Over-the-counter drug · OTC MONOGRAPH DRUG
Colgate Max Fresh Cool Mint (Sodium fluoride) NDC 35000-947
Sodium fluoride 1.1 mg/g · Gel, Dentifrice · Dental · Colgate-Palmolive Company
NDC codes
FDA NDC Directory| Package NDC | 11-digit (billing) | Package | Copy |
|---|---|---|---|
| 35000-947-81 | 35000094781 | 130 g in 1 BOTTLE (35000-947-81)Marketed from Apr 6, 2008 |
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 Max Fresh Cool Mint
- Generic name (nonproprietary)
- sodium fluoride
- Active ingredients
- Sodium fluoride — 1.1 mg/g
- Dosage form
- Gel, 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 35000-947_cca0bc5e-d37d-4dc0-8992-b2e14befb853SPL ID cca0bc5e-d37d-4dc0-8992-b2e14befb853SPL set ID f87d6f04-507a-47ae-8a66-204cf59261c0RxCUI 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
N435000094781followed by a unit qualifier and the quantityPackage 35000-0947-81. 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 35000-947
- What is NDC 35000-947?
- 35000-947 is the product NDC for Colgate Max Fresh Cool Mint (sodium fluoride), Sodium fluoride 1.1 mg/g gel, 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 Max Fresh Cool Mint (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 Max Fresh Cool Mint?
- 2 other product NDCs are listed under this name. See all Colgate Max Fresh Cool Mint NDCs.
- Is there a related HCPCS / J-code?
- Not in Med-Code's curated HCPCS directory. See Billing references above.
Related NDCs: other Colgate Max Fresh Cool Mint products
Other finished products listed under the same name: strengths, forms and labelers.
| Product | Strength | Form · route | Labeler | Product NDC | Package NDCs (11-digit) |
|---|---|---|---|---|---|
| Colgate Max Fresh Cool Mintsodium fluoride | Sodium fluoride 1.1 mg/g | Gel, DentifriceDental | Mission Hills S.A de C.V | 65954-014 | 65954-0014-0165954-0014-5865954-0014-95+1 more |
| Colgate Max Fresh Cool Mintsodium fluoride | Sodium fluoride 1.1 mg/g | Gel, DentifriceDental | Colgate-Palmolive Company | 35000-903 | 35000-0903-0135000-0903-5835000-0903-95+1 more |
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 |
|---|---|---|---|---|
| Auraglow Whiteningsodium fluoride | Sodium fluoride 2.3 mg/g | Paste, DentifriceDental | Auraglow LLC | 81740-003 |
| Crayola ANTICAVITY STRAWBERRY FLAVORsodium fluoride | Sodium fluoride .243 g/100g | Paste, DentifriceDental | Ashtel Studios, Inc. | 70108-080 |
| Made by Dentists For Kids Eyeball Juice (Watermelon)sodium fluoride | Sodium fluoride 1.5 mg/g | PasteDental | MADE BY DENTISTS INC | 75065-030 |
| White Glo Advantage Anticavity Professional Whiteningsodium monofluorophosphate | Sodium monofluorophosphate 7.6 mg/g | PasteTopical | WHITE GLO USA INC | 73656-027 |
| AutoBrush Mintsodium fluoride | Sodium fluoride .243 g/100mL | LiquidOral | Lander Enterprises, LLC | 82913-011 |
| Hello Unicorn Splashsodium fluoride | Sodium fluoride .02 g/100mL | MouthwashDental | Accupac LLC | 44038-0687 |
| Crest 3D White Stain Eraser Icy Clean Mintsodium fluoride | Sodium fluoride 1.5 mg/g | Paste, DentifriceOral | The Procter & Gamble Manufacturing Company | 69423-773 |
| White Glo Professional Choice Twin Packsodium fluoride | — | Kit | WHITE GLO USA INC | 73656-024 |
| Therabreath Healthy Gumsstannous fluoride | Stannous fluoride .454 g/100g | Paste, DentifriceOral | Church & Dwight Co., Inc. | 10237-271 |
| Crest 3D White Vibrant Mintsodium fluoride | Sodium fluoride 1.5 mg/g | Paste, DentifriceOral | The Procter & Gamble Manufacturing Company | 69423-774 |
| Complete Protectionstannous fluoride | Stannous fluoride .15 g/100g | Paste, DentifriceDental, Oral | Target | 11673-366 |
| Anticavitysodium fluoride | Sodium fluoride .1 mg/mL | RinseOral | H E B | 37808-119 |
| Listerine Total Care Alcohol Free Anticavity Fluoride Mouthwash Fresh Mintsodium fluoride | Sodium fluoride .1 mg/mL | MouthwashOral | Kenvue Brands LLC | 69968-0924 |
| White Glo Advantage Anticavity Fluoride Purplesodium monofluorophosphate | Sodium monofluorophosphate 7.6 mg/g | PasteTopical | WHITE GLO USA INC | 73656-026 |
| Hismilesodium fluoride | Sodium fluoride .243 g/100g | GelDental | HISMILE PTY LTD | 83013-321 |
| Delta Comfort Plus Amenitysodium monofluorophosphate | — | Kit | Buzz Products Inc. | 69491-043 |
| Hismilebanana flavor sodium fluoride anticavity toothpaste | Sodium fluoride 2.4 mg/g | GelDental | Hismile Pty Ltd | 83013-319 |
| TP OW Stainfighter Clean Mintsodium fluoride | Sodium fluoride 1.1 mg/g | Paste, DentifriceDental | Colgate-Palmolive Company | 35000-999 |
| Sodium Fluoride | Sodium fluoride 2.43 mg/g | Paste, DentifriceDental | Safco Dental Supply LLC | 67239-0226 |
| Delta Travel Kit Comfort plussodium monofluorophosphate | — | Kit | Buzz Products Inc. | 69491-039 |
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