Ear Wax Removal Drops
- Product NDC
- 57896-339
- 11-digit product format
- 578960339
- Labeler code
- 57896
- Product ID
- 57896-339_4589c7e6-c807-5a69-e063-6394a90a8b89
- Type
- HUMAN OTC DRUG
- Nonproprietary name
- Carbamide Peroxide - 6.5%
- Dosage form
- SOLUTION/ DROPS
- Route
- TOPICAL
- Labeler
- GeriCare Pharmaceutical Corp
- Application
- M014
- Marketing category
- OTC MONOGRAPH DRUG
- Marketing start
- 2025-09-01
- Substance
- CARBAMIDE PEROXIDE
- Active strength
- 65 mg/mL
- 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 | Package NDC | Snapshot | Source SHA-256 |
|---|---|---|---|---|---|
| 2025-12-14 17:58 UTC · source 2025-12-05 | excluded product | product | d630ba8d3edf… | 732f749b63fb… | |
| 2025-12-14 17:58 UTC · source 2025-12-05 | excluded package | package | 57896-339-05 | d630ba8d3edf… | 732f749b63fb… |
| 2025-08-27 00:01 UTC · source 2025-08-26 | excluded product | product | f5e01cc5f278… | a2eaf40c39c3… | |
| 2025-08-27 00:01 UTC · source 2025-08-26 | excluded package | package | 57896-339-05 | f5e01cc5f278… | a2eaf40c39c3… |
| 2025-04-01 02:39 UTC · source 2025-03-31 | excluded product | product | 2ef7874e63bc… | 57b86245f4fa… | |
| 2025-04-01 02:39 UTC · source 2025-03-31 | excluded package | package | 57896-339-05 | 2ef7874e63bc… | 57b86245f4fa… |
| 2025-03-28 20:22 UTC · source 2025-03-28 | excluded product | product | a1b67e2a42f9… | c4cf2c586c0d… | |
| 2025-03-28 20:22 UTC · source 2025-03-28 | excluded package | package | 57896-339-05 | a1b67e2a42f9… | c4cf2c586c0d… |
| 2025-03-22 03:12 UTC · source 2025-03-21 | excluded product | product | cfe11265f3b6… | 090c488252e2… | |
| 2025-03-22 03:12 UTC · source 2025-03-21 | excluded package | package | 57896-339-05 | cfe11265f3b6… | 090c488252e2… |
| 2025-03-10 12:48 UTC · source 2025-03-10 | excluded product | product | cdf11ea48f46… | ba0047e9e063… | |
| 2025-03-10 12:48 UTC · source 2025-03-10 | excluded package | package | 57896-339-05 | cdf11ea48f46… | ba0047e9e063… |
| 2025-02-02 03:52 UTC · source 2025-01-31 | excluded product | product | 302b2466d912… | e7b80fea0513… | |
| 2025-02-02 03:52 UTC · source 2025-01-31 | excluded package | package | 57896-339-05 | 302b2466d912… | e7b80fea0513… |
| 2025-01-20 13:05 UTC · source 2025-01-20 | excluded product | product | ed331223b511… | 672a5bd82f5f… | |
| 2025-01-20 13:05 UTC · source 2025-01-20 | excluded package | package | 57896-339-05 | ed331223b511… | 672a5bd82f5f… |
| 2025-01-11 03:41 UTC · source 2025-01-10 | excluded product | product | 0efc9e666f02… | f202fb6c5f17… | |
| 2025-01-11 03:41 UTC · source 2025-01-10 | excluded package | package | 57896-339-05 | 0efc9e666f02… | f202fb6c5f17… |
| 2024-11-09 02:27 UTC · source 2024-11-08 | excluded product | product | ad56d346431e… | cc804d4bbf1e… | |
| 2024-11-09 02:27 UTC · source 2024-11-08 | excluded package | package | 57896-339-05 | ad56d346431e… | cc804d4bbf1e… |
| 2024-10-04 04:10 UTC · source 2024-10-03 | excluded product | product | 367a005e9d99… | 383a685ebd0f… | |
| 2024-10-04 04:10 UTC · source 2024-10-03 | excluded package | package | 57896-339-05 | 367a005e9d99… | 383a685ebd0f… |
| 2024-07-10 04:00 UTC · source 2024-07-09 | excluded product | product | 557ba5c1ecfa… | 9c80585c8c6e… | |
| 2024-07-10 04:00 UTC · source 2024-07-09 | excluded package | package | 57896-339-05 | 557ba5c1ecfa… | 9c80585c8c6e… |
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
- Ear Wax Removal Drops
- Listing expiration
- 2026-12-31
Active Ingredients#
| Ingredient | Strength |
|---|---|
| CARBAMIDE PEROXIDE | 65 mg/mL |
Harmonized UNII identifiers#
| Identifier | FDA.report destination |
|---|---|
| 31PZ2VAU81 | Internal UNII lookup |
Harmonized RxCUI identifiers#
| Identifier | FDA.report destination |
|---|---|
| 702050 | Internal RxNorm lookup |
Harmonized SPL set identifiers#
| Identifier | FDA.report destination |
|---|---|
| 239702af-cf93-43ee-b1af-8e53642395c1 | Available on FDA.report |
DailyMed Product Concepts#
| Product concept | Relation | Version | Effective |
|---|---|---|---|
| e2db08c6-133f-4f4f-afb4-e90a2418d6f6 | Product name | 1 | 20230320 |
| ce6d5c06-3ae0-18a6-d5b3-8cd3cc0f8906 | Product name | 7 | 20210625 |
| f52be47f-7aa7-46c0-b1fa-50c18dd50206 | Product name | 1 | 20201029 |
| 11ed6f83-cdd2-4637-8379-b1a1d3ae3cde | Product name | 1 | 20181101 |
| 5eb9f24b-9328-475e-af0a-18021935eb6a | Product name | 1 | 20180220 |
| 86c45a79-b9f0-4476-a27c-6e10db098497 | Product name | 1 | 20180125 |
| d5e51f11-ad28-caa4-4b49-4143974782ad | Product name | 1 | 20150831 |
DailyMed Package Descriptions#
| Package NDC | Product | Description | Form | Quantity | Strength | SPL version |
|---|---|---|---|---|---|---|
| 57896-339-05 | Ear Wax Removal Drops | 1 in 1 CARTON | SOLUTION/ DROPS | 1 | 3 | |
| 57896-339-05 | Ear Wax Removal Drops | 15 mL in 1 BOTTLE, DROPPER | SOLUTION/ DROPS | 15 | 3 |
DailyMed Billing Units#
| Package NDC | Billing unit | Product NDC | DailyMed indexing SPL | SPL version | Effective |
|---|---|---|---|---|---|
| 57896-339-05 | ML - Milliliter | 57896-339 | 60f9d315-f236-4cbe-ba42-4d7e2bd5bcca | 1 | 2018-01-12 |
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 |
| 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 |
DailyMed RxNorm Mappings#
| RxCUI | RxNorm string | TTY | DailyMed | SPL version |
|---|---|---|---|---|
| 702050 | carbamide peroxide 6.5 % Otic Solution | PSN | 239702af-cf93-43ee-b1af-8e53642395c1 | 3 |
| 702050 | carbamide peroxide 6.5 % Otic Solution | PSN | 97f81751-5a8f-4943-9e37-091351867598 | 3 |
| 702050 | carbamide peroxide 65 MG/ML Otic Solution | SCD | 239702af-cf93-43ee-b1af-8e53642395c1 | 3 |
| 702050 | carbamide peroxide 65 MG/ML Otic Solution | SCD | 97f81751-5a8f-4943-9e37-091351867598 | 3 |
| 702050 | carbamide peroxide 6.5 % Otic Solution | SY | 239702af-cf93-43ee-b1af-8e53642395c1 | 3 |
| 702050 | carbamide peroxide 6.5 % Otic Solution | SY | 97f81751-5a8f-4943-9e37-091351867598 | 3 |
| 702050 | carbamide peroxide 6.5 % Otic Solution | PSN | b6e3ad1c-5134-49f2-8664-534635b9eec3 | 1 |
| 702050 | carbamide peroxide 65 MG/ML Otic Solution | SCD | b6e3ad1c-5134-49f2-8664-534635b9eec3 | 1 |
| 702050 | carbamide peroxide 6.5 % Otic Solution | SY | b6e3ad1c-5134-49f2-8664-534635b9eec3 | 1 |
Packages#
| Package NDC | 11-digit format | Description | Marketing start | Marketing end | Sample | Exclude flag | Status |
|---|---|---|---|---|---|---|---|
| 57896-339-05 | 57896033905 | 1 BOTTLE, DROPPER in 1 CARTON (57896-339-05) / 15 mL in 1 BOTTLE, DROPPER | 2025-09-01 | 0000-00-00 | No | No | Current |