Auralyt
- Product NDC
- 53145-311
- 11-digit product format
- 531450311
- Labeler code
- 53145
- Product ID
- 53145-311_3a8ad090-e1c6-7ea7-e063-6394a90a6ffc
- Type
- HUMAN OTC DRUG
- Nonproprietary name
- Carbamide Peroxide
- Dosage form
- LIQUID
- Route
- TOPICAL
- Labeler
- Menper Distributors, Inc
- Application
- M014
- Marketing category
- OTC MONOGRAPH DRUG
- Marketing start
- 2014-01-01
- Substance
- CARBAMIDE PEROXIDE
- Active strength
- 7.8 mg/12mL
- NDC exclude flag
- No
- Listing certified through
- 2026-12-31
- Current FDA listing
- Yes
Observed NDC auxiliary status history#
This history shows the information present in each captured FDA auxiliary file. It is not a continuous regulatory timeline, and a missing record does not establish a status.
| Captured / source date | Dataset | Scope | Product NDC | Package NDC | Code | Status | Reporting period | Archive | Snapshot | Source SHA-256 |
|---|---|---|---|---|---|---|---|---|---|---|
| 2019-12-08 06:16 UTC · source 2019-12-05 | excluded product | product | 53145-311 | E | Excluded after deficient or non-compliant submission was not corrected | excluded / ndc_excluded.zip | 110d247fa046… | a55b01930146… | ||
| 2019-12-08 06:16 UTC · source 2019-12-05 | excluded package | package | 53145-311 | 53145-311-04 | E | Excluded after deficient or non-compliant submission was not corrected | excluded / ndc_excluded.zip | 110d247fa046… | a55b01930146… |
Reported adverse events (FAERS/openFDA)#
Adverse event summaries are temporarily unavailable. Other product information remains available.
Additional Listing Data#
- Finished product
- Yes
- Brand name base
- Auralyt
- Listing expiration
- 2026-12-31
Active Ingredients#
| Ingredient | Strength |
|---|---|
| CARBAMIDE PEROXIDE | 7.8 mg/12mL |
Harmonized UNII identifiers#
| Identifier | FDA.report destination |
|---|---|
| 31PZ2VAU81 | Internal UNII lookup |
Harmonized SPL set identifiers#
| Identifier | FDA.report destination |
|---|---|
| 95920b87-941f-48cb-850c-40d2735596d4 | Available on FDA.report |
DailyMed Product Concepts#
| Product concept | Relation | Version | Effective |
|---|---|---|---|
| 5eb9f24b-9328-475e-af0a-18021935eb6a | Product name | 1 | 20180220 |
FDA-Initiated Inactive NDC Indexing#
DailyMed Package Descriptions#
| Package NDC | Product | Description | Form | Quantity | Strength | SPL version |
|---|---|---|---|---|---|---|
| 53145-311-04 | Auralyt | 12 mL in 1 BOTTLE, DROPPER | LIQUID | 12 | 5 | |
| 53145-311-04 | Auralyt | 1 in 1 CARTON | LIQUID | 1 | 5 |
DailyMed Socrata Ingredients#
openFDA label cross-check#
OpenFDA label data provides additional search and identifier links. DailyMed’s Structured Product Label is the canonical label on FDA.report. Matching records are deduplicated before they are shown below.
| Brand | Generic | Manufacturer | SPL set ID | Effective date | Available safety fields | Join |
|---|---|---|---|---|---|---|
| HANCHOBIT Lemon Turmeric Kojic Acid Brightening | GLYCERIN | HANCHOYEANBIOTEC Co.,Ltd. | 2ded8f31-d72a-d123-e063-6294a90a2856 | 2025-11-27 | Warnings | M014 |
| XIMONTH Wart Remover | GLYCERIN | Shantou Ximonth Biotechnology Co., Ltd. | 337d4d37-c2d6-44d3-e063-6294a90a77ce | 2025-11-26 | Warnings | M014 |
| Swimmers Ear | CLEARCANAL | Neilmed Pharmaceuticals Inc. | 43778b02-e90b-36b7-e063-6394a90ab62b | 2025-11-13 | Warnings | M014 |
| Hand Sanitizer | ALCOHOL | Charlotte Products Ltd. | 1fbfe3f9-e0db-a3a2-e063-6294a90ab6aa | 2025-10-28 | Warnings | M014 |
| Carbamide peroxide 6.5% | EARWAX REMOVAL KIT | Allegiant Health | 54515e9d-2225-4875-a1cf-a24a823300dd | 2025-10-28 | Warnings | M014 |
| OFTAL-MYCIN LUBRICANT OPHTHALMIC | LIGHT MINERAL, WHITE PETROLATUM | GRANDALL DISTRIBUTING, LLC | 298db04a-21a9-e46e-e063-6294a90acee2 | 2025-10-27 | Warnings | M014 |
| Debrox Swimmers Ear | ISOPROPYL ALCOHOL | Medtech Products Inc. | b5d57c7b-8315-4260-967e-38fdd54e2a9c | 2025-10-23 | Warnings | M014 |
| Family Care Earwax Removal | CARBAMIDE PEROXIDE | United Exchange Corp. | 958741f5-47c1-339c-e053-2a95a90a3f5f | 2025-10-22 | Warnings | M014 |
| GoodSense Ear Wax Removal Kit | CARBAMIDE PEROXIDE | Geiss, Destin & Dunn, Inc | 31ea324f-a9a1-7865-e063-6294a90a92e8 | 2025-09-19 | Warnings | M014 |
| blue goo NERVE EASE Pain RELIEF Topical Analgesic | LIDOCAINE HCL 4%, MENTHOL 1% | Garcoa, Inc. | 619d5c87-636c-407d-909e-c38512dcd553 | 2025-09-10 | Warnings | M014 |
| DEBROX | CARBAMIDE PEROXIDE | A-S Medication Solutions | 8d6f1769-eb44-4bde-b3fa-3ff4658b7dd1 | 2025-09-03 | Warnings | M014 |
| Auralyt | CARBAMIDE PEROXIDE | Menper Distributors, Inc | 95920b87-941f-48cb-850c-40d2735596d4 | 2025-07-22 | Warnings | M014 53145-311 |
| hydrocortisone | HYDROCORTISONE | NuCare Pharmaceuticals,Inc. | a0fde5c9-afb2-76a9-e053-2995a90af3e8 | 2025-07-21 | Warnings | M014 |
| Healthy Ears | CARBIDE PEROXIDE | Vitamex USA, Corp | 25953441-cd8e-5038-e063-6294a90ae401 | 2025-06-23 | Warnings | M014 |
| WaxRx Ear Wax Removal Aid Drops | CARBAMIDE PEROXIDE | DOCTOR EASY MEDICAL PRODUCTS, LLC | 7e08cd86-7ae4-7d12-e053-2991aa0a4cba | 2025-05-01 | Warnings | M014 |
| Meijer Earwax Removal Drops | CARBAMIDE PEROXIDE | Meijer Distribution Inc | 900108c6-0324-644a-e053-2a95a90a3b2b | 2025-02-28 | Warnings | M014 |
| Tech Care Earwax Removal Kit | CARBAMIDE PEROXIDE | Warner Tech-care Products, LLC | 5851c1f6-c15b-447c-b495-3707e7a12bdb | 2025-02-28 | Warnings | M014 |
| Tech Care Earwax Removal Drops | CARBAMIDE PEROXIDE | Warner Tech-care Products, LLC | 1c97783b-dcdf-4f95-8516-0d7f197cbc27 | 2025-02-28 | Warnings | M014 |
| TopCare Earwax Removal Kit | CARBAMIDE PEROXIDE | TOPCO ASSOCIATES LLC | 890cc9b6-41a5-480a-bc94-45c8d4fdeef3 | 2025-02-28 | Warnings | M014 |
| Audiologists Choice Earwax Removal Aid Drops | CARBAMIDE PEROXIDE | Oaktree Products Inc | 2922dde2-d082-437b-8f51-4a91ced20a58 | 2025-02-28 | Warnings | M014 |
Packages#
| Package NDC | 11-digit format | Description | Marketing start | Marketing end | Sample | Exclude flag | Status |
|---|---|---|---|---|---|---|---|
| 53145-311-04 | 53145031104 | 1 BOTTLE, DROPPER in 1 CARTON (53145-311-04) / 12 mL in 1 BOTTLE, DROPPER | 2014-01-01 | 0000-00-00 | No | No | Current |