FDA.reportPublic FDA data

Finafta

Product NDC
58593-780
Requested package NDC
58593-780-15
11-digit product format
585930780
Labeler code
58593
Product ID
58593-780_d230102e-3ec5-4ace-e053-2a95a90a5b3c
Type
HUMAN OTC DRUG
Nonproprietary name
Ethyl Alcohol, Salicylic Acid, Benzocaine
Dosage form
LIQUID
Route
TOPICAL
Labeler
Efficient Laboratories Inc.
Application
part356
Marketing category
OTC MONOGRAPH NOT FINAL
Marketing start
1991-10-01
Marketing end
0000-00-00
Substance
ALCOHOL; SALICYLIC ACID; BENZOCAINE
Active strength
60 mL/100mL; mg/100mL; mg/100mL
NDC exclude flag
No
Listing certified through
2022-12-31
Current FDA listing
Historical FDA.report record

NDC auxiliary status#

These records are reproduced from FDA’s unfinished, excluded, and compounder listings. They describe what appeared in the source files; a missing record does not establish a regulatory status. View all current auxiliary records, including entries without an NDC. · View the auxiliary file history.

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

Dataset, Scope, Product NDC table
DatasetScopeProduct NDCPackage NDCCodeStatusReporting periodSource date
excluded packagepackage58593-78058593-780-15DDiscontinued by firm2026-10-05

Reported adverse events (FAERS/openFDA)#

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

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
dea2eded-d1e7-46bb-9a3d-f8dc20de6277Product name120190408
7792dadb-52b6-46b6-8fdf-80b1171065b5Product name120180810

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
58593-780-152020-02-16C16284748780-19d75b9cf-f0e6-f424-e053-dadaa90a57ceFinafta
58593-780-152020-01-31C16284748780-19d75b9cf-f0e6-f424-e053-dadaa90a57ceFinafta

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
58593-780-15Finafta15 mL in 1 BOTTLE, WITH APPLICATORLIQUID1510

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
ALCOHOLACTIVE INGREDIENT3K9958V90MFINAFTA (ETHYL ALCOHOL, SALICYLIC ACID, BENZOCAINE) LIQUID [EFFICIENT LABORATORIES INC.]5
BENZOCAINEACTIVE INGREDIENTU3RSY48JW5FINAFTA (ETHYL ALCOHOL, SALICYLIC ACID, BENZOCAINE) LIQUID [EFFICIENT LABORATORIES INC.]5
SALICYLIC ACIDACTIVE INGREDIENTO414PZ4LPZFINAFTA (ETHYL ALCOHOL, SALICYLIC ACID, BENZOCAINE) LIQUID [EFFICIENT LABORATORIES INC.]5
ALCOHOLACTIVE MOIETY3K9958V90MFINAFTA (ETHYL ALCOHOL, SALICYLIC ACID, BENZOCAINE) LIQUID [EFFICIENT LABORATORIES INC.]5
BENZOCAINEACTIVE MOIETYU3RSY48JW5FINAFTA (ETHYL ALCOHOL, SALICYLIC ACID, BENZOCAINE) LIQUID [EFFICIENT LABORATORIES INC.]5
SALICYLIC ACIDACTIVE MOIETYO414PZ4LPZFINAFTA (ETHYL ALCOHOL, SALICYLIC ACID, BENZOCAINE) LIQUID [EFFICIENT LABORATORIES INC.]5
PROPYLENE GLYCOLINACTIVE INGREDIENT6DC9Q167V3FINAFTA (ETHYL ALCOHOL, SALICYLIC ACID, BENZOCAINE) LIQUID [EFFICIENT LABORATORIES INC.]5
WATERINACTIVE INGREDIENT059QF0KO0RFINAFTA (ETHYL ALCOHOL, SALICYLIC ACID, BENZOCAINE) LIQUID [EFFICIENT LABORATORIES INC.]5

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
58593-780FINAFTA (ETHYL ALCOHOL, SALICYLIC ACID, BENZOCAINE) LIQUID [EFFICIENT LABORATORIES INC.]10Legacy NDC, 1 package rows20230808_1410fa91-d1bc-4797-b888-9b6971f643e0.zip

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
58593-780-155859307801515 mL in 1 BOTTLE, WITH APPLICATOR (58593-780-15) 15 ml1991-10-010000-00-00NoNoCurrent