Over-the-counter drug · OTC MONOGRAPH DRUG
Auralyt (Carbamide peroxide) NDC 53145-311
Carbamide peroxide 7.8 mg/12mL · Liquid · Topical · Menper Distributors, Inc
NDC codes
FDA NDC Directory| Package NDC | 11-digit (billing) | Package | Copy |
|---|---|---|---|
| 53145-311-04 | 5314503110453145031104 | 1 BOTTLE, DROPPER in 1 CARTON (53145-311-04) / 12 mL in 1 BOTTLE, DROPPERMarketed from Jan 1, 2014 |
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)
- Auralyt
- Generic name (nonproprietary)
- carbamide peroxide
- Active ingredients
- Carbamide peroxide — 7.8 mg/12mL
- Dosage form
- Liquid
- Route
- Topical
- Labeler
- Menper Distributors, IncNDC labeler code 53145
- Product type
- Over-the-counter drug
- Marketing category
- OTC monograph drugApplication M 014
- Marketing start
- Listing expires
- Identifiers
- Product ID 53145-311_3a8ad090-e1c6-7ea7-e063-6394a90a6ffcSPL ID 3a8ad090-e1c6-7ea7-e063-6394a90a6ffcSPL set ID 95920b87-941f-48cb-850c-40d2735596d4UNII 31PZ2VAU81UPC 0042279104010
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
N453145031104followed by a unit qualifier and the quantityPackage 53145-0311-04. 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 53145-311
- What is NDC 53145-311?
- 53145-311 is the product NDC for Auralyt (carbamide peroxide), Carbamide peroxide 7.8 mg/12mL liquid, listed with the FDA by Menper Distributors, Inc. It has 1 package NDC, shown above in 10- and 11-digit form.
- What drug is associated with this NDC?
- Auralyt (Carbamide Peroxide).
- What is the active ingredient?
- Carbamide peroxide.
- Who is the labeler?
- Menper Distributors, Inc, NDC labeler code 53145. The labeler is the company responsible for the label; it may be the manufacturer, a repackager or a distributor.
- What other NDCs exist for Auralyt?
- 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 |
|---|---|---|---|---|
| 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 |
| 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 |
| Ear Drops Majorcarbamide peroxide 6.5% | Carbamide peroxide 6.5 g/100mL | LiquidAuricular (Otic) | A-S Medication Solutions | 50090-5273 |
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