What is NDC 83778-002?

83778-002 is the product NDC for Teeth Whitening Kit, Tribasic calcium phosphate 1 g/100mL + 2 more ingredients cream, listed with the FDA by Jiangxi Dentalbright Technology Co., Ltd. It has 1 package NDC, shown above in 10- and 11-digit form.

What is the active ingredient?

Tribasic calcium phosphate, Phthalimidoperoxycaproic acid, Potassium citrate.

Jiangxi Dentalbright Technology Co., Ltd, NDC labeler code 83778. The labeler is the company responsible for the label; it may be the manufacturer, a repackager or a distributor.

What other NDCs exist for Teeth Whitening Kit?

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.

Teeth Whitening Kit NDC 83778-002 | National Drug Code

NDC codes

FDA NDC Directory

Product NDC (as listed)83778-002Labeler and product segments. Claims need a package NDC.

Product NDC at billing width83778-0002Add 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
83778-002-01	8377800020183778000201	6 mL in 1 BOTTLE (83778-002-01)Marketed from Nov 5, 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): Teeth Whitening Kit
Generic name (nonproprietary): teeth whitening kit
Active ingredients: Tribasic calcium phosphate — 1 g/100mLPhthalimidoperoxycaproic acid — 12 g/100mLPotassium citrate — 3 g/100mL
Dosage form: Cream
Route: Topical
Labeler: Jiangxi Dentalbright Technology Co., LtdNDC labeler code 83778
Product type: Over-the-counter drug
Marketing category: Unapproved drug (other)
Marketing start: Nov 5, 2023
Listing expires: Dec 31, 2027
Other FDA classes: Acidifying Activity (Mechanism)Calcium Chelating Activity (Mechanism)Decreased Coagulation Factor Activity (Physiologic effect)
Identifiers: Product ID 83778-002_29c01cdf-48e8-77a6-e063-6294a90af25cSPL ID 29c01cdf-48e8-77a6-e063-6294a90af25cSPL set ID 0973b73d-5de9-0986-e063-6294a90a5917UNII 91D9GV0Z28, 5OEJ6FAL6C, EE90ONI6FF
Pharmacologic class: Anti-coagulant; Calculi Dissolution Agent

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. Topical products like this are usually dispensed by a pharmacy and billed by NDC.

NDC on a medical claim

N483778000201 followed by a unit qualifier and the quantity

Package 83778-0002-01. 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 20, 2024.

Indications (excerpt from the label)

Use Teeth stains from coffee, tobacco, genetic, tetracycline, food coloring, aging and other factors that may cause discoloration.

Excerpt only. Read the full label for complete information.

Full label on DailyMed (opens in a new tab)

About NDC 83778-002

What is NDC 83778-002?: 83778-002 is the product NDC for Teeth Whitening Kit, Tribasic calcium phosphate 1 g/100mL + 2 more ingredients cream, listed with the FDA by Jiangxi Dentalbright Technology Co., Ltd. It has 1 package NDC, shown above in 10- and 11-digit form.
What drug is associated with this NDC?: Teeth Whitening Kit.
What is the active ingredient?: Tribasic calcium phosphate, Phthalimidoperoxycaproic acid, Potassium citrate.
Who is the labeler?: Jiangxi Dentalbright Technology Co., Ltd, NDC labeler code 83778. The labeler is the company responsible for the label; it may be the manufacturer, a repackager or a distributor.
What other NDCs exist for Teeth Whitening Kit?: 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.