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 | 53145031104 | 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, Inc
- 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.
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 |
|---|---|---|---|---|
| Quality Choice Earwax Removal Dropscarbamide peroxide | Carbamide peroxide 65 mg/mL | LiquidTopical | Chain Drug Marketing Association, Inc. | 63868-027 |
| Quality Choice Earwax Removal Kitcarbamide peroxide | Carbamide peroxide 65 mg/mL | LiquidTopical | Chain Drug Marketing Association, Inc. | 63868-026 |
| DISCOUNT drug mart FOOD FAIR earwax removal kitcarbamide peroxide | Carbamide peroxide 65 mg/mL | SolutionTopical | Discount Drug Mart | 53943-835 |
| Dri-Ear | Isopropyl alcohol 950 mg/mL | Suspension/ dropsAuricular (Otic) | S.S.S. Company | 12258-153 |
| LEADER Ear Drops for Swimmers | Isopropyl alcohol 950 mg/mL | LiquidAuricular (Otic) | Cardinal Health, 110 dba Leader | 70000-0478 |
| Discount Drug Mart Earwax Removal Dropscarbamide peroxide | Carbamide peroxide 65 mg/mL | Solution/ dropsAuricular (Otic) | Discount Drug Mart | 53943-838 |
| Family Care Earwax Removalcarbamide peroxide | Carbamide peroxide .065 mg/mL | LiquidAuricular (Otic) | United Exchange Corp. | 65923-639 |
| 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 |
| Bodyographypro Anti-Bacterial Sanitizingethyl alcohol | Alcohol 60 mL/100mL | SprayTopical | Robanda International, Inc. | 53950-6010 |
| Harris Teeter Earwax Removal Dropscarbamide peroxide 6.5% | Carbamide peroxide 6.5 g/100mL | LiquidTopical | Harris Teeter LLC | 69256-117 |
| Hand Sanitizing with Lavender Oilalcohol | Alcohol 62 mL/100mL | GelTopical | PureTek Corporation | 59088-413 |
| ear dropscarbamide peroxide 6.5% | Carbamide peroxide .065 mg/mL | LiquidAuricular (Otic) | Bionpharma Inc. | 69452-377 |
| Family Wellness Earwax Removal Earwax and Bulbcarbamide peroxide | — | Kit | Family Dollar Services Inc | 55319-835 |
| Freskaro Earwax Removal Aidcarbamide peroxide 6.50% kit | Carbamide peroxide 6.5 g/100mL | LiquidAuricular (Otic) | Pharma Nobis, LLC | 82645-097 |
| Ear Wax Removal Drops Up and Upcarbamide peroxide - 6.5% | Carbamide peroxide 65 mg/mL | Solution/ dropsTopical | Target Corporation | 11673-761 |
| Freskaro Ear Drops for Swimmers | Glycerin 50 mg/mL; Isopropyl alcohol 950 mg/mL | LiquidAuricular (Otic) | Pharma Nobis, LLC | 82645-098 |
| Clinere Ear Wax Removercarbamide peroxide | Carbamide peroxide .065 g/mL | LiquidAuricular (Otic) | Quest Products | 68229-102 |
| XIMONTH Wart Removerglycerin | Artemisia vulgaris root .004 mg/20mg + 2 more ingredients | OintmentTopical | Shantou Ximonth Biotechnology Co., Ltd. | 84989-004 |
| Earwax Removal Dropscarbamide peroxide 6.5% | Carbamide peroxide .065 mg/mL | LiquidAuricular (Otic) | Pharma Nobis, LLC | 82645-910 |
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