FDA.reportPublic FDA data

ENT Essentials Ear Wax Remvoer

Product NDC
68093-4503
11-digit product format
680934503
Labeler code
68093
Product ID
68093-4503_5d7d078f-ef8b-8aa7-e053-2a91aa0ae3b1
Type
HUMAN OTC DRUG
Nonproprietary name
Carbamide Peroxide
Dosage form
LIQUID
Route
AURICULAR (OTIC)
Labeler
Wisconsin Pharmacal Company
Application
part356
Marketing category
OTC MONOGRAPH NOT FINAL
Marketing start
2017-02-01
Substance
CARBAMIDE PEROXIDE
Active strength
.065 g/g
NDC exclude flag
No
Listing certified through
2026-12-31
Current FDA listing
Yes

Additional Listing Data#

Finished product
Yes
Brand name base
ENT Essentials Ear Wax Remvoer
Listing expiration
2026-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
CARBAMIDE PEROXIDE.065 g/g

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
5d7d078f-ef8a-8aa7-e053-2a91aa0ae3b1Available on FDA.report

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
f52be47f-7aa7-46c0-b1fa-50c18dd50206Product name120201029
5eb9f24b-9328-475e-af0a-18021935eb6aProduct name120180220
d5e51f11-ad28-caa4-4b49-4143974782adProduct name120150831

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
68093-4503-1ENT Essentials Ear Wax Remvoer1 in 1 CARTONLIQUID11
68093-4503-1ENT Essentials Ear Wax Remvoer22 g in 1 BOTTLELIQUID221

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
68093-4503ENT ESSENTIALS EAR WAX REMVOER (CARBAMIDE PEROXIDE) LIQUID [WISCONSIN PHARMACAL COMPANY]1Current NDC, Legacy NDC, 2 package rows20171128_5d7d078f-ef8a-8aa7-e053-2a91aa0ae3b1.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 1 of 1 · 1 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
ENT Essentials Ear Wax RemvoerCARBAMIDE PEROXIDEWisconsin Pharmacal Company5d7d078f-ef8a-8aa7-e053-2a91aa0ae3b12017-11-08WarningsExact identifier
ndc (product): 68093-4503

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
702050carbamide peroxide 6.5 % Otic SolutionPSN5d7d078f-ef8a-8aa7-e053-2a91aa0ae3b11
702050carbamide peroxide 65 MG/ML Otic SolutionSCD5d7d078f-ef8a-8aa7-e053-2a91aa0ae3b11
702050carbamide peroxide 6.5 % Otic SolutionSY5d7d078f-ef8a-8aa7-e053-2a91aa0ae3b11

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
68093-4503-1680934503011 BOTTLE in 1 CARTON (68093-4503-1) / 22 g in 1 BOTTLE1 bottle2017-02-010000-00-00NoNoCurrent