Over-the-counter drug · OTC MONOGRAPH DRUG
CloSYS Fluoride Rinse (sodium fluoride) NDC 58578-1234
Sodium fluoride .05 g/100mL · Rinse · Oral · Rowpar Pharmaceuticals, Inc.
NDC codes
FDA NDC DirectoryProduct NDC (as listed)58578-1234Labeler and product segments. Claims need a package NDC.
Product NDC at billing width58578-1234Add the package segment from the table below.
Product information
- Brand name (proprietary)
- CloSYS Fluoride RinseSuffix: Fluoride Rinse
- Generic name (nonproprietary)
- sodium fluoride
- Active ingredients
- Sodium fluoride — .05 g/100mL
- Dosage form
- Rinse
- Route
- Oral
- Labeler
- Rowpar Pharmaceuticals, Inc.
- Product type
- Over-the-counter drug
- Marketing category
- OTC monograph drugApplication M 021
- Marketing start
- Listing expires
- Identifiers
- Product ID 58578-1234_42ecdcc7-82b3-49f6-bff8-0b38c247433eSPL ID 42ecdcc7-82b3-49f6-bff8-0b38c247433eSPL set ID 1a994f24-99ee-4b27-aab0-e816931a22c8RxCUI 240698UNII 8ZYQ1474W7UPC 0647692627018, 0647692227010
Billing references
What Med-Code can say about coding this product, and where each statement comes from. Nothing here is inferred from the name alone.
- HCPCS codeNo match
No HCPCS code in Med-Code's directory. Oral products like this are usually dispensed by a pharmacy and billed by NDC.
Product label
Current FDA label (SPL), effective .
Indications (excerpt from the label)
USE: Aids in the prevention of dental cavities
Excerpt only. Read the full label for complete information.
Other NDCs under M 021
Products listed under the same FDA application: other strengths and forms, and repackagers who relabel the same product.
| Product | Strength | Form · route | Labeler | Product NDC |
|---|---|---|---|---|
| Therabreath Whiteningsodium fluoride | Sodium fluoride .243 g/100g | Paste, DentifriceOral | Church & Dwight Co., Inc. | 10237-272 |
| evo ADVANCED WHITENING ANTI-CAVITY FLUORIDE PEPPERMINTsodium fluoride | Sodium fluoride .24 g/100g | Paste, DentifriceDental | Ashtel Studios, Inc. | 70108-204 |
| Dentissesodium fluoride | Sodium fluoride 1.1 mg/g | Paste, DentifriceDental, Oral | Dentisse, Inc. | 70683-0703 |
| ZONSEN Toothpaste,whitetoothpaste | Sodium fluoride .22 g/100g | Paste, DentifriceDental | Wuhan Zonsen Medical Products Co., Ltd. | 72932-016 |
| Brush Buddies Crayola Anticavity Fluoride Strawberrysodium fluoride | Sodium fluoride .02 g/100mL | LiquidOral | Kingkey MBC Life Technology Group co., LTD | 73928-042 |
| Crest 3D White Advanced Deep Clean with Stain-Blasting Foamsodium fluoride | Sodium fluoride 1.5 mg/g | Paste, DentifriceDental | The Procter & Gamble Manufacturing Company | 84126-631 |
| Dr Tichenors With Extra Whitening and Tartar Controlsodium fluoride | Sodium fluoride 2.43 mg/g | Paste, DentifriceOral | Dr. G. H. Tichenor's Antiseptic Company | 11291-243 |
| Hello Whipped Mellow Mint Dream Flavorsodium monofluorophosphate | Sodium monofluorophosphate 1.1 mg/g | Paste, DentifriceDental | Colgate-Palmolive Company | 35000-513 |
| Glowing Whitesodium fluoride | Sodium fluoride .1 mg/mL | MouthwashOral | Demoulas Super Markets, Inc | 53942-435 |
| Crest Premium Plus Breath Bacteria Blaststannous fluoride | Stannous fluoride 1.4 mg/g | Paste, DentifriceDental | The Procter & Gamble Manufacturing Company | 69423-912 |
| Brush Buddies Brbie Anticavity Fluoride Bubblegumsodium fluoride | Sodium fluoride .05 g/100mL | LiquidOral | Kingkey MBC Life Technology Group co., LTD. | 73928-039 |
| Crest 3D White Advanced Glamorous White with Stain-Blasting Foamsodium fluoride | Sodium fluoride 1.5 mg/g | Paste, DentifriceDental | The Procter & Gamble Manufacturing Company | 84126-632 |
| Orajel Kids Supermananticavity toothpaste | Sodium fluoride 1.5 mg/g | Gel, DentifriceDental | Church & Dwight Co., Inc. | 10237-732 |
| Colgate Total Whitening Charcoalstannous fluoride | Stannous fluoride 1.1 mg/g | Paste, DentifriceDental | Colgate-Palmolive Company | 35000-571 |
| Crest 3D White Glamorous Whitesodium fluoride | Sodium fluoride 1.6 mg/g | Paste, DentifriceDental | The Procter & Gamble Manufacturing Company | 69423-914 |
| ZONSEN Gel Fluoridegel fluoride toothpaste | Sodium fluoride .22 g/100g | Gel, DentifriceDental | Wuhan Zonsen Medical Products Co., Ltd. | 72932-015 |
| Crest 3D White Advanced Luminous Mint Daily Whitening Upkeepsodium fluoride | Sodium fluoride 1.5 mg/g | Paste, DentifriceDental | The Procter & Gamble Manufacturing Company | 84126-633 |
| Crest Complete Plus Scope Outlast Ultrasodium fluoride | Sodium fluoride 1.5 mg/g | Paste, DentifriceDental | The Procter & Gamble Manufacturing Company | 69423-918 |
| Brush Buddies Crayola Anticavity Fluoride Watermelonsodium fluoride | Sodium fluoride .02 g/100mL | LiquidOral | Kingkey MBC Life Technology Group co., LTD | 73928-041 |
| AutoBrush Mintsodium fluoride | Sodium fluoride .243 g/100mL | LiquidOral | Lander Enterprises, LLC | 82913-011 |
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