Over-the-counter drug · OTC MONOGRAPH DRUG
Orazen (Sodium monofluorophosphate) NDC 71927-102
Sodium monofluorophosphate .1 g/100g · Paste · Dental · Orazen Inc
NDC codes
FDA NDC Directory| Package NDC | 11-digit (billing) | Package | Copy |
|---|---|---|---|
| 71927-102-01 | 7192701020171927010201 | 1 TUBE in 1 POUCH (71927-102-01) / 28 g in 1 TUBEMarketed from Apr 1, 2023 |
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)
- Orazen
- Generic name (nonproprietary)
- sodium monofluorophosphate
- Active ingredients
- Sodium monofluorophosphate — .1 g/100g
- Dosage form
- Paste
- Route
- Dental
- Labeler
- Orazen IncNDC labeler code 71927
- Product type
- Over-the-counter drug
- Marketing category
- OTC monograph drugApplication M 022
- Marketing start
- Listing expires
- Identifiers
- Product ID 71927-102_536042f4-24c3-0778-e063-6294a90aaf42SPL ID 536042f4-24c3-0778-e063-6294a90aaf42SPL set ID fa5b6bd8-443f-79e7-e053-6394a90a5513RxCUI 545626UNII C810JCZ56Q
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
N471927010201followed by a unit qualifier and the quantityPackage 71927-0102-01. 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)
Use: Helps prevent against cavities
Excerpt only. Read the full label for complete information.
About NDC 71927-102
- What is NDC 71927-102?
- 71927-102 is the product NDC for Orazen (sodium monofluorophosphate), Sodium monofluorophosphate .1 g/100g paste, listed with the FDA by Orazen Inc. It has 1 package NDC, shown above in 10- and 11-digit form.
- What drug is associated with this NDC?
- Orazen (Sodium monofluorophosphate).
- What is the active ingredient?
- Sodium monofluorophosphate.
- Who is the labeler?
- Orazen Inc, NDC labeler code 71927. The labeler is the company responsible for the label; it may be the manufacturer, a repackager or a distributor.
- What other NDCs exist for Orazen?
- 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 |
|---|---|---|---|---|
| Oral Gel Oral Pain Reliefbenzocaine benzalkonium chloride | Benzocaine 20 g/100g; Benzalkonium chloride .1 g/100g | GelTopical | Savvy Care and Cosmetics | 83650-101 |
| Boka Sensitivepotassium nitrate | Potassium nitrate 5 g/100g | Paste, DentifriceDental | Karaka LLC | 87161-444 |
| 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 |
| Lolleez Variety Packpectin | Pectin 11.5 mg/7g | LozengeOral | BFY LLC | 72427-3195 |
| UltraCare Anesthetic Gelbenzocaine | Benzocaine 200 mg/g | GelDental, Periodontal, Topical | The Bellport Company, Inc. dba Gingi-Pak | 10129-071 |
| Chloraseptic Childrens Sore Throat Cherryphenol | Phenol 1.4 g/100mL | SprayOral | Prestige Brands Holdings, Inc. | 67172-930 |
| Quality Choicebenzocaine | Benzocaine 200 mg/g | GelTopical | Chain Drug Marketing Association, Inc. | 83324-299 |
| Chloraseptic Sore Throat Maxphenol and glycerin | Phenol 15 mg/mL; Glycerin 330 mg/mL | SprayOral | Prestige Brands Holdings, Inc. | 67172-937 |
| Orajel 3X Medicated For Toothache and Gumbenzocaine, menthol, zinc chloride | Menthol 2.6 mg/g + 2 more ingredients | GelTopical | Church & Dwight Co., Inc. | 10237-790 |
| SENSODYNE Rapid Reliefstannous fluoride | Stannous fluoride 1.1 mg/g | PasteOral | Haleon US Holdings LLC | 0135-0622 |
| Antisepticeucalyptol, menthol, methyl salicylate, thymol | Eucalyptol .92 mg/mL + 3 more ingredients | LiquidOral | WALMART INC. (see also Equate) | 79903-151 |
| Pearson Topical Anestheticbenzocaine | Benzocaine 200 mg/g | GelDental | Pearson Dental Supplies INC. | 43305-0008 |
| Mucinex Instasoothe Sore Throat Plus Pain Reliefbenzocaine and menthol, unspecified form | Benzocaine 7 g/100mL; Menthol, Unspecified form 1 g/100mL | SprayOral | Reckitt Benckiser LLC | 72854-265 |
| HEB Extra Whiteningfluoride | Sodium fluoride .15 g/100g; Potassium nitrate 5 g/100g | Paste, DentifriceDental | HEB | 37808-961 |
| Pearson Topical Anestheticbenzocaine | Benzocaine 200 mg/g | GelDental | Pearson Dental Supplies INC. | 43305-0005 |
| Mucinex Instasoothe Sore Throat Plus Pain Reliefhexylresorcinol | Hexylresorcinol 2 mg/1 | LozengeOral | Reckitt Benckiser LLC | 72854-262 |
| Crest Scope Originalcetylpyridinium chloride | Cetylpyridinium chloride .014 g/mL | RinseOral | The Procter & Gamble Manufacturing Company | 84126-602 |
| Pearson Topical Anestheticbenzocaine | Benzocaine 200 mg/g | GelDental | Pearson Dental Supplies INC. | 43305-0006 |
| HurriCaine Topical Anestheticbenzocaine | Benzocaine 200 mg/g | GelDental, Oral, Periodontal | Beutlich Pharmaceuticals, LLC | 0283-0920 |
| Pearson Topical Anestheticbenzocaine | Benzocaine 200 mg/g | GelDental | Pearson Dental Supplies INC. | 43305-0007 |
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