Over-the-counter drug · OTC MONOGRAPH DRUG
Otix Ear wax Removal System Ear wax and Bulb (Carbamide peroxide) NDC 15579-839
Kit · Bell Pharmaceuticals, Inc.
NDC codes
FDA NDC Directory| Package NDC | 11-digit (billing) | Package | Copy |
|---|---|---|---|
| 15579-839-33 | 1557908393315579083933 | 1 KIT in 1 KIT (15579-839-33) * 1 BOTTLE in 1 BOX (15579-838-34) / 15 mL in 1 BOTTLEMarketed from Oct 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)
- Otix Ear wax Removal System Ear wax and Bulb
- Generic name (nonproprietary)
- carbamide peroxide
- Dosage form
- Kit
- Labeler
- Bell Pharmaceuticals, Inc.NDC labeler code 15579
- Product type
- Over-the-counter drug
- Marketing category
- OTC monograph drugApplication M 014
- Marketing start
- Listing expires
- Identifiers
- Product ID 15579-839_0c7fb23c-2434-ee25-e063-6394a90a9f53SPL ID 0c7fb23c-2434-ee25-e063-6394a90a9f53SPL set ID 15868798-28cd-4495-9baf-711e81ad8bddRxCUI 702050, 2588948UPC 0023074805784
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
N415579083933followed by a unit qualifier and the quantityPackage 15579-0839-33. 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 for occasional use as an aid to soften, loosen, and remove excessive earwax
Excerpt only. Read the full label for complete information.
About NDC 15579-839
- What is NDC 15579-839?
- 15579-839 is the product NDC for Otix Ear wax Removal System Ear wax and Bulb kit, listed with the FDA by Bell Pharmaceuticals, Inc.. It has 1 package NDC, shown above in 10- and 11-digit form.
- What drug is associated with this NDC?
- Otix Ear wax Removal System Ear wax and Bulb (Carbamide peroxide).
- Who is the labeler?
- Bell Pharmaceuticals, Inc., NDC labeler code 15579. The labeler is the company responsible for the label; it may be the manufacturer, a repackager or a distributor.
- What other NDCs exist for Otix Ear wax Removal System Ear wax and Bulb?
- 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 014
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 |
|---|---|---|---|---|
| Family Care Earwax Removalcarbamide peroxide | Carbamide peroxide .065 mg/mL | LiquidAuricular (Otic) | United Exchange Corp. | 65923-639 |
| Pain Be Gonementhol | Menthol 9.6 mg/mL | CreamTopical | Back to Earth Inc. | 82721-001 |
| Ear Wax Removal Dropscarbamide peroxide - 6.5% | Carbamide peroxide 65 mg/mL | Solution/ dropsTopical | GeriCare Pharmaceutical Corp | 57896-339 |
| DG Health Earwax Removal kitcarbamide peroxide 6.5% | Carbamide peroxide 65 mg/mL | Solution/ dropsTopical | DOLLAR GENERAL CORPORATION | 75712-301 |
| Meijer Earwax Removal Dropscarbamide peroxide | Carbamide peroxide 65 mg/mL | Solution/ dropsAuricular (Otic) | Meijer Distribution Inc | 41250-282 |
| Best Choice Earwax Removal Kitcarbamide peroxide | Carbamide peroxide 65 mg/mL | LiquidTopical | Valu Merchandisers, Co. | 63941-835 |
| LEADER Ear Drops for Swimmers | Isopropyl alcohol 950 mg/mL | LiquidAuricular (Otic) | Cardinal Health, 110 dba Leader | 70000-0478 |
| Best Choice Earwax Removal Dropscarbamide peroxide | Carbamide peroxide 65 mg/mL | Solution/ dropsAuricular (Otic) | Valu Merchandisers Company | 63941-836 |
| CaseysDishwashingSoapdishwashing detergent juniper forest | Chloroxylenol .2 g/100g | LiquidCutaneous, Topical | KYNC DESIGN LLC | 76557-050 |
| CaseysLavendercaseys hand soap lavender scent | Benzalkonium chloride .13 g/100g | LiquidTopical | KYNC Design LLC | 76557-051 |
| TheraSealdimethicone | Dimethicone 1.7 g/170.1g | CreamTopical | Bausch Health US, LLC | 0187-1660 |
| Rite Aid Earwax Removal Dropscarbamide peroxide | Carbamide peroxide 6.5 g/100mL | LiquidTopical | Rite Aid | 11822-6117 |
| GenRx Anti-Bacterial Gelalcohol | Alcohol 62 mL/100mL | LiquidTopical | PureTek Corporation | 59088-299 |
| TopCare Swimmers Ear Dropsisopropyl alcohol | Isopropyl alcohol 950 mg/mL | LiquidAuricular (Otic) | TOPCO ASSOCIATES | 36800-064 |
| fungoid tincturemiconazole nitrate | Miconazole nitrate 20 mg/mL | TinctureTopical | Pedinol Pharmacal, Inc. | 0884-0293 |
| Germa Ubre Mastitismethyl salicylate 2% | Methyl salicylate 20 mg/mL | OintmentTopical | Germa Products, LLC | 73635-5807 |
| Germa Manteca Ubre Plus (TIN)methyl salicylate 10% | Methyl salicylate 100 mg/mL | OintmentTopical | Germa Products, LLC | 73635-5805 |
| Alcohol Wipeswipe em alcohol wipes | Alcohol 75 mL/100mL | ClothTopical | Shaoxing Elite Bio-Tech Co., Ltd. | 81079-003 |
| Earwax Removal Dropscarbamide peroxide 6.5% | Carbamide peroxide .065 mg/mL | LiquidAuricular (Otic) | Humco Holding Group, Inc | 0395-9133 |
| Clearcanal Ear Wax Softerner Dropscarbamide peroxide | Carbamide peroxide 65 mg/mL | Solution/ dropsAuricular (Otic) | A-S Medication Solutions | 50090-7426 |
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