FDA.reportPublic FDA data

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 UNII identifiers#

UNII identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
ND2M416302Internal UNII lookup

Harmonized RxCUI identifiers#

RxCUI identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
631799Internal RxNorm lookup

Harmonized SPL set identifiers#

SPL set identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
b849acb5-e20b-464c-948b-8dcc51fdaf70Available on FDA.report

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#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
ISOPROPYL ALCOHOLACTIVE INGREDIENTND2M416302SWIM-EAR SOLUTION [E. FOUGERA & CO. A DIVISION OF FOUGERA PHARMACEUTICALS INC.]1
ISOPROPYL ALCOHOLACTIVE MOIETYND2M416302SWIM-EAR SOLUTION [E. FOUGERA & CO. A DIVISION OF FOUGERA PHARMACEUTICALS INC.]1
GLYCERININACTIVE INGREDIENTPDC6A3C0OXSWIM-EAR SOLUTION [E. FOUGERA & CO. A DIVISION OF FOUGERA PHARMACEUTICALS INC.]1

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

openFDA label cross-check#

OpenFDA label data provides additional search and identifier links. DailyMed’s Structured Product Label is the canonical label on FDA.report. Matching records are deduplicated before they are shown below.

Matched openFDA labels page 1 of 1 · 1 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Swim-EARSWIM-EARFougera Pharmaceuticals, LLCb849acb5-e20b-464c-948b-8dcc51fdaf702026-03-26WarningsExact identifier
ndc (product): 0168-0126

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