Over-the-counter drug · OTC MONOGRAPH DRUG
Pearl White (Potassium nitrate, sodium fluoride) NDC 42199-006
Potassium nitrate 50 mg/g; Sodium fluoride 1 mg/g · Paste, Dentifrice · Dental · Beyond International Inc.
NDC codes
FDA NDC Directory| Package NDC | 11-digit (billing) | Package | Copy |
|---|---|---|---|
| 42199-006-05 | 4219900060542199000605 | 1 TUBE in 1 CARTON (42199-006-05) / 120 g in 1 TUBEMarketed from Jun 12, 2017 | |
| 42199-006-06 | 4219900060642199000606 | 1 TUBE in 1 CARTON (42199-006-06) / 40 g in 1 TUBEMarketed from Jun 12, 2017 |
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)
- Pearl White
- Generic name (nonproprietary)
- potassium nitrate, sodium fluoride
- Active ingredients
- Potassium nitrate — 50 mg/gSodium fluoride — 1 mg/g
- Dosage form
- Paste, Dentifrice
- Route
- Dental
- Labeler
- Beyond International Inc.NDC labeler code 42199
- Product type
- Over-the-counter drug
- Marketing category
- OTC monograph drugApplication M 022
- Marketing start
- Marketing end
- Identifiers
- Product ID 42199-006_0b3e6b1d-3644-3f2c-e063-6394a90a25a1SPL ID 0b3e6b1d-3644-3f2c-e063-6394a90a25a1SPL set ID 51c79544-9536-5863-e054-00144ff8d46cUNII RU45X2JN0Z, 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
N442199000605followed by a unit qualifier and the quantityPackage 42199-0006-05. 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)
Uses Helps reduce painful sensitivity of the teeth to cold, heat, acids, sweets or contact. Aids in the prevention of dental cavities.
Excerpt only. Read the full label for complete information.
About NDC 42199-006
- What is NDC 42199-006?
- 42199-006 is the product NDC for Pearl White, Potassium nitrate 50 mg/g; Sodium fluoride 1 mg/g paste, dentifrice, listed with the FDA by Beyond International Inc.. It has 2 package NDCs, shown above in 10- and 11-digit form.
- What drug is associated with this NDC?
- Pearl White (Potassium nitrate, Sodium fluoride).
- What is the active ingredient?
- Potassium nitrate, Sodium fluoride.
- Who is the labeler?
- Beyond International Inc., NDC labeler code 42199. The labeler is the company responsible for the label; it may be the manufacturer, a repackager or a distributor.
- What other NDCs exist for Pearl White?
- 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.
| Product | Strength | Form · route | Labeler | Product NDC |
|---|---|---|---|---|
| Hydrogen Peroxide 3 Percent ReadyInCasehydrogen peroxide | Hydrogen peroxide 3 mL/100mL | LiquidTopical | P & L Development, LLC | 49580-0268 |
| Salinenasal | Sodium chloride 6.5 mg/mL | SprayNasal | Bi-Mart | 37835-998 |
| CVS Health Sensitive Enamel Repairsodium fluoride | Sodium fluoride .15 g/100g; Potassium nitrate 5 g/100g | Paste, DentifriceOral | CVS | 51316-169 |
| Ricola Max Nasal Care Cool Mentholmenthol | Menthol 15.3 mg/1 | LozengeOral | Ricola Ag | 54305-206 |
| Orajel Medicated for Toothache and Gum, Liquidbenzocaine and menthol | Benzocaine 200 mg/mL; Menthol, Unspecified form 1 mg/mL | LiquidTopical | Church & Dwight Co., Inc. | 10237-796 |
| Throat Balm Caramel Pectinpectin | Pectin 3.8 mg/1 | LozengeOral | Ricola Ag | 54305-301 |
| Throat Balm Caramel Pectinpectin | Pectin 3.8 mg/1 | LozengeOral | Ricola USA Inc. | 63667-301 |
| Hydrogen Peroxide 3 Percenthydrogen peroxide | Hydrogen peroxide 2.65 mL/100mL | LiquidTopical | Whole Foods Market | 42681-6414 |
| Sore throat cherryphenol | Phenol 1.4 g/100mL | SprayOral | Dolgencorp, Inc. (DOLLAR GENERAL & REXALL) | 55910-376 |
| Crest Pro-Health Gum DetoxifyWinter Mintcetylpyridinium chloride | Cetylpyridinium chloride .07 g/mL | RinseOral | The Procter & Gamble Manufacturing Company | 84126-648 |
| Crest Kids Advanced Color Changingsodium monofluorophosphate | Sodium monofluorophosphate 1.6 mg/g | Paste, DentifriceDental | Procter & Gamble Manufactura, S de R.L. de C.V. | 58933-012 |
| Sootheez Berry Lemonadepectin | Pectin 11.5 mg/3.5g | LozengeOral | BFY LLC | 72427-4014 |
| Sootheez Organic Wild Cherrypectin | Pectin 11.5 mg/3.5g | LozengeOral | BFY LLC | 72427-3714 |
| Quality Choice Oral Pain Reliefbenzocaine 20%, benzalkonium chloride 1% | Benzocaine 200 mg/g; Benzalkonium chloride 10 mg/g | GelTopical | Quality Choice (CHAIN DRUG MARKETING ASSOCIATION) | 83324-035 |
| Rite Aid Professional Strengthbenzocaine | Benzocaine 20 g/100g | LiquidOral | Rite Aid | 11822-5340 |
| SENSODYNE Rapid Reliefstannous fluoride | Stannous fluoride 1.1 mg/g | PasteOral | Haleon US Holdings LLC | 0135-0622 |
| Iodent Oral Analgesicbenzocaine | Benzocaine 200 mg/g | GelTopical | United Exchange Corp. | 65923-094 |
| Sootheez Organic Wild Cherrypectin | Pectin 11.5 mg/3.5g | LozengeOral | BFY LLC | 72427-3714 |
| Topcare Sore Throat Menthol Flavorphenol | Phenol 1.4 g/100mL | SprayOral | TOPCO ASSOCIATES LLC | 36800-606 |
| Sensodyne Pronamel Gentle Whitening Advancedpotassium nitrate and sodium fluoride | Potassium nitrate 50 mg/g; Sodium fluoride 1.15 mg/g | PasteDental | Haleon US Holdings LLC | 0135-0580 |
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