TopCare Swimmers Ear Drops

Product NDC
36800-064
11-digit product format
368000064
Labeler code
36800
Product ID
36800-064_0ccb3e8a-3d00-1364-e063-6294a90a70e8
Type
HUMAN OTC DRUG
Nonproprietary name
Isopropyl Alcohol
Dosage form
LIQUID
Route
AURICULAR (OTIC)
Labeler
TOPCO ASSOCIATES
Application
M014
Marketing category
OTC MONOGRAPH DRUG
Marketing start
2019-01-03
Substance
ISOPROPYL ALCOHOL
Active strength
950 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
TopCare Swimmers Ear Drops
Listing expiration
2026-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
ISOPROPYL ALCOHOL950 mg/mL

Harmonized Identifiers#

Field, Values table
FieldValues
UniiND2M416302
Rxcui631799

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
36800-064-91TopCare Swimmers Ear Drops30 mL in 1 BOTTLE, PLASTICLIQUID304

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
36800-064TOPCARE SWIMMERS EAR DROPS (ISOPROPYL ALCOHOL) LIQUID [TOPCO ASSOCIATES]4Current NDC, Legacy NDC, 1 package rows20231219_9dccbc25-d954-f917-e053-2a95a90a0eff.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
631799isopropyl alcohol 95 % Otic SolutionPSN9dccbc25-d954-f917-e053-2a95a90a0eff4
631799isopropyl alcohol 0.95 ML/ML Otic SolutionSCD9dccbc25-d954-f917-e053-2a95a90a0eff4
631799isopropyl alcohol 94.998 % Otic SolutionSY9dccbc25-d954-f917-e053-2a95a90a0eff4
631799isopropyl alcohol 95 % Otic SolutionSY9dccbc25-d954-f917-e053-2a95a90a0eff4

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
36800-064-913680000649130 mL in 1 BOTTLE, PLASTIC (36800-064-91) 30 ml2019-01-030000-00-00NoNoCurrent