Home › NDC Lookup › Ingredients › Chlorhexidine Gluconate 0.12% Oral Rinse › 62135-0649-47
Chlorhexidine Gluconate 0.12% Oral Rinse 1.2 mg/mL Solution, 473 mL — NDC 62135-0649-47 package photo
Label image from the product's FDA listing (DailyMed) — may show a different pack size or an older label revision.

Chlorhexidine Gluconate 0.12% Oral Rinse 1.2 mg/mL Solution, 473 mL — NDC 62135-649-47 (Billing 62135-0649-47)

by Chartwell RX, LLC · 473 mL in 1 BOTTLE

This is a package of 473 mL of Chlorhexidine Gluconate 0.12% Oral Rinse 1.2 mg/mL Solution from Chartwell RX, LLC, marketed since Mar 2004 and currently FDA-listed; retail pharmacies pay about $0.0073 per mL (NADAC). It is the main listing for this product, which comes in 2 package sizes.

NDC 62135-0649-47
🏷️ FDA NDC (as labeled) 62135-649-47 billing pads the product segment with a zero
This package
Contains473 mL Cost per mL$0.0073 NADAC Per package$3.45 / 473 ml Pack sizes2 compare ↓
Also priced by: Medicaid pays $0.0200/unit · Part D plans $0.0247/unit — full pricing hub ↓
Main listing for product 62135-649 · Also comes in: 120 ml 62135-649-41
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

Identity & classification

Regulatory identifiers FDA, NLM and CMS codes for this package

FDA NDC (as labeled) 62135-649-47
Product NDC 62135-649
11-digit billing NDC 62135064947
NCPDP billing unit ML — per mL (volume)
RxCUI 834127
UNII MOR84MUD8E
UPC 0362135649470, 0362135649418
Application # ANDA075006
SPL Set ID 923e22b1-0fa2-4a3c-900d-2d2eb63f841c
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 2004-03-03
Route ORAL
Dosage form SOLUTION
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
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 62135-649-47 — 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 → 62135-0649-47. 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 $0.0200 $9.46 / 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
Dec 2023 Jan 2026 May 2026 Sep 2026 $0.007 $0.004
▲ Up 35% over the last 13 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
62135-0649-41 62135-649-41 120 mL in 1 BOTTLE — — 2023-06-28 — Active
62135-0649-47 You're viewing this Main listing 473 mL in 1 BOTTLE $0.0073 / mL $3.47 2023-06-28 — Active

You're viewing the largest of 2 pack sizes for this product.

In Medicaid, this is the most-dispensed pack of this product — about 50% 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 62135-0649-41?
Both are Chlorhexidine Gluconate 0.12% Oral Rinse 1.2 mg/mL Solution — the drug itself is identical. This page's package is the 473 mL one, while NDC 62135-0649-41 is the 120 ml package.
What NDC number is used to bill for this package of Chlorhexidine Gluconate 0.12% Oral Rinse 1.2 mg/mL Solution?
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 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 mg/mLthis 62135-0649-47 Chartwell 473 ml $0.007 AT Availability likely —
Chlorhexidine Gluconate 1.2 mg/mL 00116-2001-04 Xttrium 118 ml $0.017 AT Availability likely +129%
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 62135-0650-24 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 —
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

🏛️
2004
On the market since
Mar 2004
📍
2026
Currently FDA-listed
22 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.

What it looks like

Color blue
FlavorPeppermint
One label can cover several strengths, so colors may be combined — always confirm a loose pill against the dispensed prescription label or a pharmacist.
Where does this data come from?
Physical description (imprint, shape, color, scoring, coating) from this product’s FDA Structured Product Labeling (SPL), mirrored from DailyMed / openFDA.

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 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

LabelerChartwell RX, LLC
Application holderCHARTWELL RX SCIENCES LLC
FDA applicationANDA075006 (ANDA)
Labeler code62135
First marketedMar 2004
Product typeHuman Prescription Drug
Portfolio521 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 🆘 Overdosage 🧬 Clinical Pharmacology 📦 How Supplied / Storage and Handling 📋 Description ⚠️ Precautions 🧬 Pharmacokinetics 📄 Package Label / Principal Display Panel
🎯 Indications and Usage 65 words ▾

INDICATIONS AND USAGE: 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 102 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 toothbrushing.

Usual dosage is 15ml (1 tablespoon) 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 88 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 as serious allergic reactions, have been reported during postmarketing use with dental products containing chlorhexidine. SEE CONTRAINDICATIONS .

🤒 Adverse Reactions 174 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 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.

🆘 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 122 words ▾

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 bacteria 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.

📦 How Supplied / Storage and Handling 95 words ▾

HOW SUPPLIED: Chlorhexidine Gluconate 0.12% Oral Rinse, USP is supplied as a light blue color clear solution in 4-ounce (120 ml) [NDC 62135-649-41] and 16 ounce (473ml) [62135-649-47] child-resistant bottles, 15 mL Unit Dose Cup [62135-650-51] and 20 Unit Dose Cups 15 mL each [62135-650-24]. 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]. Dispense in original container or in amber glass bottles.

Rx only Keep out of reach of children. Manufactured for: Chartwell RX, LLC. Congers, NY 10920 L71503 Rev.

05/2024

📋 Description 93 words ▾

DESCRIPTION: Chlorhexidine Gluconate 0.12% Oral Rinse, USP is an oral rinse containing 0.12% chlorhexidine gluconate (1, 11-hexamethylene bis [5-(p-chlorophenyl) biguanide] di-D-gluconate) in a base containing water, 11.6% alcohol, glycerin, PEG-40 sorbitan diisostearate, peppermint flavor, sodium saccharin, and FD&C Blue No. 1. Chlorhexidine gluconate oral solution is a near-neutral solution (pH range 5-7).

Chlorhexidine gluconate is a salt of chlorhexidine and gluconic acid. Its molecular formula is C 22 H 30 C l2 N 10 ·2C 6 H 12 O 7 , the molecular weight is 897 and its chemical structure is: "Image Description"

⚠️ Precautions ~2 min read ▾

PRECAUTIONS: General: 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. 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 tooth staining.

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. 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. Pregnancy: Teratogenic Effects. Reproduction studies have been performed in rats and rabbits at chlorhexidine gluconate doses up to 300mg/kg/day and 40mg/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 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 30ml (2 tablespoons) 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.

🧬 Pharmacokinetics 125 words ▾

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 300mg 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.

📄 Package Label / Principal Display Panel 50 words ▾

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL Chlorhexidine Gluconate Oral Rinse, USP 0.12% - NDC-62135-649-41 - 120ml - Bottle Label Chlorhexidine Gluconate Oral Rinse, USP 0.12% - NDC-62135-649-47 - 473ml - Bottle Label Chlorhexidine Gluconate Oral Rinse, USP 0.12% - NDC-62135-650-51 - 15 mL - Unit Dose-Label "Image Description" "Image Description" image description

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
116
Units reimbursed last 4 qtrs
54.8K
Gross reimbursed last 4 qtrs
$1.1K
Avg / prescription
$9.47
Avg / unit
$0.0200
Latest quarter Q1 2026
46Rx
Medicaid pays / mL
$0.0200
gross reimbursed
vs
NADAC / mL
$0.0073
acquisition cost
=
Spread
+$0.0127
+174% 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 ⓘ
31% FFS 69% MCO
Fee-for-service · 36 Rx Managed care · 80 Rx
State Medicaid map
Alaska: no data reported AK Maine: no data reported ME Washington: no data reported WA Idaho: no data reported ID Montana: no data reported MT North Dakota: no data reported ND Minnesota: no data reported MN Wisconsin: no data reported WI Michigan: no data reported MI New York: 16,982 units · 86.8 per 100k residents NY Vermont: no data reported VT New Hampshire: no data reported NH Oregon: no data reported OR Nevada: no data reported NV Wyoming: no data reported WY South Dakota: no data reported SD Iowa: no data reported IA Illinois: no data reported IL Indiana: no data reported IN Ohio: no data reported OH Pennsylvania: no data reported PA New Jersey: no data reported NJ Massachusetts: no data reported MA California: no data reported CA Utah: no data reported UT Colorado: no data reported CO Nebraska: no data reported NE Missouri: no data reported MO Kentucky: no data reported KY West Virginia: no data reported WV Virginia: 37,847 units · 434 per 100k residents VA Maryland: no data reported MD Connecticut: no data reported CT Rhode Island: no data reported RI Arizona: no data reported AZ New Mexico: no data reported NM Kansas: no data reported KS Arkansas: no data reported AR Tennessee: no data reported TN North Carolina: no data reported NC South Carolina: no data reported SC Delaware: no data reported DE Oklahoma: no data reported OK Louisiana: no data reported LA Mississippi: no data reported MS Alabama: no data reported AL Georgia: no data reported GA D.C.: no data reported DC Hawaii: no data reported HI Texas: no data reported TX Florida: no data reported FL
Units reimbursed · per 100k residents
86.8434
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 Virginia 434 /100k
2 New York 86.8 /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 page62135-0649-47 116 Rx · $1,098
120 ml62135-0649-41 115 Rx · $1,860
Drug total (last 4 qtrs): 231 Rx · 108,292 units · $2,958 gross reimbursed
Tap a pack size to open its page. Source: CMS State Drug Utilization Data, last 4 quarters.

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 Chlorhexidine Gluconate 0.12% Oral Rinse — the ingredient across all brands.

Top reported reactions

Oral Discomfort4
Recalled Product Administered3
Stomatitis3
Bacterial Infection2
Burkholderia Test Positive2
Choking2
Dysgeusia2

Reporter sex

20 reports
Male · 33%
Female · 67%

Serious outcomes

Disabling2
Reports over time (by year) — tap or hover for the count & year
2023 2024 2025 2026 1 0
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.
← 62135-0648-90 · Chartwell 62135-0650-24 · Chartwell →
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.