What is NDC 16571-814?

16571-814 is the product NDC for Denta 5000 Plus (sodium fluoride), Sodium fluoride 1.1 g/100g cream, listed with the FDA by Rising Pharma Holdings, Inc.. It has 1 package NDC, shown above in 10- and 11-digit form.

What drug is associated with this NDC?

Denta 5000 Plus (Sodium fluoride).

Rising Pharma Holdings, Inc., NDC labeler code 16571. The labeler is the company responsible for the label; it may be the manufacturer, a repackager or a distributor.

What other NDCs exist for Denta 5000 Plus?

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.

Denta 5000 Plus NDC 16571-814 | National Drug Code

NDC codes

FDA NDC Directory

Product NDC (as listed)16571-814Labeler and product segments. Claims need a package NDC.

Product NDC at billing width16571-0814Add 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
16571-814-50	16571081450	51 g in 1 TUBE (16571-814-50)Marketed from Jul 3, 2023

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): Denta 5000 Plus
Generic name (nonproprietary): sodium fluoride
Active ingredients: Sodium fluoride — 1.1 g/100g
Dosage form: Cream
Route: Oral
Labeler: Rising Pharma Holdings, Inc.NDC labeler code 16571
Product type: Prescription drug
Marketing category: Unapproved drug (other)
Marketing start: Jul 3, 2023
Listing expires: Dec 31, 2026
Identifiers: Product ID 16571-814_82dc4f9f-0dc5-46f8-8deb-3966669470cdSPL ID 82dc4f9f-0dc5-46f8-8deb-3966669470cdSPL set ID 7142eb93-54ff-4ba1-af43-3fa3dc1fad01RxCUI 392038, 630196UNII 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

N416571081450 followed by a unit qualifier and the quantity

Package 16571-0814-50. 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 Jul 17, 2023.

Indications (excerpt from the label)

INDICATIONS AND USAGE: A dental caries preventive; for once daily self-applied topical use. It is well established that 1.1% sodium fluoride is safe and extraordinarily effective as a caries preventive when applied frequently with mouthpiece applicators. 1-4 Denta 5000 Plus brand of 1.1% sodium fluoride in a squeeze-tube is easily applied onto a toothbrush. This prescription dental cream should be used once daily in place of your regular toothpaste unless otherwise instructed by your dental professional. May be used whether or not drinking water is fluoridated, since topical fluoride cannot produce fluorosis. (See WARNINGS for exception.)

Excerpt only. Read the full label for complete information.

Full label on DailyMed (opens in a new tab)

About NDC 16571-814

What is NDC 16571-814?: 16571-814 is the product NDC for Denta 5000 Plus (sodium fluoride), Sodium fluoride 1.1 g/100g cream, listed with the FDA by Rising Pharma Holdings, Inc.. It has 1 package NDC, shown above in 10- and 11-digit form.
What drug is associated with this NDC?: Denta 5000 Plus (Sodium fluoride).
What is the active ingredient?: Sodium fluoride.
Who is the labeler?: Rising Pharma Holdings, Inc., NDC labeler code 16571. The labeler is the company responsible for the label; it may be the manufacturer, a repackager or a distributor.
What other NDCs exist for Denta 5000 Plus?: 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.

Denta 5000 Plus (Sodium fluoride) NDC 16571-814