FDA.reportPublic FDA data

Ongo - Fin

Product NDC
58593-800
Requested package NDC
58593-800-01
11-digit product format
585930800
Labeler code
58593
Product ID
58593-800_24708234-0886-bb16-e063-6294a90a6898
Type
HUMAN OTC DRUG
Nonproprietary name
TOLNAFTATE
Dosage form
LIQUID
Route
TOPICAL
Labeler
Efficient Laboratories Inc.
Application
M005
Marketing category
OTC MONOGRAPH DRUG
Marketing start
2004-02-01
Substance
TOLNAFTATE
Active strength
1 mg/100mL
NDC exclude flag
No
Listing certified through
2027-12-31
Current FDA listing
Yes

Observed NDC auxiliary status history#

This history shows the information present in each captured FDA auxiliary file. It is not a continuous regulatory timeline, and a missing record does not establish a status.

Historic NDC status page 1 of 1 · 1 matching rows.

View current auxiliary records. · View the auxiliary file history.

Captured / source date, Dataset, Scope table
Captured / source dateDatasetScopeProduct NDCPackage NDCCodeStatusReporting periodArchiveSnapshotSource SHA-256
2019-12-08 06:16 UTC · source 2019-12-05excluded packagepackage58593-80058593-800-01IInactivated by FDAexcluded / ndc_excluded.zip110d247fa046…a55b01930146…

Reported adverse events (FAERS/openFDA)#

Adverse event summaries are temporarily unavailable. Other product information remains available.

Additional Listing Data#

Finished product
Yes
Brand name base
Ongo - Fin
Listing expiration
2027-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
TOLNAFTATE1 mg/100mL

Harmonized UNII identifiers#

UNII identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
06KB629TKVInternal UNII lookup

Harmonized SPL set identifiers#

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

Identifier, FDA.report destination table
IdentifierFDA.report destination
bb5fb71f-bee0-42fa-9c9f-6231b555324cAvailable on FDA.report

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Related label table
NDCEffectiveRelated label
58593-800-012020-02-19Drud Facts
58593-800-022020-02-19Drud Facts
58593-800-012019-10-29Drud Facts
58593-800-022019-10-29Drud Facts

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
58593-800-01Ongo - Fin30 mL in 1 BOTTLE, WITH APPLICATORLIQUID308
58593-800-02Ongo - Fin30 mL in 1 BOTTLE, SPRAYLIQUID308

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
TOLNAFTATEACTIVE INGREDIENT06KB629TKVONGO - FIN (TOLNAFTATE) LIQUID [EFFICIENT LABORATORIES INC.]1
TOLNAFTATEACTIVE MOIETY06KB629TKVONGO - FIN (TOLNAFTATE) LIQUID [EFFICIENT LABORATORIES INC.]1
ACETONEINACTIVE INGREDIENT1364PS73AFONGO - FIN (TOLNAFTATE) LIQUID [EFFICIENT LABORATORIES INC.]1
ALOE VERA LEAFINACTIVE INGREDIENTZY81Z83H0XONGO - FIN (TOLNAFTATE) LIQUID [EFFICIENT LABORATORIES INC.]1
ALPHA-TOCOPHEROLINACTIVE INGREDIENTH4N855PNZ1ONGO - FIN (TOLNAFTATE) LIQUID [EFFICIENT LABORATORIES INC.]1
PROPYLENE GLYCOLINACTIVE INGREDIENT6DC9Q167V3ONGO - FIN (TOLNAFTATE) LIQUID [EFFICIENT LABORATORIES INC.]1
WATERINACTIVE INGREDIENT059QF0KO0RONGO - FIN (TOLNAFTATE) LIQUID [EFFICIENT LABORATORIES INC.]1

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
58593-800ONGO - FIN (TOLNAFTATE) LIQUID [EFFICIENT LABORATORIES INC.]8Current NDC, Legacy NDC, 2 package rows20241016_bb5fb71f-bee0-42fa-9c9f-6231b555324c.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 49 of 49 · 969 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Povidone Iodine ImpregnatedPOVIDONE IODINEJianerkang Medical Co., Ltd14f2a1dd-92c2-49e8-9fa0-a9d88e8c530d2023-10-23WarningsExact identifier
application number: M005
Povidone Iodine ImpregnatedPOVIDONE IODINEJianerkang Medical Co., Ltdb82cea56-b09f-411d-a6cf-c53b3ce0e3b62023-10-23WarningsExact identifier
application number: M005
Povidone Iodine ScrubPOVIDONE-IODINEJianerkang Medical Co., Ltd78131b57-1ffc-4eb8-821e-f7bb73300fe92023-10-23WarningsExact identifier
application number: M005
Povidone IodinePOVIDONE IODINEJianerkang Medical Co., Ltdeb30e5de-9074-4760-8e92-e1d1c127227d2023-10-23WarningsExact identifier
application number: M005
Povidone IodinePOVIDONE IODINEJianerkang Medical Co., Ltd0bd3de76-b726-41f1-87bc-14ab8a1eca8e2023-10-23WarningsExact identifier
application number: M005
Povidone Iodine Prep PadPOVIDONE-IODINEJianerkang Medical Co., Ltdbe85ec5b-eb49-4f1a-a87d-5c9705a20f232023-10-22WarningsExact identifier
application number: M005
EVERLIT CARE Hand SanitizerETHYL ALCOHOLNantong Health & Beyond Hygienic Products Inc.579c1ab5-50b4-4b5a-a189-c1e2827d0c3a2023-10-14WarningsExact identifier
application number: M005
Micomitin AntifungalCLOTRIMAZOLEPureTek Corporationdd05f5f9-2412-1295-e053-2995a90acb962022-02-14WarningsExact identifier
application number: M005
MicatinMICONAZOLE NITRATEWellSpring Pharmaceutical Corporation96c56ba1-c3a8-48ce-ab58-550959485e3c2016-04-07WarningsExact identifier
application number: M005

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
58593-800-015859308000130 mL in 1 BOTTLE, WITH APPLICATOR (58593-800-01) 30 ml2004-02-010000-00-00NoNoCurrent