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 16 of 49 · 973 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
EXTRA STRENGTH TOENAIIL RENEWAL PENUNDECYLENIC ACID, TOLNAFTATEGUANGZHOU SAWEILAN IMPORT & EXPORT TRADING CO., LTD4eea5ee7-0ef9-8d34-e063-6294a90af5952026-04-07WarningsExact identifier
application number: M005
EXTRA STRENGTH TOENAIIL RENEWAL SolutionUNDECYLENIC ACID, TOLNAFTATEGUANGZHOU SAWEILAN IMPORT & EXPORT TRADING CO., LTD4eeaa2f0-efc7-eab3-e063-6294a90a13b32026-04-07WarningsExact identifier
application number: M005
Extra Strength Toenail Renewal PenUNDECYLENIC ACID, TOLNAFTATEGUANGZHOU SAWEILAN IMPORT & EXPORT TRADING CO., LTD4eeb59d2-3891-2e45-e063-6294a90a4fcf2026-04-07WarningsExact identifier
application number: M005
RoyceDerm Tinea ANTIFUNGAL .soap.CLOTRIMAZOLE 1%RoyceDerm LLC4e889f2b-9ea1-b1a6-e063-6394a90a46542026-04-03WarningsExact identifier
application number: M005
Toenail Fungus Treatment Extra Strength PenTOLNAFTATE, UNDECYLENIC ACIDLianjiang Shanlilai E-commerce Co., Ltd.28fbcc50-a3ac-d6d1-e063-6294a90aa2b62026-04-02WarningsExact identifier
application number: M005
TOENAIL FUNGUS TREATMENT LiquidTOLNAFTATE, UNDECYLENIC ACIDLianjiang Shanlilai E-commerce Co., Ltd.28fc7049-e367-42bf-e063-6394a90a6f062026-04-02WarningsExact identifier
application number: M005
Fungal Nail PatchesTOLNAFTATE, UNDECYLENIC ACIDLianjiang Shanlilai E-commerce Co., Ltd.299a63ad-f321-117c-e063-6394a90a3a222026-04-02WarningsExact identifier
application number: M005
Secura Antifungal GreaselessMICONAZOLE NITRATESmith & Nephew Medical Ltd9be600e4-76ec-4071-a8ec-a0b23155271d2026-04-02WarningsExact identifier
application number: M005
FifthPulse Bacitracin ZincBACITRACIN ZINCWeCare Products LLC5c6b3ad8-c158-4cc0-b1ba-b829b5df12842026-04-02WarningsExact identifier
application number: M005
FifthPulse Miconazole Nitrate AntifungalMICONAZOLE NITRATEWeCare Products LLCb70238eb-afcb-4e09-976f-973df249241c2026-04-02WarningsExact identifier
application number: M005
ANTIFUNGAL PENUNDECYLENIC ACID, TERBINAFINE HYDROCHLORIDEHanyang Qisheng (Shenzhen) Technology Co., Ltd.4e85f338-ffd7-85b1-e063-6294a90a3c872026-04-02WarningsExact identifier
application number: M005
RoyceDerm Anti-Fungal CreamMICONAZOLE NITRATE 2%RoyceDerm LLC4e861073-88e8-b2f7-e063-6394a90ab94a2026-04-02WarningsExact identifier
application number: M005
Miconazole NitrateJOCK ITCH SPRAYCVS Pharmacy7b70d3ea-126a-42aa-8509-b982893c710b2026-04-01WarningsExact identifier
application number: M005
Fungicure Anti-Fungal LiquidTOLNAFTATEKobayashi Healthcare International, Inc.b18ee199-0659-733c-e053-2a95a90ab6b52026-04-01WarningsExact identifier
application number: M005
TolnaftateANTIFUNGAL LIQUID SPRAYCVS Pharmacy96cc594d-85c8-4f62-bc0a-3176c8739f212026-04-01WarningsExact identifier
application number: M005
TolnafateTOLNAFTATE POWDER SPRAYCVS Pharmacya7b6bd7c-23db-43e1-92f7-e27f5f4801de2026-04-01WarningsExact identifier
application number: M005
Baza AntifungalMICONAZOLE NITRATEColoplast Corp75182cb7-840a-423a-9c20-10840d6e1d652026-03-31WarningsExact identifier
application number: M005
MICONAZOLE Nitrate 2% Cream ANTIFUNGALMICONAZOLE NITRATETrifecta Pharmaceuticals Usa Llc80217dbb-a0f0-414a-8d22-a9a346b017aa2026-03-31WarningsExact identifier
application number: M005
RoyceDerm Antifungal BarCLOTRIMAZOLERoyceDerm LLC3abdc4a8-58dd-5bd0-e063-6294a90a1bca2026-03-31WarningsExact identifier
application number: M005
Critic Aid Clear AFMICONAZOLE NITRATEColoplast Corpcbc5d976-850a-476e-b179-b7a5a86755242026-03-31WarningsExact 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