Over-the-counter drug · OTC MONOGRAPH DRUG
ProRinse Earwax Removal System (Carbamide peroxide) NDC 66354-007
Carbamide peroxide 65 mg/mL · Solution/ drops · Auricular (Otic) · McKeon Products Inc
NDC codes
FDA NDC Directory| Package NDC | 11-digit (billing) | Package | Copy |
|---|---|---|---|
| 66354-007-82 | 66354000782 | 1 BOTTLE in 1 BOX (66354-007-82) / 15 mL in 1 BOTTLEMarketed from Feb 5, 2026 |
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)
- ProRinse Earwax Removal System
- Generic name (nonproprietary)
- carbamide peroxide
- Active ingredients
- Carbamide peroxide — 65 mg/mL
- Dosage form
- Solution/ drops
- Route
- Auricular (Otic)
- Labeler
- McKeon Products IncNDC labeler code 66354
- Product type
- Over-the-counter drug
- Marketing category
- OTC monograph drugApplication M 014
- Marketing start
- Listing expires
- Identifiers
- Product ID 66354-007_4a636cb5-104c-7811-e063-6294a90afcb0SPL ID 4a636cb5-104c-7811-e063-6294a90afcb0SPL set ID ca82db28-1ef7-41c6-a46b-7bfc7b09281cRxCUI 702050UNII 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
N466354000782followed by a unit qualifier and the quantityPackage 66354-0007-82. 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 66354-007
- What is NDC 66354-007?
- 66354-007 is the product NDC for ProRinse Earwax Removal System (carbamide peroxide), Carbamide peroxide 65 mg/mL solution/ drops, listed with the FDA by McKeon Products Inc. It has 1 package NDC, shown above in 10- and 11-digit form.
- What drug is associated with this NDC?
- ProRinse Earwax Removal System (Carbamide peroxide).
- What is the active ingredient?
- Carbamide peroxide.
- Who is the labeler?
- McKeon Products Inc, NDC labeler code 66354. The labeler is the company responsible for the label; it may be the manufacturer, a repackager or a distributor.
- What other NDCs exist for ProRinse Earwax Removal System?
- 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 |
|---|---|---|---|---|
| Foster and Thrive Earwax Removal Kit Ear wax dropscarbamide peroxide | — | Kit | Mckesson Corp. Via Strategic Sourcing Services | 70677-1153 |
| Foster and Thrive Earwax Removal Dropscarbamide peroxide | Carbamide peroxide 65 mg/mL | Solution/ dropsTopical | Mckesson Corp. Via Strategic Sourcing Services | 70677-1154 |
| Good Neighbor Pharmacy Earwax Removal Dropscarbamide peroxide | Carbamide peroxide 65 mg/mL | LiquidTopical | Preferred Pharmaceuticals Inc. | 68788-8586 |
| CVS Health Earwax Removal Drops Earwax Removal Aidcarbamide peroxide | Carbamide peroxide 65 mg/mL | Solution/ dropsTopical | CVS Pharmacy, Inc. | 51316-822 |
| CVS Health Earwax Removal Kitcarbamide peroxide | — | Kit | CVS Pharmacy, Inc. | 51316-823 |
| HUMCO Ear Drops for Swimmersisopropyl alcohol | Isopropyl alcohol 950 mg/mL | LiquidAuricular (Otic) | Humco Holding Group, Inc. | 0395-0098 |
| Ear Wax Removal Drops Up and Upcarbamide peroxide - 6.5% | Carbamide peroxide 65 mg/mL | Solution/ dropsTopical | Target Corporation | 11673-761 |
| Walgreens Ear Wax Removercarbamide peroxide 6.5% | Carbamide peroxide .065 mg/mL | LiquidAuricular (Otic) | Walgreens Company | 0363-2068 |
| Deluxe Ear Wash systemcarbamide peroxide | — | Kit | Walgreens | 0363-2231 |
| EarBalance Ear Pain Dropslidocaine hydrochloride otic solution | Lidocaine 40 mg/mL | Solution/ dropsAuricular (Otic) | Marie's Original Formulas LLC | 87541-644 |
| EarBalance Ear Pain Dropslidocaine hydrochloride otic solution | Lidocaine 40 mg/mL | Solution/ dropsAuricular (Otic) | Marie's Original Formulas LLC | 87541-896 |
| CareOne Earwax Removal Dropscarbamide peroxide | Carbamide peroxide 65 mg/mL | Solution/ dropsAuricular (Otic) | Retail Business Services, LLC | 72476-838 |
| Meijer Earwax Removal Kitcarbamide peroxide | Carbamide peroxide 65 mg/mL | LiquidTopical | Meijer Distribution Inc. | 41250-835 |
| Major Earwax Removal Drops Earwax Removal Aidcarbamide peroxide | Carbamide peroxide 65 mg/mL | Solution/ dropsTopical | Major Pharmaceuticals | 0904-7478 |
| Debrox Swimmers Earisopropyl alcohol | Isopropyl alcohol 95 mL/100mL | LiquidAuricular (Otic) | Medtech Products Inc. | 63029-323 |
| Clearcanal Ear Wax Softerner Dropscarbamide peroxide | Carbamide peroxide 65 mg/mL | Solution/ dropsAuricular (Otic) | A-S Medication Solutions | 50090-7426 |
| Debroxcarbamide peroxide | Carbamide peroxide 65 mg/mL | LiquidAuricular (Otic) | Medtech Products Inc. | 63029-321 |
| DDM Ear Drops for Swimmersisopropyl alcohol | Isopropyl alcohol 950 mg/mL | LiquidAuricular (Otic) | Discount Drug Mart | 53943-098 |
| Bacitracin | Bacitracin 500 [USP'U]/g | OintmentTopical | NuCare Pharmaceuticals,Inc. | 68071-5253 |
| Debrox Kidsisopropyl alcohol | Isopropyl alcohol 95 mL/100mL | LiquidAuricular (Otic) | Medtech Products Inc. | 63029-325 |
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