Over-the-counter drug · OTC MONOGRAPH DRUG
ERO Ear Wax Removal Kit (Carbamide peroxide 6.5%) NDC 52412-175
Carbamide peroxide 6.5 g/100mL · Liquid · Topical · Randob Labs
NDC codes
FDA NDC Directory| Package NDC | 11-digit (billing) | Package | Copy |
|---|---|---|---|
| 52412-175-01 | 52412017501 | 1 BOTTLE in 1 CARTON (52412-175-01) / 15 mL in 1 BOTTLEMarketed from Apr 16, 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)
- ERO Ear Wax Removal Kit
- Generic name (nonproprietary)
- carbamide peroxide 6.5%
- Active ingredients
- Carbamide peroxide — 6.5 g/100mL
- Dosage form
- Liquid
- Route
- Topical
- Labeler
- Randob LabsNDC labeler code 52412
- Product type
- Over-the-counter drug
- Marketing category
- OTC monograph drugApplication M 014
- Marketing start
- Listing expires
- Identifiers
- Product ID 52412-175_29575528-5bed-065e-e063-6394a90a4ecaSPL ID 29575528-5bed-065e-e063-6394a90a4ecaSPL set ID fbf8a6f2-531d-5047-e053-6294a90aaa01RxCUI 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 HCPCS code in Med-Code's directory. Topical products like this are usually dispensed by a pharmacy and billed by NDC.
- NDC on a medical claim
N452412017501followed by a unit qualifier and the quantityPackage 52412-0175-01. 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)
For occasional use as an aid to soften, loosen, and remove excessive earwax.
Excerpt only. Read the full label for complete information.
About NDC 52412-175
- What is NDC 52412-175?
- 52412-175 is the product NDC for ERO Ear Wax Removal Kit (carbamide peroxide 6.5%), Carbamide peroxide 6.5 g/100mL liquid, listed with the FDA by Randob Labs. It has 1 package NDC, shown above in 10- and 11-digit form.
- What drug is associated with this NDC?
- ERO Ear Wax Removal Kit (Carbamide Peroxide 6.5%).
- What is the active ingredient?
- Carbamide peroxide.
- Who is the labeler?
- Randob Labs, NDC labeler code 52412. The labeler is the company responsible for the label; it may be the manufacturer, a repackager or a distributor.
- What other NDCs exist for ERO Ear Wax Removal Kit?
- 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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