FDA.reportPublic FDA data

Good Neighbor Pharmacy Earwax Removal Drops

Product NDC
68788-8586
11-digit product format
687888586
Labeler code
68788
Product ID
68788-8586_b5fd067c-ad53-4af6-927c-7b91b8906861
Type
HUMAN OTC DRUG
Nonproprietary name
CARBAMIDE PEROXIDE
Dosage form
LIQUID
Route
TOPICAL
Labeler
Preferred Pharmaceuticals Inc.
Application
M014
Marketing category
OTC MONOGRAPH DRUG
Marketing start
2019-01-01
Substance
CARBAMIDE PEROXIDE
Active strength
65 mg/mL
NDC exclude flag
No
Listing certified through
2027-12-31
Current FDA listing
Yes

Additional Listing Data#

Finished product
Yes
Brand name base
Good Neighbor Pharmacy Earwax Removal Drops
Listing expiration
2027-12-31

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
5eb9f24b-9328-475e-af0a-18021935eb6aProduct name120180220

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
68788-8586-1Good Neighbor Pharmacy Earwax Removal Drops15 mL in 1 BOTTLE, DISPENSINGLIQUID153
68788-8586-1Good Neighbor Pharmacy Earwax Removal Drops1 in 1 CARTONLIQUID13

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
68788-8586-1ML - Milliliter68788-85867ba431c9-32c1-4b34-b9e8-9ea7efc798b912024-05-16

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
68788-8586GOOD NEIGHBOR PHARMACY EARWAX REMOVAL DROPS (CARBAMIDE PEROXIDE) LIQUID [PREFERRED PHARMACEUTICALS INC.]2Current NDC, 2 package rows20250409_52f733a7-1301-4078-9267-5ce95b006ccc.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
702050carbamide peroxide 6.5 % Otic SolutionPSN52f733a7-1301-4078-9267-5ce95b006ccc3
702050carbamide peroxide 65 MG/ML Otic SolutionSCD52f733a7-1301-4078-9267-5ce95b006ccc3
702050carbamide peroxide 6.5 % Otic SolutionSY52f733a7-1301-4078-9267-5ce95b006ccc3

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionMarketing startSampleExclude flagStatus
68788-8586-1687888586011 BOTTLE, DISPENSING in 1 CARTON (68788-8586-1) / 15 mL in 1 BOTTLE, DISPENSING2024-02-20NoNoHistorical