Over-the-counter drug · OTC MONOGRAPH DRUG
Kaylaan (Zero waste refill for toothpaste) NDC 82091-113
Sodium fluoride .37 mg/440mg · Tablet, Chewable · Dental · Kaylaan LLC
NDC codes
FDA NDC Directory| Package NDC | 11-digit (billing) | Package | Copy |
|---|---|---|---|
| 82091-113-10 | 8209101131082091011310 | 74.3 mg in 1 BOTTLE, UNIT-DOSE (82091-113-10)Marketed from Sep 13, 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)
- Kaylaan
- Generic name (nonproprietary)
- zero waste refill for toothpaste
- Active ingredients
- Sodium fluoride — .37 mg/440mg
- Dosage form
- Tablet, Chewable
- Route
- Dental
- Labeler
- Kaylaan LLCNDC labeler code 82091
- Product type
- Over-the-counter drug
- Marketing category
- OTC monograph drugApplication M 022
- Marketing start
- Listing expires
- Identifiers
- Product ID 82091-113_2b4940da-237f-e433-e063-6294a90a47f0SPL ID 2b4940da-237f-e433-e063-6294a90a47f0SPL set ID 2b494372-de59-e462-e063-6294a90a08daUNII 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 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
N482091011310followed by a unit qualifier and the quantityPackage 82091-0113-10. 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)
INDICATION and USAGE
Excerpt only. Read the full label for complete information.
About NDC 82091-113
- What is NDC 82091-113?
- 82091-113 is the product NDC for Kaylaan (zero waste refill for toothpaste), Sodium fluoride .37 mg/440mg tablet, chewable, listed with the FDA by Kaylaan LLC. It has 1 package NDC, shown above in 10- and 11-digit form.
- What drug is associated with this NDC?
- Kaylaan (Zero Waste Refill For Toothpaste).
- What is the active ingredient?
- Sodium fluoride.
- Who is the labeler?
- Kaylaan LLC, NDC labeler code 82091. The labeler is the company responsible for the label; it may be the manufacturer, a repackager or a distributor.
- What other NDCs exist for Kaylaan?
- 3 other product NDCs are listed under this name. See all Kaylaan NDCs.
- Is there a related HCPCS / J-code?
- Not in Med-Code's curated HCPCS directory. See Billing references above.
Related NDCs: other Kaylaan products
Other finished products listed under the same name: strengths, forms and labelers.
| Product | Strength | Form · route | Labeler | Product NDC | Package NDCs (11-digit) |
|---|---|---|---|---|---|
| Kaylaanzero waste refill for toothpaste | Sodium fluoride .37 mg/440mg | Tablet, ChewableDental | Kaylaan LLC | 82091-115 | 82091-0115-01 |
| Kaylaanzero waste refill for toothpaste | Sodium fluoride .37 mg/440mg | Tablet, ChewableDental | Kaylaan LLC | 82091-116 | 82091-0116-01 |
| Kaylaanzero waste refill for toothpaste | Sodium fluoride .37 mg/440mg | Tablet, ChewableDental | Kaylaan LLC | 82091-112 | 82091-0112-11 |
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 |
|---|---|---|---|---|
| HurriCaine Topical Anestheticbenzocaine | Benzocaine 200 mg/g | GelDental, Oral, Periodontal | Beutlich Pharmaceuticals, LLC | 0283-1820 |
| Organic Peppermint Herb Throat Dropsmenthol | Menthol 1.9 mg/1 | LozengeOral | Ricola USA Inc. | 63667-010 |
| Equate Sculpted White TP Equate Sculpted White TPsodium fluoride | Sodium fluoride .15 g/100g | Paste, DentifriceOral | Walmart | 79903-282 |
| Ki No Sincalcium carbonate | Calcium carbonate 55 mg/500mg | TabletOral | NPG Bio Pharmaceuticals Co.,Ltd. | 84540-322 |
| R B onephosphatidylserine, zinc oxide | Zinc oxide 6.38 mg/1100mg + 2 more ingredients | TabletOral | NPG Bio Pharmaceuticals Co.,Ltd. | 84540-140 |
| Sensodynepotassium nitrate and sodium fluoride | Potassium nitrate 50 mg/g; Sodium fluoride 1.1 mg/g | PasteDental | Haleon US Holdings LLC | 0135-0550 |
| parodontaxstannous fluoride | Stannous fluoride 1.1 mg/g | PasteDental | Haleon US Holdings LLC | 0135-0598 |
| CVS Health Sensitive Enamel Repairsodium fluoride | Sodium fluoride .15 g/100g; Potassium nitrate 5 g/100g | Paste, DentifriceOral | CVS | 51316-169 |
| Alzh Lphosphatidylserine, magnesium oxide | Phosphatidyl serine 214.43 mg/450mg + 2 more ingredients | TabletOral | NPG Bio Pharmaceuticals Co.,Ltd. | 84540-230 |
| Topicalebenzocaine | Benzocaine 180 mg/g | OintmentOral | Medical Products Laboratories, Inc. | 10733-162 |
| Walgreens Maximum Strengthbenzocaine | Benzocaine 20 g/100g | Paste, DentifriceTopical | Walgreens | 0363-5337 |
| Walgreens Maximum Strengthbenzocaine | Benzocaine 20 g/100g | LiquidOral | Walgreens | 0363-5820 |
| Dem Zerophosphatidylserine, magnesium oxide | Phosphatidyl serine 214.43 mg/450mg + 2 more ingredients | TabletOral | NPG Bio Pharmaceuticals Co.,Ltd. | 84540-240 |
| Benzoin Tincturebenzoin resin | Benzoin resin 1000 mg/mL | LiquidTopical | 116956644 | 70677-1200 |
| Rite Aid Maximum Strengthbenzocaine | Benzocaine 20 g/100g | LiquidOral | Rite Aid | 11822-0345 |
| Chloraseptic Sore Throat Citrusphenol | Phenol 1.4 g/100mL | SprayOral | Prestige Brands Holdings, Inc. | 67172-112 |
| Sore Throat Relief Cherry Flavorphenol | Phenol 1.4 g/100mL | SprayOral | Cardinal Health | 70000-0458 |
| HurriCaine Topical Anesthetic Gelbenzocaine | Benzocaine 200 mg/g | GelDental, Oral, Periodontal | Beutlich Pharmaceuticals, LLC | 0283-0293 |
| Rite Aid Professional Strengthbenzocaine | Benzocaine 20 g/100g | LiquidOral | Rite Aid | 11822-5340 |
| Benzocaine 20% | Benzocaine 200 mg/mL | SolutionTopical | PAI Holdings, LLC dba PAI Pharma | 0121-1077 |
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