Prescription drug
Where is Fluoride Ion made?
48 companies sell it under their own name and 1 repackager rebottle it. Their labels name 12 factories in the United States and Canada.
United States 11Canada 1
Companies and their factories
| Company on the label | Factory | Where | Last FDA inspection |
|---|---|---|---|
| DMG America, LLC0.9 mg per 1 g, 1.23 g per 1 g, 1.23 mg per 1 g, 12.3 mg per 1 mL · NDC 25047-765, 25047-762, 25047-763 +7 | Keystone IndustriesMakes it | Gibbstown, NJ, United States | Problems found, fixed voluntarilyNov 2025 |
| Medical Products Laboratories, Inc.Makes it, packages it and labels it | Philadelphia, PA, United States | Problems found, fixed voluntarilyJul 2023 | |
| Henry Schein, Inc.0.0272 g per 1 g, 1.1 g per 100 g, 5 mg per 1 g, 11 mg per 1 g · NDC 0404-1731, 0404-1711, 0404-1701 +6 | Den-Mat Holdings, LLC dba Clinician's ChoiceMakes it | Lompoc, CA, United States | Problems found, fixed voluntarilyDec 2023 |
| Medical Products Laboratories, Inc.Makes it | Philadelphia, PA, United States | Problems found, fixed voluntarilyJul 2023 | |
| Cypress Pharmaceutical, Inc.5 mg per 1 g, 11 mg per 1 g · NDC 60258-151, 60258-150 | Sheffield Pharmaceuticals LLCMakes it | New London, CT, United States | Problems found, fixed voluntarilyJun 2025 |
| Dental Alliance Holdings LLC5000 ug per 1 g · NDC 61578-215, 61578-216 | Oral Biotech LLCMakes it | Albany, OR, United States | Problems found, fixed voluntarilyOct 2024 |
| Dharma Research, Inc.1.5498 g per 126 g, 2 g per 1 L, 4.41 g per 100 g, 4.41 g per 490 g, 6.027 g per 490 g, 10.241 g per 100 g · NDC 53045-251, 53045-250, 53045-252 +32 | Dharma Research, Inc.Makes it | Miami, FL, United States | Problems found, fixed voluntarilySep 2022 |
| Elevate Oral Care1.1 g per 100 g · NDC 57511-0504, 57511-0001, 57511-0002 +2 | Elevate Oral CareMakes it | West Palm Beach, FL, United States | No problems foundSep 2025 |
| Fluoritab Corporation0.5 mg, 1 mg, 2.5 mg per 1 mL · NDC 0288-1106, 0288-2203, 0288-5523 | Medical Products Laboratories, Inc.Makes it | Philadelphia, PA, United States | Problems found, fixed voluntarilyJul 2023 |
| Massco Dental A Division of Dunagin Pharmaceuticals0.12 g per 120 g, 0.19 g per 100 g, 1.1 g per 112 g, 1.428 g per 120 g · NDC 63783-011, 63783-005, 63783-006 +9 | Massco DentalMakes it | Rogers, AR, United States | Serious problems, FDA actionSep 2022 |
| Mycone Dental Supply Co., Inc DBA Keystone Industries and Deepak Products Inc.0.34 g per 283.5 g, 4.086 g per 454 g, 5.6 g per 454 g, 1702.5 mg per 113.5 mL · NDC 68400-206, 68400-202, 68400-328 +16 | Keystone IndustriesMakes it and labels it | Gibbstown, NJ, United States | Problems found, fixed voluntarilyNov 2025 |
| Pascal Company, Inc.3.8 mg per 1 g, 7 mg per 1 g, 9.05 mg per 1 g, 11.28 mg per 1 g, 12.3 mg per 1 g, 27.73 mg per 1 g · NDC 10866-0110, 10866-0185, 10866-0385 +8 | Pascal Company, Inc.Makes it | Bellevue, WA, United States | Problems found, fixed voluntarilyAug 2025 |
| Rising Pharma Holdings, Inc.1.1 g per 100 g · NDC 16571-815, 16571-814 | Lyne Laboratories, Inc.Makes it | Brockton, MA, United States | Problems found, fixed voluntarilyMar 2026 |
| Ross Healthcare, Inc..02 mg per 1 mL, .0272 mg per 1 g, 0.0272 g per 1 g, 2 mL per 100 mL, 2.5 g per 125 g, 16 1 per 1 mg · NDC 62007-054, 62007-270, 62007-058 +31 | Ross Healthcare, Inc.Makes it | Delta, Canada | Serious problems, FDA actionJun 2017 |
| Sheffield Pharmaceuticals LLC0.9 mg per 1 mL, 6 mg per 1 mL, 6.1 mg per 1 mL · NDC 11527-735, 11527-750, 11527-730 +1 | Sheffield Pharmaceuticals LLCMakes it and tests it | New London, CT, United States | Problems found, fixed voluntarilyJun 2025 |
| Suhan Aerosol2.2 mg per 1 g · NDC 73398-114 | Suhan AerosolMakes it | Location not on file | Not inspected on record |
| Winder Laboratories, LLC0.25 mg, 0.5 mg, 1 mg · NDC 75826-163, 75826-164, 75826-165 | Winder Laboratories, LLCMakes it | Winder, GA, United States | Serious problems, FDA actionAug 2025 |
| Young Dental Manufacturing Co 1, LLC.0.5 mg per 1 g, 1 g per 1 g, 2 mg per 1 mL, 2.72 g per 100 g, 4.4 mg per 1 g / 7.9 mg per 1 g, 7.9 g per 1 g / 4.4 mg per 1 g · NDC 0273-0241, 0273-0348, 0273-8009 +35 | Medical Products Laboratories, Inc.Makes it | Philadelphia, PA, United States | Problems found, fixed voluntarilyJul 2023 |
| AMD Medicom0.02 g per 1 mL · NDC 64778-0446 | The label doesn't name the factory. Plants this company names for other drugs | ||
| AR Medicom Inc.0176 g per 1 g / 0.010 g per 1 g · NDC 64778-1379, 64778-1378, 64778-1373 +2 | The label doesn't name the factory. Plants this company names for other drugs | ||
| AvKARE, Inc.5 mg per 1 mL · NDC 42291-741 | The label doesn't name the factory. Plants this company names for other drugs | ||
| AvPAK5 mg per 1 g · NDC 50268-733 | The label doesn't name the factory. Plants this company names for other drugs | ||
| Benco Dental0.11 g per 100 g, 5.6 g per 454 g · NDC 66975-782, 66975-050, 66975-051 +3 | The label doesn't name the factory. Plants this company names for other drugs | ||
| Burel Pharmaceuticals, LLC5 mg per 1 g · NDC 35573-435 | The label doesn't name the factory. Plants this company names for other drugs | ||
| Burkhart Dental Supply Co., Inc0.3408 g per 284 g, 0.597 g per 120 g, 4.086 g per 454 g, 5.6 g per 454 g · NDC 43498-201, 43498-200, 43498-301 +12 | The label doesn't name the factory. Plants this company names for other drugs | ||
| Colgate Oral Pharmaceuticals, Inc.0.9 mg per 1 mL, 5 mg per 1 g, 6 mg per 1 mL, 6.1 mg per 1 mL, 11 mg per 1 g · NDC 0126-0033, 0126-0287, 0126-0286 +7 | The label doesn't name the factory. Plants this company names for other drugs | ||
| Crosstex International Inc.4.086 g per 454 g, 5.6 g per 454 g · NDC 24794-108, 24794-101, 24794-102 +7 | The label doesn't name the factory. Plants this company names for other drugs | ||
| Darby Dental Supply, LLC2.72 g per 100 g, 5.6 g per 454 g · NDC 66467-8003, 66467-8004, 66467-8005 +7 | The label doesn't name the factory. Plants this company names for other drugs | ||
| Deepak Products, inc.2.5 g per 125 g · NDC 68400-138 | The label doesn't name the factory. Plants this company names for other drugs | ||
| Den-Mat Holdings, Llc0.9 mg per 1 mL, 5 mg per 1 g, 9 mg per 1 mL · NDC 59883-912, 59883-920, 59883-922 +3 | The label doesn't name the factory. Plants this company names for other drugs | ||
| Dental Technologies, Inc.4.4 mg per 1 g / 7.9 mg per 1 g · NDC 55346-0943, 55346-0942 | The label doesn't name the factory. Plants this company names for other drugs | ||
| Everbrands, Inc. dba Everpure, Inc.27 mg per 1 mL · NDC 72655-400 | The label doesn't name the factory. Plants this company names for other drugs | ||
| IQ Dental Supply, LLC5.6 g per 454 g · NDC 42756-1116, 42756-1115, 42756-1112 +4 | The label doesn't name the factory. Plants this company names for other drugs | ||
| M&S Dental Supply Co., LLC5.6 g per 454 g · NDC 69745-019, 69745-016, 69745-013 +7 | The label doesn't name the factory. Plants this company names for other drugs | ||
| Medical Products Laboratories, Inc.11 mg per 1 g, 27.2 mg per 1 g · NDC 10733-130, 10733-395, 10733-372 +1 | The label doesn't name the factory. Plants this company names for other drugs | ||
| Method Pharmaceuticals, LLC.0.25 mg, 0.5 mg, 0.5 mg per 1 mL, 1 mg · NDC 58657-160, 58657-161, 58657-322 +1 | The label doesn't name the factory. Plants this company names for other drugs | ||
| Oral-B Laboratories10 mg per 1 g / 2.3 mg per 1 g · NDC 0041-0342 | The label doesn't name the factory. Plants this company names for other drugs | ||
| Patterson Dental Supply, Inc.5 mg per 1 g, 12.3 mg per 1 g, 123 mg per 1 g · NDC 50227-3221, 50227-3231, 50227-3251 +11 | The label doesn't name the factory. Plants this company names for other drugs | ||
| Pearson Dental Supply Co.11 mg per 1 g · NDC 29494-1105, 29494-1104 | The label doesn't name the factory. Plants this company names for other drugs | ||
| Phocal Therapy Inc0.055 mg · NDC 55918-002 | The label doesn't name the factory. Plants this company names for other drugs | ||
| PureLife Dental1.5375 g per 125 g, 5.6 g per 454 g · NDC 68987-024, 68987-021, 68987-014 +4 | The label doesn't name the factory. Plants this company names for other drugs | ||
| Ross Healthcare Inc.0.02 g per 1 g, 0.0272 g per 1 g, 2 mg per 1 g, 2 mg per 1 mL, 11.1 mg per 1 mL, 16.4 mg per 1 mL · NDC 62007-103, 62007-102, 62007-101 +45 | The label doesn't name the factory. Plants this company names for other drugs | ||
| Sancilio & Company Inc0.25 mg, 0.5 mg, 1.0 mg, 20 mg per 1 mL · NDC 44946-1015, 44946-1016, 44946-1017 +1 | The label doesn't name the factory. Plants this company names for other drugs | ||
| Scott's Dental Supply LLC0.0123 g per 1 mL, 0.02 g per 1 mL · NDC 69638-067, 69638-068, 69638-066 +1 | The label doesn't name the factory. Plants this company names for other drugs | ||
| Solventum US LLC5 mg per 1 g · NDC 48878-3120, 48878-3130, 48878-3140 | The label doesn't name the factory. Plants this company names for other drugs | ||
| SuperMouth, LLC.1.1 g per 100 g · NDC 83729-102, 83729-101, 83729-100 +1 | The label doesn't name the factory. Plants this company names for other drugs | ||
| Tiger Supply Inc5.6 g per 454 g · NDC 69484-051, 69484-052, 69484-055 +5 | The label doesn't name the factory. Plants this company names for other drugs | ||
| Tri State Dental5.6 g per 454 g · NDC 69509-050, 69509-059, 69509-051 +7 | The label doesn't name the factory. Plants this company names for other drugs | ||
| U.S.I.A. Inc0.0094 mg / 0.0466 mg · NDC 55918-001 | The label doesn't name the factory. Plants this company names for other drugs | ||
| Westminster Pharmaceuticals, LLC5 mg per 1 g, 6 mg per 1 mL · NDC 69367-309, 69367-310, 69367-311 +1 | The label doesn't name the factory. Plants this company names for other drugs | ||
Repackaged by
These companies buy Fluoride Ion in bulk and rebottle it, often for mail-order, clinic or hospital pharmacies. If your bottle shows one of these names, open its NDC to see who made the pills inside.
- Bryant Ranch Prepack:
63629-1130,72162-1652,63629-1132,72162-1653+4
Recalls
- Oct 17, 2024 · Class II · Keystone Industries
Subpotent Drug - Aug 11, 2023 · Class II · Avkare Llc
Cases of Sodium Fluoride 1.1% Prescription Dental Toothpaste may contain cartons labeled as Capsaicin Cream 0.025% but contain correctly labeled tubes of Sodium Fluoride 1.1% Prescription Dental Toothpaste - Feb 13, 2017 · Class III · Colgate Palmolive Co
Label Mix up; rear panel is incorrectly labeled with the PreviDent 5000 Enamel Protect rear panel. - Dec 19, 2014 · Class III · 3M Company/3m Espe Dental Products
Labeling: Incorrect or Missing Lot and/or Exp. Date - The subject lot is missing the lot number and expiration date stamp on the primary box..
Class I recalls are the most serious; Class III the least. A recall covers specific lots, listed on each recall.