Over-the-counter drug · OTC MONOGRAPH DRUG
Anticavity (Sodium fluoride) NDC 36800-803
Sodium fluoride .1 mg/mL · Mouthwash · Oral · Topco Associates LLC
NDC codes
FDA NDC Directory| Package NDC | 11-digit (billing) | Package | Copy |
|---|---|---|---|
| 36800-803-43 | 3680008034336800080343 | 474 mL in 1 BOTTLE, PLASTIC (36800-803-43)Marketed from Sep 15, 2015 | |
| 36800-803-45 | 3680008034536800080345 | 946 mL in 1 BOTTLE, PLASTIC (36800-803-45)Marketed from Sep 15, 2015 |
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)
- Anticavity
- Generic name (nonproprietary)
- sodium fluoride
- Active ingredients
- Sodium fluoride — .1 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 36800-803_4ab95103-9408-07c3-e063-6394a90a5921SPL ID 4ab95103-9408-07c3-e063-6394a90a5921SPL set ID c337c982-bd18-4a1a-851a-fca1551a242eRxCUI 313029UNII 8ZYQ1474W7
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
N436800080343followed by a unit qualifier and the quantityPackage 36800-0803-43. 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 aids in the prevention of dental cavities
Excerpt only. Read the full label for complete information.
About NDC 36800-803
- What is NDC 36800-803?
- 36800-803 is the product NDC for Anticavity (sodium fluoride), Sodium fluoride .1 mg/mL mouthwash, listed with the FDA by Topco Associates LLC. It has 2 package NDCs, shown above in 10- and 11-digit form.
- What drug is associated with this NDC?
- Anticavity (Sodium fluoride).
- What is the active ingredient?
- Sodium fluoride.
- 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 Anticavity?
- 34 other product NDCs are listed under this name. See all Anticavity NDCs.
- Is there a related HCPCS / J-code?
- Not in Med-Code's curated HCPCS directory. See Billing references above.
Related NDCs: other Anticavity products
Other finished products listed under the same name: strengths, forms and labelers.
| Product | Strength | Form · route | Labeler | Product NDC | Package NDCs (11-digit) |
|---|---|---|---|---|---|
| Anticavitysodium fluoride | Sodium fluoride .1 mg/mL | RinseOral | The Kroger Co. | 59450-971 | 59450-0971-86 |
| Anticavitysodium fluoride | Sodium fluoride .2 mg/mL | RinseOral | Retail Business Services, LLC | 72476-971 | 72476-0971-86 |
| Anticavitysodium fluoride | Sodium fluoride .2 mg/mL | RinseOral | Rite Aid Corporation | 11822-9718 | 11822-9718-06 |
| Anticavitysodium fluoride | Sodium fluoride .1 mg/mL | RinseOral | Demoulas Super Markets, Inc | 53942-971 | 53942-0971-86 |
| Anticavitysodium fluoride | Sodium fluoride .1 mg/mL | RinseOral | United Natural Foods, Inc. dba UNFI | 41163-971 | 41163-0971-86 |
| Anticavitysodium fluoride | Sodium fluoride .1 mg/mL | RinseOral | Old East Main Co. | 55910-971 | 55910-0971-86 |
| Anticavitysodium fluoride | Sodium fluoride .1 mg/mL | RinseOral | H E B | 37808-119 | 37808-0119-86 |
| Anticavitysodium fluoride | Sodium fluoride .1 mg/mL | RinseOral | CVS Pharmacy, Inc. | 69842-548 | 69842-0548-86 |
| Anticavitysodium fluoride | Sodium fluoride .2 mg/mL | RinseOral | Walmart Inc. | 79903-033 | 79903-0033-44 |
| Anticavitysodium fluoride | Sodium fluoride .2 mg/mL | MouthwashOral | United Natural Foods, Inc. dba UNFI | 41163-581 | 41163-0581-86 |
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.