Over-the-counter drug · OTC MONOGRAPH DRUG
Antigingivitis/Antiplaque (Cetylpyridinium chloride) NDC 11344-900
Cetylpyridinium chloride .7 mg/mL · Mouthwash · Oral · Nice-Pak Products, LLC
NDC codes
FDA NDC Directory| Package NDC | 11-digit (billing) | Package | Copy |
|---|---|---|---|
| 11344-900-77 | 1134409007711344090077 | 500 mL in 1 BOTTLE, PLASTIC (11344-900-77)Marketed from May 1, 2024 |
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)
- Antigingivitis/Antiplaque
- Generic name (nonproprietary)
- cetylpyridinium chloride
- Active ingredients
- Cetylpyridinium chloride — .7 mg/mL
- Dosage form
- Mouthwash
- Route
- Oral
- Labeler
- Nice-Pak Products, LLCNDC labeler code 11344
- Product type
- Over-the-counter drug
- Marketing category
- OTC monograph drugApplication 505G(a)(3)
- Marketing start
- Listing expires
- Identifiers
- Product ID 11344-900_59918e31-dd50-5017-e063-6394a90a6b26SPL ID 59918e31-dd50-5017-e063-6394a90a6b26SPL set ID a66d8d21-1ebf-45e6-97bd-dbe17ee67162RxCUI 1100924UNII D9OM4SK49P
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. Oral products like this are usually dispensed by a pharmacy and billed by NDC.
- NDC on a medical claim
N411344090077followed by a unit qualifier and the quantityPackage 11344-0900-77. 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 control plaque that leads to gingivitis
Excerpt only. Read the full label for complete information.
About NDC 11344-900
- What is NDC 11344-900?
- 11344-900 is the product NDC for Antigingivitis/Antiplaque (cetylpyridinium chloride), Cetylpyridinium chloride .7 mg/mL mouthwash, listed with the FDA by Nice-Pak Products, LLC. It has 1 package NDC, shown above in 10- and 11-digit form.
- What drug is associated with this NDC?
- Antigingivitis/Antiplaque (Cetylpyridinium Chloride).
- What is the active ingredient?
- Cetylpyridinium chloride.
- Who is the labeler?
- Nice-Pak Products, LLC, NDC labeler code 11344. The labeler is the company responsible for the label; it may be the manufacturer, a repackager or a distributor.
- What other NDCs exist for Antigingivitis/Antiplaque?
- 6 other product NDCs are listed under this name. See all Antigingivitis/Antiplaque NDCs.
- Is there a related HCPCS / J-code?
- Not in Med-Code's curated HCPCS directory. See Billing references above.
Related NDCs: other Antigingivitis/Antiplaque products
Other finished products listed under the same name: strengths, forms and labelers.
| Product | Strength | Form · route | Labeler | Product NDC | Package NDCs (11-digit) |
|---|---|---|---|---|---|
| Antigingivitis/Antiplaquecetylpyridinium chloride | Cetylpyridinium chloride .5 mg/mL | MouthwashOral | Topco Associates LLC | 76162-953 | 76162-0953-86 |
| Antigingivitis/Antiplaquecetylpyridinium chloride | Cetylpyridinium chloride .7 mg/mL | MouthwashOral | Topco Associates LLC | 76162-090 | 76162-0090-86 |
| Antigingivitis/Antiplaquecetylpyridinium chloride | Cetylpyridinium chloride .5 mg/mL | MouthwashOral | The Kroger Co. | 59450-953 | 59450-0953-86 |
| Antigingivitis/Antiplaquecetylpyridinium chloride | Cetylpyridinium chloride .7 mg/mL | MouthwashOral | Meijer, Inc. | 79481-0900 | 79481-0900-01 |
| Antigingivitis/Antiplaquecetylpyridinium chloride | Cetylpyridinium chloride .5 mg/mL | MouthwashOral | Meijer, Inc. | 79481-0953 | 79481-0953-01 |
| Antigingivitis/Antiplaquecetylpyridinium chloride | Cetylpyridinium chloride .7 mg/mL | MouthwashOral | The Kroger Co. | 59450-997 | 59450-0997-86 |
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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