Over-the-counter drug · OTC MONOGRAPH DRUG
SENSODYNE PRONAMEL Intensive Enamel Repair Extra Fresh (Sodium fluoride) NDC 0135-0451
Sodium fluoride .5 mg/mL · Liquid · Oral · Haleon US Holdings LLC
NDC codes
FDA NDC Directory| Package NDC | 11-digit (billing) | Package | Copy |
|---|---|---|---|
| 0135-0451-01 | 00135045101 | 500 mL in 1 BOTTLE (0135-0451-01)Marketed from Jan 2, 2024 |
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 PRONAMEL Intensive Enamel Repair Extra FreshSuffix: Intensive Enamel Repair Extra Fresh
- Generic name (nonproprietary)
- sodium fluoride
- Active ingredients
- Sodium fluoride — .5 mg/mL
- Dosage form
- Liquid
- Route
- Oral
- 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 0135-0451_0a03a9b2-cbbd-4b73-91db-aea9d3a32264SPL ID 0a03a9b2-cbbd-4b73-91db-aea9d3a32264SPL set ID 817c0dad-d109-428e-adb5-3354604acc94RxCUI 240698UNII 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 HCPCS code in Med-Code's directory. Oral products like this are usually dispensed by a pharmacy and billed by NDC.
- NDC on a medical claim
N400135045101followed by a unit qualifier and the quantityPackage 00135-0451-01. 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)
Uses • aids in the prevention of dental cavities. • the combined daily use of a fluoride preventive treatment rinse and a fluoride toothpaste can help reduce the incidence of dental cavities.
Excerpt only. Read the full label for complete information.
About NDC 0135-0451
- What is NDC 0135-0451?
- 0135-0451 is the product NDC for SENSODYNE PRONAMEL Intensive Enamel Repair Extra Fresh, Sodium fluoride .5 mg/mL liquid, listed with the FDA by Haleon US Holdings LLC. It has 1 package NDC, shown above in 10- and 11-digit form.
- What drug is associated with this NDC?
- SENSODYNE PRONAMEL Intensive Enamel Repair Extra Fresh (Sodium fluoride).
- What is the active ingredient?
- Sodium 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 PRONAMEL Intensive Enamel Repair Extra Fresh?
- 1 other product NDC are listed under this name. See all SENSODYNE PRONAMEL Intensive Enamel Repair Extra Fresh NDCs.
- Is there a related HCPCS / J-code?
- Not in Med-Code's curated HCPCS directory. See Billing references above.
Related NDCs: other SENSODYNE PRONAMEL Intensive Enamel Repair Extra Fresh products
Other finished products listed under the same name: strengths, forms and labelers.
| Product | Strength | Form · route | Labeler | Product NDC | Package NDCs (11-digit) |
|---|---|---|---|---|---|
| SENSODYNE PRONAMEL Intensive Enamel Repair Extra Freshpotassium nitrate and sodium fluoride | Potassium nitrate 50 mg/g; Sodium fluoride 1.15 mg/g | PasteOral | Haleon US Holdings LLC | 0135-0486 | 00135-0486-0100135-0486-02 |
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 |
|---|---|---|---|---|
| Topicalebenzocaine | Benzocaine 180 mg/g | GelOral | Medical Products Laboratories, Inc. | 10733-171 |
| Cepacol Extra Strength Sore Throat cherrybenzocaine and menthol | Benzocaine 15 mg/1; Menthol, Unspecified form 3.6 mg/1 | LozengeOral | Reckitt Benckiser LLC | 63824-713 |
| Hydrogen Peroxide | Hydrogen peroxide 2.65 mL/100mL | LiquidTopical | Safeway, Inc. | 21130-979 |
| Fishermans Friend Orange Gingermenthol | Menthol 5 mg/1 | LozengeOral | Lofthouse of Fleetwood | 55711-101 |
| HurriCaine Topical Anestheticbenzocaine | Benzocaine 200 mg/g | GelDental, Oral, Periodontal | Beutlich Pharmaceuticals, LLC | 0283-1820 |
| Wintergreen Peppermintpotassium nitrate, sodium fluoride | Potassium nitrate 50 mg/g; Sodium fluoride 1.5 mg/g | Paste, DentifriceDental | Twice Twice LLC | 72164-005 |
| HurriCaine Topical Anestheticbenzocaine | Benzocaine 200 mg/g | GelDental, Oral, Periodontal | Beutlich Pharmaceuticals, LLC | 0283-0522 |
| Betadine Garglepovidone-iodine | Povidone-iodine .05 mg/mL | SolutionOral | Atlantis Consumer Healthcare, Inc. | 67618-181 |
| Sore Throat Cherryphenol | Phenol 1.4 g/100mL | SprayOral | QUALITY CHOICE (Chain Drug Marketing Association) | 63868-811 |
| Orajel 2X Medicated Geloral pain reliever | Benzocaine 200 mg/g; Menthol 2.6 mg/g | GelTopical | Church & Dwight Co., Inc. | 10237-782 |
| NATEAN Clean plus Sensitivity Reliefpotassium nitrate, sodium fluoride | Potassium nitrate 50 mg/g; Sodium fluoride 1.5 mg/g | PasteOral | Haleon US Holdings LLC | 0135-1250 |
| Meijer Enamel Guardpotassium nitrate, sodium fluoride | Sodium fluoride .15 g/100g; Potassium nitrate 5 g/100g | Paste, DentifriceDental | Meijer Distribution Inc | 41250-514 |
| Sore Mouth Cleanserhydrogen peroxide | Hydrogen peroxide 1588 mg/mL | MouthwashTopical | Rite Aid Corporation | 11822-1462 |
| Candee Caine Topical Anestheticbenzocaine | Benzocaine 200 mg/g | GelDental | American Medical & Hospital Supply Co., Inc. | 71922-101 |
| 4x Medicated Toothache and Gum Gelbenzocaine | Benzalkonium chloride .13 g/100g + 3 more ingredients | GelOral | CVS | 69842-642 |
| Candee Caine Topical Anestheticbenzocaine | Benzocaine 200 mg/g | GelDental | American Medical & Hospital Supply Co., Inc. | 71922-104 |
| Made by Dentists Sensitive and Whitening Fresh Mintpotassium nitrate, sodium fluoride | Potassium nitrate 50 mg/g; Sodium fluoride 1.5 mg/g | PasteDental | MADE BY DENTISTS INC | 75065-029 |
| Benzo-Jelbenzocaine | Benzocaine 200 mg/g | GelDental | Henry Schein Inc. | 0404-0036 |
| Candee Caine Topical Anestheticbenzocaine | Benzocaine 200 mg/g | GelDental | American Medical & Hospital Supply Co., Inc. | 71922-102 |
| CVS Health Sore Throat Fast Relief Oral Anestheticphenol | Phenol 1.4 g/100mL | SprayOral | CVS Pharmacy,Inc. | 59779-895 |
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