FDA.reportPublic FDA data

DISCOUNT drug mart FOOD FAIR earwax removal kit

Product NDC
53943-835
11-digit product format
539430835
Labeler code
53943
Product ID
53943-835_0c86980d-ee66-96f8-e063-6294a90a42a6
Type
HUMAN OTC DRUG
Nonproprietary name
CARBAMIDE PEROXIDE
Dosage form
SOLUTION
Route
TOPICAL
Labeler
Discount Drug Mart
Application
M014
Marketing category
OTC MONOGRAPH DRUG
Marketing start
2014-11-27
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
DISCOUNT drug mart FOOD FAIR earwax removal kit
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
83fdf4d6-3cdf-429d-b53d-80775a35d0c9Available on FDA.report

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
5eb9f24b-9328-475e-af0a-18021935eb6aProduct name120180220
d5e51f11-ad28-caa4-4b49-4143974782adProduct name120150831

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
53943-835-33DISCOUNT drug mart FOOD FAIR earwax removal kit15 mL in 1 BOTTLE, DISPENSINGSOLUTION154
53943-835-33DISCOUNT drug mart FOOD FAIR earwax removal kit1 in 1 CARTONSOLUTION14

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
CARBAMIDE PEROXIDEACTIVE INGREDIENT31PZ2VAU81DISCOUNT DRUG MART FOOD FAIR EARWAX REMOVAL KIT (CARBAMIDE PEROXIDE) SOLUTION [DISCOUNT DRUG MART]2
HYDROGEN PEROXIDEACTIVE MOIETYBBX060AN9VDISCOUNT DRUG MART FOOD FAIR EARWAX REMOVAL KIT (CARBAMIDE PEROXIDE) SOLUTION [DISCOUNT DRUG MART]2
ANHYDROUS CITRIC ACIDINACTIVE INGREDIENTXF417D3PSLDISCOUNT DRUG MART FOOD FAIR EARWAX REMOVAL KIT (CARBAMIDE PEROXIDE) SOLUTION [DISCOUNT DRUG MART]2
GLYCERININACTIVE INGREDIENTPDC6A3C0OXDISCOUNT DRUG MART FOOD FAIR EARWAX REMOVAL KIT (CARBAMIDE PEROXIDE) SOLUTION [DISCOUNT DRUG MART]2
PROPYLENE GLYCOLINACTIVE INGREDIENT6DC9Q167V3DISCOUNT DRUG MART FOOD FAIR EARWAX REMOVAL KIT (CARBAMIDE PEROXIDE) SOLUTION [DISCOUNT DRUG MART]2
SODIUM CITRATEINACTIVE INGREDIENT1Q73Q2JULRDISCOUNT DRUG MART FOOD FAIR EARWAX REMOVAL KIT (CARBAMIDE PEROXIDE) SOLUTION [DISCOUNT DRUG MART]2
SODIUM LAURYL SULFATEINACTIVE INGREDIENT368GB5141JDISCOUNT DRUG MART FOOD FAIR EARWAX REMOVAL KIT (CARBAMIDE PEROXIDE) SOLUTION [DISCOUNT DRUG MART]2
WATERINACTIVE INGREDIENT059QF0KO0RDISCOUNT DRUG MART FOOD FAIR EARWAX REMOVAL KIT (CARBAMIDE PEROXIDE) SOLUTION [DISCOUNT DRUG MART]2

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
53943-835DISCOUNT DRUG MART FOOD FAIR EARWAX REMOVAL KIT (CARBAMIDE PEROXIDE) SOLUTION [DISCOUNT DRUG MART]4Current NDC, Legacy NDC, 2 package rows20231215_83fdf4d6-3cdf-429d-b53d-80775a35d0c9.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 7 · 136 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
EarBalance Ear Pain DropsLIDOCAINE HYDROCHLORIDE OTIC SOLUTIONMarie's Original Formulas LLC54dc3642-0b7a-07d8-e063-6294a90ad5562026-07-22WarningsExact identifier
application number: M014
EarBalance Ear Pain DropsLIDOCAINE HYDROCHLORIDE OTIC SOLUTIONMarie's Original Formulas LLC55057e1b-b11e-51b9-e063-6394a90a9fca2026-07-22WarningsExact identifier
application number: M014
Macks Dry n ClearEAR DRYING AIDMcKeon Products Inc1ea1da54-2412-c25c-e063-6294a90aa2642026-06-26WarningsExact identifier
application number: M014
Equate Swimmers Instant Ear DryEQUATE SWIMMERS INSTANT EAR DRYWalmart Stores, Inc76b58a7a-48cf-866c-e053-2a91aa0a7e632026-06-26WarningsExact identifier
application number: M014
Quality Choice Earwax Removal Drops Earwax Removal AidCARBAMIDE PEROXIDEChain Drug Marketing Association, Inc.c68b40d9-c1d4-4425-8063-50c00299e7182026-06-10WarningsExact identifier
application number: M014
Quality Choice Earwax Removal Kit Earwax Removal Aid and BulbCARBAMIDE PEROXIDEChain Drug Marketing Association, Inc.b2a641da-e070-4223-b836-5ca9ffb89f3f2026-06-10WarningsExact identifier
application number: M014
Freskaro Ear Drops for SwimmersFRESKARO EAR DROPS FOR SWIMMERSPharma Nobis, LLC4f724d85-cd38-41da-e063-6394a90a9fd72026-06-03WarningsExact identifier
application number: M014
Audiologists Choice Earwax Removal SystemCARBAMIDE PEROXIDEOaktree Products Inc.c9ad507b-341c-474f-aaa2-3c3a97a30dd82026-05-29WarningsExact identifier
application number: M014
CVS Health Earwax Removal KitCARBAMIDE PEROXIDECVS Pharmacy, Inc.f842534c-46dd-42c7-8386-9a03ce16da862026-05-29WarningsExact identifier
application number: M014
Lucid Hearing Earwax Removal Kit and BulbCARBAMIDE PEROXIDEHearing Lab Technology LLC5e09f566-397f-44d6-8ba2-90987765c7372026-05-29WarningsExact identifier
application number: M014
Good Neighbor Pharmacy Earwax Removal DropsCARBAMIDE PEROXIDEAmerisource Bergen89eac1b0-c700-45b5-8478-da53ace72e162026-05-29WarningsExact identifier
application number: M014
Good Neighbor Pharmacy Earwax RemovalCARBAMIDE PEROXIDEAmerisource Bergend503b10f-85cd-4bb8-9dec-82d651d525fa2026-05-29WarningsExact identifier
application number: M014
Meijer Earwax Removal KitCARBAMIDE PEROXIDEMeijer Distribution Inc.a5f7bd55-55c3-4b0e-a16c-33bbea40536a2026-05-29WarningsExact identifier
application number: M014
Quality Choice Earwax Removal DropsCARBAMIDE PEROXIDEChain Drug Marketing Association, Inc.d8fd8102-114f-415d-9083-f98a63f9d1b32026-05-29WarningsExact identifier
application number: M014
Menthol Pain Relieving GelPAIN RELIEVING GELNeilMed Pharmaceuticals Inc513a206c-bbf6-3e51-e063-6294a90adf7a2026-05-07WarningsExact identifier
application number: M014
ear dropsCARBAMIDE PEROXIDE 6.5%Bionpharma Inc.e8bcf92c-ad32-49d5-e053-2995a90ae0c62026-04-27WarningsExact identifier
application number: M014
Freskaro Earwax Removal AidCARBAMIDE PEROXIDE 6.50% KITPharma Nobis, LLC4f5967ee-bc05-341c-e063-6394a90a35c62026-04-15WarningsExact identifier
application number: M014
GoodSense Ear Wax Removal KitCARBAMIDE PEROXIDEPreferred Pharmaceuticals Inc.9a4198d2-cbea-466a-a252-d5c63d9ea0c12026-04-09WarningsExact identifier
application number: M014
Good Neighbor Pharmacy Earwax Removal DropsCARBAMIDE PEROXIDEPreferred Pharmaceuticals Inc.52f733a7-1301-4078-9267-5ce95b006ccc2026-04-09WarningsExact identifier
application number: M014
Walgreens Swimmers EarISOPROPYL ALCOHOLWalgreens Co3fb65a5c-c47f-ef2b-e063-6394a90af21a2026-04-01WarningsExact identifier
application number: M014

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
702050carbamide peroxide 6.5 % Otic SolutionPSN83fdf4d6-3cdf-429d-b53d-80775a35d0c94
702050carbamide peroxide 65 MG/ML Otic SolutionSCD83fdf4d6-3cdf-429d-b53d-80775a35d0c94
702050carbamide peroxide 6.5 % Otic SolutionSY83fdf4d6-3cdf-429d-b53d-80775a35d0c94

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionMarketing startMarketing endSampleExclude flagStatus
53943-835-33539430835331 BOTTLE, DISPENSING in 1 CARTON (53943-835-33) / 15 mL in 1 BOTTLE, DISPENSING2014-11-270000-00-00NoNoCurrent