FDA.reportPublic FDA data

ProClearz

Product NDC
29784-181
11-digit product format
297840181
Labeler code
29784
Product ID
29784-181_4c0c1702-95ab-d4ad-e063-6294a90afb7c
Type
HUMAN OTC DRUG
Nonproprietary name
Tolnaftate
Dosage form
SOLUTION
Route
TOPICAL
Labeler
Rooftop Consumer Health, Inc.
Application
M005
Marketing category
OTC MONOGRAPH DRUG
Marketing start
2012-10-22
Substance
TOLNAFTATE
Active strength
10 mg/mL
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
ProClearz
Brand name suffix
Maximum Strength Fungal Shield Brush-on Antifungal
Listing expiration
2027-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
TOLNAFTATE10 mg/mL

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 · 2 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
313423Internal RxNorm lookup
1311221Internal RxNorm lookup

Harmonized SPL set identifiers#

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

Identifier, FDA.report destination table
IdentifierFDA.report destination
4d451e87-c25b-49cf-92b8-747b053930c2Available on FDA.report

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
29784-181-01ProClearzMaximum Strength Fungal Shield Brush-on Antifungal30 mL in 1 BOTTLE, WITH APPLICATORSOLUTION3038
29784-181-02ProClearzMaximum Strength Fungal Shield Brush-on Antifungal1 in 1 BOXSOLUTION138

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
TOLNAFTATEACTIVE INGREDIENT06KB629TKVPROCLEARZ MAXIMUM STRENGTH FUNGAL SHIELD BRUSH-ON ANTIFUNGAL (TOLNAFTATE) LIQUID [PROFOOT, INC.]6
TOLNAFTATEACTIVE MOIETY06KB629TKVPROCLEARZ MAXIMUM STRENGTH FUNGAL SHIELD BRUSH-ON ANTIFUNGAL (TOLNAFTATE) LIQUID [PROFOOT, INC.]6
.ALPHA.-TOCOPHEROL ACETATEINACTIVE INGREDIENT9E8X80D2L0PROCLEARZ MAXIMUM STRENGTH FUNGAL SHIELD BRUSH-ON ANTIFUNGAL (TOLNAFTATE) LIQUID [PROFOOT, INC.]6
ACETONEINACTIVE INGREDIENT1364PS73AFPROCLEARZ MAXIMUM STRENGTH FUNGAL SHIELD BRUSH-ON ANTIFUNGAL (TOLNAFTATE) LIQUID [PROFOOT, INC.]6
ALOE VERA LEAFINACTIVE INGREDIENTZY81Z83H0XPROCLEARZ MAXIMUM STRENGTH FUNGAL SHIELD BRUSH-ON ANTIFUNGAL (TOLNAFTATE) LIQUID [PROFOOT, INC.]6
PROPYLENE GLYCOLINACTIVE INGREDIENT6DC9Q167V3PROCLEARZ MAXIMUM STRENGTH FUNGAL SHIELD BRUSH-ON ANTIFUNGAL (TOLNAFTATE) LIQUID [PROFOOT, INC.]6
WATERINACTIVE INGREDIENT059QF0KO0RPROCLEARZ MAXIMUM STRENGTH FUNGAL SHIELD BRUSH-ON ANTIFUNGAL (TOLNAFTATE) LIQUID [PROFOOT, INC.]6

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
29784-181PROCLEARZ MAXIMUM STRENGTH FUNGAL SHIELD BRUSH-ON ANTIFUNGAL (TOLNAFTATE) SOLUTION [ROOFTOP CONSUMER HEALTH, INC.]36Current NDC, Legacy NDC, 2 package rows20250105_4d451e87-c25b-49cf-92b8-747b053930c2.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 33 of 49 · 973 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Unishield Hand SanitizerETHYL ALCOHOLUnishieldeae1fc97-eb39-4353-adfa-7c549d50b5db2025-09-24WarningsExact identifier
application number: M005
RUGBY ANTIFUNGAL CLOTRIMAZOLECLOTRIMAZOLERugby Laboratories0b32a369-ea1c-4cb8-8ea1-07bba8f16b722025-09-16WarningsExact identifier
application number: M005
SKIN TAG WART AND CORN REMOVERSALICYLIC ACIDZhenping Renren Industry Co., Ltd.3e6dad69-b301-f7dc-e063-6394a90ad3802025-09-14WarningsExact identifier
application number: M005
FUNGAL NAILS REPAIRING ESSENCEPEPPERMINT OILZhenping Renren Industry Co., Ltd.3e82649c-d784-d64c-e063-6294a90ac95d2025-09-11WarningsExact identifier
application number: M005
equate Athletes FootTOLNAFTATEWal-Mart Stores Ince90297d0-0f87-4ae3-b9b7-959266d57c242025-09-11WarningsExact identifier
application number: M005
Bee Venom Toenail Fungus TreatmentBEE VENOM TOENAIL FUNGUS TREATMENTShenzhen Earth Surface Trading Co., Ltd.3e7d22b0-2f57-fcac-e063-6394a90aefd92025-09-10WarningsExact identifier
application number: M005
Amerfresh Antibacterial DeodorantBENZETHONIUM CHLORIDELiufangjing Biotechnology (Yangzhou) Co., Ltdcdc4f0ff-07bd-47c8-850b-1698308bb6602025-09-09WarningsExact identifier
application number: M005
Antifungal CreamMICONAZOLE NITRATEEncube Ethicals, Inc.8be4bbfa-424c-4ccf-b8bc-65b16c1260532025-09-04WarningsExact identifier
application number: M005
ANTIFUNGALCLOTRIMAZOLEEncube Ethicals, Inc.afbc28f8-bb76-424d-9d73-136e6c283ead2025-09-04WarningsExact identifier
application number: M005
Hermon Balanitis relief kitSULFUR 1X HPUSBeautivity LLC3dce086e-a4eb-4b21-e063-6394a90aa1b22025-09-02WarningsExact identifier
application number: M005
Extra Strength Nail Fungus TreatmentUNDECYLENIC ACID, TOLNAFTATEGUANGZHOU SAWEILAN IMPORT & EXPORT TRADING CO., LTD3abc0892-e52b-a40f-e063-6294a90a0e352025-09-02WarningsExact identifier
application number: M005
Hermon Balanitis CreamSULFUR 1X HPUSBeautivity LLC3dba4e4b-8224-6a96-e063-6394a90a91292025-09-01WarningsExact identifier
application number: M005
CaseysBENZALKONIUM CHLORIDEZhejiang Bright Care Co., Ltd.a29d6c19-01aa-45b0-92cd-3f1148bad4f82025-08-30WarningsExact identifier
application number: M005
TolnafateTOLNAFTATE JOCK ITCH POWDER SPRAY - TALC FREEVALU MERCHANDISERS, CO.1d258684-9034-460c-953d-78e2b51981672025-08-26WarningsExact identifier
application number: M005
Femmesil Maximum StrengthMICONAZOLE NITRATEAidance Skincare & Topical Solutions, LLCd8b01fe1-4465-497b-909e-f51f31fdf8332025-08-25WarningsExact identifier
application number: M005
femmesil Ultra TherapyCLOTRIMAZOLEAidance Scientific, Inc.3d36794a-07d0-860c-e063-6294a90a6e8f2025-08-25WarningsExact identifier
application number: M005
Nedtol Folliculitis Treatment CreamsMICONAZOLE NITRATEJiashen International Trade Limited3d0a1e39-82e4-9337-e063-6294a90aa9a32025-08-23WarningsExact identifier
application number: M005
ClotrimazoleCLOTRIMAZOLETRIFECTA PHARMACEUTICALS USA LLC6b74d405-42d6-4c46-ba78-3007d1e8ffb82025-08-23WarningsExact identifier
application number: M005
FUNGLARA Anti FungalUNDECYLENIC ACIDFUNGLARA LLCa23c2399-36ea-4f22-8140-066e22c9a8622025-08-20WarningsExact identifier
application number: M005
Rapid MicroGelTOLNAFTATEThe Tetra Corporationafb6d7c4-1f75-4694-83c8-d6469250d6a12025-08-19WarningsExact identifier
application number: M005

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
1311221ProClearz 1 % Topical SolutionPSN4d451e87-c25b-49cf-92b8-747b053930c238
313423tolnaftate 1 % Topical SolutionPSN4d451e87-c25b-49cf-92b8-747b053930c238
1311221tolnaftate 10 MG/ML Topical Solution [Proclearz]SBD4d451e87-c25b-49cf-92b8-747b053930c238
313423tolnaftate 10 MG/ML Topical SolutionSCD4d451e87-c25b-49cf-92b8-747b053930c238
1311221Proclearz 1 % Topical SolutionSY4d451e87-c25b-49cf-92b8-747b053930c238
1311221Proclearz 10 MG/ML Topical SolutionSY4d451e87-c25b-49cf-92b8-747b053930c238
313423tolnaftate 1 % Topical SolutionSY4d451e87-c25b-49cf-92b8-747b053930c238

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
29784-181-012978401810130 mL in 1 BOTTLE, WITH APPLICATOR30 mlHistorical
29784-181-02297840181021 BOTTLE, WITH APPLICATOR in 1 BOX (29784-181-02) / 30 mL in 1 BOTTLE, WITH APPLICATOR (29784-181-01) 2012-10-220000-00-00NoNoCurrent