FDA-filed SPL labeling · retrieved through openFDA

Fluoride

Fluoride is a mineral used in toothpastes, gels, and mouth rinses to help prevent dental cavities and support overall tooth health.

Brand names Ortho GuardKolorzListerineLudentMentadent +11 more
Rx/OTC Forms 3 Routes Dental · Topical · Oral · Dental, Topical +1
Dr. Brian Staiger, PharmD, BCPS
Reviewed by Last reviewed Jul 10, 2026
🧬 Where this information comes from Click to expand

The clinical label records used on this page are FDA-filed Structured Product Labeling (SPL) retrieved through openFDA. We identified 17 clinical label sets within the page’s selected clinical scope after exact ingredient or ingredient-combination matching and applicable route/form matching. Forms, routes, brands, labelers, strengths, and NDC product-record counts are built separately from matching FDA National Drug Code Directory records. The linked DailyMed document is a representative official source for verification, not the page’s only clinical source. View the linked label on DailyMed →

At a glance
Linked label effectiveJan 16, 2024
Clinical labels in scope ⓘ17
AvailabilityRx/OTC
Earliest approval/marketing year ⓘ1972
FDA-listed product records ⓘ49
Boxed warningNone found in compared labels
How we combine label and product data →
✓No current FDA shortage listed · checked Sep 20, 2026
⭐ Fluoride at a glance The quick version — the full detail is in the Patient Information Guide below.
💊
HelloPharmacist Editorial Team Bottom Line
Fluoride toothpastes, gels, and mouth rinses are a well-established way to help prevent dental cavities. Use them as directed — brush or rinse thoroughly and always spit, never swallow. If gum problems persist for more than two weeks, check in with your dentist.
How we write & review this content — our editorial policy →

📖 Fluoride: Patient Information Guide

A plain-language walkthrough of Fluoride — what it treats, how it works, how it’s taken, side effects, warnings and interactions. Tap any section to expand it.

🎯What it's used for▾

Fluoride is used in toothpastes, gels, and mouth rinses to protect teeth. Here are the supported uses across these products:

  • Helps prevent dental cavities — supported across all fluoride toothpastes, gels, and mouth rinses in this set.
  • CVS Pharmacy toothpaste: also helps control bleeding gums and helps interfere with the harmful effects of plaque associated with gingivitis.
  • H E B toothpaste: also builds increasing protection against painful tooth sensitivity to cold, heat, acids, sweets, or contact.
💊How it's taken▾

How you use fluoride depends on the product form. Always follow the directions on your specific product and your dentist's or doctor's guidance.

  • Toothpastes and gels: Brush teeth thoroughly, preferably after each meal or at least twice a day. Spit out after brushing — do not swallow. For children under 6, use a pea-sized amount and supervise. Some products, like H E B toothpaste, are directed for children 12 and older only — check your label.
  • Mouth rinses (365 Whole Foods Market Spearmint Flavored Fluoride Mouthwash Anticavity and Equate Anticavity Oral Rinse): Use twice a day after brushing. Swish 10 mL (2 teaspoonfuls) between teeth for 1 minute, then spit. Do not eat or drink for 30 minutes after rinsing. For children under 6, consult a dentist or doctor first.
⚠️Warnings & precautions▾

The most critical safety point: do not swallow fluoride products. If more than the amount used for brushing or rinsing is accidentally swallowed, contact a Poison Control Center or get medical help immediately. Keep all fluoride products out of reach of children under 6 years of age.

  • Stop use and see a dentist if gingivitis, bleeding, or redness of the gums persists for more than 2 weeks.
  • Stop use and see a dentist if you notice painful or swollen gums, pus from the gum line, loose teeth, or increasing space between teeth — these can be signs of periodontitis, a serious form of gum disease.
  • Discontinue use if any irritation occurs in the mouth.
📋Before taking it▾
  • Children under 2 years of age: consult a dentist or doctor before using any fluoride toothpaste or gel.
  • Children under 6 years of age: use only a pea-sized amount of toothpaste; supervise brushing to minimize swallowing.
  • Children under 6 years of age: consult a dentist or doctor before using fluoride mouth rinse.
  • Children under 12 years of age using a mouth rinse: teach good rinsing habits to minimize swallowing, and supervise as needed.
  • H E B toothpaste is directed for adults and children 12 years and older; consult a dentist or doctor for younger children.
🚑If you take too much▾

If more fluoride is swallowed than what is normally used for brushing or rinsing, get medical help or contact a Poison Control Center right away. Do not wait for symptoms to appear before seeking help.

📦How to store it▾

Store in a cool dry place.

📄 Written from Fluoride’s FDA-approved label information, summarized in plain language with AI, and reviewed by our pharmacy team before publication. Every point is grounded in that labeling — nothing is invented. How we use AI →

🩺 Pharmacist Counseling Corner

Quick, plain-English answers to the questions patients ask most about Fluoride — the kind of thing our pharmacy team would talk through with you at the counter.

What is fluoride toothpaste actually doing for my teeth? ▾
Fluoride toothpaste works to protect your teeth from cavities. When you brush with it regularly, it helps shield your teeth from the acids that break down enamel (the hard outer layer of your teeth). CVS Pharmacy's fluoride toothpaste also helps with bleeding gums and plaque-related gingivitis, and H E B's version can help reduce tooth sensitivity to things like cold, heat, and sweets.
How often should I use a fluoride mouth rinse? ▾
Both 365 Whole Foods Market Spearmint Flavored Fluoride Mouthwash Anticavity and Equate Anticavity Oral Rinse are meant to be used twice a day, after you've already brushed your teeth. Swish 2 teaspoonfuls (10 mL) around for a full minute, then spit it out completely. Don't eat or drink anything for 30 minutes after — that gives the fluoride time to do its job. And don't swallow it.
My child is 4 — can they use fluoride toothpaste or rinse? ▾
Children 2 and older can use most of the fluoride toothpastes listed here, but you should only use a pea-sized amount and supervise their brushing so they don't swallow it. Fluoride mouth rinses are a different story — kids under 6 should not use them unless a dentist or doctor says it's okay. For children under 2, always check with a dentist or doctor first before using any fluoride product.
What happens if my child swallows some toothpaste while brushing? ▾
A tiny accidental taste during brushing is a common worry, which is exactly why you use just a pea-sized amount for young kids and teach them to spit. But if more than the small brushing amount is swallowed, you should contact a Poison Control Center or get medical help right away — don't wait to see if symptoms develop. That's true for both toothpaste and mouth rinse.
My gums have been bleeding a little when I brush. Should I stop using fluoride? ▾
A little occasional bleeding can happen, but if your gums are bleeding, red, or irritated for more than two weeks, stop using the product and see your dentist. Also watch out for swollen or painful gums, pus near the gum line, or teeth that feel loose — those are potential signs of periodontitis, a serious gum disease that needs professional attention. CVS Pharmacy's fluoride toothpaste is specifically labeled to help with gingivitis-related bleeding, but it's not a replacement for a dental visit if problems persist.
Does it matter which fluoride toothpaste I pick? ▾
All the fluoride toothpastes in this group help prevent cavities, which is the core job. A few have extras: H E B's version also targets tooth sensitivity, and CVS Pharmacy's is also labeled for bleeding gums and gingivitis-related plaque effects. Check the label on your specific product for the age range and directions — some, like H E B, are directed for ages 12 and older, while most others are okay from age 2. When in doubt, your dentist or doctor can help you choose the right one for your situation.
Is Fluoride available over the counter? ▾
Both — Fluoride is sold both over the counter and by prescription, according to its FDA labeling. Lower strengths or certain forms are often available without a prescription, while higher strengths or specialized forms still require one. Ask your pharmacist which version is right for you.
When was Fluoride first available? ▾
Fluoride has been available in the United States since at least 1972, based on FDA approval history (Drugs@FDA) and product marketing records.
Who makes Fluoride? ▾
Fluoride is supplied by 17 manufacturers listed in the FDA NDC Directory, including Ross Healthcare Inc., CVS Pharmacy, Heb.

💬 Answers drafted from Fluoride’s FDA-approved label information, summarized in plain language with AI, and reviewed by our pharmacy team before publication. Grounded in that labeling — nothing is made up. How we use AI →

🧰 Keep exploring

🌿Drug & Supplement CheckerFluoride vs. vitamins & herbs 💬Ask a PharmacistFree answer, usually < 24h 🔎NDC & pricing lookupFind Fluoride NDCs & costs 🅰️Browse Drugs A–ZLook up any medication

💊 How Fluoride comes

Fluoride is available in 3 forms. Different forms and brands can have different approved uses, doses, schedules, and directions. Follow the instructions for your exact product, and do not switch forms without guidance from your prescriber or pharmacist.

Topical cream, ointment or gel

By mouth · Dental · On the skin
Brands CVS Pharmacy Enamur Fluoride AntiCavity Toothpast Fluoride Anti Caries 65g Coconut Whip Juicy Peach Mango Smoothie Summer Watermelon Hami Melom Cream Strawberries Blueberry Fluoride Anticavity,toothpaste H E B
How this form is used
What it may be used for
  • CVS Pharmacy: aids in the prevention of dental cavities, helps control bleeding gums, and helps interfere with harmful effects of plaque associated with gingivitis.
  • H E B: aids in the prevention of dental cavities and builds increasing protection against tooth sensitivity to cold, heat, acids, sweets, or contact.
  • Enamur Fluoride AntiCavity Toothpast: helps protect against cavities.
  • Fluoride Anti Caries 65g Coconut Whip Juicy Peach Mango Smoothie Summer Watermelon Hami Melom Cream Strawberries Blueberry: helps protect against cavities.
Important instructions
  • CVS Pharmacy: Adults and children 2 years and older — brush teeth thoroughly, preferably after each meal or at least twice a day, and not more than 3 times a day. For children under 6, use a pea-sized amount and supervise brushing. Spit out after brushing.
  • H E B: Adults and children 12 years and older — apply at least a 1-inch strip to a soft bristle toothbrush and brush for at least one minute, preferably after each meal or at least twice a day. Children under 12: consult a dentist or doctor.
  • Enamur Fluoride AntiCavity Toothpast: Adults and children 2 years and older — brush thoroughly, preferably after each meal or at least twice a day. Children 2–6 years: use only a pea-sized amount and supervise brushing. Children under 2: ask a dentist or physician.
  • Fluoride Anti Caries 65g Coconut Whip Juicy Peach Mango Smoothie Summer Watermelon Hami Melom Cream Strawberries Blueberry: Adults and children 2 years and older — brush thoroughly, preferably after each meal or at least twice a day. Supervise children under 6. Children under 2: consult a dentist or doctor.
Available strengths 11 strengths
1.4 mg/g 2 mg/g 2 mg/mL 20 mg/mL 0.15 g/100 g 0.243 g/100 g
Show 5 more strengths Show fewer strengths
0.25 g/100 g 0.454 g/100 g 0.76 g 0.76 g/100 g 0.76 g/g
46 FDA-listed product records ⓘ

Oral solution

By mouth
Brands Equate Anticavity Oral Rinse
How this form is used
What it may be used for
  • Equate Anticavity Oral Rinse: aids in the prevention of dental cavities
Important instructions
  • Equate Anticavity Oral Rinse: Adults and children 6 years and older — use twice a day after brushing your teeth with toothpaste.
  • Equate Anticavity Oral Rinse: Vigorously swish 10 mL (2 teaspoonfuls) between your teeth for 1 minute, then spit out. Do not swallow.
  • Equate Anticavity Oral Rinse: Do not eat or drink for 30 minutes after rinsing.
  • Equate Anticavity Oral Rinse: Children under 6 years of age — consult a dentist or doctor before use.
Available strengths 1 strength
0.021 g/mL
2 FDA-listed product records ⓘ

Mouth rinse

By mouth
Brands 365 Whole Foods Market Spearmint Flavored Fluoride Mouthwash Anticavity
How this form is used
What it may be used for
  • 365 Whole Foods Market Spearmint Flavored Fluoride Mouthwash Anticavity: aids in the prevention of dental cavities
Important instructions
  • 365 Whole Foods Market Spearmint Flavored Fluoride Mouthwash Anticavity: Adults and children 6 years and older — use twice a day after brushing your teeth with toothpaste.
  • 365 Whole Foods Market Spearmint Flavored Fluoride Mouthwash Anticavity: Vigorously swish 10 mL (2 teaspoonfuls) between your teeth for 1 minute, then spit out. Do not swallow.
  • 365 Whole Foods Market Spearmint Flavored Fluoride Mouthwash Anticavity: Do not eat or drink for 30 minutes after rinsing.
  • 365 Whole Foods Market Spearmint Flavored Fluoride Mouthwash Anticavity: Children under 6 years of age — consult a dentist or doctor before use.
Available strengths 1 strength
0.1 mg/mL
1 FDA-listed product record ⓘ

📊 Fluoride across the U.S. market

How Fluoride appears in the FDA’s National Drug Code Directory — including its dosage forms, strengths, brand names, manufacturers, and FDA-listed product records. These are directory records, not sales or prescription volume.

3
Dose forms ⓘ
17
Manufacturers
27
Brand names
49
FDA-listed product records ⓘ
1972
First marketed ⓘ

FDA-listed product records by dose form (tablet variants merged) — FDA National Drug Code Directory. Record counts are not sales or prescription volume.

Ross Healthcare Inc.24%
CVS Pharmacy16%
Heb14%
Laclede, Inc.6%
Caldwell Consumer Health LLC6%
Caldwell Health LLC4%
Other makers29%

Share of FDA-listed product records by manufacturer — FDA National Drug Code Directory. Record counts are not sales or prescription volume.

🔍 Compare Fluoride products

A representative set of FDA-listed product records for Fluoride — across manufacturers, strengths, and dosage forms, grouped by form with each product’s manufacturer and how the FDA approved it. The same medicine may be made and packaged by different companies, so a single drug can have many directory entries. (It’s also why a refill can look different — a new shape, color, or box — even though it contains the same medication.)

Showing 49 of 49 products — FDA National Drug Code Directory. See every product, package size and price: browse all 49 Fluoride NDCs →

🏷️ Sold under these brand names

Ortho Guard Kolorz Listerine Ludent Mentadent Opalescence Ora-Line Oral Defense Oral-B Glister Pepsodent Peroxi-Care Pro-Den Rx Simply White Vortex Whole Care

🏭 Manufacturers & labelers

Ross Healthcare Inc. 12 CVS Pharmacy 8 Heb 7 Laclede, Inc. 3 Caldwell Consumer Health LLC 3 Caldwell Health LLC 2 Kroger Company 2 Lornamead 2 Wal-Mart Stores, Inc. 2 World Dentists Association America Limited 1 Whole Foods 1 United Exchange Corp. 1 Shulisa (Foshan) Daily ChemicalIndustry Co., Ltd 1 Protegera, Inc. 1 Protegera, Inc 1 McKesson 1 Lornamead Products 1

🔬 Where this comes from

Core label, product, RxNorm, safety, and utilization data on this page come from the sources identified below. AI-written, editorial, and licensed sections are labeled separately.

📄
FDA-filed drug labels (SPL) Uses, dosing, warnings & side effects from SPL records retrieved through openFDA; the linked representative set can be verified on DailyMed. ✓ Linked label effective Jan 16, 2024
🏭
Forms, brands & labelersAggregated from ingredient-matched FDA National Drug Code Directory product records for Fluoride.
📈
Real-world reportsThe FDA Adverse Event Reporting System (FAERS), served through openFDA.
🚨
Recalls & shortagesopenFDA drug-enforcement reports and the FDA drug-shortage database.
🧾 Clinical label set — FDA-filed SPL labels retained for Fluoride after exact ingredient or ingredient-combination matching and applicable route/form matching
Clinical labels in scope
17
NDC products indexed
49
Distinct labelers/manufacturers represented
17
Linked representative label ⓘ
Caldwell Consumer Health LLC
Linked label effective
Jan 16, 2024
Composite sections available
7
Linked SPL Set ID
087abbed-1f58-4b45-a76b-a950fa81c18c
Linked SPL Document ID
f4474bf0-e311-4883-8f70-e40e21afa994
Open the linked representative label on DailyMed ↗

How we combine label and product data

HelloPharmacist combines public FDA and NLM records; we don’t author the underlying clinical facts. We identified 17 FDA-filed SPL label sets within the page’s selected clinical scope after exact ingredient or ingredient-combination matching and applicable route/form matching. The representative label is the starting point for the displayed reference monograph; the 12 largest stored in-scope SPL records, which may include that representative, are compared section by section, and the longest available version of each section is retained. Forms, routes, brands, labelers, product-listed strengths, and product-record counts are aggregated separately from ingredient-matched FDA NDC Directory records; package records listed above are associated with the linked SPL; and the normalized concept hierarchy comes from NLM RxNorm.

For canonical ingredient pages, bounded product-attributed indication and administration excerpts may be added to the AI evidence, and the generator is instructed to preserve available product, brand, route, and form qualifiers instead of treating one label as universal. Where a section is identified as AI-written, its plain-language text is generated from bounded label evidence. New draft drug pages remain in the admin review queue before first publication. Caldwell Consumer Health LLC is the representative DailyMed label linked for verification and dates; it is not the sole source used for the page.

This is general education, not medical advice — always consult your doctor or pharmacist about your medications and any medical condition. For the exact wording of the linked representative label, view that label on DailyMed; some displayed composite sections may come from other in-scope SPL labels. Learn how we use AI and our data sources & update cadence.