FDA.reportPublic FDA data

Ear Wax Removal Drops

Product NDC
50804-341
Requested package NDC
50804-341-61
11-digit product format
508040341
Labeler code
50804
Product ID
50804-341_c9fde66d-9e49-4fbc-8dc5-419c7ee35f89
Type
HUMAN OTC DRUG
Nonproprietary name
Carbamide Peroxide - 6.5%
Dosage form
SOLUTION/ DROPS
Route
TOPICAL
Labeler
GOODSENSE
Application
part344
Marketing category
OTC MONOGRAPH FINAL
Marketing start
2019-06-05
Marketing end
0000-00-00
Substance
CARBAMIDE PEROXIDE
Active strength
65 mg/mL
NDC exclude flag
No
Listing certified through
2022-12-31
Current FDA listing
Historical FDA.report record

NDC auxiliary status#

These records are reproduced from FDA’s unfinished, excluded, and compounder listings. They describe what appeared in the source files; a missing record does not establish a regulatory status. View all current auxiliary records, including entries without an NDC. · View the auxiliary file history.

Current NDC status page 1 of 1 · 1 matching rows.

Dataset, Scope, Product NDC table
DatasetScopeProduct NDCPackage NDCCodeStatusReporting periodSource date
excluded packagepackage50804-34150804-341-61IInactivated by FDA2026-08-17

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 · 15 matching rows.

View current auxiliary records. · View the auxiliary file history.

Captured / source date, Snapshot, Source SHA-256 table
Captured / source dateSnapshotSource SHA-256
2025-12-14 17:58 UTC · source 2025-12-05d630ba8d3edf…732f749b63fb…
2025-08-27 00:01 UTC · source 2025-08-26f5e01cc5f278…a2eaf40c39c3…
2025-04-01 02:39 UTC · source 2025-03-312ef7874e63bc…57b86245f4fa…
2025-03-28 20:22 UTC · source 2025-03-28a1b67e2a42f9…c4cf2c586c0d…
2025-03-22 03:12 UTC · source 2025-03-21cfe11265f3b6…090c488252e2…
2025-03-10 12:48 UTC · source 2025-03-10cdf11ea48f46…ba0047e9e063…
2025-02-02 03:52 UTC · source 2025-01-31302b2466d912…e7b80fea0513…
2025-01-20 13:05 UTC · source 2025-01-20ed331223b511…672a5bd82f5f…
2025-01-11 03:41 UTC · source 2025-01-100efc9e666f02…f202fb6c5f17…
2024-11-09 02:27 UTC · source 2024-11-08ad56d346431e…cc804d4bbf1e…
2024-10-04 04:10 UTC · source 2024-10-03367a005e9d99…383a685ebd0f…
2024-07-10 04:00 UTC · source 2024-07-09557ba5c1ecfa…9c80585c8c6e…
2024-05-28 21:12 UTC · source 2024-05-288af77b9d5b6f…d9bbb34c5368…
2024-05-15 03:39 UTC · source 2024-05-14834df4deac94…adcc014656a3…
2024-03-11 06:39 UTC · source 2024-03-081332a3947898…d4bfe170f9cd…

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
f52be47f-7aa7-46c0-b1fa-50c18dd50206Product name120201029

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
50804-341-512023-01-30C16284748780-1f386c649-ed78-0266-e053-dadaa90a7c1aGoodsense Ear wax Remover
50804-341-612023-01-30C16284748780-1f386c649-ed78-0266-e053-dadaa90a7c1aGoodsense Ear wax Remover

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
50804-341EAR WAX REMOVAL DROPS (CARBAMIDE PEROXIDE - 6.5%) SOLUTION/ DROPS [GOODSENSE]1Legacy NDC20210827_d96688fe-c47b-4762-bc2c-19ea9c44fd3e.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
702050carbamide peroxide 6.5 % Otic SolutionPSNd96688fe-c47b-4762-bc2c-19ea9c44fd3e1
702050carbamide peroxide 65 MG/ML Otic SolutionSCDd96688fe-c47b-4762-bc2c-19ea9c44fd3e1
702050carbamide peroxide 6.5 % Otic SolutionSYd96688fe-c47b-4762-bc2c-19ea9c44fd3e1

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionMarketing startMarketing endSampleExclude flagStatus
50804-341-61508040341611 BOTTLE, DROPPER in 1 KIT (50804-341-61) > 15 mL in 1 BOTTLE, DROPPER2019-06-050000-00-00NoNoCurrent