Over-the-counter drug · OTC MONOGRAPH DRUG
Whitening Tooth Polish (Sodium fluoride) NDC 54473-301
Sodium fluoride .26244 g/108g · Paste · Topical · Melaleuca, Inc.
NDC codes
FDA NDC Directory| Package NDC | 11-digit (billing) | Package | Copy |
|---|---|---|---|
| 54473-301-04 | 54473030104 | 108 g in 1 TUBE (54473-301-04)Marketed from Jan 1, 2018 |
How the 11-digit form is made: The product segment has 3 digits, so one leading zero is added to it (5-3-2 → 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)
- Whitening Tooth PolishSuffix: Tooth Polish
- Generic name (nonproprietary)
- sodium fluoride
- Active ingredients
- Sodium fluoride — .26244 g/108g
- Dosage form
- Paste
- Route
- Topical
- Labeler
- Melaleuca, Inc.NDC labeler code 54473
- Product type
- Over-the-counter drug
- Marketing category
- OTC monograph drugApplication M 021
- Marketing start
- Listing expires
- Identifiers
- Product ID 54473-301_47484305-ef48-52ab-e063-6394a90abf93SPL ID 47484305-ef48-52ab-e063-6394a90abf93SPL set ID 6893405a-a2c4-068e-e053-2a91aa0ae5b1RxCUI 891775UNII 8ZYQ1474W7
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. Topical products like this are usually dispensed by a pharmacy and billed by NDC.
- NDC on a medical claim
N454473030104followed by a unit qualifier and the quantityPackage 54473-0301-04. 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 54473-301
- What is NDC 54473-301?
- 54473-301 is the product NDC for Whitening Tooth Polish (sodium fluoride), Sodium fluoride .26244 g/108g paste, listed with the FDA by Melaleuca, Inc.. It has 1 package NDC, shown above in 10- and 11-digit form.
- What drug is associated with this NDC?
- Whitening Tooth Polish (Sodium Fluoride).
- What is the active ingredient?
- Sodium fluoride.
- Who is the labeler?
- Melaleuca, Inc., NDC labeler code 54473. The labeler is the company responsible for the label; it may be the manufacturer, a repackager or a distributor.
- What other NDCs exist for Whitening Tooth Polish?
- 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 |
|---|---|---|---|---|
| Pepsodent Complete Care Originalsodium fluoride | Sodium fluoride 2.4 mg/g | Paste, DentifriceDental | Church & Dwight Co., Inc. | 10237-651 |
| Colgate Total SF Clean Mintstannous fluoride | Stannous fluoride 1.1 mg/g | Paste, DentifriceDental | Colgate-Palmolive Company | 35000-172 |
| Tom Whole Care Peppermint fights cavities whitening fresh breath helps fight tartarsodium monofluorophosphate | Sodium monofluorophosphate 1.4 mg/g | Paste, DentifriceDental | Tom's of Maine, Inc. | 51009-202 |
| DG health Sensitive Maximum Strengthpotassium nitrate, sodium fluoride | Sodium fluoride .24 g/100g; Potassium nitrate 5 g/100g | Paste, DentifriceDental | Dolgencorp, LLC | 55910-360 |
| Freshen Upsodium fluoride | Sodium fluoride 24 mg/100g | Gel, DentifriceDental | MKJ BRANDS LLC | 77782-015 |
| Colgate Phos-Flur Ortho Defense Alcohol Free Anticavity Mint Fluoridesodium fluoride | Sodium fluoride 2 mg/10mL | RinseDental | Colgate Oral Pharmaceuticals, Inc. | 0126-0032 |
| Colgate MaxFresh Citrus Freshsodium fluoride | Sodium fluoride 1.1 mg/g | Gel, DentifriceDental | Colgate-Palmolive Company | 35000-137 |
| Crest Complete Plus Scope Outlast Ultrasodium fluoride | Sodium fluoride 1.5 mg/g | Paste, DentifriceDental | The Procter & Gamble Manufacturing Company | 69423-918 |
| evo ADVANCED WHITENING ANTI-CAVITY FLUORIDE PEPPERMINTsodium fluoride | Sodium fluoride .24 g/100g | Paste, DentifriceDental | Ashtel Studios, Inc. | 70108-204 |
| Anticavity Fluoride Rinsesodium fluoride | Sodium fluoride .2 mg/mL | MouthwashOral | Nice-Pak Products, LLC | 11344-004 |
| Colgate MaxFresh Watermelon Blastsodium fluoride | Sodium fluoride 1.1 mg/g | Gel, DentifriceDental | Colgate-Palmolive Company | 35000-138 |
| Brush Buddies ADVANCED WHITENING ANTI-CAVITY FLUORIDE PEPPERMINTsodium fluoride | Sodium fluoride .24 g/100g | Paste, DentifriceDental | Ashtel Studios, Inc. | 70108-205 |
| Colgate Total SF Advanced Deep Cleanstannous fluoride | Stannous fluoride 1.1 mg/g | Paste, DentifriceDental | Colgate-Palmolive Company | 35000-169 |
| Crest Pro-Health Advanced Gum Restore Deep Cleanstannous fluoride | Stannous fluoride 1.4 mg/g | Paste, DentifriceDental | The Procter & Gamble Manufacturing Company | 69423-925 |
| Brush Buddies Oral Rinse Sparkle Mintsodium fluoride | Sodium fluoride .2 mg/mL | MouthwashDental | ASHTEL STUDIOS, INC | 70108-206 |
| Enamur Fluoride AntiCavity Toothpastfluoride toothpast | Sodium fluoride 1.4 mg/g | Paste, DentifriceOral | Protegera, Inc | 83610-1050 |
| Watermelon Flavor Sodium Fluoride Anticavity Toothpastsodium fluoride | Sodium fluoride .243 g/100g | GelTopical | HISMILE PTY LTD | 83013-337 |
| Meijer Restore and Defend Sensitivestannous fluoride | Stannous fluoride .15 g/100g | Paste, DentifriceDental | Meijer Distribution Inc | 41250-530 |
| Crest 4in1sodium fluoride | Sodium fluoride 1.5 mg/g | Paste, DentifriceDental | The Procter & Gamble Manufacturing Company | 69423-852 |
| AutoBrush kids strawberrysodium fluoride | Sodium fluoride .243 g/100mL | LiquidOral | Lander Enterprises, LLC | 82913-009 |
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