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
2027-12-31
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
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#

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 5 of 7 · 129 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
TheraSealDIMETHICONEBausch Health US, LLC2c8dc616-20c1-4d33-8a89-9bcdb22b35c82024-10-17WarningsExact identifier
application number: M014
fungoid tinctureMICONAZOLE NITRATEPedinol Pharmacal, Inc.250d0a66-01d1-4aba-8f24-4cb4ca529fda2024-10-17WarningsExact identifier
application number: M014
GenRx Anti-Bacterial GelALCOHOLPureTek Corporationa124e37e-1a44-212a-e053-2995a90a0af02024-10-01WarningsExact identifier
application number: M014
Hand Sanitizing with Lavender OilALCOHOLPureTek Corporationa75d25a7-1e23-717f-e053-2a95a90a6d932024-10-01WarningsExact identifier
application number: M014
Leader Earwax Removal Drops Earwax Removal AidCARBAMIDE PEROXIDECardinal Health, Inc.0022a174-8377-44af-84a9-31adb27de1312024-08-23WarningsExact identifier
application number: M014
Leader Earwax Removal Kit Earwax Removal Aid and BulbCARBAMIDE PEROXIDECardinal Health 110 DBA Leader36c1408b-4287-4e9f-aa17-4f05add500382024-08-12WarningsExact identifier
application number: M014
Major Earwax Removal Drops Earwax Removal AidCARBAMIDE PEROXIDEMajor Pharmaceuticals513bf82e-a36f-49d0-ba74-c834fea4f3b52024-08-12WarningsExact identifier
application number: M014
Alcohol WipesWIPE EM ALCOHOL WIPESShaoxing Elite Bio-Tech Co., Ltd.1f373096-d3d5-af7f-e063-6394a90a3b552024-08-08WarningsExact identifier
application number: M014
Benzoyl Peroxide Acne MedicationBENZOYL PEROXIDENuCare Pharmaceuticals,Inc.b55acec6-5a4d-08b7-e053-2995a90a0f742024-07-17WarningsExact identifier
application number: M014
BacitracinBACITRACINNuCare Pharmaceuticals,Inc.a526ae4b-baae-5d50-e053-2a95a90ae2932024-07-17WarningsExact identifier
application number: M014
clotrimazoleCLOTRIMAZOLENuCare Pharmaceuticals, Inc.54241254-1d9a-346a-e054-00144ff8d46c2024-07-17WarningsExact identifier
application number: M014
Dr Sheffield Muscle Rub CreamMUSCLE RUB CREAMNuCare Pharmaceuticals,Inc.5786a559-a387-120d-e053-2991aa0ab6472024-07-15WarningsExact identifier
application number: M014
CVS Health Earwax Removal Drops Earwax Removal AidCARBAMIDE PEROXIDECVS Pharmacy, Inc.42a22e06-1b66-4359-852c-7c39e1b3940a2024-06-24WarningsExact identifier
application number: M014
TolnaftateTOLNAFTATENuCare Pharmaceuticals,Inc.63665de7-8415-651f-e053-2991aa0ac2bb2024-06-06WarningsExact identifier
application number: M014
Rite Aid Earwax Removal DropsCARBAMIDE PEROXIDERite Aid1262531e-0674-cf32-e063-6294a90a0d0b2024-05-10WarningsExact identifier
application number: M014
Debrox KidsISOPROPYL ALCOHOLMedtech Products Inc.f42eee70-c4ee-44ad-85d5-a06d98ecb8b02024-05-09WarningsExact identifier
application number: M014
Rite Aid Swimmers Ear DropsISOPROPYL ALCOHOLRite Aid12875b9d-3ae8-bd0c-e063-6294a90ab4ae2024-02-29WarningsExact identifier
application number: M014
Topcare Swimmers Ear DropsISOPROPYL ALCOHOLTopco Associates LLC0fddeb43-fee0-d43c-e063-6394a90a738a2024-01-26WarningsExact identifier
application number: M014
NeilMed Clear Canal Earwax Removal kitCARBAMIDE PEROXIDENEILMED PHARMACEUTICALS INCd330552d-07b6-f01e-e053-2a95a90a7ca52024-01-11WarningsExact identifier
application number: M014
Wax Out PlusCARBAMIDE PEROXIDE DROPSNEILMED PHARMACEUTICALS INCcf64f4b8-279c-8c1d-e053-2995a90ac8532024-01-11WarningsExact 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