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 |
|---|---|---|---|---|
| Alcohol Wipeswipe em alcohol wipes | Alcohol 75 mL/100mL | ClothTopical | Shaoxing Elite Bio-Tech Co., Ltd. | 81079-003 |
| Audiologists Choice Earwax Removal Aid Dropscarbamide peroxide | Carbamide peroxide 65 mg/mL | Solution/ dropsAuricular (Otic) | Oaktree Products Inc | 59256-836 |
| Audiologists Choice Earwax Removal Systemcarbamide peroxide | Carbamide peroxide 65 mg/mL | LiquidTopical | Oaktree Products Inc. | 59256-001 |
| Auralytcarbamide peroxide | Carbamide peroxide 7.8 mg/12mL | LiquidTopical | Menper Distributors, Inc | 53145-311 |
| Auro Driisopropyl alcohol | Isopropyl alcohol 95 mL/100mL | LiquidAuricular (Otic) | Insight Pharmaceuticals LLC | 63736-327 |
| Bacitracin | Bacitracin 500 [USP'U]/g | OintmentTopical | NuCare Pharmaceuticals,Inc. | 68071-5253 |
| Benzoyl Peroxide Acne Medicationbenzoyl peroxide | Benzoyl peroxide 50 mg/mL | GelTopical | NuCare Pharmaceuticals,Inc. | 68071-2307 |
| Best Choice Earwax Removal Dropscarbamide peroxide | Carbamide peroxide 65 mg/mL | Solution/ dropsAuricular (Otic) | Valu Merchandisers Company | 63941-836 |
| Best Choice Earwax Removal Kitcarbamide peroxide | Carbamide peroxide 65 mg/mL | LiquidTopical | Valu Merchandisers, Co. | 63941-835 |
| blue goo FREEZING PAIN RELIEF Topical Analgesicmenthol 4% | Menthol 40 mg/mL | LiquidTopical | Garcoa, Inc. | 67385-286 |
| blue goo NERVE EASE Pain RELIEF Topical Analgesiclidocaine hcl 4%, menthol 1% | Lidocaine 40 mg/mL; Menthol 10 mg/mL | LiquidTopical | Garcoa, Inc. | 67385-825 |
| Bodyographypro Anti-Bacterial Sanitizingethyl alcohol | Alcohol 60 mL/100mL | SprayTopical | Robanda International, Inc. | 53950-6010 |
| Caladrylferric oxide red, zinc oxide, and pramoxine hydrochloride | Ferric oxide red 1.36 mg/mL + 2 more ingredients | LotionTopical | Bausch Health US, LLC | 0187-5465 |
| Caladryl Clearpramoxine hydrochloride and zinc acetate | Pramoxine hydrochloride 10 mg/mL; Zinc acetate 1 mg/mL | LotionTopical | Bausch Health US, LLC | 0187-5466 |
| Carbamide peroxide 6.5%earwax removal kit | Carbamide peroxide 65 mg/mL | Solution/ dropsAuricular (Otic) | Allegiant Health | 69168-488 |
| CareOne Earwax Removal Dropscarbamide peroxide | Carbamide peroxide 65 mg/mL | Solution/ dropsAuricular (Otic) | Retail Business Services, LLC | 72476-838 |
| 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 |
| ClearCanal Ear Wax Softerner Dropscarbamide peroxide | Carbamide peroxide 65 mg/mL | Solution/ dropsAuricular (Otic) | NeilMed Pharmaceuticals, Inc. | 13709-230 |
| Clearcanal Ear Wax Softerner Dropscarbamide peroxide | Carbamide peroxide 65 mg/mL | Solution/ dropsAuricular (Otic) | A-S Medication Solutions | 50090-7426 |
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