Over-the-counter drug · OTC MONOGRAPH DRUG
Debrox (Carbamide peroxide) NDC 63029-321
Carbamide peroxide 65 mg/mL · Liquid · Auricular (Otic) · Medtech Products Inc.
NDC codes
FDA NDC Directory| Package NDC | 11-digit (billing) | Package | Copy |
|---|---|---|---|
| 63029-321-01 | 6302903210163029032101 | 1 BOTTLE, DROPPER in 1 CARTON (63029-321-01) / 15 mL in 1 BOTTLE, DROPPERMarketed from Aug 1, 2012 | |
| 63029-321-02 | 6302903210263029032102 | 1 BOTTLE, DROPPER in 1 CARTON (63029-321-02) / 15 mL in 1 BOTTLE, DROPPERMarketed from Aug 1, 2012 |
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)
- Debrox
- Generic name (nonproprietary)
- carbamide peroxide
- Active ingredients
- Carbamide peroxide — 65 mg/mL
- Dosage form
- Liquid
- Route
- Auricular (Otic)
- Labeler
- Medtech Products Inc.NDC labeler code 63029
- Product type
- Over-the-counter drug
- Marketing category
- OTC monograph drugApplication M 014
- Marketing start
- Listing expires
- Identifiers
- Product ID 63029-321_69ef758d-a912-4696-8f5e-ac6cd1aa63dcSPL ID 69ef758d-a912-4696-8f5e-ac6cd1aa63dcSPL set ID 43649ba3-75e0-4dcf-9172-23767dbaeda6RxCUI 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
N463029032101followed by a unit qualifier and the quantityPackage 63029-0321-01. 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 For occasional use as an aid to soften, loosen, and remove excessive earwax
Excerpt only. Read the full label for complete information.
About NDC 63029-321
- What is NDC 63029-321?
- 63029-321 is the product NDC for Debrox (carbamide peroxide), Carbamide peroxide 65 mg/mL liquid, listed with the FDA by Medtech Products Inc.. It has 2 package NDCs, 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?
- Medtech Products Inc., NDC labeler code 63029. 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) | A-S Medication Solutions | 50090-4201 | 50090-4201-00 |
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 |
| Debroxcarbamide peroxide | Carbamide peroxide 65 mg/mL | LiquidAuricular (Otic) | A-S Medication Solutions | 50090-4201 |
| 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 |
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