What is NDC 16571-815?

16571-815 is the product NDC for DentaGel (sodium fluoride), Sodium fluoride 1.1 g/100g gel, listed with the FDA by Rising Pharma Holdings, Inc.. It has 1 package NDC, shown above in 10- and 11-digit form.

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 DentaGel?

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.

DentaGel NDC 16571-815 | National Drug Code

NDC codes

FDA NDC Directory

Product NDC (as listed)16571-815Labeler and product segments. Claims need a package NDC.

Product NDC at billing width16571-0815Add 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
16571-815-60	16571081560	56 g in 1 TUBE (16571-815-60)Marketed from May 9, 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): DentaGel
Generic name (nonproprietary): sodium fluoride
Active ingredients: Sodium fluoride — 1.1 g/100g
Dosage form: Gel
Route: Oral
Labeler: Rising Pharma Holdings, Inc.NDC labeler code 16571
Product type: Prescription drug
Marketing category: Unapproved drug (other)
Marketing start: May 9, 2023
Listing expires: Dec 31, 2026
Identifiers: Product ID 16571-815_6ff13596-e232-4e07-bb60-b1d88a01b503SPL ID 6ff13596-e232-4e07-bb60-b1d88a01b503SPL set ID cda9e1f6-275d-43ba-9e30-f34094e80d95RxCUI 392038, 1101938UNII 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

N416571081560 followed by a unit qualifier and the quantity

Package 16571-0815-60. 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 May 9, 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 DentaGel 1.1% Brush-On Gel in a squeeze-tube is easily applied onto a toothbrush as well as a mouthpiece tray. This prescription dental gel should be used once daily following use of a 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 16571-815

What is NDC 16571-815?: 16571-815 is the product NDC for DentaGel (sodium fluoride), Sodium fluoride 1.1 g/100g gel, 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?: DentaGel (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 DentaGel?: 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.

DentaGel (Sodium fluoride) NDC 16571-815