FDA.reportPublic FDA data

Tech Care Earwax Removal Drops

Product NDC
69428-002
11-digit product format
694280002
Labeler code
69428
Product ID
69428-002_2f391337-e895-4812-e063-6294a90a44fd
Type
HUMAN OTC DRUG
Nonproprietary name
CARBAMIDE PEROXIDE
Dosage form
SOLUTION/ DROPS
Route
AURICULAR (OTIC)
Labeler
Warner Tech-care Products, LLC
Application
M014
Marketing category
OTC MONOGRAPH DRUG
Marketing start
2014-05-01
Substance
CARBAMIDE PEROXIDE
Active strength
65 mg/mL
NDC exclude flag
No
Listing certified through
2026-12-31
Current FDA listing
Yes

Additional Listing Data#

Finished product
Yes
Brand name base
Tech Care Earwax Removal Drops
Listing expiration
2026-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
CARBAMIDE PEROXIDE65 mg/mL

Harmonized Identifiers#

Field, Values table
FieldValues
Unii31PZ2VAU81
Rxcui702050

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
e2db08c6-133f-4f4f-afb4-e90a2418d6f6Product name120230320
ce6d5c06-3ae0-18a6-d5b3-8cd3cc0f8906Product name720210625
f52be47f-7aa7-46c0-b1fa-50c18dd50206Product name120201029
11ed6f83-cdd2-4637-8379-b1a1d3ae3cdeProduct name120181101
5eb9f24b-9328-475e-af0a-18021935eb6aProduct name120180220
86c45a79-b9f0-4476-a27c-6e10db098497Product name120180125
d5e51f11-ad28-caa4-4b49-4143974782adProduct name120150831

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
69428-002-00Tech Care Earwax Removal Drops1 in 1 BOXSOLUTION/ DROPS13
69428-002-00Tech Care Earwax Removal Drops15 mL in 1 BOTTLESOLUTION/ DROPS153
69428-002-00Tech Care Earwax Removal Kit15 mL in 1 BOTTLESOLUTION/ DROPS15 mL65 mg in 1mL3
69428-002-00Tech Care Earwax Removal Kit1 in 1 BOXSOLUTION/ DROPS65 mg in 1mL3

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
69428-002TECH CARE EARWAX REMOVAL DROPS (CARBAMIDE PEROXIDE) SOLUTION/ DROPS [WARNER TECH-CARE PRODUCTS, LLC]3Current NDC, Legacy NDC, 2 package rows20250303_1c97783b-dcdf-4f95-8516-0d7f197cbc27.zip
69428-002TECH CARE EARWAX REMOVAL KIT (CARBAMIDE PEROXIDE) KIT [WARNER TECH-CARE PRODUCTS, LLC]3Current NDC, Legacy NDC20250303_5851c1f6-c15b-447c-b495-3707e7a12bdb.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
702050carbamide peroxide 6.5 % Otic SolutionPSN1c97783b-dcdf-4f95-8516-0d7f197cbc273
702050carbamide peroxide 6.5 % Otic SolutionPSN5851c1f6-c15b-447c-b495-3707e7a12bdb3
702050carbamide peroxide 65 MG/ML Otic SolutionSCD1c97783b-dcdf-4f95-8516-0d7f197cbc273
702050carbamide peroxide 65 MG/ML Otic SolutionSCD5851c1f6-c15b-447c-b495-3707e7a12bdb3
702050carbamide peroxide 6.5 % Otic SolutionSY1c97783b-dcdf-4f95-8516-0d7f197cbc273
702050carbamide peroxide 6.5 % Otic SolutionSY5851c1f6-c15b-447c-b495-3707e7a12bdb3

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
69428-002-00694280002001 BOTTLE in 1 BOX (69428-002-00) / 15 mL in 1 BOTTLE1 bottle2014-05-010000-00-00NoNoCurrent