Over-the-counter drug · OTC MONOGRAPH DRUG
Signature Care Enamel Guard Sensitive Gentle Whitening (Potassium nitrate, sodium fluoride) NDC 21130-350
Sodium fluoride .15 g/100g; Potassium nitrate 5 g/100g · Paste, Dentifrice · Dental · Safeway
NDC codes
FDA NDC Directory| Package NDC | 11-digit (billing) | Package | Copy |
|---|---|---|---|
| 21130-350-19 | 2113003501921130035019 | 1 TUBE in 1 CARTON (21130-350-19) / 113 g in 1 TUBEMarketed from Mar 2, 2019 |
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)
- Signature Care Enamel Guard Sensitive Gentle WhiteningSuffix: Gentle Whitening
- Generic name (nonproprietary)
- potassium nitrate, sodium fluoride
- Active ingredients
- Sodium fluoride — .15 g/100gPotassium nitrate — 5 g/100g
- Dosage form
- Paste, Dentifrice
- Route
- Dental
- Labeler
- SafewayNDC labeler code 21130
- Product type
- Over-the-counter drug
- Marketing category
- OTC monograph drugApplication M 022
- Marketing start
- Listing expires
- Identifiers
- Product ID 21130-350_439565f2-cf1a-87f8-e063-6294a90a12b1SPL ID 439565f2-cf1a-87f8-e063-6294a90a12b1SPL set ID 83222361-b89d-90e7-e053-2991aa0a7579RxCUI 1038929UNII 8ZYQ1474W7, RU45X2JN0Z
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
N421130035019followed by a unit qualifier and the quantityPackage 21130-0350-19. 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 aids in the prevention of dental cavities aids in reducing sensitivity
Excerpt only. Read the full label for complete information.
About NDC 21130-350
- What is NDC 21130-350?
- 21130-350 is the product NDC for Signature Care Enamel Guard Sensitive Gentle Whitening, Sodium fluoride .15 g/100g; Potassium nitrate 5 g/100g paste, dentifrice, listed with the FDA by Safeway. It has 1 package NDC, shown above in 10- and 11-digit form.
- What drug is associated with this NDC?
- Signature Care Enamel Guard Sensitive Gentle Whitening (Potassium nitrate, sodium fluoride).
- What is the active ingredient?
- Sodium fluoride, Potassium nitrate.
- Who is the labeler?
- Safeway, NDC labeler code 21130. The labeler is the company responsible for the label; it may be the manufacturer, a repackager or a distributor.
- What other NDCs exist for Signature Care Enamel Guard Sensitive Gentle Whitening?
- 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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