CVS Health Earwax Removal Drops Earwax Removal Aid

Product NDC
51316-822
11-digit product format
513160822
Labeler code
51316
Product ID
51316-822_1ba4260c-f726-77de-e063-6294a90ab529
Type
HUMAN OTC DRUG
Nonproprietary name
CARBAMIDE PEROXIDE
Dosage form
SOLUTION/ DROPS
Route
TOPICAL
Labeler
CVS Pharmacy, Inc.
Application
M014
Marketing category
OTC MONOGRAPH DRUG
Marketing start
2024-08-01
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
CVS Health Earwax Removal Drops Earwax Removal Aid
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
e2db08c6-133f-4f4f-afb4-e90a2418d6f6Product name120230320
ce6d5c06-3ae0-18a6-d5b3-8cd3cc0f8906Product name720210625
f52be47f-7aa7-46c0-b1fa-50c18dd50206Product name120201029
11ed6f83-cdd2-4637-8379-b1a1d3ae3cdeProduct name120181101
5eb9f24b-9328-475e-af0a-18021935eb6aProduct name120180220
86c45a79-b9f0-4476-a27c-6e10db098497Product name120180125
d5e51f11-ad28-caa4-4b49-4143974782adProduct name120150831

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
51316-822-00CVS Health Earwax Removal Drops Earwax Removal Aid1 in 1 BOXSOLUTION/ DROPS11
51316-822-00CVS Health Earwax Removal Drops Earwax Removal Aid15 mL in 1 BOTTLESOLUTION/ DROPS151
51316-822-00CVS Health Earwax Removal Kit15 mL in 1 BOTTLESOLUTION/ DROPS15 mL65 mg in 1mL1
51316-822-00CVS Health Earwax Removal Kit1 in 1 BOXSOLUTION/ DROPS65 mg in 1mL1

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
51316-822CVS HEALTH EARWAX REMOVAL DROPS EARWAX REMOVAL AID (CARBAMIDE PEROXIDE) SOLUTION/ DROPS [CVS PHARMACY, INC.]1Current NDC, 2 package rows20240802_42a22e06-1b66-4359-852c-7c39e1b3940a.zip
51316-822CVS HEALTH EARWAX REMOVAL KIT (CARBAMIDE PEROXIDE) KIT [CVS PHARMACY, INC.]1Current NDC20240802_f842534c-46dd-42c7-8386-9a03ce16da86.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
702050carbamide peroxide 6.5 % Otic SolutionPSNf842534c-46dd-42c7-8386-9a03ce16da862
702050carbamide peroxide 65 MG/ML Otic SolutionSCDf842534c-46dd-42c7-8386-9a03ce16da862
702050carbamide peroxide 6.5 % Otic SolutionSYf842534c-46dd-42c7-8386-9a03ce16da862
702050carbamide peroxide 6.5 % Otic SolutionPSN42a22e06-1b66-4359-852c-7c39e1b3940a1
702050carbamide peroxide 65 MG/ML Otic SolutionSCD42a22e06-1b66-4359-852c-7c39e1b3940a1
702050carbamide peroxide 6.5 % Otic SolutionSY42a22e06-1b66-4359-852c-7c39e1b3940a1

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startSampleExclude flagStatus
51316-822-00513160822001 BOTTLE in 1 BOX (51316-822-00) / 15 mL in 1 BOTTLE1 bottle2024-08-01NoNoCurrent