Over-the-counter drug · OTC MONOGRAPH DRUG
SprinJene Natural (Sodium monofluorophosphate) NDC 63404-0201
Sodium monofluorophosphate 1.5 mg/g · Paste, Dentifrice · Dental · Health and Natural Beauty USA Corp
NDC codes
FDA NDC Directory| Package NDC | 11-digit (billing) | Package | Copy |
|---|---|---|---|
| 63404-0201-1 | 6340402010163404020101 | 1 TUBE in 1 CARTON (63404-0201-1) / 99 g in 1 TUBEMarketed from Feb 1, 2017 |
How the 11-digit form is made: The package segment has 1 digit, so one leading zero is added to it (5-4-1 → 5-4-2). Formatting the NDC does not by itself make it billable — the product, package and quantity must match what was dispensed or administered, and payer rules apply. Conversion rules
Product information
- Brand name (proprietary)
- SprinJene NaturalSuffix: Natural
- Generic name (nonproprietary)
- sodium monofluorophosphate
- Active ingredients
- Sodium monofluorophosphate — 1.5 mg/g
- Dosage form
- Paste, Dentifrice
- Route
- Dental
- Labeler
- Health and Natural Beauty USA CorpNDC labeler code 63404
- Product type
- Over-the-counter drug
- Marketing category
- OTC monograph drugApplication M 021
- Marketing start
- Listing expires
- Identifiers
- Product ID 63404-0201_d02d031a-f428-4114-b5f3-8a518ffc08cfSPL ID d02d031a-f428-4114-b5f3-8a518ffc08cfSPL set ID e64cecc3-0845-4bdf-a449-d78248791ccfRxCUI 545626UNII C810JCZ56Q
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 drug-specific HCPCS code in Med-Code's directory for this product. The directory is curated and not complete — check the current CMS HCPCS file before billing.
- NDC on a medical claim
N463404020101followed by a unit qualifier and the quantityPackage 63404-0201-01. Unit qualifiers: F2 (international unit), GR (gram), ME (milligram), ML (milliliter), UN (unit (each)). The qualifier and quantity depend on what was given. About the N4 qualifier
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.
About NDC 63404-0201
- What is NDC 63404-0201?
- 63404-0201 is the product NDC for SprinJene Natural (sodium monofluorophosphate), Sodium monofluorophosphate 1.5 mg/g paste, dentifrice, listed with the FDA by Health and Natural Beauty USA Corp. It has 1 package NDC, shown above in 10- and 11-digit form.
- What drug is associated with this NDC?
- SprinJene Natural (Sodium Monofluorophosphate).
- What is the active ingredient?
- Sodium monofluorophosphate.
- Who is the labeler?
- Health and Natural Beauty USA Corp, NDC labeler code 63404. The labeler is the company responsible for the label; it may be the manufacturer, a repackager or a distributor.
- What other NDCs exist for SprinJene Natural?
- None: this is the only finished product listed under this name.
- Is there a related HCPCS / J-code?
- Not in Med-Code's curated HCPCS directory. See Billing references above.
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 |
|---|---|---|---|---|
| Colgate Strawberry Burstsodium fluoride | Sodium fluoride 1.1 mg/g | Gel, DentifriceDental | Colgate-Palmolive Company | 35000-915 |
| Toms Of Maine Whiten Plus Deep Clean Spearmintsodium fluoride | Sodium fluoride 1.1 mg/g | Paste, DentifriceDental | Tom's of Maine, Inc. | 51009-921 |
| Freshen Upsodium fluoride | Sodium fluoride 24 mg/100g | Gel, DentifriceDental | MKJ BRANDS LLC | 77782-015 |
| Alcohol-Free Anticavitysodium fluoride | Sodium fluoride .1 mg/mL | LiquidOral | Walmart Inc. | 79903-279 |
| Crest 3D White Fresh Mintsodium fluoride | Sodium fluoride 1.5 mg/g | Paste, DentifriceDental | Procter & Gamble Manufactura, S. de R.L. de C.V. | 58933-881 |
| Colgate Sparkling White Cinnamintsodium fluoride | Sodium fluoride 1.1 mg/g | Gel, DentifriceDental | Colgate-Palmolive Company | 35000-900 |
| Toms Of Maine Wicked Cool Mild Mintsodium monofluorophosphate | Sodium monofluorophosphate 1 mg/g | Paste, DentifriceDental | Tom's of Maine, Inc. | 51009-912 |
| DG health Sensitive Maximum Strengthpotassium nitrate, sodium fluoride | Sodium fluoride .24 g/100g; Potassium nitrate 5 g/100g | Paste, DentifriceDental | Dolgencorp, LLC | 55910-360 |
| GuruNanda Anticavitysodium fluoride | Sodium fluoride .2 mg/mL | MouthwashOral | GURUNANDA, LLC | 70708-927 |
| Equate Optimal Care TP Equate Optimal Care TPstannous fluoride | Stannous fluoride .16 g/100g | Paste, DentifriceOral | Walmart Inc. | 79903-280 |
| Crest 3D White Stain Eraser Icy Clean Mintsodium fluoride | Sodium fluoride 1.5 mg/g | Paste, DentifriceDental | Procter & Gamble Manufacturing Mxico, S. de R.L. de C.V. | 58933-932 |
| Colgate Max Fresh Cool Mintsodium fluoride | Sodium fluoride 1.1 mg/g | Gel, DentifriceDental | Colgate-Palmolive Company | 35000-903 |
| Toms of Maine Whiten Plus Deep Clean Peppermintsodium fluoride | Sodium fluoride 1.1 mg/g | Paste, DentifriceDental | Tom's of Maine | 51009-920 |
| Equate Pro-Advanced TP Equate Pro-Advanced TPstannous fluoride | Stannous fluoride .16 g/100g | Paste, DentifriceOral | Walmart Inc. | 79903-281 |
| COLGATE Great Regular Flavorsodium monofluorophosphate | Sodium monofluorophosphate 1 mg/g | Paste, DentifriceDental | Colgate-Palmolive Company | 35000-913 |
| Crest Complete plus Whiteningsodium fluoride | Sodium fluoride 1.5 mg/g | Paste, DentifriceDental | The Procter & Gamble Manufacturing Company | 69423-894 |
| Eversmile OrthoFoam Anticavity0.05% sodium fluoride rinse | Sodium fluoride .05 g/100mL | LiquidDental | Everbrands, Inc. | 72655-600 |
| Crest Premium Plus Deep Clean Active Foam plus Whitening Foaming Mintsodium fluoride | Sodium fluoride 1.5 mg/g | Paste, DentifriceDental | The Procter & Gamble Manufacturing Company | 84126-662 |
| Therabreath Healthy Gumsstannous fluoride | Stannous fluoride .454 g/100g | Paste, DentifriceOral | Church & Dwight Co., Inc. | 10237-271 |
| Crest 3D White Brilliance Charcoalsodium fluoride | Sodium fluoride 1.5 mg/g | Paste, DentifriceDental | Procter & Gamble Manfuacturing Company | 37000-989 |
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