Listerine UltraClean Gum Plus Whitening Protection Cool Mint Antigingivitis/ Antiplaque Mouthwash
Listerine UltraClean Gum Plus Whitening Protection Cool Mint Antigingivitis/ Antiplaque Mouthwash is an FDA drug label for the active ingredient EUCALYPTOL, MENTHOL, METHYL SALICYLATE, THYMOL manufactured by Kenvue Brands LLC administered by ORAL. This page reproduces the FDA-approved indications and usage, dosage, contraindications, warnings, and adverse reactions exactly as published in the drug label. Data source: openFDA (U.S. FDA), label effective 20260819.
- Generic name
- EUCALYPTOL, MENTHOL, METHYL SALICYLATE, THYMOL
- Manufacturer
- Kenvue Brands LLC
- Product type
- HUMAN OTC DRUG
- Route
- ORAL
- Dosage form
- N/A
- NDC
- 69968-1023
- Application
- M022
- Label effective
- 20260819
About this product
Listerine UltraClean Gum Plus Whitening Protection Cool Mint Antigingivitis/ Antiplaque Mouthwash is an FDA-registered drug product whose active ingredient is EUCALYPTOL, MENTHOL, METHYL SALICYLATE, THYMOL. It is labelled by Kenvue Brands LLC taken by oral and marketed as a human otc drug product. Identifiers on file: NDC 69968-1023, application M022, label effective 20260819. It is one of 23 FDA drug label records sharing the active ingredient EUCALYPTOL, MENTHOL, METHYL SALICYLATE, THYMOL. This page reproduces the FDA-approved label text so you can check what a product is, who makes it and how it is supplied before discussing it with a pharmacist or prescriber.
What it is used for
Across FDA labelling, products containing EUCALYPTOL, MENTHOL, METHYL SALICYLATE, THYMOL are most often described in connection with: helps prevent, reduce plaque. Wording differs between labels, and the full indications section on this page takes precedence when it is present.
Active ingredients
Indications & Usage
Uses helps prevent and reduce: • plaque • gingivitis
Dosage & Administration
Directions • rinse full strength for 30 seconds with 20 mL (2/3 fluid ounce or 4 teaspoonfuls) morning and night • do not swallow
Warnings
Warnings Warnings Do not use in children under 12 years of age Ask a dentist if symptoms persist, new symptoms appear, or conditions worsen after regular use Keep out of reach of children. If more than used for rinsing is accidentally swallowed, get medical help or contact a Poison Control Center right away.
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View labelHow products containing EUCALYPTOL, MENTHOL, METHYL SALICYLATE, THYMOL compare
FDA lists 23 drug label records with EUCALYPTOL, MENTHOL, METHYL SALICYLATE, THYMOL as the active ingredient. The most common dosage forms and the manufacturers with the most records are summarised below; strengths, pack sizes and inactive ingredients can still differ between apparently similar products.
| Dosage form | Products | Manufacturer | Products |
|---|---|---|---|
| — | — | Nice-Pak Products, LLC | 4 |
| — | — | Publix Super Markets, Inc. | 3 |
| — | — | WALMART INC. (see also Equate) | 3 |
| — | — | DISCOUNT DRUG MART | 2 |
| — | — | H E B | 2 |
Recall and safety notices
1 FDA recall record(s) match this product name or manufacturer. A match means the firm or product name appears in the enforcement report; confirm lot numbers and dates against the official FDA notice before acting.
| Recall | Product | Firm | Class | Status | Reported |
|---|---|---|---|---|---|
| D-0121-2026 | TYLENOL, Acetaminophen, Extra Strength, 24 Caplets, 500mg each, distributed by: Johnson & Johnson Consumer Inc., McNeil Consumer Healthcare Division, Fort Washington, PA 19034, NDC: 50580-378-04. | Kenvue Brands LLC | Class II | Ongoing | 20251105 |
Frequently asked questions
What is Listerine UltraClean Gum Plus Whitening Protection Cool Mint Antigingivitis/ Antiplaque Mouthwash used for?
Uses helps prevent and reduce: • plaque • gingivitis
Who makes Listerine UltraClean Gum Plus Whitening Protection Cool Mint Antigingivitis/ Antiplaque Mouthwash?
Kenvue Brands LLC is the labeler of record for Listerine UltraClean Gum Plus Whitening Protection Cool Mint Antigingivitis/ Antiplaque Mouthwash. 23 FDA label records share the active ingredient EUCALYPTOL, MENTHOL, METHYL SALICYLATE, THYMOL, so generic and branded versions may come from different companies; the manufacturer named on your pack is the one that matters for any enquiry.
What form does Listerine UltraClean Gum Plus Whitening Protection Cool Mint Antigingivitis/ Antiplaque Mouthwash come in?
administered by oral. Strengths and pack sizes vary by label, so compare the NDC on your pack with the identifier listed on this page.
Is Listerine UltraClean Gum Plus Whitening Protection Cool Mint Antigingivitis/ Antiplaque Mouthwash prescription or over-the-counter?
The FDA label for this product is recorded as human otc drug. Marketing status can differ between strengths and countries, so check the dispensing rules where you live.
Are there other products containing EUCALYPTOL, MENTHOL, METHYL SALICYLATE, THYMOL?
Yes. 23 FDA drug label records list EUCALYPTOL, MENTHOL, METHYL SALICYLATE, THYMOL as the active ingredient. Products with the same active ingredient can usually be substituted only when a prescriber or pharmacist confirms it is appropriate.
Has Listerine UltraClean Gum Plus Whitening Protection Cool Mint Antigingivitis/ Antiplaque Mouthwash been recalled?
1 FDA recall record(s) match this product name or manufacturer. Review the recall and safety notices section on this page and confirm lot numbers against the official FDA enforcement report.
Where does this information come from?
All content is reproduced from FDA Structured Product Labelling data via openFDA. It is provided for identification and reference only and is not medical advice.
This page reproduces FDA Structured Product Labelling data for identification and reference. It is not medical advice, does not diagnose or treat any condition, and does not sell or price any medicine.