Home NDC 57896-339 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.
Historic NDC status page 1 of 1 · 24 matching rows.
View current auxiliary records. · View the auxiliary file history.
Captured / source date, Dataset, Scope table 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 table Ingredient Strength CARBAMIDE PEROXIDE 65 mg/mL
Harmonized UNII identifiers# UNII identifiers page 1 of 1 · 1 matching rows.
Identifier, FDA.report destination table Identifier FDA.report destination 31PZ2VAU81 Internal UNII lookup
Harmonized RxCUI identifiers# RxCUI identifiers page 1 of 1 · 1 matching rows.
Identifier, FDA.report destination table Identifier FDA.report destination 702050 Internal RxNorm lookup
Harmonized SPL set identifiers# SPL set identifiers page 1 of 1 · 1 matching rows.
DailyMed Product Concepts# DailyMed Package Descriptions# Package NDC, Product, Description table 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
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.
Matched openFDA labels page 1 of 7 · 135 matching rows.
Brand, Generic, Manufacturer table Brand Generic Manufacturer SPL set ID Effective date Available safety fields Join ClearCanal Ear Wax Softerner Drops CARBAMIDE PEROXIDE NeilMed Pharmaceuticals, Inc. 0ef2be5b-cc39-48ae-b5c5-e787464dea08 2026-08-17 Warnings Exact identifier application number: M014 EarBalance Ear Pain Drops LIDOCAINE HYDROCHLORIDE OTIC SOLUTION Marie's Original Formulas LLC 54dc3642-0b7a-07d8-e063-6294a90ad556 2026-07-22 Warnings Exact identifier application number: M014 EarBalance Ear Pain Drops LIDOCAINE HYDROCHLORIDE OTIC SOLUTION Marie's Original Formulas LLC 55057e1b-b11e-51b9-e063-6394a90a9fca 2026-07-22 Warnings Exact identifier application number: M014 Freskaro Ear Drops for Swimmers FRESKARO EAR DROPS FOR SWIMMERS Pharma Nobis, LLC 4f724d85-cd38-41da-e063-6394a90a9fd7 2026-07-08 Warnings Exact identifier application number: M014 Macks Dry n Clear EAR DRYING AID McKeon Products Inc 1ea1da54-2412-c25c-e063-6294a90aa264 2026-06-26 Warnings Exact identifier application number: M014 Equate Swimmers Instant Ear Dry EQUATE SWIMMERS INSTANT EAR DRY Walmart Stores, Inc 76b58a7a-48cf-866c-e053-2a91aa0a7e63 2026-06-26 Warnings Exact identifier application number: M014 Quality Choice Earwax Removal Drops Earwax Removal Aid CARBAMIDE PEROXIDE Chain Drug Marketing Association, Inc. c68b40d9-c1d4-4425-8063-50c00299e718 2026-06-10 Warnings Exact identifier application number: M014 Quality Choice Earwax Removal Kit Earwax Removal Aid and Bulb CARBAMIDE PEROXIDE Chain Drug Marketing Association, Inc. b2a641da-e070-4223-b836-5ca9ffb89f3f 2026-06-10 Warnings Exact identifier application number: M014 Audiologists Choice Earwax Removal System CARBAMIDE PEROXIDE Oaktree Products Inc. c9ad507b-341c-474f-aaa2-3c3a97a30dd8 2026-05-29 Warnings Exact identifier application number: M014 CVS Health Earwax Removal Kit CARBAMIDE PEROXIDE CVS Pharmacy, Inc. f842534c-46dd-42c7-8386-9a03ce16da86 2026-05-29 Warnings Exact identifier application number: M014 Lucid Hearing Earwax Removal Kit and Bulb CARBAMIDE PEROXIDE Hearing Lab Technology LLC 5e09f566-397f-44d6-8ba2-90987765c737 2026-05-29 Warnings Exact identifier application number: M014 Good Neighbor Pharmacy Earwax Removal Drops CARBAMIDE PEROXIDE Amerisource Bergen 89eac1b0-c700-45b5-8478-da53ace72e16 2026-05-29 Warnings Exact identifier application number: M014 Good Neighbor Pharmacy Earwax Removal CARBAMIDE PEROXIDE Amerisource Bergen d503b10f-85cd-4bb8-9dec-82d651d525fa 2026-05-29 Warnings Exact identifier application number: M014 Meijer Earwax Removal Kit CARBAMIDE PEROXIDE Meijer Distribution Inc. a5f7bd55-55c3-4b0e-a16c-33bbea40536a 2026-05-29 Warnings Exact identifier application number: M014 Quality Choice Earwax Removal Drops CARBAMIDE PEROXIDE Chain Drug Marketing Association, Inc. d8fd8102-114f-415d-9083-f98a63f9d1b3 2026-05-29 Warnings Exact identifier application number: M014 Menthol Pain Relieving Gel PAIN RELIEVING GEL NeilMed Pharmaceuticals Inc 513a206c-bbf6-3e51-e063-6294a90adf7a 2026-05-07 Warnings Exact identifier application number: M014 ear drops CARBAMIDE PEROXIDE 6.5% Bionpharma Inc. e8bcf92c-ad32-49d5-e053-2995a90ae0c6 2026-04-27 Warnings Exact identifier application number: M014 Freskaro Earwax Removal Aid CARBAMIDE PEROXIDE 6.50% KIT Pharma Nobis, LLC 4f5967ee-bc05-341c-e063-6394a90a35c6 2026-04-15 Warnings Exact identifier application number: M014 GoodSense Ear Wax Removal Kit CARBAMIDE PEROXIDE Preferred Pharmaceuticals Inc. 9a4198d2-cbea-466a-a252-d5c63d9ea0c1 2026-04-09 Warnings Exact identifier application number: M014 Good Neighbor Pharmacy Earwax Removal Drops CARBAMIDE PEROXIDE Preferred Pharmaceuticals Inc. 52f733a7-1301-4078-9267-5ce95b006ccc 2026-04-09 Warnings Exact identifier application number: M014
DailyMed RxNorm Mappings# Packages# Package NDC, 11-digit format, Description table 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