What is NDC 64778-0446?

64778-0446 is the product NDC for Denti-Care Denti-Rinse Neutral Sodium Fluoride Oral Rinse, Sodium fluoride .02 g/mL liquid, listed with the FDA by AMD Medicom. It has 1 package NDC, shown above in 10- and 11-digit form.

What drug is associated with this NDC?

Denti-Care Denti-Rinse Neutral Sodium Fluoride Oral Rinse (Sodium Fluoride).

AMD Medicom, NDC labeler code 64778. The labeler is the company responsible for the label; it may be the manufacturer, a repackager or a distributor.

What other NDCs exist for Denti-Care Denti-Rinse Neutral Sodium Fluoride Oral Rinse?

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.

NDC 64778-0446

NDC codes

FDA NDC Directory

Product NDC (as listed)64778-0446Labeler and product segments. Claims need a package NDC.

Product NDC at billing width64778-0446Add the package segment from the table below.

Package NDCs as listed with the FDA, and the 11-digit 5-4-2 form used on claims. The highlighted digit is the added leading zero.
Package NDC	11-digit (billing)	Package	Copy
64778-0446-3	6477804460364778044603	12 BOTTLE, PUMP in 1 CASE (64778-0446-3) / 1900 mL in 1 BOTTLE, PUMP (64778-0446-1)Marketed from Dec 1, 2017

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): Denti-Care Denti-Rinse Neutral Sodium Fluoride Oral RinseSuffix: Neutral Sodium Fluoride Oral Rinse
Generic name (nonproprietary): sodium fluoride
Active ingredients: Sodium fluoride — .02 g/mL
Dosage form: Liquid
Route: Dental
Labeler: AMD MedicomNDC labeler code 64778
Product type: Prescription drug
Marketing category: Unapproved drug (other)
Marketing start: Mar 1, 2001
Marketing end: May 31, 2027
Identifiers: Product ID 64778-0446_4c4b0fd6-ca08-179a-e063-6394a90a6628SPL ID 4c4b0fd6-ca08-179a-e063-6394a90a6628SPL set ID 1da64824-9389-4109-bea9-b91600caf023RxCUI 251960, 991007UNII 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 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

N464778044603 followed by a unit qualifier and the quantity

Package 64778-0446-03. 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 Mar 5, 2026.

Indications (excerpt from the label)

Indications and Directions Indications: Topical anti-carie solution. Neutral pH is safe for patients with crowns and restorations. Directions: Dispense 10mL of solution into a measuring cup. Instruct patient to rinse vigorously for 60 seconds, around and in between teeth, then expectorate. For maximum benefit, repeat the rinse procedure with an additional 10mL. Advise patient not to eat, drink or rinse for 30 minutes after application. Pro-Rinse solution may also be applied with a cotton tip applicator to teeth isolated with cotton rolls

Excerpt only. Read the full label for complete information.

Full label on DailyMed (opens in a new tab)

About NDC 64778-0446

What is NDC 64778-0446?: 64778-0446 is the product NDC for Denti-Care Denti-Rinse Neutral Sodium Fluoride Oral Rinse, Sodium fluoride .02 g/mL liquid, listed with the FDA by AMD Medicom. It has 1 package NDC, shown above in 10- and 11-digit form.
What drug is associated with this NDC?: Denti-Care Denti-Rinse Neutral Sodium Fluoride Oral Rinse (Sodium Fluoride).
What is the active ingredient?: Sodium fluoride.
Who is the labeler?: AMD Medicom, NDC labeler code 64778. The labeler is the company responsible for the label; it may be the manufacturer, a repackager or a distributor.
What other NDCs exist for Denti-Care Denti-Rinse Neutral Sodium Fluoride Oral Rinse?: 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.

Denti-Care Denti-Rinse Neutral Sodium Fluoride Oral Rinse (Sodium fluoride) NDC 64778-0446