What is NDC 61578-216?

61578-216 is the product NDC for PRO Gel 5000 Citrus (sodium fluoride), Sodium fluoride 5000 ug/g gel, dentifrice, listed with the FDA by DENTAL ALLIANCE HOLDINGS LLC. It has 1 package NDC, shown above in 10- and 11-digit form.

What drug is associated with this NDC?

PRO Gel 5000 Citrus (Sodium fluoride).

DENTAL ALLIANCE HOLDINGS LLC, NDC labeler code 61578. The labeler is the company responsible for the label; it may be the manufacturer, a repackager or a distributor.

What other NDCs exist for PRO Gel 5000 Citrus?

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.

PRO Gel 5000 Citrus NDC 61578-216 | National Drug Code

NDC codes

FDA NDC Directory

Product NDC (as listed)61578-216Labeler and product segments. Claims need a package NDC.

Product NDC at billing width61578-0216Add 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
61578-216-01	61578021601	68 g in 1 TUBE, WITH APPLICATOR (61578-216-01)Marketed from May 10, 2022

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): PRO Gel 5000 CitrusSuffix: Citrus
Generic name (nonproprietary): sodium fluoride
Active ingredients: Sodium fluoride — 5000 ug/g
Dosage form: Gel, Dentifrice
Route: Dental
Labeler: DENTAL ALLIANCE HOLDINGS LLCNDC labeler code 61578
Product type: Prescription drug
Marketing category: Unapproved drug (other)
Marketing start: May 10, 2022
Listing expires: Dec 31, 2026
Identifiers: Product ID 61578-216_424ae751-1f8e-4e67-ba2e-b368d447053eSPL ID 424ae751-1f8e-4e67-ba2e-b368d447053eSPL set ID f127e236-5207-948b-e053-2a95a90ab740RxCUI 392038UNII 8ZYQ1474W7UPC 0361578216010, 0361578215013

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

N461578021601 followed by a unit qualifier and the quantity

Package 61578-0216-01. 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 Dec 29, 2025.

Indications (excerpt from the label)

Indications and Use: A dental caries preventive; for once daily self-applied topical use. It is well established that a 1.1% sodium fluoride is safe and extraordinarily effective as a caries preventive when applied frequently with mouthpiece applicators.1-4 CariFree CTx4 Gel 5000 brand of 1.1% sodium fluoride toothpaste 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 in areas where 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 61578-216

What is NDC 61578-216?: 61578-216 is the product NDC for PRO Gel 5000 Citrus (sodium fluoride), Sodium fluoride 5000 ug/g gel, dentifrice, listed with the FDA by DENTAL ALLIANCE HOLDINGS LLC. It has 1 package NDC, shown above in 10- and 11-digit form.
What drug is associated with this NDC?: PRO Gel 5000 Citrus (Sodium fluoride).
What is the active ingredient?: Sodium fluoride.
Who is the labeler?: DENTAL ALLIANCE HOLDINGS LLC, NDC labeler code 61578. The labeler is the company responsible for the label; it may be the manufacturer, a repackager or a distributor.
What other NDCs exist for PRO Gel 5000 Citrus?: 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.

PRO Gel 5000 Citrus (Sodium fluoride) NDC 61578-216