Debrox Kids

Product NDC
63029-325
11-digit product format
630290325
Labeler code
63029
Product ID
63029-325_1b8b21f4-8317-4f77-94c6-ba5bc6b5dd96
Type
HUMAN OTC DRUG
Nonproprietary name
isopropyl alcohol
Dosage form
LIQUID
Route
AURICULAR (OTIC)
Labeler
Medtech Products Inc.
Application
M014
Marketing category
OTC MONOGRAPH DRUG
Marketing start
2024-06-01
Substance
ISOPROPYL ALCOHOL
Active strength
95 mL/100mL
NDC exclude flag
No
Listing certified through
2026-12-31
Current FDA listing
Yes

Additional Listing Data#

Finished product
Yes
Brand name base
Debrox Kids
Listing expiration
2026-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
ISOPROPYL ALCOHOL95 mL/100mL

Harmonized Identifiers#

Field, Values table
FieldValues
UniiND2M416302
Rxcui631799

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
63029-325-01Debrox Kids1 in 1 CARTONLIQUID12
63029-325-01Debrox Kids30 mL in 1 BOTTLELIQUID302

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
63029-325DEBROX KIDS (ISOPROPYL ALCOHOL) LIQUID [MEDTECH PRODUCTS INC.]2Current NDC, 2 package rows20240601_f42eee70-c4ee-44ad-85d5-a06d98ecb8b0.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
631799isopropyl alcohol 95 % Otic SolutionPSNf42eee70-c4ee-44ad-85d5-a06d98ecb8b02
631799isopropyl alcohol 0.95 ML/ML Otic SolutionSCDf42eee70-c4ee-44ad-85d5-a06d98ecb8b02
631799isopropyl alcohol 94.998 % Otic SolutionSYf42eee70-c4ee-44ad-85d5-a06d98ecb8b02
631799isopropyl alcohol 95 % Otic SolutionSYf42eee70-c4ee-44ad-85d5-a06d98ecb8b02

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startSampleExclude flagStatus
63029-325-01630290325011 BOTTLE in 1 CARTON (63029-325-01) / 30 mL in 1 BOTTLE1 bottle2024-06-01NoNoCurrent