Over-the-counter drug · OTC MONOGRAPH DRUG
Cloveden 100 times higher concentrated (Cetylpyridinium chloride) NDC 84516-040
Cetylpyridinium chloride 2.29 g/100mL · Mouthwash · Oral · Acuseplanet Inc
NDC codes
FDA NDC Directory| Package NDC | 11-digit (billing) | Package | Copy |
|---|---|---|---|
| 84516-040-02 | 8451600400284516004002 | 1 BOTTLE in 1 CARTON (84516-040-02) / 50 mL in 1 BOTTLE (84516-040-01)Marketed from Aug 1, 2025 |
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)
- Cloveden 100 times higher concentrated
- Generic name (nonproprietary)
- cetylpyridinium chloride
- Active ingredients
- Cetylpyridinium chloride — 2.29 g/100mL
- Dosage form
- Mouthwash
- Route
- Oral
- Labeler
- Acuseplanet IncNDC labeler code 84516
- Product type
- Over-the-counter drug
- Marketing category
- OTC monograph drugApplication M 021
- Marketing start
- Listing expires
- Identifiers
- Product ID 84516-040_3c0e1862-2940-4d23-e063-6294a90a33e1SPL ID 3c0e1862-2940-4d23-e063-6294a90a33e1SPL set ID 3c0e1862-293f-4d23-e063-6294a90a33e1RxCUI 2590919UNII 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
N484516004002followed by a unit qualifier and the quantityPackage 84516-0040-02. 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(s) ■ Refreshing the mouth ■ Plaque removal ■ Oral cleanliness ■ Bad breath removal
Excerpt only. Read the full label for complete information.
About NDC 84516-040
- What is NDC 84516-040?
- 84516-040 is the product NDC for Cloveden 100 times higher concentrated, Cetylpyridinium chloride 2.29 g/100mL mouthwash, listed with the FDA by Acuseplanet Inc. It has 1 package NDC, shown above in 10- and 11-digit form.
- What drug is associated with this NDC?
- Cloveden 100 times higher concentrated (Cetylpyridinium Chloride).
- What is the active ingredient?
- Cetylpyridinium chloride.
- Who is the labeler?
- Acuseplanet Inc, NDC labeler code 84516. The labeler is the company responsible for the label; it may be the manufacturer, a repackager or a distributor.
- What other NDCs exist for Cloveden 100 times higher concentrated?
- 1 other product NDC are listed under this name. See all Cloveden 100 times higher concentrated NDCs.
- Is there a related HCPCS / J-code?
- Not in Med-Code's curated HCPCS directory. See Billing references above.
Related NDCs: other Cloveden 100 times higher concentrated products
Other finished products listed under the same name: strengths, forms and labelers.
| Product | Strength | Form · route | Labeler | Product NDC | Package NDCs (11-digit) |
|---|---|---|---|---|---|
| Cloveden 100 times higher concentratedcetylpyridinium chloride | Cetylpyridinium chloride 2.29 g/100mL | MouthwashOral | DONG IL PHARMS CO.,LTD | 73242-1115 | 73242-1115-02 |
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 |
|---|---|---|---|---|
| 365 Everyday Value Cavity Fighting and Whiteningsodium monoflourophosphate | Sodium monofluorophosphate .13 g/100g | Paste, DentifriceDental | Whole Foods Market, Inc. | 42681-5002 |
| 365 Everyday Value Kids Flouridesodium monofluorophosphate | Sodium monofluorophosphate .13 g/100g | Paste, DentifriceDental | Whole Foods Market, Inc. | 42681-5276 |
| 3ECARE Dual FormulaToothpastefor sensitiveteethpotassium nitrate sodium monofluorophosphate | Potassium nitrate 5 g/100g; Sodium monofluorophosphate 5 g/100g | Paste, DentifriceDental | Hangzhou Namei Zhikang Technology Co., Ltd. | 87514-004 |
| 3ECARE Dual FormulaWhiteningToothpastesodium fluoride | Sodium fluoride .155 g/100g | Paste, DentifriceDental | Hangzhou Namei Zhikang Technology Co., Ltd. | 87514-003 |
| A and H Plus Therabreath Breath Freshnerssodium fluoride | Sodium fluoride .243 g/100g | Paste, DentifriceOral | Church & Dwight Co., Inc. | 10237-676 |
| ACT Anticavity Fluoride Arctic Blastsodium fluoride | Sodium fluoride .2 mg/mL | MouthwashTopical | Chattem, Inc. | 41167-0937 |
| ACT Anticavity Fluoride Cinnamonsodium fluoride | Sodium fluoride .2 mg/mL | RinseTopical | Chattem, Inc. | 41167-0940 |
| ACT Anticavity Fluoride Kids Bubblegumsodium fluoride | Sodium fluoride .2 mg/mL | RinseTopical | Chattem, Inc. | 41167-0944 |
| ACT Anticavity Fluoride Kids Groovy Grapesodium fluoride | Sodium fluoride .2 mg/mL | RinseTopical | Chattem, Inc. | 41167-0945 |
| ACT Anticavity Fluoride Kids Wild Watermelonsodium fluoride 0.24 (0.14 w/v fluoride ion) | Sodium fluoride 1.4 mg/g | PasteTopical | Chattem, Inc. | 41167-0924 |
| ACT Anticavity Fluoride Mintsodium fluoride | Sodium fluoride .2 mg/mL | RinseTopical | Chattem, Inc. | 41167-0942 |
| ACT Kids Anticavity Fluoride Bubble Gum Blowoutsodium fluoride | Sodium fluoride 1.4 mg/g | PasteTopical | Chattem, Inc. | 41167-0922 |
| ACT Kids Anticavity Fluoride Groovy Grapesodium fluoride | Sodium fluoride 1.4 mg/g | Paste, DentifriceTopical | Chattem, Inc. | 41167-0926 |
| ACT Kids Anticavity Fluoride Pineapple Punchsodium fluoride | Sodium fluoride .2 mg/mL | MouthwashTopical | Chattem, Inc. | 41167-0953 |
| ACT Kids Anticavity Fluoride Wild Watermelonsodium fluoride | Sodium fluoride .5 mg/mL | RinseTopical | Chattem, Inc. | 41167-0938 |
| ACT Kids Berry Blastsodium fluoride | Sodium fluoride .5 mg/mL | RinseOral | Chattem, Inc. | 41167-0976 |
| ACT Kids Pure Protect Anticavity- Simply Strawberrysodium fluoride | Sodium fluoride .5 mg/mL | RinseOral | Chattem, Inc. | 41167-0915 |
| ACT Restoring Anticavity Fluoride Cool Mintsodium fluoride | Sodium fluoride .2 mg/mL | MouthwashTopical | Chattem, Inc. | 41167-0957 |
| ACT Restoring Anticavity Fluoride Cool Mintsodium fluoride | Sodium fluoride .09 mg/mL | MouthwashTopical | Chattem, Inc. | 41167-0981 |
| ACT Restoring Anticavity Fluoride Mint Burstsodium fluoride | Sodium fluoride .2 mg/mL | MouthwashOral | Chattem, Inc. | 41167-0978 |
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