Over-the-counter drug · OTC MONOGRAPH DRUG
Antiseptic Mouth Rinse NDC 11344-318
eucalyptol, menthol, methyl salicylate, thymol · Eucalyptol .92 mg/mL + 3 more ingredients · Mouthwash · Oral · Nice-Pak Products, LLC
NDC codes
FDA NDC Directory| Package NDC | 11-digit (billing) | Package | Copy |
|---|---|---|---|
| 11344-318-69 | 1134403186911344031869 | 250 mL in 1 BOTTLE, PLASTIC (11344-318-69)Marketed from Jan 4, 2001 | |
| 11344-318-77 | 1134403187711344031877 | 500 mL in 1 BOTTLE, PLASTIC (11344-318-77)Marketed from Jan 4, 2001 | |
| 11344-318-86 | 1134403188611344031886 | 1000 mL in 1 BOTTLE, PLASTIC (11344-318-86)Marketed from Jan 4, 2001 |
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)
- Antiseptic Mouth Rinse
- Generic name (nonproprietary)
- eucalyptol, menthol, methyl salicylate, thymol
- Active ingredients
- Eucalyptol — .92 mg/mLMenthol — .42 mg/mLMethyl salicylate — .6 mg/mLThymol — .64 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 11344-318_58b2b7d6-f4fb-cb6c-e063-6394a90a2074SPL ID 58b2b7d6-f4fb-cb6c-e063-6394a90a2074SPL set ID 5b9c19a1-e3c0-4bed-92dd-8bff48477e2eRxCUI 1043619UNII RV6J6604TK, L7T10EIP3A, LAV5U5022Y, 3J50XA376E
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
N411344031869followed by a unit qualifier and the quantityPackage 11344-0318-69. 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 11344-318
- What is NDC 11344-318?
- 11344-318 is the product NDC for Antiseptic Mouth Rinse, Eucalyptol .92 mg/mL + 3 more ingredients mouthwash, listed with the FDA by Nice-Pak Products, LLC. It has 3 package NDCs, shown above in 10- and 11-digit form.
- What drug is associated with this NDC?
- Antiseptic Mouth Rinse (Eucalyptol, Menthol, Methyl Salicylate, Thymol).
- What is the active ingredient?
- Eucalyptol, Menthol, Methyl salicylate, Thymol.
- 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 Antiseptic Mouth Rinse?
- 23 other product NDCs are listed under this name. See all Antiseptic Mouth Rinse NDCs.
- Is there a related HCPCS / J-code?
- Not in Med-Code's curated HCPCS directory. See Billing references above.
Related NDCs: other Antiseptic Mouth Rinse products
Other finished products listed under the same name: strengths, forms and labelers.
| Product | Strength | Form · route | Labeler | Product NDC | Package NDCs (11-digit) |
|---|---|---|---|---|---|
| Antiseptic Mouth Rinseeucalyptol, menthol, methyl salicylate, thymol | Eucalyptol .92 mg/mL + 3 more ingredients | MouthwashOral | Chain Drug Marketing Association | 83324-180 | 83324-0180-33 |
| Antiseptic Mouth Rinseeucalyptol, menthol, methyol salicylate, thymol | Eucalyptol .92 mg/mL + 3 more ingredients | MouthwashOral | Marc Glassman, Inc | 68998-072 | 68998-0072-12 |
| Antiseptic Mouth Rinseeucalyptol, menthol, methyl salicylate, thymol | Eucalyptol .92 mg/mL + 3 more ingredients | MouthwashOral | Marc Glassman, Inc | 68998-318 | 68998-0318-12 |
| Antiseptic Mouth Rinseeucalyptol, menthol, methyl salicylate, thymol | Eucalyptol .92 mg/mL + 3 more ingredients | MouthwashOral | Lidl US, LLC | 71141-157 | 71141-0157-12 |
| Antiseptic Mouth Rinseeucalyptol, menthol, methyl salicylate, thymol | Eucalyptol .92 mg/mL + 3 more ingredients | MouthwashOral | Cariba International | 67860-318 | 67860-0318-6967860-0318-86 |
| Antiseptic Mouth Rinseeucalyptol, menthol, methyl salicylate, thymol | Eucalyptol .92 mg/mL + 3 more ingredients | MouthwashOral | WinCo Foods, LLC | 67091-106 | 67091-0106-33 |
| Antiseptic Mouth Rinseeucalyptol, menthol, methyl salicylate, thymol | Eucalyptol .92 mg/mL + 3 more ingredients | MouthwashOral | Harris Teeter | 72036-318 | 72036-0318-86 |
| Antiseptic Mouth Rinseeucalyptol, menthol, methyl salicylate, thymol | Eucalyptol .92 mg/mL + 3 more ingredients | MouthwashOral | Nice-Pak Products, LLC | 11344-072 | 11344-0072-6911344-0072-7711344-0072-86 |
| Antiseptic Mouth Rinseeucalyptol | Eucalyptol .92 mg/mL + 3 more ingredients | MouthwashOral | Perrigo Direct, Inc | 50804-072 | 50804-0072-86 |
| Antiseptic Mouth Rinseeucalyptol | Eucalyptol .92 mg/mL + 3 more ingredients | MouthwashOral | HARRIS TEETER | 72036-072 | 72036-0072-86 |
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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