FDA.reportPublic FDA data

Hal Hen Earwax Removal Aid Drops

Product NDC
69428-001
Requested package NDC
69428-001-00
11-digit product format
694280001
Labeler code
69428
Product ID
69428-001_bbfe98c8-e372-b021-e053-2a95a90a7c32
Type
HUMAN OTC DRUG
Nonproprietary name
CARBAMIDE PEROXIDE
Dosage form
SOLUTION/ DROPS
Route
AURICULAR (OTIC)
Labeler
Warner Tech-care Products, LLC
Application
part344
Marketing category
OTC MONOGRAPH FINAL
Marketing start
2014-05-01
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 packagepackage69428-00169428-001-00DDiscontinued by firm2026-10-15

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 · 1 matching rows.

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

Captured / source date, Dataset, Scope table
Captured / source dateDatasetScopeProduct NDCPackage NDCCodeStatusReporting periodArchiveSnapshotSource SHA-256
2025-12-14 17:58 UTC · source 2025-12-05excluded packagepackage69428-00169428-001-00DDiscontinued by firmexcluded / ndc_excluded.zipd630ba8d3edf…732f749b63fb…

Reported adverse events (FAERS/openFDA)#

Adverse event summaries are temporarily unavailable. Other product information remains available.

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
69428-001HAL HEN EARWAX REMOVAL AID DROPS (CARBAMIDE PEROXIDE) SOLUTION/ DROPS [WARNER TECH-CARE PRODUCTS, LLC]3Legacy NDC20250223_89667661-24fa-4562-80bf-9ae3d3d9c81d.zip
69428-001HAL-HEN EARWAX REMOVAL SYSTEM (CARBAMIDE PEROXIDE) KIT [WARNER TECH-CARE PRODUCTS, LLC]3Legacy NDC20250223_50935e2d-b1fb-4fb0-aff3-fdde4dff9a36.zip

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
69428-001-00694280001001 BOTTLE in 1 BOX (69428-001-00) > 15 mL in 1 BOTTLE1 bottle2014-05-010000-00-00NoNoCurrent