Topcare Swimmers Ear Drops

Product NDC
76162-107
11-digit product format
761620107
Labeler code
76162
Product ID
76162-107_0fddeb43-fee1-d43c-e063-6394a90a738a
Type
HUMAN OTC DRUG
Nonproprietary name
Isopropyl Alcohol
Dosage form
LIQUID
Route
AURICULAR (OTIC)
Labeler
Topco Associates LLC
Application
M014
Marketing category
OTC MONOGRAPH DRUG
Marketing start
2024-01-26
Substance
ISOPROPYL ALCOHOL
Active strength
95 mL/100g
NDC exclude flag
No
Listing certified through
2026-12-31
Current FDA listing
Yes

Additional Listing Data#

Finished product
Yes
Brand name base
Topcare Swimmers Ear Drops
Listing expiration
2026-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
ISOPROPYL ALCOHOL95 mL/100g

Harmonized Identifiers#

Field, Values table
FieldValues
UniiND2M416302
Rxcui631799

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
6c13b22c-b3ba-4127-b768-0132dd5ab0d1Product name120230829

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
76162-107-01Topcare Swimmers Ear Drops1 in 1 BOXLIQUID11
76162-107-01Topcare Swimmers Ear Drops28 g in 1 BOTTLELIQUID281

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
76162-107TOPCARE SWIMMERS EAR DROPS (ISOPROPYL ALCOHOL) LIQUID [TOPCO ASSOCIATES LLC]1Current NDC, 2 package rows20240127_0fddeb43-fee0-d43c-e063-6394a90a738a.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
631799isopropyl alcohol 95 % Otic SolutionPSN0fddeb43-fee0-d43c-e063-6394a90a738a1
631799isopropyl alcohol 0.95 ML/ML Otic SolutionSCD0fddeb43-fee0-d43c-e063-6394a90a738a1
631799isopropyl alcohol 94.998 % Otic SolutionSY0fddeb43-fee0-d43c-e063-6394a90a738a1
631799isopropyl alcohol 95 % Otic SolutionSY0fddeb43-fee0-d43c-e063-6394a90a738a1

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startSampleExclude flagStatus
76162-107-01761620107011 BOTTLE in 1 BOX (76162-107-01) / 28 g in 1 BOTTLE1 bottle2024-01-26NoNoCurrent