Swim-EAR

Product NDC
0168-0126
11-digit product format
001680126
Labeler code
0168
Product ID
0168-0126_f41c4af6-33dd-48b1-bff2-a4eefad5e70a
Type
HUMAN OTC DRUG
Nonproprietary name
Swim-EAR
Dosage form
SOLUTION
Route
AURICULAR (OTIC)
Labeler
Fougera Pharmaceuticals, LLC
Application
344
Marketing category
OTC MONOGRAPH DRUG
Marketing start
1970-04-03
Substance
ISOPROPYL ALCOHOL
Active strength
950 mg/mL
NDC exclude flag
No
Listing certified through
2027-12-31
Current FDA listing
Yes

Additional Listing Data#

Finished product
Yes
Brand name base
Swim-EAR
Listing expiration
2027-12-31

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
0168-0126-91Swim-EAR1 in 1 CARTONSOLUTION15
0168-0126-91Swim-EAR29.57 mL in 1 BOTTLE, DROPPERSOLUTION29.575

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
0168-0126-91ML - Milliliter0168-012601ba05f7-fd07-4cd7-97c5-04ba2d1887ca12013-12-02

DailyMed Socrata Ingredients#

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
0168-0126SWIM-EAR SOLUTION [FOUGERA PHARMACEUTICALS INC.]4Current NDC, Legacy NDC, 2 package rows20241127_b849acb5-e20b-464c-948b-8dcc51fdaf70.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
631799isopropyl alcohol 95 % Otic SolutionPSNb849acb5-e20b-464c-948b-8dcc51fdaf705
631799isopropyl alcohol 0.95 ML/ML Otic SolutionSCDb849acb5-e20b-464c-948b-8dcc51fdaf705
631799isopropyl alcohol 94.998 % Otic SolutionSYb849acb5-e20b-464c-948b-8dcc51fdaf705
631799isopropyl alcohol 95 % Otic SolutionSYb849acb5-e20b-464c-948b-8dcc51fdaf705

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionMarketing startMarketing endSampleExclude flagStatus
0168-0126-91001680126911 BOTTLE, DROPPER in 1 CARTON (0168-0126-91) / 29.57 mL in 1 BOTTLE, DROPPER1970-04-030000-00-00NoNoCurrent