Over-the-counter drug · OTC MONOGRAPH DRUG
Colgate Total Advanced Gum Health Mouthwash (Cetylpyridinium chloride) NDC 35000-723
Cetylpyridinium chloride .75 mg/mL · Rinse · Dental · Colgate-Palmolive Company
NDC codes
FDA NDC Directory| Package NDC | 11-digit (billing) | Package | Copy |
|---|---|---|---|
| 35000-723-16 | 3500007231635000072316 | 500 mL in 1 BOTTLE (35000-723-16)Marketed from Mar 1, 2015 | |
| 35000-723-33 | 3500007233335000072333 | 1000 mL in 1 BOTTLE (35000-723-33)Marketed from Mar 1, 2015 |
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 Total Advanced Gum Health Mouthwash
- Generic name (nonproprietary)
- cetylpyridinium chloride
- Active ingredients
- Cetylpyridinium chloride — .75 mg/mL
- Dosage form
- Rinse
- Route
- Dental
- Labeler
- Colgate-Palmolive CompanyNDC labeler code 35000
- Product type
- Over-the-counter drug
- Marketing category
- OTC monograph drugApplication 505G(a)(3)
- Marketing start
- Marketing end
- Identifiers
- Product ID 35000-723_ad74fe6e-e781-48af-908c-16d59d06e8f0SPL ID ad74fe6e-e781-48af-908c-16d59d06e8f0SPL set ID 51296af5-4d95-4e9c-97c4-7defc13c9b7eRxCUI 1599135, 1599137UNII D9OM4SK49PUPC 0035000671530
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
N435000072316followed by a unit qualifier and the quantityPackage 35000-0723-16. 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 prevent and reduce plaque and gingivitis helps control plaque bacteria that contribute to the development of gingivitis, an early form of gum disease, and bleeding gums
Excerpt only. Read the full label for complete information.
About NDC 35000-723
- What is NDC 35000-723?
- 35000-723 is the product NDC for Colgate Total Advanced Gum Health Mouthwash, Cetylpyridinium chloride .75 mg/mL rinse, listed with the FDA by Colgate-Palmolive Company. It has 2 package NDCs, shown above in 10- and 11-digit form.
- What drug is associated with this NDC?
- Colgate Total Advanced Gum Health Mouthwash (Cetylpyridinium chloride).
- What is the active ingredient?
- Cetylpyridinium chloride.
- 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 Total Advanced Gum Health Mouthwash?
- 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 505G(a)(3)
Products listed under the same FDA application: other strengths and forms, and repackagers who relabel the same product.
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