FDA.reportPublic FDA data

PHARMBANNER Tinea Versicolor Cream

Product NDC
83818-020
11-digit product format
838180020
Labeler code
83818
Product ID
83818-020_4aa15a3b-a40d-3a74-e063-6394a90a09cb
Type
HUMAN OTC DRUG
Nonproprietary name
Tinea Versicolor Cream
Dosage form
CREAM
Route
TOPICAL
Labeler
Shenzhen Xinxin Yunhai Technology Co., Ltd.
Application
M005
Marketing category
OTC MONOGRAPH DRUG
Marketing start
2025-07-16
Substance
SALICYLIC ACID
Active strength
4 g/100g
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
PHARMBANNER Tinea Versicolor Cream
Listing expiration
2027-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
SALICYLIC ACID4 g/100g

Harmonized UNII identifiers#

UNII identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
O414PZ4LPZInternal UNII lookup

Harmonized RxCUI identifiers#

RxCUI identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
2675319Internal RxNorm lookup

Harmonized SPL set identifiers#

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

Identifier, FDA.report destination table
IdentifierFDA.report destination
3a095194-c7ea-7f30-e063-6294a90a7ea1Available on FDA.report

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
624001e0-0eba-4aac-a60c-c2ecb37d4f08Product name120220927
1cbe9071-502b-482d-9c24-839b43446576Product name120200123
dea2eded-d1e7-46bb-9a3d-f8dc20de6277Product name120190408
ce567bde-218c-2386-f79b-42addb0c34fbProduct name220180829
e3a04dc3-1a9e-4fba-b2b4-a18279351082Product name220180620
1e8b10fc-5c6a-4af6-9363-4bda9402a4f4Product name120180209
fa8c1c3a-f36c-46b1-b4f1-4e877f3dcb1dProduct name220170613
aa7deb41-117b-479c-8362-130fd1c222deProduct name120160112
511188c3-b8c1-4966-aa31-5463cfd4fa48Product name120141222
6dcdf27c-6d6a-2465-ccae-faeb308e8070Product name120140508
aca60174-7f12-2753-ec74-0eb827cf0776Product name120140508

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
83818-020-01PHARMBANNER Tinea Versicolor Cream60 g in 1 TUBECREAM603

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 43 of 49 · 973 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
ClotrimazoleDRS. CLOTRIMAZOLEOL PHARMA TECH,LLCb0e9fc77-6d5c-2472-e053-2995a90a3de42025-01-09WarningsExact identifier
application number: M005
Anti-Bacterial WipesBENZALKONIUM CHLORIDETongling Jieya Biological Technology Co., Ltd.d7aeb18f-abf2-49bd-a8a3-ac57f60fbe7d2025-01-04WarningsExact identifier
application number: M005
AVON HeXashield Athletes Foot CreamTOLNAFTATETai Guk Pharm. Co., Ltd.8f2b6a09-8cb0-0d17-e053-2995a90aa07f2025-01-01WarningsExact identifier
application number: M005
TolnaftateTOLNAFTATE 1%Trifecta Pharmaceuticals USA, LLC091b907f-544a-86c9-e063-6294a90a5d872024-12-31WarningsExact identifier
application number: M005
terrasil Fungal TreatmentCLOTRIMAZOLEAidance Scientific, Inc., DBA Aidance Skincare & Topical Solutions278290f9-be14-81a8-e063-6294a90ad8cc2024-12-26WarningsExact identifier
application number: M005
DEO PEDICO ABOVE NEYMAR JR MENDEO PEDICO ABOVE NEYMAR JR MENBASTON INDUSTRIA DE AEROSSOIS LTDAed4a9844-f20b-da5d-e053-2995a90adc092024-12-26WarningsExact identifier
application number: M005
Vite20MICONAZOLE NITRATEBlaine Labs Inc.28a8d0dd-aab9-44ff-bab6-7ec4b5036a712024-12-24WarningsExact identifier
application number: M005
Vite20UNDECYLENIC ACIDBlaine Labs Inc.18f8ea1c-360e-43c0-98df-5816af4dec662024-12-24WarningsExact identifier
application number: M005
Tolnaftate Cream 1% ANTIFUNGALFAMILY WELLNESS TOLNAFTATETrifecta Pharmaceuticals USA, LLC915759af-0d7f-6a87-e053-2a95a90acbd62024-12-20WarningsExact identifier
application number: M005
Rugby Clotrimazole Antifungal CreamCLOTRIMAZOLERugby Laboratoriesa1365bc7-b376-adca-e053-2a95a90acf192024-12-20WarningsExact identifier
application number: M005
Miconazole NitrateANTIFUNGAL MICONAZOLE POWDER SPRAYPremier Brands of America Inc.dc7a23bb-b246-89b1-e053-2995a90a9f2d2024-12-20WarningsExact identifier
application number: M005
Warrior Antifungal FootMICONAZOLE NITRATE 2%Derma Care Research Labs, LLCcf2e9dc1-275b-4454-e053-2995a90af2952024-12-20WarningsExact identifier
application number: M005
Tolnaftate Cream 1%TOLNAFTATEPharmacy Value Alliance, LLC.3abfd734-229b-1a0e-e054-00144ff88e882024-12-20WarningsExact identifier
application number: M005
Dermatool Fungal Nail TreatmentTOLNAFTATE 1%Derma Care Research Labs, LLCfbc1a55e-b994-4962-e053-6394a90a13ba2024-12-19WarningsExact identifier
application number: M005
Novonail SolutionTOLNAFTATE 1%Derma Care Research Labs, LLC013d6107-e3b0-0264-e063-6394a90ae1e22024-12-19WarningsExact identifier
application number: M005
MICONAZOLE Nitrate 2% Cream ANTIFUNGALMICONAZOLE NITRATERugbyf420de00-408f-9a2c-e053-2995a90adced2024-12-17WarningsExact identifier
application number: M005
Relispray Antifungal LiquidTOLNAFTATEMidas-Care Pharmaceuticals Pvt. Ltd.6522ad59-f810-408c-a9f9-9359d79302ce2024-12-17WarningsExact identifier
application number: M005
ClotrimazoleFAMILY WELLNESS CLOTRIMAZOLETrifecta Pharmaceuticals USA LLC915759af-0d7b-6a87-e053-2a95a90acbd62024-12-13WarningsExact identifier
application number: M005
Blistex Odor-Eaters PowderTOLNAFTATEBlistex Inc819edb2f-dda7-45c3-b0da-ebcae354154e2024-12-12WarningsExact identifier
application number: M005
Walgreens Athletes FootTOLNAFTATE SPRAYWalgreensc68ad65d-b016-0069-e053-2995a90ae7ef2024-12-11WarningsExact identifier
application number: M005

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
2675319salicylic acid 4 % Topical CreamPSN3a095194-c7ea-7f30-e063-6294a90a7ea13
2675319salicylic acid 40 MG/ML Topical CreamSCD3a095194-c7ea-7f30-e063-6294a90a7ea13
2675319salicylic acid 4 % Topical CreamSY3a095194-c7ea-7f30-e063-6294a90a7ea13

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startSampleExclude flagStatus
83818-020-018381800200160 g in 1 TUBE (83818-020-01) 60 g2025-07-16NoNoCurrent