Over-the-counter drug · OTC MONOGRAPH DRUG
NATEAN Clean and Whiten (Sodium fluoride) NDC 0135-1200
Sodium fluoride 1.5 mg/g · Paste · Oral · Haleon US Holdings LLC
NDC codes
FDA NDC Directory| Package NDC | 11-digit (billing) | Package | Copy |
|---|---|---|---|
| 0135-1200-03 | 00135120003 | 1 TUBE in 1 CARTON (0135-1200-03) / 133 g in 1 TUBEMarketed from Jan 3, 2022 |
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)
- NATEAN Clean and WhitenSuffix: Clean and Whiten
- Generic name (nonproprietary)
- sodium fluoride
- Active ingredients
- Sodium fluoride — 1.5 mg/g
- Dosage form
- Paste
- 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 0135-1200_1408ef2f-8220-6b90-e063-6394a90a1abcSPL ID 1408ef2f-8220-6b90-e063-6394a90a1abcSPL set ID 71b95962-2693-49f5-94d2-f2a035b5e0c8RxCUI 1044547UNII 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
N400135120003followed by a unit qualifier and the quantityPackage 00135-1200-03. 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 aids in the prevention of dental cavities.
Excerpt only. Read the full label for complete information.
About NDC 0135-1200
- What is NDC 0135-1200?
- 0135-1200 is the product NDC for NATEAN Clean and Whiten (sodium fluoride), Sodium fluoride 1.5 mg/g paste, 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?
- NATEAN Clean and Whiten (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 NATEAN Clean and Whiten?
- 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 |
|---|---|---|---|---|
| Alpha-Caine Topical Anestheticbenzocaine | Benzocaine 200 mg/g | GelDental, Periodontal | Dental Technologies, Inc. | 55346-2903 |
| LISTERINE Original Antisepticeucalyptol, menthol, unspecified form, methyl salicylate, and thymol | Eucalyptol .92 mg/mL + 3 more ingredients | MouthwashOral | Kenvue Brands LLC | 69968-0400 |
| Lolleez Watermelonpectin | Pectin 11.5 mg/7g | LozengeOral | BFY LLC | 72427-3295 |
| meijer Sensitive FRESH MINTpotassium nitrate, sodium fluoride | Potassium nitrate 5 g/100g; Sodium fluoride .24 g/100g | Paste, DentifriceDental | Meijer, Inc. | 79481-0039 |
| parodontax Active Gum Repair Whiteningstannous fluoride | Stannous fluoride 1.1 mg/g | PasteDental | Haleon US Holdings LLC | 0135-0638 |
| Opalescence Sensitivity Relief Whiteningpotassium nitrate and sodium fluoride | Potassium nitrate 50 mg/g; Sodium fluoride 1.1 mg/g | Gel, DentifriceDental | Ultradent Products, Inc. | 51206-308 |
| Sensitivity Relief Fluoride Freepotassium nitrate | Potassium nitrate 50 mg/g | Paste, DentifriceDental | Health and Natural Beauty USA Corp | 63404-2105 |
| Sucrets Sore Throat Wild Cherrydyclonine hydrochloride | Dyclonine hydrochloride 2 mg/1 | LozengeOral | Insight Pharmaceuticals LLC | 63736-560 |
| BencoCaine Topical Anestheticbenzocaine | Benzocaine 200 mg/g | GelDental | Benco Dental | 66975-356 |
| Lemon Glyceringlycerin | Glycerin .3 g/4g | SwabOral | Dynarex Corporation | 67777-161 |
| Anesgerm LA MUELA Fast Pain Reliefbenzocaine 20% | Benzocaine 200 mg/mL | LiquidTopical | Germa Products, LLC | 73635-7101 |
| 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 |
| UltraCare Anesthetic Gelbenzocaine | Benzocaine 200 mg/g | GelDental, Periodontal, Topical | The Bellport Company, Inc. dba Gingi-Pak | 10129-071 |
| Opal by Opalescence Sensitivitypotassium nitrate and sodium fluoride | Potassium nitrate 50 mg/g; Sodium fluoride 1.1 mg/g | Gel, DentifriceDental | Ultradent Products, Inc. | 51206-311 |
| Alpha-Caine Topical Anestheticbenzocaine | Benzocaine 200 mg/g | GelDental, Periodontal | Dental Technologies, Inc. | 55346-2901 |
| Sensitivity and Gum with Cavity Protectionpotassium nitrate and sodium fluoride | Potassium nitrate 50 mg/g; Sodium fluoride 7.6 mg/g | Paste, DentifriceDental | Health and Natural Beauty USA Corp | 63404-2210 |
| Sucretsdyclonine hcl, menthol, and pectin | Dyclonine hydrochloride 2 mg/1 + 2 more ingredients | LozengeOral | Insight Pharmaceuticals LLC | 63736-567 |
| BencoCaine Topical Anestheticbenzocaine | Benzocaine 200 mg/g | GelDental | Benco Dental | 66975-357 |
| Sore Mouth Cleanserhydrogen peroxide | Hydrogen peroxide 150 mg/10mL | MouthwashTopical | CVS Pharmacy, Inc. | 69842-008 |
| Lolleez Variety Packpectin | Pectin 11.5 mg/7g | LozengeOral | BFY LLC | 72427-3195 |
Showing 20 of 40.