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 |
|---|---|---|---|---|
| Alcohol Wipeswipe em alcohol wipes | Alcohol 75 mL/100mL | ClothTopical | Shaoxing Elite Bio-Tech Co., Ltd. | 81079-003 |
| Audiologists Choice Earwax Removal Aid Dropscarbamide peroxide | Carbamide peroxide 65 mg/mL | Solution/ dropsAuricular (Otic) | Oaktree Products Inc | 59256-836 |
| Audiologists Choice Earwax Removal Systemcarbamide peroxide | Carbamide peroxide 65 mg/mL | LiquidTopical | Oaktree Products Inc. | 59256-001 |
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| Bacitracin | Bacitracin 500 [USP'U]/g | OintmentTopical | NuCare Pharmaceuticals,Inc. | 68071-5253 |
| Benzoyl Peroxide Acne Medicationbenzoyl peroxide | Benzoyl peroxide 50 mg/mL | GelTopical | NuCare Pharmaceuticals,Inc. | 68071-2307 |
| Best Choice Earwax Removal Dropscarbamide peroxide | Carbamide peroxide 65 mg/mL | Solution/ dropsAuricular (Otic) | Valu Merchandisers Company | 63941-836 |
| Best Choice Earwax Removal Kitcarbamide peroxide | Carbamide peroxide 65 mg/mL | LiquidTopical | Valu Merchandisers, Co. | 63941-835 |
| blue goo FREEZING PAIN RELIEF Topical Analgesicmenthol 4% | Menthol 40 mg/mL | LiquidTopical | Garcoa, Inc. | 67385-286 |
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| Bodyographypro Anti-Bacterial Sanitizingethyl alcohol | Alcohol 60 mL/100mL | SprayTopical | Robanda International, Inc. | 53950-6010 |
| Caladrylferric oxide red, zinc oxide, and pramoxine hydrochloride | Ferric oxide red 1.36 mg/mL + 2 more ingredients | LotionTopical | Bausch Health US, LLC | 0187-5465 |
| Caladryl Clearpramoxine hydrochloride and zinc acetate | Pramoxine hydrochloride 10 mg/mL; Zinc acetate 1 mg/mL | LotionTopical | Bausch Health US, LLC | 0187-5466 |
| Carbamide peroxide 6.5%earwax removal kit | Carbamide peroxide 65 mg/mL | Solution/ dropsAuricular (Otic) | Allegiant Health | 69168-488 |
| CareOne Earwax Removal Dropscarbamide peroxide | Carbamide peroxide 65 mg/mL | Solution/ dropsAuricular (Otic) | Retail Business Services, LLC | 72476-838 |
| 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 |
| ClearCanal Ear Wax Softerner Dropscarbamide peroxide | Carbamide peroxide 65 mg/mL | Solution/ dropsAuricular (Otic) | NeilMed Pharmaceuticals, Inc. | 13709-230 |
| Clearcanal Ear Wax Softerner Dropscarbamide peroxide | Carbamide peroxide 65 mg/mL | Solution/ dropsAuricular (Otic) | A-S Medication Solutions | 50090-7426 |
| Clinere Ear Wax Removercarbamide peroxide | Carbamide peroxide .065 g/mL | LiquidAuricular (Otic) | Quest Products | 68229-102 |
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