Over-the-counter drug · OTC MONOGRAPH DRUG
Debrox (Carbamide peroxide) NDC 50090-4201
Carbamide peroxide 65 mg/mL · Liquid · Auricular (Otic) · A-S Medication Solutions
NDC codes
FDA NDC Directory| Package NDC | 11-digit (billing) | Package | Copy |
|---|---|---|---|
| 50090-4201-0 | 5009042010050090420100 | 1 BOTTLE, DROPPER in 1 CARTON (50090-4201-0) / 15 mL in 1 BOTTLE, DROPPERMarketed from Mar 19, 2019 |
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)
- Debrox
- Generic name (nonproprietary)
- carbamide peroxide
- Active ingredients
- Carbamide peroxide — 65 mg/mL
- Dosage form
- Liquid
- Route
- Auricular (Otic)
- Labeler
- A-S Medication SolutionsNDC labeler code 50090
- Product type
- Over-the-counter drug
- Marketing category
- OTC monograph drugApplication M 014
- Marketing start
- Listing expires
- Identifiers
- Product ID 50090-4201_b34a6756-91f6-448d-be3f-a40632075df0SPL ID b34a6756-91f6-448d-be3f-a40632075df0SPL set ID 8d6f1769-eb44-4bde-b3fa-3ff4658b7dd1RxCUI 702050, 827654UNII 31PZ2VAU81
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
N450090420100followed by a unit qualifier and the quantityPackage 50090-4201-00. 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 50090-4201
- What is NDC 50090-4201?
- 50090-4201 is the product NDC for Debrox (carbamide peroxide), Carbamide peroxide 65 mg/mL liquid, listed with the FDA by A-S Medication Solutions. It has 1 package NDC, shown above in 10- and 11-digit form.
- What drug is associated with this NDC?
- Debrox (Carbamide Peroxide).
- What is the active ingredient?
- Carbamide peroxide.
- Who is the labeler?
- A-S Medication Solutions, NDC labeler code 50090. The labeler is the company responsible for the label; it may be the manufacturer, a repackager or a distributor.
- What other NDCs exist for Debrox?
- 1 other product NDC are listed under this name. See all Debrox NDCs.
- Is there a related HCPCS / J-code?
- Not in Med-Code's curated HCPCS directory. See Billing references above.
Related NDCs: other Debrox products
Other finished products listed under the same name: strengths, forms and labelers.
| Product | Strength | Form · route | Labeler | Product NDC | Package NDCs (11-digit) |
|---|---|---|---|---|---|
| Debroxcarbamide peroxide | Carbamide peroxide 65 mg/mL | LiquidAuricular (Otic) | Medtech Products Inc. | 63029-321 | 63029-0321-0163029-0321-02 |
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 |
|---|---|---|---|---|
| Audiologists Choice Earwax Removal Aid Dropscarbamide peroxide | Carbamide peroxide 65 mg/mL | Solution/ dropsAuricular (Otic) | Oaktree Products Inc | 59256-836 |
| TopCare Earwax Removal Dropscarbamide peroxide | Carbamide peroxide 65 mg/mL | Solution/ dropsAuricular (Otic) | Topco Associates LLC | 76162-836 |
| Equate Swimmers Instant Ear Dry | Isopropyl alcohol 950 mg/mL | LiquidAuricular (Otic) | Walmart Stores, Inc | 49035-989 |
| Macks Dry n Clearear drying aid | Isopropyl alcohol 950 mg/mL | LiquidAuricular (Otic) | McKeon Products Inc | 66354-001 |
| Wax Away Earwax Removal Aidcarbamide peroxide | Carbamide peroxide 65 mg/mL | Solution/ dropsAuricular (Otic) | McKeon Products Inc | 66354-005 |
| Wax Away Earwax Removal Systemcarbamide peroxide | Carbamide peroxide 65 mg/mL | Solution/ dropsAuricular (Otic) | McKeon Products Inc | 66354-006 |
| ProRinse Earwax Removal Systemcarbamide peroxide | Carbamide peroxide 65 mg/mL | Solution/ dropsAuricular (Otic) | McKeon Products Inc | 66354-007 |
| HylaTearseye drops | Hypromellose 2910 (4000 mpa.s) 3 mg/10mL | LiquidOphthalmic | Hyalogic LLC | 72094-001 |
| Dri-Ear | Isopropyl alcohol 950 mg/mL | Suspension/ dropsAuricular (Otic) | S.S.S. Company | 12258-153 |
| Ear Wash Refill Equatecarbamide peroxide | — | Kit | Walmart | 79903-403 |
| ERO Ear Wax Removal Kitcarbamide peroxide 6.5% | Carbamide peroxide 6.5 g/100mL | LiquidTopical | Randob Labs | 52412-175 |
| GoodSense Ear Wax Removal Kitcarbamide peroxide | Carbamide peroxide 6.5 g/100mL | LiquidTopical | Geiss, Destin & Dunn, Inc | 50804-117 |
| Foster and Thrive Earwax Removal Kit Ear wax dropscarbamide peroxide | — | Kit | Mckesson Corp. Via Strategic Sourcing Services | 70677-1153 |
| HANCHOBIT Lemon Turmeric Kojic Acid Brighteningglycerin | Lemon .02 g/100g; Turmeric .02 g/100g | SoapTopical | HANCHOYEANBIOTEC Co.,Ltd. | 85164-002 |
| Foster and Thrive Earwax Removal Dropscarbamide peroxide | Carbamide peroxide 65 mg/mL | Solution/ dropsTopical | Mckesson Corp. Via Strategic Sourcing Services | 70677-1154 |
| Earwax Removal Dropscarbamide peroxide 6.5% | Carbamide peroxide .065 mg/mL | LiquidAuricular (Otic) | Randob Labs, Ltd. | 52412-600 |
| Auralytcarbamide peroxide | Carbamide peroxide 7.8 mg/12mL | LiquidTopical | Menper Distributors, Inc | 53145-311 |
| Major Earwax Removal Drops Earwax Removal Aidcarbamide peroxide | Carbamide peroxide 65 mg/mL | Solution/ dropsTopical | Major Pharmaceuticals | 0904-7478 |
| JAYSUING Silicone Scar Gelglycerin | Centella asiatica root .006 mg/30mg | GelTopical | Shantou Jaysuing Cleaning and Environmental Protection Technology Co., Ltd. | 85060-007 |
| Ear Drops Majorcarbamide peroxide 6.5% | Carbamide peroxide 6.5 g/100mL | LiquidAuricular (Otic) | A-S Medication Solutions | 50090-5273 |
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