oral rinse USP, 0.12% should not be used by persons who are known to be hypersensitive to chlorhexidine gluconate or other formula ingredients.

⚠️ Warnings 91 words ▾

WARNINGS: The effect of chlorhexidine gluconate oral rinse USP, 0.12% on periodontitis has not been determined. An increase in supragingival calculus was noted in clinical testing with users of chlorhexidine gluconate oral rinse USP, 0.12% compared with control users. It is not known if chlorhexidine gluconate use results in an increase of subgingival calculus.

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

🤒 Adverse Reactions 178 words ▾

ADVERSE REACTIONS: The most common side effects associated with chlorhexidine gluconate oral rinse USP, 0.12% 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 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 1.0%. Among postmarketing reports, the most frequently reported oral mucosal symptoms associated with chlorhexidine gluconate oral rinse USP, 0.12% 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 70 words ▾

Pregnancy: Teratogenic Effects: Pregnancy Category B. 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 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 24 words ▾

Pediatric Use: Clinical effectiveness and safety of chlorhexidine gluconate oral rinse USP, 0.12% have not been established in children under the age of 18.

🆘 Overdosage 52 words ▾

OVERDOSAGE: Ingestion of 1 or 2 ounces of chlorhexidine gluconate oral rinse USP, 0.12% by a small child (~10 kg body weight) might result in gastric distress, including nausea. Medical attention should be sought if more than 4 ounces of chlorhexidine gluconate oral rinse USP, 0.12% is ingested by a small child.

🧬 Clinical Pharmacology ~1 min read ▾

CLINICAL PHARMACOLOGY: Chlorhexidine gluconate oral rinse USP, 0.12% 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 USP, 0.12% 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 USP, 0.12% 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 a chlorhexidine gluconate oral rinse USP, 0.12% indicate approximately 30% of the active ingredient 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 μg/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 121 words ▾

HOW SUPPLIED: Chlorhexidine gluconate oral rinse USP, 0.12% is a blue liquid supplied as follows: NDC 66689-106-01: 15 mL unit-dose cup NDC 66689-106-50: Case contains 50 unit-dose cups of 15 mL (NDC 66689-106-01), packaged in 5 trays of 10 unit-dose cups each. NDC 66689-106-99: Case contains 100 unit-dose cups of 15 mL (NDC 66689-106-01), packaged in 10 trays of 10 unit-dose cups each. Store at 20° to 25°C (68° to 77°F) excursions permitted between 15° to 30°C (59° to 86°F) [see USP Controlled Room Temperature].

DIRECTIONS FOR USE: 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.

📋 Description 72 words ▾

DESCRIPTION: Chlorhexidine gluconate oral rinse USP, 0.12% is an oral rinse containing 0.12% chlorhexidine gluconate (1,1’-hexamethylene bis [5-(p-chlorophenyl) biguanide] di-D-gluconate) in a base containing water, propylene glycol, glycerin, sorbitol, polyoxyl 40 hydrogenated castor oil, flavor, cetylpyridinium chloride, and FD&C blue no. 1. Chlorhexidine gluconate oral rinse USP, 0.12% product is a near neutral solution (pH range 5-7).

Chlorhexidine gluconate is a salt of chlorhexidine and gluconic acid. Its chemical structure is: Structure

⚠️ Precautions ~3 min read ▾

PRECAUTIONS: General: 1. For patients having coexisting gingivitis and periodontitis, the presence or absence of gingival inflammation following treatment with chlorhexidine gluconate oral rinse USP, 0.12% should not be used as a major indicator of underlying periodontitis. 2.

Chlorhexidine gluconate oral rinse USP, 0.12% 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 tooth staining. In clinical testing, 56% of the chlorhexidine gluconate oral rinse USP, 0.12% users exhibited a measurable increase in facial anterior stain, compared to 35% of control users after six months; 15% of the chlorhexidine gluconate oral rinse USP, 0.12% 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 the use of chlorhexidine gluconate oral rinse USP, 0.12% 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 USP, 0.12% 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 a chlorhexidine gluconate oral rinse USP, 0.12%.

Rare instances of permanent taste alteration following chlorhexidine gluconate oral rinse USP, 0.12% use have been reported via postmarketing product surveillance. Pregnancy: Teratogenic Effects: Pregnancy Category B. 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 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: 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 USP, 0.12% 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 doses) of chlorhexidine gluconate oral rinse USP, 0.12% per day. Pediatric Use: Clinical effectiveness and safety of chlorhexidine gluconate oral rinse USP, 0.12% have not been established in children under the age of 18.

Carcinogenesis, Mutagenesis, 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.

🍼 Nursing Mothers 96 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 USP, 0.12% 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 doses) of chlorhexidine gluconate oral rinse USP, 0.12% per day.

🧬 Pharmacokinetics 126 words ▾

PHARMACOKINETICS: Pharmacokinetic studies with a chlorhexidine gluconate oral rinse USP, 0.12% indicate approximately 30% of the active ingredient 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 μg/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.

📄 Carcinogenesis, Mutagenesis, Impairment of Fertility 76 words ▾

Carcinogenesis, Mutagenesis, 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 37 words ▾

PRINCIPAL DISPLAY PANEL Chlorhexidine Gluconate Oral Rinse USP, 0.12% Alcohol-Free Delivers 15 mL Store at 20°-25°C [68°-77°F]; [see USP CRT conditions]. Distributed by: VistaPharm Largo, FL 33771, USA XactDose Rx Only VP2535 06/21 NDC 66689-106-01 Lidding Label

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

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

Medicare Part D (outpatient prescription) spending for Chlorhexidine Gluconate — 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.

About this NDC listing & data coverage

Finished prescription 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 — Not published for this NDC No photo available yet for this listing.
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 ✓ Available
HCPCS J-code billing crosswalk — Not published for this NDC Most self-administered / retail products have no J-code — that is normal.
Medicaid utilization (CMS SDUD) — Not published for this NDC CMS reports utilization only for NDCs with Medicaid claims above its privacy threshold.
“Not published” reflects what the public FDA / CMS / NLM sources provide for this exact package code — it is a property of the data feeds, not a judgment about the product.

Questions about this listing

Why is there no price listed?
The pricing shown on our NDC pages comes from CMS NADAC, a voluntary survey of retail community pharmacy invoices. CMS does not publish a NADAC for every NDC — packages outside the retail survey (institutional and hospital products, bulk packages, discontinued items, and many OTC items) may never receive one. A missing price reflects the survey's scope, not this product's actual cost, and does not mean the product is free or unavailable.
Is the NDC printed on the package the same as the 11-digit billing NDC?
Yes, they identify this exact package in different formats. The form printed on the packaging and shown on DailyMed is the one the FDA registered. Insurance claims use a fixed 11-digit 5-4-2 format, so the short segment is padded with a leading zero and the dashes are dropped. The Identity section at the top of this page lists each form of this code.
Is this package still being marketed?
Yes, per the latest FDA NDC Directory data on this page: this package is listed as actively marketed, with no marketing end date reported by VistaPharm, LLC. 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 1 other package presentation of this same product, including 100 cups (66689-0106-99). 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?
VistaPharm, LLC 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 a prescription product, so it is dispensed under a prescriber's order. Your pharmacist can tell you whether any over-the-counter forms of the same medication exist.
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.
← 66689-0063-10 · VistaPharm, 66689-0113-08 · VistaPharm, →
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.