Over-the-counter drug · OTC MONOGRAPH DRUG
Colgate Ultra White Charcoal (Sodium fluoride) NDC 35000-418
Sodium fluoride 1.1 mg/g · Paste, Dentifrice · Dental · Colgate-Palmolive Company
NDC codes
FDA NDC Directory| Package NDC | 11-digit (billing) | Package | Copy |
|---|---|---|---|
| 35000-418-98 | 35000041898 | 1 TUBE in 1 CARTON (35000-418-98) / 62 g in 1 TUBEMarketed from Jul 31, 2020 |
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)
- Colgate Ultra White Charcoal
- Generic name (nonproprietary)
- sodium fluoride
- Active ingredients
- Sodium fluoride — 1.1 mg/g
- Dosage form
- Paste, Dentifrice
- Route
- Dental
- Labeler
- Colgate-Palmolive CompanyNDC labeler code 35000
- Product type
- Over-the-counter drug
- Marketing category
- OTC monograph drugApplication M 021
- Marketing start
- Listing expires
- Identifiers
- Product ID 35000-418_bdbe6b77-2bc6-4c43-8ae7-8aa8ac9b8e50SPL ID bdbe6b77-2bc6-4c43-8ae7-8aa8ac9b8e50SPL set ID 95d06fcc-f56d-43f1-924a-3f91fda59bdfRxCUI 416783UNII 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 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
N435000041898followed by a unit qualifier and the quantityPackage 35000-0418-98. 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 helps protect against cavities
Excerpt only. Read the full label for complete information.
About NDC 35000-418
- What is NDC 35000-418?
- 35000-418 is the product NDC for Colgate Ultra White Charcoal (sodium fluoride), Sodium fluoride 1.1 mg/g paste, dentifrice, listed with the FDA by Colgate-Palmolive Company. It has 1 package NDC, shown above in 10- and 11-digit form.
- What drug is associated with this NDC?
- Colgate Ultra White Charcoal (Sodium fluoride).
- What is the active ingredient?
- Sodium fluoride.
- Who is the labeler?
- Colgate-Palmolive Company, NDC labeler code 35000. The labeler is the company responsible for the label; it may be the manufacturer, a repackager or a distributor.
- What other NDCs exist for Colgate Ultra White Charcoal?
- 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 |
|---|---|---|---|---|
| Pro-Syssodium fluoride | Sodium fluoride .11 g/100g | Paste, DentifriceDental, Oral | Benco Dental | 66975-720 |
| Colgate Kids Mild Bubble Fruit Flavorsodium fluoride | Sodium fluoride 1.1 mg/g | Gel, DentifriceDental | Colgate-Palmolive Company | 35000-918 |
| ACT Restoring Anticavity Fluoride Cool Mintsodium fluoride | Sodium fluoride .2 mg/mL | MouthwashTopical | Chattem, Inc. | 41167-0957 |
| Anticavity Fluoride Rinsesodium fluoride | Sodium fluoride .2 mg/mL | MouthwashOral | HARRIS TEETER | 72036-213 |
| Freshmint Anticavity Fluoridesodium fluoride | Sodium fluoride 2.2 mg/g | Gel, DentifriceDental | New World Imports, Inc | 51824-068 |
| Ionite Hstannous fluoride | Stannous fluoride .63 mg/100mL | MouthwashDental | Dharma Research, Inc. | 53045-275 |
| smart way MINT cavity protectionsodium monofluorophosphate | Sodium monofluorophosphate .13 g/100g | Paste, DentifriceDental | The Kroger Co. | 59450-010 |
| Sodium Monofluorophosphatewhite toothpaste | Sodium monofluorophosphate 760 mg/g | PasteDental | Dynarex Corporation | 67777-181 |
| Anticavity mouth rinse Low-foaming Spearmint718 us variant anticavity mouth rinse low-foaming spearmint | Sodium fluoride .02 g/100mL | MouthwashOral | Dyson Technology Limited | 87649-7180 |
| TheraBreath Anticavitysodium fluoride | Sodium fluoride .002 mg/10mL | RinseOral | Church & Dwight Co., Inc. | 10237-265 |
| Colgate Strawberry Burstsodium fluoride | Sodium fluoride 1.1 mg/g | Gel, DentifriceDental | Colgate-Palmolive Company | 35000-915 |
| ACT Anticavity Fluoride Kids Bubblegumsodium fluoride | Sodium fluoride .2 mg/mL | RinseTopical | Chattem, Inc. | 41167-0944 |
| United Airlines Therabody UPP Kitsodium monofluorophosphate | — | Kit | Wessco International | 42509-136 |
| Ionite Hstannous fluoride | Stannous fluoride .63 mg/100mL | MouthwashDental | Dharma Research, Inc. | 53045-276 |
| Morning Fresh Mint Toothpaste, with Fluoride | Sodium monofluorophosphate 1.3 mg/mL | PasteDental | Dynarex Corporation | 67777-190 |
| ULTRA BRITE Baking Soda and Peroxide Whitening Cool Mintsodium monofluorophosphate | Sodium monofluorophosphate 1 mg/g | Paste, DentifriceDental | Colgate-Palmolive Company | 35000-916 |
| ACT Anticavity Fluoride Kids Groovy Grapesodium fluoride | Sodium fluoride .2 mg/mL | RinseTopical | Chattem, Inc. | 41167-0945 |
| Eurofresh Whiteningsodium fluoride | Sodium fluoride 1.08 mg/g | Paste, DentifriceTopical | Farmasi US LLC | 74690-008 |
| Bubble Fresh Toothpaste, with Fluoride | Sodium fluoride 220 mg/g | PasteDental | Dynarex Corporation | 67777-191 |
| Pro-Syssodium fluoride and potassium nitrate | Sodium fluoride .11 g/100g | Paste, DentifriceDental, Oral | Benco Dental | 66975-700 |
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