Freshen-up Matcha Mint
Freshen-up Matcha Mint is an FDA drug label for the active ingredient SODIUM FLUORIDE manufactured by Dabur India Limited administered by DENTAL. 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 20260715.
- Generic name
- SODIUM FLUORIDE
- Manufacturer
- Dabur India Limited
- Product type
- HUMAN OTC DRUG
- Route
- DENTAL
- Dosage form
- N/A
- NDC
- 87846-003
- Application
- M021
- Label effective
- 20260715
About this product
Freshen-up Matcha Mint is an FDA-registered drug product whose active ingredient is SODIUM FLUORIDE. It is labelled by Dabur India Limited taken by dental and marketed as a human otc drug product. Identifiers on file: NDC 87846-003, application M021, label effective 20260715. It is one of 263 FDA drug label records sharing the active ingredient SODIUM FLUORIDE. 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 SODIUM FLUORIDE are most often described in connection with: helps protect, against cavities. Wording differs between labels, and the full indications section on this page takes precedence when it is present.
Active ingredients
Indications & Usage
Use helps protect against cavities
Dosage & Administration
Directions adults and children 2 years of age and older brush teeth thoroughly, preferably after each meal or at least twice a day or as directed by physician or dentist children 2 to 6 years use only a pea siz amount and supervise child's brushing and rinsing (to minimize swallowing) children under 2 years ask a dentist or physician
Warnings
Warnings keep out of reach of chilren under 6 yeras of age if more than used for brushing is accidently swallowed get medical help or contact a posion control right away, Keep out of reach of children under 6 years of age. If more than used for brushing is accidentally swallowed, get medical help or contact a Poison Control Center right away.
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View labelHow products containing SODIUM FLUORIDE compare
FDA lists 263 drug label records with SODIUM FLUORIDE 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 |
|---|---|---|---|
| — | — | Colgate-Palmolive Company | 34 |
| — | — | The Procter & Gamble Manufacturing Company | 25 |
| — | — | Church & Dwight Co., Inc. | 14 |
| — | — | Burkhart Dental Supply Inc | 12 |
| — | — | Dharma Research, inc. | 12 |
Recall and safety notices
5 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-0633-2026 | Rapidol, Triple Antibiotic First Aid Ointment, Bacitracin Zinc 400 units, Neomycin Sulfate 3.5 mg, Polymyxin-B Sulfate 5,000 units, net wt. 2oz (57g) tubes, Distributed by/por: Pharmadel LLC, New Castle, DE 19720, Made in India, UPC 8 10096 77162 9. | Dabur India Limited | Class II | Ongoing | 20260624 |
| D-0641-2026 | Med Pride, Triple Antibiotic Ointment, Bacitracin Zinc (equivalent to 400 units), Neomycin Sulfate 5 mg, Polymixin B 5000 units, 0.9g packets, 144 packets per box, 130g, Manufactured for: Shield Line LLC, 59 Hook Road, Bayonne, NJ 07002 USA, Made in India, UPC 1 03 52410 30253 1. | Dabur India Limited | Class II | Ongoing | 20260624 |
| D-0630-2026 | Lucky Super Soft, First Aid Triple Antibiotic Ointment, Bacitracin zinc 400 units, neomycin sulphate 3.5 mg, polymyxin B sulphate 5000 units, Net Wt. 0.5 oz (14g) tubes, Manufactured for Delta Brands Inc., 580 White Plains Rd., Tarrytown, NY 10591 USA, Made in India, UPC 8 08829 10372 4. | Dabur India Limited | Class II | Ongoing | 20260624 |
| D-0637-2026 | Med Pride, Bacitracin Zinc Ointment, 1oz (28.3g) per tube, 72 tubes per case, Manufactured for: Shield Line LLC, 59 Hook Road, Bayonne, NJ 07002 USA, Made in India, UPC X004WB4LKT. | Dabur India Limited | Class II | Ongoing | 20260624 |
| D-0640-2026 | Med Pride, HYDROCORTISONE CREAM 1%, Net Wt. 1 oz (28.3g) tubes, Manufactured for: Shield Line LLC, 59 Hook Road, Bayonne, NJ 07002 USA, Made in India, UPC 3 52410 30503 0. | Dabur India Limited | Class II | Ongoing | 20260624 |
Frequently asked questions
What is Freshen-up Matcha Mint used for?
Use helps protect against cavities
Who makes Freshen-up Matcha Mint?
Dabur India Limited is the labeler of record for Freshen-up Matcha Mint. 263 FDA label records share the active ingredient SODIUM FLUORIDE, 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 Freshen-up Matcha Mint come in?
administered by dental. Strengths and pack sizes vary by label, so compare the NDC on your pack with the identifier listed on this page.
Is Freshen-up Matcha Mint 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 SODIUM FLUORIDE?
Yes. 263 FDA drug label records list SODIUM FLUORIDE 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 Freshen-up Matcha Mint been recalled?
5 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.