Over-the-counter drug · OTC MONOGRAPH DRUG
Sensodyne Complete Protection (Stannous fluoride) NDC 0135-0573
Stannous fluoride 1.1 mg/g · Paste · Dental · Haleon US Holdings LLC
NDC codes
FDA NDC Directory| Package NDC | 11-digit (billing) | Package | Copy |
|---|---|---|---|
| 0135-0573-02 | 00135057302 | 1 TUBE in 1 CARTON (0135-0573-02) / 96.4 g in 1 TUBEMarketed from Jul 14, 2014 | |
| 0135-0573-03 | 00135057303 | 1 TUBE in 1 CARTON (0135-0573-03) / 23 g in 1 TUBEMarketed from Jul 14, 2014 |
How the 11-digit form is made: The labeler segment has 4 digits, so one leading zero is added to it (4-4-2 → 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)
- Sensodyne Complete Protection
- Generic name (nonproprietary)
- stannous fluoride
- Active ingredients
- Stannous fluoride — 1.1 mg/g
- Dosage form
- Paste
- Route
- Dental
- Labeler
- Haleon US Holdings LLCNDC labeler code 0135
- Product type
- Over-the-counter drug
- Marketing category
- OTC monograph drugApplication M 022
- Marketing start
- Listing expires
- Identifiers
- Product ID 0135-0573_78b76a64-361a-41e8-aead-29ac143c0901SPL ID 78b76a64-361a-41e8-aead-29ac143c0901SPL set ID e3cc3146-8aed-4f6b-a252-e379418c2b8dRxCUI 416784UNII 3FTR44B32Q
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
N400135057302followed by a unit qualifier and the quantityPackage 00135-0573-02. 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. • helps prevent gingivitis, an early form of gum disease. • helps interfere with harmful effects of plaque associated with gingivitis. • builds increasing protection against painful sensitivity of the teeth to cold, heat, acids, sweets, or contact.
Excerpt only. Read the full label for complete information.
About NDC 0135-0573
- What is NDC 0135-0573?
- 0135-0573 is the product NDC for Sensodyne Complete Protection (stannous fluoride), Stannous fluoride 1.1 mg/g paste, listed with the FDA by Haleon US Holdings LLC. It has 2 package NDCs, shown above in 10- and 11-digit form.
- What drug is associated with this NDC?
- Sensodyne Complete Protection (Stannous fluoride).
- What is the active ingredient?
- Stannous fluoride.
- Who is the labeler?
- Haleon US Holdings LLC, NDC labeler code 0135. The labeler is the company responsible for the label; it may be the manufacturer, a repackager or a distributor.
- What other NDCs exist for Sensodyne Complete Protection?
- 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 |
|---|---|---|---|---|
| Vicks VapoCool SEVERE plus Intense Pain Reliefbenzocaine and menthol | Benzocaine 15 mg/1; Menthol 20 mg/1 | LozengeOral | The Procter & Gamble Manufacturing Company | 84126-366 |
| Meijer Sore Throatphenol | Phenol 1.4 g/100mL | SprayOral | MEIJER DISTRIBUTION INC. | 41250-632 |
| Advance Topical Anesthetic Gelbenzocaine | Benzocaine 200 mg/g | GelDental | The Atlanta Dental Supply Company DBA Advanced Dental Products | 71347-105 |
| Anadent Kanka Gelbenzocaine | Benzocaine 200 mg/g | GelDental | BELMORA LLC | 27854-177 |
| Rexall Maximum Strengthbenzocaine | Benzocaine 20 g/100mL | LiquidOral | Rexall | 55910-346 |
| HurriCaine Topical Anesthetic Gelbenzocaine | Benzocaine 200 mg/g | GelDental, Oral, Periodontal | Beutlich Pharmaceuticals, LLC | 0283-0886 |
| Orajel 3X Medicated For All Mouth Soresbenzocaine, menthol, zinc chloride | Benzocaine 200 mg/g + 2 more ingredients | GelTopical | Church & Dwight Co., Inc. | 10237-783 |
| 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 |
| Gelato Topical Anestheticbenzocaine | Benzocaine 11.4 g/57g | Spray, MeteredDental | Mycone Dental Supply Co., Inc DBA Keystone Industries and Deepak Products Inc | 68400-323 |
| Vicks Vapo Breathersmenthol | Menthol 20 mg/1 | LozengeOral | The Procter & Gamble Manufacturing Company | 84126-320 |
| SENSODYNE PRONAMEL Active Shield Fresh Mintpotassium nitrate and sodium fluoride | Potassium nitrate 50 mg/g; Sodium fluoride 1.15 mg/g | PasteOral | Haleon US Holdings LLC | 0135-0700 |
| Sore Throatphenol | Phenol 1.4 g/100mL | SprayOral | EQUATE (Wal-Mart Stores, Inc.) (see also WAL-MART INC) | 49035-376 |
| Ludens Honey Licorice Throat Dropsmenthol | Menthol 1.6 mg/1 | LozengeOral | Prestige Brands Holdings, Inc. | 52183-255 |
| Kaylaanzero waste refill for toothpaste | Sodium fluoride .37 mg/440mg | Tablet, ChewableDental | Kaylaan LLC | 82091-113 |
| Candee Caine Topical Anestheticbenzocaine | Benzocaine 200 mg/g | GelDental | Top Quality Manufacturing, Inc. | 69301-061 |
| Kaylaanzero waste refill for toothpaste | Sodium fluoride .37 mg/440mg | Tablet, ChewableDental | Kaylaan LLC | 82091-115 |
| Ludens Wild Cherry Throat Dropspectin | Pectin 2.8 mg/1 | LozengeOral | Prestige Brands Holdings, Inc. | 52183-229 |
| Kaylaanzero waste refill for toothpaste | Sodium fluoride .37 mg/440mg | Tablet, ChewableDental | Kaylaan LLC | 82091-116 |
| SENSODYNE Sensitivity Gum and Enamel Mintstannous fluoride | Stannous fluoride 1.1 mg/g | PasteOral | Haleon US Holdings LLC | 0135-5022 |
| Ludens Sugar Free Wild Cherry Throatpectin | Pectin 2.8 mg/1 | LozengeOral | Prestige Brands Holdings, Inc. | 52183-249 |
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