FDA.reportPublic FDA data

TINEACIDE

Product NDC
63347-511
Requested package NDC
63347-511-03
11-digit product format
633470511
Labeler code
63347
Product ID
63347-511_7929e269-caee-4126-a9ba-14cbc2dd73d1
Type
HUMAN OTC DRUG
Nonproprietary name
TOLNAFTATE
Dosage form
LIQUID
Route
TOPICAL
Labeler
Blaine Labs Inc.
Application
M005
Marketing category
OTC MONOGRAPH DRUG
Marketing start
2012-09-19
Substance
TOLNAFTATE
Active strength
140 mg/15mL
NDC exclude flag
No
Listing certified through
2026-12-31
Current FDA listing
Yes

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
TINEACIDE
Listing expiration
2026-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
TOLNAFTATE140 mg/15mL

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
273eb424-5dc3-40c8-9ea7-2f732cbd11c9Available on FDA.report

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
63347-511-032022-02-21C16284748780-1d6a99b39-66fc-a426-e053-dadaa90af4c2273eb424-5dc3-40c8-9ea7-2f732cbd11c9
63347-511-032022-01-28C16284748780-1d6a99b39-66fc-a426-e053-dadaa90af4c2273eb424-5dc3-40c8-9ea7-2f732cbd11c9

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
63347-511-03TINEACIDE15 mL in 1 BOTTLELIQUID159

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
TOLNAFTATEACTIVE INGREDIENT06KB629TKVTINEACIDE (TOLNAFTATE) LIQUID [BLAINE LABS INC.]4
TOLNAFTATEACTIVE MOIETY06KB629TKVTINEACIDE (TOLNAFTATE) LIQUID [BLAINE LABS INC.]4
.ALPHA.-TOCOPHEROL ACETATEINACTIVE INGREDIENT9E8X80D2L0TINEACIDE (TOLNAFTATE) LIQUID [BLAINE LABS INC.]4
BUTYLATED HYDROXYANISOLEINACTIVE INGREDIENTREK4960K2UTINEACIDE (TOLNAFTATE) LIQUID [BLAINE LABS INC.]4
BUTYLATED HYDROXYTOLUENEINACTIVE INGREDIENT1P9D0Z171KTINEACIDE (TOLNAFTATE) LIQUID [BLAINE LABS INC.]4
BUTYLPARABENINACTIVE INGREDIENT3QPI1U3FV8TINEACIDE (TOLNAFTATE) LIQUID [BLAINE LABS INC.]4
ETHYLPARABENINACTIVE INGREDIENT14255EXE39TINEACIDE (TOLNAFTATE) LIQUID [BLAINE LABS INC.]4
ISOBUTYLPARABENINACTIVE INGREDIENT0QQJ25X58GTINEACIDE (TOLNAFTATE) LIQUID [BLAINE LABS INC.]4
JOJOBA OILINACTIVE INGREDIENT724GKU717MTINEACIDE (TOLNAFTATE) LIQUID [BLAINE LABS INC.]4
METHYLPARABENINACTIVE INGREDIENTA2I8C7HI9TTINEACIDE (TOLNAFTATE) LIQUID [BLAINE LABS INC.]4
MINERAL OILINACTIVE INGREDIENTT5L8T28FGPTINEACIDE (TOLNAFTATE) LIQUID [BLAINE LABS INC.]4
OREGANO LEAF OILINACTIVE INGREDIENT7D0CGR40U1TINEACIDE (TOLNAFTATE) LIQUID [BLAINE LABS INC.]4
PHENOXYETHANOLINACTIVE INGREDIENTHIE492ZZ3TTINEACIDE (TOLNAFTATE) LIQUID [BLAINE LABS INC.]4
PROPYLPARABENINACTIVE INGREDIENTZ8IX2SC1OHTINEACIDE (TOLNAFTATE) LIQUID [BLAINE LABS INC.]4
SAFFLOWER OILINACTIVE INGREDIENT65UEH262ISTINEACIDE (TOLNAFTATE) LIQUID [BLAINE LABS INC.]4

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
63347-511TINEACIDE (TOLNAFTATE) LIQUID [BLAINE LABS INC.]9Current NDC, Legacy NDC, 1 package rows20231222_273eb424-5dc3-40c8-9ea7-2f732cbd11c9.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 5 of 49 · 973 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
SERYNTH Multi-Purpose Nail SolutionTOLNAFTATE 1% MULTI-PURPOSE NAIL SOLUTIONJiangxi Yudexi Pharmaceutical Co., LTD4a4af770-2bba-52a8-e063-6294a90ac2872026-07-21WarningsExact identifier
application number: M005
SERYNTH ClotrimazoleCLOTRIMAZOLE1% CLOTRIMAZOLEJiangxi Yudexi Pharmaceutical Co., LTD4a4b304a-1acc-9185-e063-6394a90a11762026-07-21WarningsExact identifier
application number: M005
SERYNTH FUNGI NAILTOLNAFTATE 1% FUNGI NAILJiangxi Yudexi Pharmaceutical Co., LTD4a4c6b7a-3c3e-1510-e063-6294a90a409a2026-07-21WarningsExact identifier
application number: M005
SERYNTH HELPS WITH FUNGAL NAILTOLNAFTATE 1% HELPS WITH FUNGAL NAILJiangxi Yudexi Pharmaceutical Co., LTD4a4c9ad1-e652-2b3b-e063-6394a90a29352026-07-21WarningsExact identifier
application number: M005
DERMFREE HELPS WITH NAGELPILZTOLNAFTATE 1% HELPS WITH NAGELPILZJiangxi Yudexi Pharmaceutical Co., LTD4a4d9361-3633-59b2-e063-6294a90aa3ea2026-07-21WarningsExact identifier
application number: M005
OURUI ONE FUNGAL NAIL TREATMENTTOLNAFTATE 1% FUNGAL NAIL TREATMENTJiangxi Yudexi Pharmaceutical Co., LTD4a473f03-f4cc-74ef-e063-6394a90ac7072026-07-20WarningsExact identifier
application number: M005
AVENASTER FUNGAL NAIL CARE DUO SET (NIGHT)UNDECYLENIC ACID 25% FUNGAL NAIL CARE DUO SET (NIGHT)Jiangxi Yudexi Pharmaceutical Co., LTD51eb8766-cc94-360d-e063-6294a90a69532026-07-20WarningsExact identifier
application number: M005
TINGOLE FUNGAL NAIL PatchesTOLNAFTATE 1% FUNGAL NAIL PATCHESJiangxi Yudexi Pharmaceutical Co., LTD5272c6fa-75f7-c698-e063-6394a90ac81e2026-07-20WarningsExact identifier
application number: M005
Vamy ANTIFUNGALTOLNAFTATE 1% ANTIFUNGALJiangxi Yudexi Pharmaceutical Co., LTD4dfdf3a2-95a8-9176-e063-6294a90a64de2026-07-20WarningsExact identifier
application number: M005
Antifungal creamANTIFUNGAL CREAMShenzhen Earth Surface Trading Co., Ltd.5708cc16-9a26-fd3c-e063-6394a90ac0ee2026-07-20WarningsExact identifier
application number: M005
TrpWinner TOENAIL FUNGUS PENUNDECYLENIC ACID 25% TOENAIL FUNGUS PENJiangxi Yudexi Pharmaceutical Co., LTD523c2a9c-3b35-bf73-e063-6394a90ae17d2026-07-20WarningsExact identifier
application number: M005
Charmpoo Antifungal CreamMICONAZOLE NITRATE 2% ANTIFUNGAL CREAMJiangxi Yudexi Pharmaceutical Co., LTD4ac347b5-d21b-cc9a-e063-6394a90a54962026-07-20WarningsExact identifier
application number: M005
Charmpoo TINEA VERSICOLOR TREATMENT ANTIFUNGALCLOTRIMAZOLE 1% TINEA VERSICOLOR TREATMENT ANTIFUNGALJiangxi Yudexi Pharmaceutical Co., LTD4ac31b1d-59d7-f45c-e063-6294a90a0d3d2026-07-20WarningsExact identifier
application number: M005
IraEvanes ANTIFUNGAL FOOTTOLNAFTATE 1% ANTIFUNGAL FOOTJiangxi Yudexi Pharmaceutical Co., LTD4d851a99-a453-e829-e063-6294a90a91182026-07-20WarningsExact identifier
application number: M005
LYSSERA Fungal Nail RenewalUNDECYLENIC ACID 25% ANTIFUNGAJiangxi Yudexi Pharmaceutical Co., LTD4dea6df4-e66b-c24a-e063-6294a90afca72026-07-20WarningsExact identifier
application number: M005
Kakalsa TOENAIL FUNGUS TREATMENTUNDECYLENIC ACID 25% TOENAIL FUNGUS TREATMENTJiangxi Yudexi Pharmaceutical Co., LTD5123c0c3-bba8-d61c-e063-6394a90aab702026-07-20WarningsExact identifier
application number: M005
SOVS FUNGAL NAIL REPAIR RENEWALUNDECYLENIC ACID 25% FUNGAL NAIL REPAIR RENEWALJiangxi Yudexi Pharmaceutical Co., LTD536b0c48-691e-755b-e063-6294a90a778e2026-07-20WarningsExact identifier
application number: M005
Tea Tree AntifungalCLOTRIMAZOLEHONG KONG UNORDERED TRADING CO., LIMITED56de35b7-b57d-1c62-e063-6294a90a757d2026-07-18WarningsExact identifier
application number: M005
ACTIV-CHARCOAL ANTIFUNGALTOLNAFTATEHONG KONG UNORDERED TRADING CO., LIMITED56def103-40ef-cd88-e063-6394a90a07172026-07-18WarningsExact identifier
application number: M005
SOVS MULTI-PURPOSE NAIL REPAIRTOLNAFTATE 1% MULTI-PURPOSE NAIL REPAIRWenzhou Yuyuan Pharmaceutical Co., Ltd.56df87a7-7fc2-5ba4-e063-6394a90a652b2026-07-18WarningsExact identifier
application number: M005

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
63347-511-036334705110315 mL in 1 BOTTLE (63347-511-03) 15 ml2012-09-190000-00-00NoNoCurrent