FDA.reportPublic FDA data

SSPROTIP X Extra Strength Nail Renewal Patches

Product NDC
85966-016
11-digit product format
859660016
Labeler code
85966
Product ID
85966-016_52512e7e-5e29-4383-e063-6294a90a448a
Type
HUMAN OTC DRUG
Nonproprietary name
Tolnaftate
Dosage form
PATCH
Route
TOPICAL
Labeler
GUANGZHOU SAWEILAN IMPORT & EXPORT TRADING CO., LTD
Application
M005
Marketing category
OTC MONOGRAPH DRUG
Marketing start
2026-05-21
Substance
TOLNAFTATE
Active strength
.01 g/1
NDC exclude flag
No
Listing certified through
2027-12-31
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
SSPROTIP X Extra Strength Nail Renewal Patches
Listing expiration
2027-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
TOLNAFTATE.01 g/1

Harmonized UNII identifiers#

UNII identifiers page 1 of 1 · 1 matching rows.

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

Harmonized RxCUI identifiers#

RxCUI identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
2677690Internal RxNorm lookup

Harmonized SPL set identifiers#

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

Identifier, FDA.report destination table
IdentifierFDA.report destination
52512e7e-5e28-4383-e063-6294a90a448aAvailable on FDA.report

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
85966-016-01SSPROTIP X Extra Strength Nail Renewal Patches1 in 1 PATCHPATCH11
85966-016-01SSPROTIP X Extra Strength Nail Renewal Patches38 in 1 BOXPATCH381

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

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
2677690tolnaftate 1 % Medicated PatchPSN52512e7e-5e28-4383-e063-6294a90a448a1
2677690tolnaftate 0.01 MG/MG Medicated PatchSCD52512e7e-5e28-4383-e063-6294a90a448a1
2677690tolnaftate 1 % Medicated PatchSY52512e7e-5e28-4383-e063-6294a90a448a1

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startSampleExclude flagStatus
85966-016-018596600160138 PATCH in 1 BOX (85966-016-01) / 1 PATCH in 1 PATCH38 patch2026-05-21NoNoCurrent