Over-the-counter drug · OTC MONOGRAPH DRUG
Major Earwax Removal Drops Earwax Removal Aid (Carbamide peroxide) NDC 0904-7478
Carbamide peroxide 65 mg/mL · Solution/ drops · Topical · Major Pharmaceuticals
NDC codes
FDA NDC Directory| Package NDC | 11-digit (billing) | Package | Copy |
|---|---|---|---|
| 0904-7478-35 | 00904747835 | 1 BOTTLE in 1 BOX (0904-7478-35) / 15 mL in 1 BOTTLEMarketed from Jul 9, 2024 |
How the 11-digit form is made: The labeler segment has 4 digits, so one leading zero is added to it (4-4-2 → 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)
- Major Earwax Removal Drops Earwax Removal Aid
- Generic name (nonproprietary)
- carbamide peroxide
- Active ingredients
- Carbamide peroxide — 65 mg/mL
- Dosage form
- Solution/ drops
- Route
- Topical
- Labeler
- Major PharmaceuticalsNDC labeler code 0904
- Product type
- Over-the-counter drug
- Marketing category
- OTC monograph drugApplication M 014
- Marketing start
- Listing expires
- Identifiers
- Product ID 0904-7478_1f7fbab4-f5a2-0187-e063-6394a90afba1SPL ID 1f7fbab4-f5a2-0187-e063-6394a90afba1SPL set ID 513bf82e-a36f-49d0-ba74-c834fea4f3b5RxCUI 702050UNII 31PZ2VAU81UPC 0309047478354
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
N400904747835followed by a unit qualifier and the quantityPackage 00904-7478-35. 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 0904-7478
- What is NDC 0904-7478?
- 0904-7478 is the product NDC for Major Earwax Removal Drops Earwax Removal Aid, Carbamide peroxide 65 mg/mL solution/ drops, listed with the FDA by Major Pharmaceuticals. It has 1 package NDC, shown above in 10- and 11-digit form.
- What drug is associated with this NDC?
- Major Earwax Removal Drops Earwax Removal Aid (Carbamide peroxide).
- What is the active ingredient?
- Carbamide peroxide.
- Who is the labeler?
- Major Pharmaceuticals, NDC labeler code 0904. The labeler is the company responsible for the label; it may be the manufacturer, a repackager or a distributor.
- What other NDCs exist for Major Earwax Removal Drops Earwax Removal Aid?
- 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 |
| 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 |
| clotrimazole | Clotrimazole 1 g/100g | CreamTopical | NuCare Pharmaceuticals, Inc. | 68071-3395 |
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