Over-the-counter drug · OTC MONOGRAPH DRUG
Home Care Fluoride (Stannous fluoride) NDC 55346-0404
Stannous fluoride .969 mg/g · Gel · Dental, Oral · Dental Technologies, Inc.
NDC codes
FDA NDC Directory| Package NDC | 11-digit (billing) | Package | Copy |
|---|---|---|---|
| 55346-0404-1 | 5534604040155346040401 | 121.9 g in 1 TUBE (55346-0404-1)Marketed from Dec 31, 1999 |
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)
- Home Care Fluoride
- Generic name (nonproprietary)
- stannous fluoride
- Active ingredients
- Stannous fluoride — .969 mg/g
- Dosage form
- Gel
- Route
- Dental, Oral
- Labeler
- Dental Technologies, Inc.NDC labeler code 55346
- Product type
- Over-the-counter drug
- Marketing category
- OTC monograph drugApplication M 021
- Marketing start
- Listing expires
- Identifiers
- Product ID 55346-0404_42c873be-f572-d9df-e063-6394a90a16b4SPL ID 42c873be-f572-d9df-e063-6394a90a16b4SPL set ID 16ebcb37-5703-4e10-b965-570e18434b52UNII 3FTR44B32Q
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
N455346040401followed by a unit qualifier and the quantityPackage 55346-0404-01. 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)
Uses Helps aid in the prevention of dental cavities.
Excerpt only. Read the full label for complete information.
About NDC 55346-0404
- What is NDC 55346-0404?
- 55346-0404 is the product NDC for Home Care Fluoride (stannous fluoride), Stannous fluoride .969 mg/g gel, listed with the FDA by Dental Technologies, Inc.. It has 1 package NDC, shown above in 10- and 11-digit form.
- What drug is associated with this NDC?
- Home Care Fluoride (Stannous Fluoride).
- What is the active ingredient?
- Stannous fluoride.
- Who is the labeler?
- Dental Technologies, Inc., NDC labeler code 55346. The labeler is the company responsible for the label; it may be the manufacturer, a repackager or a distributor.
- What other NDCs exist for Home Care Fluoride?
- 3 other product NDCs are listed under this name. See all Home Care Fluoride NDCs.
- Is there a related HCPCS / J-code?
- Not in Med-Code's curated HCPCS directory. See Billing references above.
Related NDCs: other Home Care Fluoride products
Other finished products listed under the same name: strengths, forms and labelers.
| Product | Strength | Form · route | Labeler | Product NDC | Package NDCs (11-digit) |
|---|---|---|---|---|---|
| Home Care Fluoridestannous fluoride | Stannous fluoride .969 mg/g | GelDental, Oral | Dental Technologies, Inc. | 55346-0401 | 55346-0401-01 |
| Home Care Fluoridestannous fluoride | Stannous fluoride .969 mg/g | GelDental, Oral | Dental Technologies, Inc. | 55346-0402 | 55346-0402-01 |
| Home Care Fluoridestannous fluoride | Stannous fluoride .969 mg/g | GelDental, Oral | Dental Technologies, Inc. | 55346-0408 | 55346-0408-01 |
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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