Over-the-counter drug · OTC MONOGRAPH DRUG
Original Antiseptic NDC 36800-318
eucalyptol, menthol, methyl salicylate, thymol · Eucalyptol .92 mg/mL + 3 more ingredients · Mouthwash · Oral · Topco Associates LLC
NDC codes
FDA NDC Directory| Package NDC | 11-digit (billing) | Package | Copy |
|---|---|---|---|
| 36800-318-12 | 3680003181236800031812 | 1500 mL in 1 BOTTLE, PLASTIC (36800-318-12)Marketed from Jul 15, 1990 | |
| 36800-318-69 | 3680003186936800031869 | 250 mL in 1 BOTTLE, PLASTIC (36800-318-69)Marketed from Jul 15, 1990 | |
| 36800-318-86 | 3680003188636800031886 | 1000 mL in 1 BOTTLE, PLASTIC (36800-318-86)Marketed from Jul 15, 1990 |
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)
- Original Antiseptic
- 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
- Topco Associates LLCNDC labeler code 36800
- Product type
- Over-the-counter drug
- Marketing category
- OTC monograph drugApplication 505G(a)(3)
- Marketing start
- Listing expires
- Identifiers
- Product ID 36800-318_4ab8b01d-aab7-692f-e063-6394a90a34d6SPL ID 4ab8b01d-aab7-692f-e063-6394a90a34d6SPL set ID b6c8d5b1-4b19-463c-826a-cccdcec09e2dRxCUI 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
N436800031812followed by a unit qualifier and the quantityPackage 36800-0318-12. 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 36800-318
- What is NDC 36800-318?
- 36800-318 is the product NDC for Original Antiseptic, Eucalyptol .92 mg/mL + 3 more ingredients mouthwash, listed with the FDA by Topco Associates LLC. It has 3 package NDCs, shown above in 10- and 11-digit form.
- What drug is associated with this NDC?
- Original Antiseptic (EUCALYPTOL, Menthol, Methyl salicylate, Thymol).
- What is the active ingredient?
- Eucalyptol, Menthol, Methyl salicylate, Thymol.
- Who is the labeler?
- Topco Associates LLC, NDC labeler code 36800. The labeler is the company responsible for the label; it may be the manufacturer, a repackager or a distributor.
- What other NDCs exist for Original Antiseptic?
- 2 other product NDCs are listed under this name. See all Original Antiseptic NDCs.
- Is there a related HCPCS / J-code?
- Not in Med-Code's curated HCPCS directory. See Billing references above.
Related NDCs: other Original Antiseptic products
Other finished products listed under the same name: strengths, forms and labelers.
| Product | Strength | Form · route | Labeler | Product NDC | Package NDCs (11-digit) |
|---|---|---|---|---|---|
| Original Antisepticeucalyptol, menthol, methyl salicylate, thymol | Eucalyptol .92 mg/mL + 3 more ingredients | MouthwashOral | Amazon.com Services LLC | 72288-318 | 72288-0318-12 |
| Original Antisepticeucalyptol, menthol, methyl salicylate, thymol | Eucalyptol .92 mg/mL + 3 more ingredients | MouthwashOral | Publix Super Markets, Inc. | 56062-318 | 56062-0318-86 |
Other NDCs under 505G(a)(3)
Products listed under the same FDA application: other strengths and forms, and repackagers who relabel the same product.
Showing 20 of 40.