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 |
|---|---|---|---|---|---|---|
| Best Choice Earwax Removal Drops | CARBAMIDE PEROXIDE | Valu Merchandisers Company | 3ae6255f-f494-412b-af76-3579de08ed23 | 2025-02-28 | Warnings | M014 |
| Equaline Earwax Removal Drops | CARBAMIDE PEROXIDE | United Natural Foods | d853567a-ce8d-40a8-be1e-27176802ff64 | 2025-02-28 | Warnings | M014 |
| Family Wellness Earwax Removal Earwax and Bulb | CARBAMIDE PEROXIDE | Family Dollar Services Inc | 26ebf208-4710-4af2-aa2d-b2040b85cf85 | 2025-02-28 | Warnings | M014 |
| FOSTER AND THRIVE EARWAX REMOVAL DROPS | CARBAMIDE PEROXIDE | A-S Medication Solutions | 0a571ae8-237b-447d-b697-02b30692b6b1 | 2025-02-24 | Warnings | M014 |
| Pain Be Gone | MENTHOL | Back to Earth Inc. | f49e718b-ef89-b648-e053-2a95a90a96c8 | 2025-01-29 | Warnings | M014 |
| DEBROX | CARBAMIDE PEROXIDE | Medtech Products Inc. | 43649ba3-75e0-4dcf-9172-23767dbaeda6 | 2025-01-27 | Warnings | M014 |
| HylaTears | EYE DROPS | Hyalogic LLC | 2b5fc4c4-843c-8d3d-e063-6394a90a5a1b | 2025-01-10 | Warnings | M014 |
| BODYOGRAPHYPRO ANTI-BACTERIAL SANITIZING | ETHYL ALCOHOL | Robanda International, Inc. | ebec43d4-4676-40f9-b989-5381f4a737c8 | 2025-01-08 | Warnings | M014 |
| Dr. Talbots | ETHYL ALCOHOL | Talbots Pharmaceuticals Family Products, LLC. | a6a94205-a9ff-7709-e053-2995a90a066b | 2025-01-08 | Warnings | M014 |
| Foster and Thrive Earwax Removal Kit Ear wax drops | CARBAMIDE PEROXIDE | Mckesson Corp. Via Strategic Sourcing Services | c9bd4c1f-b3b8-4bdc-b529-3a98b657e628 | 2024-12-31 | Warnings | M014 |
| Foster and Thrive Earwax Removal Drops | CARBAMIDE PEROXIDE | Mckesson Corp. Via Strategic Sourcing Services | 6180835c-d7a7-4bf7-95cb-0fd3c8140253 | 2024-12-31 | Warnings | M014 |
| OIDO SANA | ISOPROPYL ALCOHOL | ProMex LLC | 71e84695-49e8-459f-ac5e-118b5235fe06 | 2024-12-18 | Warnings | M014 |
| ERO Ear Wax Removal Kit | CARBAMIDE PEROXIDE 6.5% | Randob Labs | fbf8a6f2-531d-5047-e053-6294a90aaa01 | 2024-12-15 | Warnings | M014 |
| Harris Teeter Earwax Removal Drops | CARBAMIDE PEROXIDE 6.5% | Harris Teeter LLC | dda4c4bf-425e-4fff-e053-2a95a90a51bc | 2024-12-15 | Warnings | M014 |
| Isopropyl Alcohol | ISOPROPYL ALCOHOL | Mazza Healthcare, LLC | ee83ba9f-ac65-48b7-9f84-5be6fec9a909 | 2024-11-21 | Warnings | M014 |
| Ear Wax Removal Drops Up and Up | CARBAMIDE PEROXIDE - 6.5% | Target Corporation | 829ece50-1f26-4f69-b000-010a34d4cd54 | 2024-11-21 | Warnings | M014 |
| Walgreens Ear Wax Remover | CARBAMIDE PEROXIDE 6.5% | Walgreens Company | d3b7362b-2826-4b86-bfa3-ef302dc79143 | 2024-11-20 | Warnings | M014 |
| CLEARCANAL EAR WAX SOFTERNER DROPS | CARBAMIDE PEROXIDE | A-S Medication Solutions | ac3d57a4-08d5-45f1-be84-f68eef9d1398 | 2024-11-04 | Warnings | M014 |
| Caladryl Clear | PRAMOXINE HYDROCHLORIDE AND ZINC ACETATE | Bausch Health US, LLC | fca6f08b-7fa0-4ae6-bce3-61f3bcae4332 | 2024-10-17 | Warnings | M014 |
| Caladryl | FERRIC OXIDE RED, ZINC OXIDE, AND PRAMOXINE HYDROCHLORIDE | Bausch Health US, LLC | 67d4fd42-9fed-4238-9f5a-c9403abbcf20 | 2024-10-17 | 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 |