Home NDC 57896-339-05 Ear Wax Removal Drops
Product NDC 57896-339
Requested package NDC 57896-339-05
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 · 12 matching rows.
View current auxiliary records. · View the auxiliary file history.
Captured / source date, Snapshot, Source SHA-256 table Captured / source date Snapshot Source SHA-256 2025-12-14 17:58 UTC · source 2025-12-05 d630ba8d3edf…732f749b63fb…2025-08-27 00:01 UTC · source 2025-08-26 f5e01cc5f278…a2eaf40c39c3…2025-04-01 02:39 UTC · source 2025-03-31 2ef7874e63bc…57b86245f4fa…2025-03-28 20:22 UTC · source 2025-03-28 a1b67e2a42f9…c4cf2c586c0d…2025-03-22 03:12 UTC · source 2025-03-21 cfe11265f3b6…090c488252e2…2025-03-10 12:48 UTC · source 2025-03-10 cdf11ea48f46…ba0047e9e063…2025-02-02 03:52 UTC · source 2025-01-31 302b2466d912…e7b80fea0513…2025-01-20 13:05 UTC · source 2025-01-20 ed331223b511…672a5bd82f5f…2025-01-11 03:41 UTC · source 2025-01-10 0efc9e666f02…f202fb6c5f17…2024-11-09 02:27 UTC · source 2024-11-08 ad56d346431e…cc804d4bbf1e…2024-10-04 04:10 UTC · source 2024-10-03 367a005e9d99…383a685ebd0f…2024-07-10 04:00 UTC · source 2024-07-09 557ba5c1ecfa…9c80585c8c6e…
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.
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