Over-the-counter drug · OTC MONOGRAPH DRUG
Moon Charcoal Whitening Anticavity (Sodium fluoride) NDC 82214-003
Sodium fluoride .24 g/100g · Paste · Topical · Moon Oral Care, LLC
NDC codes
FDA NDC Directory| Package NDC | 11-digit (billing) | Package | Copy |
|---|---|---|---|
| 82214-003-02 | 82214000302 | 1 TUBE in 1 CARTON (82214-003-02) / 119 g in 1 TUBE (82214-003-01)Marketed from Jan 1, 2021 |
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)
- Moon Charcoal Whitening Anticavity
- Generic name (nonproprietary)
- sodium fluoride
- Active ingredients
- Sodium fluoride — .24 g/100g
- Dosage form
- Paste
- Route
- Topical
- Labeler
- Moon Oral Care, LLCNDC labeler code 82214
- Product type
- Over-the-counter drug
- Marketing category
- OTC monograph drugApplication M 022
- Marketing start
- Listing expires
- Identifiers
- Product ID 82214-003_0c55f7b3-fea2-58f3-e063-6394a90a3bdeSPL ID 0c55f7b3-fea2-58f3-e063-6394a90a3bdeSPL set ID 0c55f7b3-fea1-58f3-e063-6394a90a3bdeRxCUI 416783UNII 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. Topical products like this are usually dispensed by a pharmacy and billed by NDC.
- NDC on a medical claim
N482214000302followed by a unit qualifier and the quantityPackage 82214-0003-02. 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)
Children of 6 years and younger: Use a pea sized amount with supervised brushing to minimize swallowing.
Excerpt only. Read the full label for complete information.
About NDC 82214-003
- What is NDC 82214-003?
- 82214-003 is the product NDC for Moon Charcoal Whitening Anticavity, Sodium fluoride .24 g/100g paste, listed with the FDA by Moon Oral Care, LLC. It has 1 package NDC, shown above in 10- and 11-digit form.
- What drug is associated with this NDC?
- Moon Charcoal Whitening Anticavity (Sodium Fluoride).
- What is the active ingredient?
- Sodium fluoride.
- Who is the labeler?
- Moon Oral Care, LLC, NDC labeler code 82214. The labeler is the company responsible for the label; it may be the manufacturer, a repackager or a distributor.
- What other NDCs exist for Moon Charcoal Whitening Anticavity?
- 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 |
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