Over-the-counter drug · OTC MONOGRAPH DRUG
Hello Peace Out Plaque (Cetypyridinium chlloride) NDC 44038-0683
Cetylpyridinium chloride 15 mg/20mL · Mouthwash · Dental · Accupac LLC
NDC codes
FDA NDC Directory| Package NDC | 11-digit (billing) | Package | Copy |
|---|---|---|---|
| 44038-0683-1 | 4403806830144038068301 | 473 mL in 1 BOTTLE (44038-0683-1)Marketed from Jul 1, 2023 |
How the 11-digit form is made: The package segment has 1 digit, so one leading zero is added to it (5-4-1 → 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)
- Hello Peace Out Plaque
- Generic name (nonproprietary)
- cetypyridinium chlloride
- Active ingredients
- Cetylpyridinium chloride — 15 mg/20mL
- Dosage form
- Mouthwash
- Route
- Dental
- Labeler
- Accupac LLCNDC labeler code 44038
- Product type
- Over-the-counter drug
- Marketing category
- OTC monograph drugApplication 505G(a)(3)
- Marketing start
- Marketing end
- Identifiers
- Product ID 44038-0683_48fd2c23-c2f6-4289-e063-6294a90a0dd0SPL ID 48fd2c23-c2f6-4289-e063-6294a90a0dd0SPL set ID 23070859-3c79-d4b7-e063-6394a90a83c3RxCUI 1599135UNII 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 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
N444038068301followed by a unit qualifier and the quantityPackage 44038-0683-01. 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 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 44038-0683
- What is NDC 44038-0683?
- 44038-0683 is the product NDC for Hello Peace Out Plaque (cetypyridinium chlloride), Cetylpyridinium chloride 15 mg/20mL mouthwash, listed with the FDA by Accupac LLC. It has 1 package NDC, shown above in 10- and 11-digit form.
- What drug is associated with this NDC?
- Hello Peace Out Plaque (Cetypyridinium chlloride).
- What is the active ingredient?
- Cetylpyridinium chloride.
- Who is the labeler?
- Accupac LLC, NDC labeler code 44038. The labeler is the company responsible for the label; it may be the manufacturer, a repackager or a distributor.
- What other NDCs exist for Hello Peace Out Plaque?
- 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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