FDA.reportPublic FDA data

Good Neighbor Pharmacy Earwax Removal Drops

Product NDC
46122-557
11-digit product format
461220557
Labeler code
46122
Product ID
46122-557_52f609e5-4f3f-1bab-e063-6394a90ae042
Type
HUMAN OTC DRUG
Nonproprietary name
CARBAMIDE PEROXIDE
Dosage form
LIQUID
Route
TOPICAL
Labeler
Amerisource Bergen
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

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
Good Neighbor Pharmacy Earwax Removal Drops
Listing expiration
2027-12-31

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
89eac1b0-c700-45b5-8478-da53ace72e16Available 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
46122-557-05Good Neighbor Pharmacy Earwax Removal Drops15 mL in 1 BOTTLE, DISPENSINGLIQUID153
46122-557-05Good 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
46122-557-05ML - Milliliter46122-5571e495b15-dc1f-45b7-a171-f21fb79c003612019-04-11

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
46122-557GOOD NEIGHBOR PHARMACY EARWAX REMOVAL DROPS (CARBAMIDE PEROXIDE) LIQUID [AMERISOURCE BERGEN]3Current NDC, Legacy NDC, 2 package rows20250303_89eac1b0-c700-45b5-8478-da53ace72e16.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 7 of 7 · 129 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
EAR WAX RMVL Rite AidCARBAMIDE PEROXIDE 6.5%Rite Aid9e3cedcc-e523-2653-e053-2a95a90ad1432023-12-15WarningsExact identifier
application number: M014
EarWax Removal Kit Rite AidCARBAMIDE PEROXIDE 6.5%Rite Aidda78ac58-6c1c-4fa9-baac-e9dec02413852023-12-15WarningsExact identifier
application number: M014
Otix Ear wax Removal System Ear wax and BulbCARBAMIDE PEROXIDEBell Pharmaceuticals, Inc.15868798-28cd-4495-9baf-711e81ad8bdd2023-12-14WarningsExact identifier
application number: M014
Otix Ear wax Removal DropsCARBAMIDE PEROXIDEBell Pharmaceuticals, Inc.0e70ab09-9360-4ab6-a1fe-6f82af3925812023-12-14WarningsExact identifier
application number: M014
TopCare Earwax Removal DropsCARBAMIDE PEROXIDETopco Associates LLCc5b1ad0e-3712-40fd-afbe-54c0b5f1160b2023-12-14WarningsExact identifier
application number: M014
DG Health Earwax Removal kitCARBAMIDE PEROXIDE 6.5%DOLLAR GENERAL CORPORATION4b6fc00f-72d7-4675-9881-b763f27c06e32023-12-07WarningsExact identifier
application number: M014
Ear Wax Removal Drops EquateCARBAMIDE PEROXIDE - 6.5%WALMART STORES INC33065ba2-5ce2-4db7-9d7a-d8aa2f38a90d2023-12-04WarningsExact identifier
application number: M014
Good Neighbor Pharmacy Earwax Removal DropsCARBAMIDE PEROXIDEProficient Rx LPa131447b-a5a0-45cd-a59c-a9f719275baa2023-12-01WarningsExact identifier
application number: M014
Ear Wax Removal DropsCARBAMIDE PEROXIDE - 6.5%Sheffield Pharmaceuticals LLCaad7e2cd-cb28-423c-a441-eabe6516d40f2022-12-06WarningsExact identifier
application number: M014

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
702050carbamide peroxide 6.5 % Otic SolutionPSN89eac1b0-c700-45b5-8478-da53ace72e165
702050carbamide peroxide 6.5 % Otic SolutionPSNa131447b-a5a0-45cd-a59c-a9f719275baa5
702050carbamide peroxide 65 MG/ML Otic SolutionSCD89eac1b0-c700-45b5-8478-da53ace72e165
702050carbamide peroxide 65 MG/ML Otic SolutionSCDa131447b-a5a0-45cd-a59c-a9f719275baa5
702050carbamide peroxide 6.5 % Otic SolutionSY89eac1b0-c700-45b5-8478-da53ace72e165
702050carbamide peroxide 6.5 % Otic SolutionSYa131447b-a5a0-45cd-a59c-a9f719275baa5
702050carbamide peroxide 6.5 % Otic SolutionPSN52f733a7-1301-4078-9267-5ce95b006ccc3
702050carbamide peroxide 6.5 % Otic SolutionPSNd503b10f-85cd-4bb8-9dec-82d651d525fa3
702050carbamide peroxide 65 MG/ML Otic SolutionSCD52f733a7-1301-4078-9267-5ce95b006ccc3
702050carbamide peroxide 65 MG/ML Otic SolutionSCDd503b10f-85cd-4bb8-9dec-82d651d525fa3
702050carbamide peroxide 6.5 % Otic SolutionSY52f733a7-1301-4078-9267-5ce95b006ccc3
702050carbamide peroxide 6.5 % Otic SolutionSYd503b10f-85cd-4bb8-9dec-82d651d525fa3

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionMarketing startMarketing endSampleExclude flagStatus
46122-557-05461220557051 BOTTLE, DISPENSING in 1 CARTON (46122-557-05) / 15 mL in 1 BOTTLE, DISPENSING2019-01-010000-00-00NoNoCurrent