Over-the-counter drug · OTC MONOGRAPH DRUG
TeethWhitening Kit NDC 83778-012
Potassium citrate 3 g/100mL + 2 more ingredients · Cream · Topical · Jiangxi Dentalbright Technology Co., Ltd.
NDC codes
FDA NDC Directory| Package NDC | 11-digit (billing) | Package | Copy |
|---|---|---|---|
| 83778-012-01 | 83778001201 | 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
- Product type
- Over-the-counter drug
- Marketing category
- OTC monograph drugApplication M 022
- Marketing start
- Listing expires
- 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
N483778001201followed by a unit qualifier and the quantityPackage 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 .
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.
Other NDCs under M 022
Products listed under the same FDA application: other strengths and forms, and repackagers who relabel the same product.
| Product | Strength | Form · route | Labeler | Product NDC |
|---|---|---|---|---|
| Finafta MultiOralbenzocaine | Benzocaine 7.5 mg/100mL | SprayOral | Efficient Laboratories Inc. | 58593-782 |
| DenTek Instant Pain Relief Maximum Strengthbenzocaine | Benzocaine 200 mg/mL | LiquidDental, Topical | DenTek Oral Care, Inc. | 60630-078 |
| Astra-dent Topical Anesthetic Gelbenzocaine | Benzocaine 200 mg/g | GelDental | Zag Usa Inc | 71363-102 |
| Pearson Topical Anestheticbenzocaine | Benzocaine 200 mg/g | GelDental | Pearson Dental Supplies INC. | 43305-0008 |
| Natural Cherry Honey Herb Throat Dropsmenthol | Menthol 2.1 mg/1 | LozengeOral | Ricola USA Inc. | 63667-517 |
| Pearson Topical Anestheticbenzocaine | Benzocaine 200 mg/g | GelDental | Pearson Dental Supplies INC. | 43305-0009 |
| HurriCaine Topical Anestheticbenzocaine | Benzocaine 200 mg/g | GelDental, Oral, Periodontal | Beutlich Pharmaceuticals, LLC | 0283-0622 |
| Astra-dent Topical Anesthetic Gelbenzocaine | Benzocaine 200 mg/g | GelDental | Zag Usa Inc | 71363-100 |
| Toothachepolyhexamethylene biguanide hydrochloride | Polihexanide hydrochloride .25 g/100mL | SprayTopical | Guchutang Biotechnology (Longyan) Co., Ltd | 87083-012 |
| Sore Mouth Cleanserhydrogen peroxide | Hydrogen peroxide 15 mg/mL | MouthwashTopical | Meijer, Inc. | 41250-750 |
| Pearson Topical Anestheticbenzocaine | Benzocaine 200 mg/g | GelDental | Pearson Dental Supplies INC. | 43305-0010 |
| Cherry Throat Dropsmenthol | Menthol 1.3 mg/1 | LozengeOral | Ricola USA Inc. | 63667-518 |
| Astra-dent Topical Anesthetic Gelbenzocaine | Benzocaine 200 mg/g | GelDental | Zag Usa Inc | 71363-101 |
| EcoDent Ultimate Essential Mouthcare Sparkling Clean Mintsodium bicarbonate | Sodium bicarbonate 25 mg/mL | LiquidOral | Lotus Brands, Inc. | 76328-223 |
| Parodontax Active Gum Health Daily Mouthwash Breath Freshenercetylpyridinium chloride | Cetylpyridinium chloride 70 mg/mL | LiquidOral | Haleon US Holdings LLC | 0135-0652 |
| Patterson Dental Topical Anestheticbenzocaine | Benzocaine 200 mg/g | GelDental | Patterson Dental | 50227-1014 |
| Natural Lemon Mint Herb Throat Dropsmenthol | Menthol 1.5 mg/1 | LozengeOral | Ricola Ag | 54305-489 |
| Quality Choice Maximum Strength Oral Pain Relievingbenzocaine | Benzocaine 20 g/100g | GelTopical | Chain Drug Marketing Association Inc | 63868-953 |
| Kaylaanzero waste refill for toothpaste | Sodium fluoride .37 mg/440mg | Tablet, ChewableDental | Kaylaan LLC | 82091-116 |
| Patterson Dental Topical Anestheticbenzocaine | Benzocaine 200 mg/g | GelDental | Patterson Dental | 50227-1011 |
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