FDA.reportPublic FDA data

Wax B Gone Ear Wax Removal Drops

Product NDC
82498-149
11-digit product format
824980149
Labeler code
82498
Product ID
82498-149_e1c35778-377e-44e8-9681-9dee84b04723
Type
HUMAN OTC DRUG
Nonproprietary name
Carbamide Peroxide - 6.5%
Dosage form
SOLUTION/ DROPS
Route
TOPICAL
Labeler
SIGMAR, LLC
Application
M014
Marketing category
OTC MONOGRAPH DRUG
Marketing start
2022-03-30
Substance
CARBAMIDE PEROXIDE
Active strength
65 mg/mL
NDC exclude flag
No
Listing certified through
2026-12-31
Current FDA listing
Yes

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
Wax B Gone Ear Wax Removal Drops
Listing expiration
2026-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
CARBAMIDE PEROXIDE65 mg/mL

Harmonized UNII identifiers#

UNII identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
31PZ2VAU81Internal UNII lookup

Harmonized RxCUI identifiers#

RxCUI identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
702050Internal RxNorm lookup

Harmonized SPL set identifiers#

SPL set identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
3339cac0-8f32-4f71-bef3-dd1524c4b244Available on FDA.report

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
82498-149-15Wax B Gone Ear Wax Removal Drops15 mL in 1 BOTTLE, DROPPERSOLUTION/ DROPS152
82498-149-15Wax B Gone Ear Wax Removal Drops1 in 1 CARTONSOLUTION/ DROPS12

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
82498-149WAX B GONE EAR WAX REMOVAL DROPS (CARBAMIDE PEROXIDE - 6.5%) SOLUTION/ DROPS [SIGMAR, LLC]2Current NDC, Legacy NDC, 2 package rows20240110_3339cac0-8f32-4f71-bef3-dd1524c4b244.zip

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 4 of 7 · 129 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Best Choice Earwax Removal DropsCARBAMIDE PEROXIDEValu Merchandisers Company3ae6255f-f494-412b-af76-3579de08ed232025-02-28WarningsExact identifier
application number: M014
Equaline Earwax Removal DropsCARBAMIDE PEROXIDEUnited Natural Foodsd853567a-ce8d-40a8-be1e-27176802ff642025-02-28WarningsExact identifier
application number: M014
Family Wellness Earwax Removal Earwax and BulbCARBAMIDE PEROXIDEFamily Dollar Services Inc26ebf208-4710-4af2-aa2d-b2040b85cf852025-02-28WarningsExact identifier
application number: M014
FOSTER AND THRIVE EARWAX REMOVAL DROPSCARBAMIDE PEROXIDEA-S Medication Solutions0a571ae8-237b-447d-b697-02b30692b6b12025-02-24WarningsExact identifier
application number: M014
Pain Be GoneMENTHOLBack to Earth Inc.f49e718b-ef89-b648-e053-2a95a90a96c82025-01-29WarningsExact identifier
application number: M014
DEBROXCARBAMIDE PEROXIDEMedtech Products Inc.43649ba3-75e0-4dcf-9172-23767dbaeda62025-01-27WarningsExact identifier
application number: M014
HylaTearsEYE DROPSHyalogic LLC2b5fc4c4-843c-8d3d-e063-6394a90a5a1b2025-01-10WarningsExact identifier
application number: M014
BODYOGRAPHYPRO ANTI-BACTERIAL SANITIZINGETHYL ALCOHOLRobanda International, Inc.ebec43d4-4676-40f9-b989-5381f4a737c82025-01-08WarningsExact identifier
application number: M014
Dr. TalbotsETHYL ALCOHOLTalbots Pharmaceuticals Family Products, LLC.a6a94205-a9ff-7709-e053-2995a90a066b2025-01-08WarningsExact identifier
application number: M014
Foster and Thrive Earwax Removal Kit Ear wax dropsCARBAMIDE PEROXIDEMckesson Corp. Via Strategic Sourcing Servicesc9bd4c1f-b3b8-4bdc-b529-3a98b657e6282024-12-31WarningsExact identifier
application number: M014
Foster and Thrive Earwax Removal DropsCARBAMIDE PEROXIDEMckesson Corp. Via Strategic Sourcing Services6180835c-d7a7-4bf7-95cb-0fd3c81402532024-12-31WarningsExact identifier
application number: M014
OIDO SANAISOPROPYL ALCOHOLProMex LLC71e84695-49e8-459f-ac5e-118b5235fe062024-12-18WarningsExact identifier
application number: M014
ERO Ear Wax Removal KitCARBAMIDE PEROXIDE 6.5%Randob Labsfbf8a6f2-531d-5047-e053-6294a90aaa012024-12-15WarningsExact identifier
application number: M014
Harris Teeter Earwax Removal DropsCARBAMIDE PEROXIDE 6.5%Harris Teeter LLCdda4c4bf-425e-4fff-e053-2a95a90a51bc2024-12-15WarningsExact identifier
application number: M014
Isopropyl AlcoholISOPROPYL ALCOHOLMazza Healthcare, LLCee83ba9f-ac65-48b7-9f84-5be6fec9a9092024-11-21WarningsExact identifier
application number: M014
Ear Wax Removal Drops Up and UpCARBAMIDE PEROXIDE - 6.5%Target Corporation829ece50-1f26-4f69-b000-010a34d4cd542024-11-21WarningsExact identifier
application number: M014
Walgreens Ear Wax RemoverCARBAMIDE PEROXIDE 6.5%Walgreens Companyd3b7362b-2826-4b86-bfa3-ef302dc791432024-11-20WarningsExact identifier
application number: M014
CLEARCANAL EAR WAX SOFTERNER DROPSCARBAMIDE PEROXIDEA-S Medication Solutionsac3d57a4-08d5-45f1-be84-f68eef9d13982024-11-04WarningsExact identifier
application number: M014
Caladryl ClearPRAMOXINE HYDROCHLORIDE AND ZINC ACETATEBausch Health US, LLCfca6f08b-7fa0-4ae6-bce3-61f3bcae43322024-10-17WarningsExact identifier
application number: M014
CaladrylFERRIC OXIDE RED, ZINC OXIDE, AND PRAMOXINE HYDROCHLORIDEBausch Health US, LLC67d4fd42-9fed-4238-9f5a-c9403abbcf202024-10-17WarningsExact identifier
application number: M014

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
702050carbamide peroxide 6.5 % Otic SolutionPSN3339cac0-8f32-4f71-bef3-dd1524c4b2442
702050carbamide peroxide 65 MG/ML Otic SolutionSCD3339cac0-8f32-4f71-bef3-dd1524c4b2442
702050carbamide peroxide 6.5 % Otic SolutionSY3339cac0-8f32-4f71-bef3-dd1524c4b2442

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionMarketing startMarketing endSampleExclude flagStatus
82498-149-15824980149151 BOTTLE, DROPPER in 1 CARTON (82498-149-15) / 15 mL in 1 BOTTLE, DROPPER2022-03-300000-00-00NoNoCurrent