Active ingredient
Sodium Fluoride
954 finished FDA listings contain Sodium Fluoride as their only active ingredient; 196 combination products also contain it.
FDA NDC Directory
- Ingredient names as written by FDA
- SODIUM FLUORIDE, SODIUM FLUORIDE F-18
- Dosage forms
- Aerosol, Foam, Cream, Gel, Gel, Dentifrice, Injection, Injection, Solution, Liquid, Mouthwash, Ointment, Paste, Paste, Dentifrice, Pellet, Powder, Rinse, Solution/ Drops, Sponge, Tablet, Tablet, Chewable
- Routes
- Buccal, Dental, Intravenous, Oral, Subgingival, Topical
- Manufacturers / labelers
- 195
- Strengths listed (first 60 of 119, A–Z)
- .002 mg/10ml · .00243 g/g · .005 mg/10ml · .02 g/100ml · .02 g/20ml · .02 g/ml · .02 mg/ml · .0272 g/g · .03 g/100ml · .05 g/100ml · .05 mg/ml · .09 mg/ml · .1 g/100g · .1 g/100ml · .1 mg/ml · .11 g/100g · .122 g/100ml · .15 g/100g · .155 g/100g · .2 g/100g · .2 mg/ml · .22 g/100g · .22 g/100ml · .22 g/g · .221 g/100g · .225 mg/ml · .23 g/100g · .24 g/1000g · .24 g/100g · .24 g/100ml · .24 mg/100g · .24 mg/100ml · .24 mg/g · .243 g/100g · .243 g/100ml · .25 g/100g · .25 mg/1 · .2592 g/108g · .26244 g/108g · .32 mg/1 · .37 mg/440mg · .5 mg/1 · .5 mg/ml · .62 mg/1 · .9 mg/g · .9 mg/ml · .916 mg/g · .95 mg/g · 1 [hp_m]/1 · 1 [hp_q]/1 · 1 mg/1 · 1 mg/10ml · 1 mg/g · 1 mg/ml · 1.08 mg/g · 1.1 g/100g · 1.1 g/112g · 1.1 mg/g · 1.13 mg/g · 1.15 mg/g
- Brand names in FDA listings (first 80 of 623, A–Z)
- 3ecare Dual Formula Whiteningtoothpaste Refill, 3ecare Dual Formulawhiteningtoothpaste, 60 Second Fluoride Gel, 60 Second Taste Strawberry, A And H Plus Therabreath Breath Freshners, Acclean Anti-Cavity, Acclean Foam Fluoride 60 Second Application, Act Anticavity Fluoride Arctic Blast, Act Anticavity Fluoride Cinnamon, Act Anticavity Fluoride Kids Bubblegum, Act Anticavity Fluoride Kids Groovy Grape, Act Anticavity Fluoride Kids Wild Watermelon, Act Anticavity Fluoride Mint, Act Kids Anticavity Fluoride Bubble Gum Blowout, Act Kids Anticavity Fluoride Groovy Grape, Act Kids Anticavity Fluoride Pineapple Punch, Act Kids Anticavity Fluoride Wild Watermelon, Act Kids Berry Blast, Act Kids Pure Protect Anticavity- Simply Strawberry, Act Restoring Anticavity Fluoride Cool Mint, Act Restoring Anticavity Fluoride Mint Burst, Act Total Care Anticavity Fluoride Fresh Mint, Act Total Care Anticavity Fluoride Icy Clean Mint, Act Total Care Dry Mouth Anticavity Mouth, Act Whitening Anticavity Gentle Mint, Adoptaplatoon, Advance White Extreme Whitening Tartar Control, Advance White Tartar Control Breath Freshening, Aim Bubble Berry, Aim Cavity Protection Multi Benefit, Aim Cavity Protection With Whitening, Aim Tartar Control Plus Mouthwash And Whitening, Aim Whitening With Baking Soda, Alcohol Free Refreshing Mint, Alcohol-Free Anticavity, Allday 5000, Amerfresh Fluoride, Amerfresh Fluoride Gel, Amerfresh Toothpowder, Anticavity, Anticavity Fluoride, Anticavity Fluoride Rinse, Anticavity Mouth Rinse Low-Foaming Spearmint, Anticavity Rinse, Aquafresh Cavity Protection, Aquafresh Extra Fresh Plus Whitening, Aquafresh Extreme Clean Pure Breath Action, Aquafresh Extreme Clean Whitening Action, Arm And Hammer, Aru Cavity Protection, Auraglow Whitening, Autobrush Bubblegum, Autobrush Kids Bubblegum, Autobrush Kids Strawberry, Autobrush Kids Watermelon, Autobrush Mint, Autobrush Strawberry, Autobrush Watermelon, Avant, Avon Whitening Essentials 10x Charcoal Black Clean Mint, Avon Whitening Essentials Blanc Charcoal Fresh Mint, Avon Whitening Essentials Original Cool Mint, Barbie Bubble Gum Anticavity Fluoride, Beyond Activated Coconut Charcoal And Sea Salt, Bio Spectra Attitude, Biotene Fresh Mint Original, Biotene Gentle Mint, Blue Raspberry Flavor Sodium Fluoride Anticavity Toothpast, Botalab Herbal Complete Tooth, Botao Kids Strawberry Flavored With Fluoride, Brush Buddies - Hot Wheels Anticavity Fluoride, Brush Buddies Advanced Whitening Anti-Cavity Fluoride Peppermint, Brush Buddies Barbie Anticavity Fluoride - Bubble Gum Flavor, Brush Buddies Barbie Anticavity Fluoride Bubblegum, Brush Buddies Brbie Anticavity Fluoride Bubblegum, Brush Buddies Cars Anticavity Fluoride - Ka-Chow Cherry, Brush Buddies Chocolate Ice Cream Flavored Anticavity Fluoride, Brush Buddies Cookies N Cream Ice Cream Flavored Anticavity Fluoride, Brush Buddies Crayola Anticavity Fluoride - Bubble Gum Flavor, Brush Buddies Crayola Anticavity Fluoride - Strawberry Flavor
RxNorm (National Library of Medicine)
Ingredient concept RxCUI 9873
Drugs@FDA applications
Linked only where the FDA listing’s application number matches Drugs@FDA exactly. A listing in the NDC Directory does not by itself mean FDA approval.
| Application | Sponsor | Original approval | Listings |
|---|---|---|---|
| ANDA 203605 | MCPRF | 2013-06-28 | 1 |
| ANDA 204328 | THE FEINSTEIN INST | 2014-11-19 | 2 |
| ANDA 204351 | BIOMEDCL RES FDN | 2015-01-09 | 1 |
| ANDA 204542 | PRECISION NUCLEAR | 2015-02-27 | 1 |
| ANDA 204497 | UNIV UTAH CYCLOTRON | 2015-04-20 | 1 |
| ANDA 203780 | CARDINAL HEALTH 414 | 2015-07-30 | 1 |
| ANDA 203592 | SOFIE | 2015-08-18 | 1 |
| ANDA 203890 | PETNET | 2015-09-28 | 1 |
| ANDA 203777 | 3D IMAGING DRUG | 2015-10-19 | 1 |
| ANDA 203936 | KREITCHMAN PET CTR | 2016-05-19 | 1 |
Official labeling on DailyMed
- COLGATE OPTIC WHITE STAIN FIGHTER FRESH MINT (SODIUM FLUORIDE) GEL, DENTIFRICE [COLGATE-PALMOLIVE COMPANY] · version 1 · 2026-09-21
- OPAL BY OPALESCENCE ORIGINAL (SODIUM FLUORIDE) GEL, DENTIFRICE [ULTRADENT PRODUCTS, INC.] · version 6 · 2026-09-11
- OPALESCENCE WHITENING COOL MINT (SODIUM FLUORIDE) GEL, DENTIFRICE [ULTRADENT PRODUCTS, INC.] · version 4 · 2026-09-11
- OPALESCENCE WHITENING (SODIUM FLUORIDE) GEL, DENTIFRICE [ULTRADENT PRODUCTS, INC] · version 10 · 2026-09-11
- COLGATE MAXFRESH CHARCOAL (SODIUM FLUORIDE) GEL, DENTIFRICE [COLGATE-PALMOLIVE COMPANY] · version 3 · 2026-09-10
- COLGATE MAXFRESH KNOCKOUT (SODIUM FLUORIDE) GEL, DENTIFRICE [COLGATE-PALMOLIVE COMPANY] · version 3 · 2026-09-10
- FRESHMINT PREMIUM ANTICAVITY (SODIUM FLUORIDE) PASTE, DENTIFRICE [NEW WORLD IMPORTS, INC] · version 9 · 2026-09-10
- FRESHMINT PREMIUM ANTICAVITY GEL (SODIUM FLUORIDE) PASTE, DENTIFRICE [NEW WORLD IMPORTS, INC] · version 7 · 2026-09-10
- FRESHMINT PREMIUM ANTICAVITY (SODIUM FLUORIDE) PASTE, DENTIFRICE [NEW WORLD IMPORTS, INC] · version 8 · 2026-09-10
- DENTALCLEAN ADVANCED PRO (SODIUM FLUORIDE 0.24%) PASTE, DENTIFRICE [RABBIT INDÚSTRIA E COMÉRCIO DE PRODUTOS DE HIGIENE PESSOAL LTDA] · version 3 · 2026-09-07
- DENTALCLEAN REGENERATOR SENSITIVE DENTAL GEL WITH FLUORIDE (SODIUM FLUORIDE 0.24%) PASTE, DENTIFRICE [RABBIT INDÚSTRIA E COMÉRCIO DE PRODUTOS DE HIGIENE PESSOAL LTDA] · version 2 · 2026-09-03
- UNPASTE (ZERO WASTE FLUORIDE MINT TOOTH TABS) TABLET, CHEWABLE [AVESPAN LLC] · version 2 · 2026-09-02
Showing the 12 most recent of 883 labels.
Sources: FDA NDC Directory (2026-09-29), RxNorm, Drugs@FDA, DailyMed. Each source’s facts are shown separately as published.