DG Health Earwax Removal kit

Product NDC
75712-301
11-digit product format
757120301
Labeler code
75712
Product ID
75712-301_5c0fd2e6-1c99-4f3f-8127-1b3bd72d91ac
Type
HUMAN OTC DRUG
Nonproprietary name
Carbamide Peroxide 6.5%
Dosage form
SOLUTION/ DROPS
Route
TOPICAL
Labeler
DOLLAR GENERAL CORPORATION
Application
M014
Marketing category
OTC MONOGRAPH DRUG
Marketing start
2023-11-01
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
DG Health Earwax Removal kit
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
5eb9f24b-9328-475e-af0a-18021935eb6aProduct name120180220
d5e51f11-ad28-caa4-4b49-4143974782adProduct name120150831

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
75712-301-14DG Health Earwax Removal kit1 in 1 CARTONSOLUTION/ DROPS13
75712-301-14DG Health Earwax Removal kit15 mL in 1 BOTTLE, DROPPERSOLUTION/ DROPS153

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
75712-301DG HEALTH EARWAX REMOVAL KIT (CARBAMIDE PEROXIDE 6.5%) SOLUTION/ DROPS [DOLLAR GENERAL CORPORATION]3Current NDC, 2 package rows20231208_4b6fc00f-72d7-4675-9881-b763f27c06e3.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
702050carbamide peroxide 6.5 % Otic SolutionPSN4b6fc00f-72d7-4675-9881-b763f27c06e33
702050carbamide peroxide 65 MG/ML Otic SolutionSCD4b6fc00f-72d7-4675-9881-b763f27c06e33
702050carbamide peroxide 6.5 % Otic SolutionSY4b6fc00f-72d7-4675-9881-b763f27c06e33

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionMarketing startSampleExclude flagStatus
75712-301-14757120301141 BOTTLE, DROPPER in 1 CARTON (75712-301-14) / 15 mL in 1 BOTTLE, DROPPER2023-11-01NoNoCurrent