What is NDC 35573-435?

35573-435 is the product NDC for Sodium Fluoride 1.1% (sodium fluoride), Sodium fluoride 5 mg/g gel, dentifrice, listed with the FDA by Burel Pharmaceuticals LLC. It has 1 package NDC, shown above in 10- and 11-digit form.

What drug is associated with this NDC?

Sodium Fluoride 1.1% (Sodium Fluoride).

Burel Pharmaceuticals LLC, NDC labeler code 35573. The labeler is the company responsible for the label; it may be the manufacturer, a repackager or a distributor.

What other NDCs exist for Sodium Fluoride 1.1%?

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.

Sodium Fluoride 1.1% NDC 35573-435 | National Drug Code

NDC codes

FDA NDC Directory

Product NDC (as listed)35573-435Labeler and product segments. Claims need a package NDC.

Product NDC at billing width35573-0435Add 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
35573-435-56	35573043556	1 TUBE in 1 CARTON (35573-435-56) / 56 g in 1 TUBEMarketed from Feb 28, 2020

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): Sodium Fluoride 1.1%
Generic name (nonproprietary): sodium fluoride
Active ingredients: Sodium fluoride — 5 mg/g
Dosage form: Gel, Dentifrice
Route: Dental
Labeler: Burel Pharmaceuticals LLCNDC labeler code 35573
Product type: Prescription drug
Marketing category: Unapproved drug (other)
Marketing start: Feb 28, 2020
Listing expires: Dec 31, 2026
Identifiers: Product ID 35573-435_43929099-b98f-86b0-e063-6394a90a83e5SPL ID 43929099-b98f-86b0-e063-6394a90a83e5SPL set ID 6e021467-08b3-40b3-9a39-2e9d9830085dRxCUI 1486566UNII 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

N435573043556 followed by a unit qualifier and the quantity

Package 35573-0435-56. 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 Nov 14, 2025.

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 Sodium Fluoride 1.1% Dental Gel in a squeeze-tube is easily applied onto a toothbrush. This prescription dental gel should be used once daily following use 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 35573-435

What is NDC 35573-435?: 35573-435 is the product NDC for Sodium Fluoride 1.1% (sodium fluoride), Sodium fluoride 5 mg/g gel, dentifrice, listed with the FDA by Burel Pharmaceuticals LLC. It has 1 package NDC, shown above in 10- and 11-digit form.
What drug is associated with this NDC?: Sodium Fluoride 1.1% (Sodium Fluoride).
What is the active ingredient?: Sodium fluoride.
Who is the labeler?: Burel Pharmaceuticals LLC, NDC labeler code 35573. The labeler is the company responsible for the label; it may be the manufacturer, a repackager or a distributor.
What other NDCs exist for Sodium Fluoride 1.1%?: 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.

Sodium Fluoride 1.1% (Sodium fluoride) NDC 35573-435