Ear Wax Removal Drops

Product NDC
11527-143
11-digit product format
115270143
Labeler code
11527
Product ID
11527-143_184c7110-33c6-4b58-bc79-451870131f3a
Type
HUMAN OTC DRUG
Nonproprietary name
Carbamide Peroxide - 6.5%
Dosage form
SOLUTION/ DROPS
Route
TOPICAL
Labeler
Sheffield Pharmaceuticals LLC
Application
M014
Marketing category
OTC MONOGRAPH DRUG
Marketing start
2017-02-02
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
Ear Wax 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
f52be47f-7aa7-46c0-b1fa-50c18dd50206Product name120201029

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
11527-143-51Ear Wax Removal Drops1 in 1 CARTONSOLUTION/ DROPS11
11527-143-51Ear Wax Removal Drops15 mL in 1 BOTTLE, DROPPERSOLUTION/ DROPS151

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
11527-143-51ML - Milliliter11527-1438306e8f7-af13-4b97-9fef-770f1180633f12024-11-05

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
11527-143EAR WAX REMOVAL DROPS (CARBAMIDE PEROXIDE - 6.5%) SOLUTION/ DROPS [SHEFFIELD PHARMACEUTICALS LLC]1Current NDC, 2 package rows20240628_aad7e2cd-cb28-423c-a441-eabe6516d40f.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
702050carbamide peroxide 6.5 % Otic SolutionPSNaad7e2cd-cb28-423c-a441-eabe6516d40f1
702050carbamide peroxide 65 MG/ML Otic SolutionSCDaad7e2cd-cb28-423c-a441-eabe6516d40f1
702050carbamide peroxide 6.5 % Otic SolutionSYaad7e2cd-cb28-423c-a441-eabe6516d40f1

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionMarketing startSampleExclude flagStatus
11527-143-51115270143511 BOTTLE, DROPPER in 1 CARTON (11527-143-51) / 15 mL in 1 BOTTLE, DROPPER2017-02-02NoNoCurrent