Over-the-counter drug · OTC MONOGRAPH DRUG
Kalaya Breath Refresh (Mouthwash) NDC 43493-0005
Cetylpyridinium chloride .7 mg/mL · Liquid · Oral · Avaria Health and Beauty Corp
NDC codes
FDA NDC Directory| Package NDC | 11-digit (billing) | Package | Copy |
|---|---|---|---|
| 43493-0005-1 | 4349300050143493000501 | 500 mL in 1 BOTTLE, DISPENSING (43493-0005-1)Marketed from Nov 16, 2018 |
How the 11-digit form is made: The package segment has 1 digit, so one leading zero is added to it (5-4-1 → 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)
- Kalaya Breath Refresh
- Generic name (nonproprietary)
- mouthwash
- Active ingredients
- Cetylpyridinium chloride — .7 mg/mL
- Dosage form
- Liquid
- Route
- Oral
- Labeler
- Avaria Health and Beauty CorpNDC labeler code 43493
- Product type
- Over-the-counter drug
- Marketing category
- OTC monograph drugApplication M 022
- Marketing start
- Listing expires
- Identifiers
- Product ID 43493-0005_40a7a6ff-9f82-0249-e063-6294a90a257bSPL ID 40a7a6ff-9f82-0249-e063-6294a90a257bSPL set ID 750e99ff-72e4-3c2f-e053-2a91aa0ad5a0RxCUI 1100924UNII D9OM4SK49P
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
N443493000501followed by a unit qualifier and the quantityPackage 43493-0005-01. 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
Excerpt only. Read the full label for complete information.
About NDC 43493-0005
- What is NDC 43493-0005?
- 43493-0005 is the product NDC for Kalaya Breath Refresh (mouthwash), Cetylpyridinium chloride .7 mg/mL liquid, listed with the FDA by Avaria Health and Beauty Corp. It has 1 package NDC, shown above in 10- and 11-digit form.
- What drug is associated with this NDC?
- Kalaya Breath Refresh (Mouthwash).
- What is the active ingredient?
- Cetylpyridinium chloride.
- Who is the labeler?
- Avaria Health and Beauty Corp, NDC labeler code 43493. The labeler is the company responsible for the label; it may be the manufacturer, a repackager or a distributor.
- What other NDCs exist for Kalaya Breath Refresh?
- 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.
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| 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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