FDA.reportPublic FDA data

ProClearz Laser Antifungal

Product NDC
29784-183
11-digit product format
297840183
Labeler code
29784
Product ID
29784-183_4988109f-6e4b-0acb-e063-6294a90a419e
Type
HUMAN OTC DRUG
Nonproprietary name
TOLNAFTATE
Dosage form
LIQUID
Route
TOPICAL
Labeler
Rooftop Consumer Health, inc
Application
M005
Marketing category
OTC MONOGRAPH DRUG
Marketing start
2025-01-01
Substance
TOLNAFTATE
Active strength
10 mg/g
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 Laser Antifungal
Listing expiration
2027-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
TOLNAFTATE10 mg/g

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
313421Internal RxNorm lookup
2700695Internal RxNorm lookup

Harmonized SPL set identifiers#

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

Identifier, FDA.report destination table
IdentifierFDA.report destination
53648135-7b79-4775-993b-48fa1298b747Available on FDA.report

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
29784-183-01ProClearz Laser Antifungal85 g in 1 BOTTLE, SPRAYLIQUID853

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
29784-183PROCLEARZ LASER ANTIFUNGAL (TOLNAFTATE) LIQUID [ROOFTOP CONSUMER HEALTH, INC]2Current NDC, 1 package rows20250105_53648135-7b79-4775-993b-48fa1298b747.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 28 of 49 · 973 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Cura Hongo AntifungalCLOTRIMAZOLEPharmadel LLCdf031309-2778-00cf-e053-2a95a90a5eea2025-11-17WarningsExact identifier
application number: M005
CharmTex All in One Antibacterial Shave Gel Body WashBENZETHONIUM CHLORIDELiufangjing Biotechnology (Yangzhou) Co., Ltda7433f39-a8d9-4c78-864d-d7ef193a7daf2025-11-16WarningsExact identifier
application number: M005
Mint Blast Foot and Shoe AntifungalUNDECYLENIC ACID 10%SANSAR, LLCf7fcac19-7b72-4b7a-a28e-669a0eebec9c2025-11-15WarningsExact identifier
application number: M005
Lavender Foot and Shoe AntifungalUNDECYLENIC ACID 10%SANSAR, LLC9db58924-a84d-4763-badb-b3aeb46e1ea62025-11-15WarningsExact identifier
application number: M005
Citrus Detox Foot and Shoe AntifungalUNDECYLENIC ACID 10%SANSAR, LLC6585c9f5-a6cb-4534-9a61-ecbb6dcb7bdc2025-11-15WarningsExact identifier
application number: M005
AlphaTip Nail Repair PenNAIL REPAIR PENGuangzhou Qiexiran Cosmetics Co., Ltd.435c7973-8a67-8f51-e063-6394a90af58f2025-11-11WarningsExact identifier
application number: M005
Pharmlitalia Antifungal Medicated BodyTOLNAFTATEFoshan Sugar Max Cosmetics CO.,Ltd399302d2-0da4-4167-8884-b34a9aba86862025-11-10WarningsExact identifier
application number: M005
PerfectHeal AntifungalCLOTRIMAZOLEZhejiang Dingtai Pharmaceutical Co., Ltdd9750991-8f10-4d6b-8841-bea022d5ad732025-11-10WarningsExact identifier
application number: M005
PiYanPing AntifungalMICONAZOLE NITRATEZhejiang Dingtai Pharmaceutical Co., Ltd840364aa-d799-4163-a9e8-3f10c18f86ae2025-11-10WarningsExact identifier
application number: M005
SKINHEAL ANTIFUNGALTOLNAFTATEZhejiang Dingtai Pharmaceutical Co., Ltd570ee9fb-a495-4a99-9215-0cd1bb2e02902025-11-10WarningsExact identifier
application number: M005
HUA TUO XIAN GAO ANTIFUNGALCLOTRIMAZOLEMADISON ONE ACME INCe11c4d87-8dc2-44b1-bf6b-12e7ef4f3d1d2025-11-10WarningsExact identifier
application number: M005
Selan AntifungalSELAN ANTIFUNGALTrividia Manufacturing Solutions, Inc8c7e51a0-0cd5-4ae3-a904-fad7ac6c1a292025-11-07WarningsExact identifier
application number: M005
Fortinia UltraCLOTRIMAZOLE 1%The Podiatree Company43065a59-fb81-b1c2-e063-6294a90a36e02025-11-07WarningsExact identifier
application number: M005
MICOCLEARCLOTRIMAZOLE ANTIFUNGALRising Pharma Holdings, Inc.d75b7d3c-3f1c-47e1-8122-4645f56a444e2025-11-06WarningsExact identifier
application number: M005
MedlineMICONAZOLE NITRATEMedline Industries, LP1ea444eb-f2f5-8c63-e063-6294a90acac82025-11-06WarningsExact identifier
application number: M005
Miconazole NitrateANTIFUNGAL POWDER SPRAYPremier Brands of America Inc.38ccf19c-2290-ad99-e063-6394a90a54692025-11-06WarningsExact identifier
application number: M005
TolnaftateANTIFUNGAL POWDER SPRAY WITH BAKING SODATarget Corporation37792b12-c3dc-558f-e063-6294a90a7e752025-11-06WarningsExact identifier
application number: M005
TolnafateTOLNAFTATE POWDER SPRAYTopco Associates LLC5f8ae9ab-5e34-7a60-e053-2991aa0a98172025-11-06WarningsExact identifier
application number: M005
TolnaftateTOLNAFTATE JOCK ITCH POWDER SPRAY TALC FREETopco Associates LLC5f8ac6b7-c46c-226c-e053-2991aa0a96062025-11-06WarningsExact identifier
application number: M005
TolnaftateANTIFUNGAL LIQUID SPRAYTopco Associates LLC3dd0df06-3c74-4c34-a69e-4240945f5fa52025-11-06WarningsExact identifier
application number: M005

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
2700695Proclearz 1 % Topical SprayPSN53648135-7b79-4775-993b-48fa1298b7473
313421tolnaftate 1 % Topical SprayPSN53648135-7b79-4775-993b-48fa1298b7473
2700695tolnaftate 10 MG/ML Topical Spray [Proclearz]SBD53648135-7b79-4775-993b-48fa1298b7473
313421tolnaftate 10 MG/ML Topical SpraySCD53648135-7b79-4775-993b-48fa1298b7473
2700695Proclearz 1 % Topical SpraySY53648135-7b79-4775-993b-48fa1298b7473
2700695Proclearz 10 MG/ML Topical SpraySY53648135-7b79-4775-993b-48fa1298b7473
313421tolnaftate 1 % Topical SpraySY53648135-7b79-4775-993b-48fa1298b7473

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startSampleExclude flagStatus
29784-183-012978401830185 g in 1 BOTTLE, SPRAY (29784-183-01) 85 g2025-01-01NoNoCurrent