What is NDC 83778-012?

83778-012 is the product NDC for TeethWhitening Kit, Potassium citrate 3 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?

Potassium citrate, Phthalimidoperoxycaproic acid, Tribasic calcium phosphate.

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 TeethWhitening 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.

TeethWhitening Kit NDC 83778-012 | National Drug Code

NDC codes

FDA NDC Directory

Product NDC (as listed)83778-012Labeler and product segments. Claims need a package NDC.

Product NDC at billing width83778-0012Add 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
83778-012-01	8377800120183778001201	6 mL in 1 BOTTLE (83778-012-01)Marketed from Dec 14, 2024

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): TeethWhitening Kit
Generic name (nonproprietary): teethwhitening kit
Active ingredients: Potassium citrate — 3 g/100mLPhthalimidoperoxycaproic acid — 12 g/100mLTribasic calcium phosphate — 1 g/100mL
Dosage form: Cream
Route: Topical
Labeler: Jiangxi Dentalbright Technology Co., Ltd.NDC labeler code 83778
Product type: Over-the-counter drug
Marketing category: OTC monograph drugApplication M 022
Marketing start: Dec 14, 2024
Listing expires: Dec 31, 2026
Other FDA classes: Acidifying Activity (Mechanism)Calcium Chelating Activity (Mechanism)Decreased Coagulation Factor Activity (Physiologic effect)
Identifiers: Product ID 83778-012_29ae5783-e7c6-a892-e063-6394a90a47e2SPL ID 29ae5783-e7c6-a892-e063-6394a90a47e2SPL set ID 29393313-217a-dc3a-e063-6294a90addb1UNII EE90ONI6FF, 5OEJ6FAL6C, 91D9GV0Z28
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

N483778001201 followed by a unit qualifier and the quantity

Package 83778-0012-01. 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)

1. Dry your teeth and rinse mouthpiece before use 2. Looking in the mirror to recor which stage you are with shadeyuide paper. 3. Twist whitening pen until the gel flows. apply the gel evenly on bath upper and lower..teeth. Each time use about 0.5-0.7ml 4. Put mouthpiece into your mouth and bite it, then press power bltton for 1.5 secondst with blue color, press again to turn red within 5 to start the treatment.(Tips: stad and blue within 5 seconds.)seconds; double press to turn re 5. The led light will turn off automatically after 16 minutes, rinse themouthpiece andmouth with water and compareour teeth with shade guide paperagain to see howmany stages you have improved 6. Don't eat or drink…

Excerpt only. Read the full label for complete information.

Full label on DailyMed (opens in a new tab)

About NDC 83778-012

What is NDC 83778-012?: 83778-012 is the product NDC for TeethWhitening Kit, Potassium citrate 3 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?: TeethWhitening Kit.
What is the active ingredient?: Potassium citrate, Phthalimidoperoxycaproic acid, Tribasic calcium phosphate.
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 TeethWhitening 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.

Other NDCs under M 022

Products listed under the same FDA application: other strengths and forms, and repackagers who relabel the same product.

FDA NDC Directory listings under M 022
Product	Strength	Form · route	Labeler	Product NDC
365 Whole Foods Market Spearmint Flavored Fluoride Mouthwash Anticavityfluoride	Fluoride ion .1 mg/mL	MouthwashOral	WHOLE FOODS	42681-0048
3ECARE Dual formula WhiteningToothpaste Refillsodium fluoride	Sodium fluoride .155 g/100g	OintmentSubgingival	Hangzhou Namei Zhikang Technology Co., Ltd.	87514-002
3x Medicated Mouth Sore Gelbenzocaine	Zinc chloride .15 g/100g + 2 more ingredients	GelOral	Walgreens	0363-1605
3X Medicated Mouth Sore Gelbenzocaine	Benzocaine 20 g/100g + 2 more ingredients	GelOral	Rite Aid	11822-6170
3x Medicated Mouth Sore Gelbenzocaine	Menthol, Unspecified form .1 g/100g + 2 more ingredients	GelOral	HEB	37808-691
3x Medicated Mouth Sore Gelbenzocaine	Benzocaine 20 g/100g + 2 more ingredients	GelOral	CVS	69842-660
3x Medicated Toothache and Gum Gelbenzocaine	Benzocaine 20 g/100g + 2 more ingredients	GelOral	CVS	69842-693
4-in-1 Teeth Care Pens	Sodium fluoride .25 g/100g	Gel, DentifriceTopical	Jiangxi Dentalbright Technology Co., Ltd	83778-011
4X Medicated Severe Toothache and Gum Creambenzocaine	Benzocaine 20 g/100g + 3 more ingredients	CreamOral	Rite Aid	11822-0614
4X Medicated Severe Toothache and Gum Gelbenzocaine	Benzalkonium chloride .13 g/100g + 3 more ingredients	GelOral	Rite Aid	11822-0615
4x Medicated Toothache and Gum Creambenzocaine	Benzocaine 20 g/100g + 3 more ingredients	CreamOral	HEB	37808-116
4x Medicated Toothache and Gum Creambenzocaine	Benzalkonium chloride .13 g/100g + 3 more ingredients	CreamOral	CVS	69842-631
4x Medicated Toothache and Gum Gelbenzocaine	Menthol, Unspecified form .5 g/100g + 3 more ingredients	GelOral	Walgreens	0363-6008
4X Medicated Toothache and Gum Gelbenzocaine	Benzocaine 20 g/100g + 3 more ingredients	GelOral	Walmart	49035-569
4x Medicated Toothache and Gum Gelbenzocaine	Benzocaine 20 g/100g + 3 more ingredients	Gel, DentifriceOral	Publix Super Markets INC	56062-312
4x Medicated Toothache and Gum Gelbenzocaine	Benzalkonium chloride .13 g/100g + 3 more ingredients	GelOral	CVS	69842-642
7 Select Oral Pain Maximum Strength Reliefbenzocaine	Benzocaine 200 mg/g	GelTopical	7-ELEVEN, INC.	10202-853
ABC Sore Throat Menthol Flavorphenol	Phenol 1.4 g/100mL	SprayOral	AMERISOURCE BERGEN	46122-749
Acetaminophen	Acetaminophen 160 mg/5mL	SuspensionOral	NuCare Pharmaceuticals,Inc.	68071-4860
Advance Topical Anesthetic Gelbenzocaine	Benzocaine 200 mg/g	GelDental	The Atlanta Dental Supply Company DBA Advanced Dental Products	71347-100

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