Debrox Swimmers Ear

Product NDC
63029-323
11-digit product format
630290323
Labeler code
63029
Product ID
63029-323_26ccea52-4ce6-4e95-b838-4824523e579c
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
2019-04-01
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 Swimmers Ear
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
63029-323-01Debrox Swimmers Ear30 mL in 1 BOTTLELIQUID303

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
63029-323DEBROX SWIMMERS EAR (ISOPROPYL ALCOHOL) LIQUID [MEDTECH PRODUCTS INC.]2Current NDC, Legacy NDC, 1 package rows20241210_b5d57c7b-8315-4260-967e-38fdd54e2a9c.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
631799isopropyl alcohol 95 % Otic SolutionPSNb5d57c7b-8315-4260-967e-38fdd54e2a9c3
631799isopropyl alcohol 0.95 ML/ML Otic SolutionSCDb5d57c7b-8315-4260-967e-38fdd54e2a9c3
631799isopropyl alcohol 94.998 % Otic SolutionSYb5d57c7b-8315-4260-967e-38fdd54e2a9c3
631799isopropyl alcohol 95 % Otic SolutionSYb5d57c7b-8315-4260-967e-38fdd54e2a9c3

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
63029-323-016302903230130 mL in 1 BOTTLE (63029-323-01) 30 ml2019-04-010000-00-00NoNoCurrent