Tea Tree Oil Antifungal

Product NDC
85593-105
11-digit product format
855930105
Labeler code
85593
Product ID
85593-105_55a48fc6-1964-66ea-e063-6294a90a3501
Type
HUMAN OTC DRUG
Nonproprietary name
Tolnaftate
Dosage form
SOAP
Route
TOPICAL
Labeler
Guangzhou ChuanMa International Trading Co.,Ltd.
Application
M002
Marketing category
OTC MONOGRAPH DRUG
Marketing start
2026-07-03
Substance
TOLNAFTATE
Active strength
1 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
Tea Tree Oil Antifungal
Listing expiration
2027-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
TOLNAFTATE1 g/100g

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
1807715Internal RxNorm lookup

Harmonized SPL set identifiers#

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

Identifier, FDA.report destination table
IdentifierFDA.report destination
55a48fc6-1963-66ea-e063-6294a90a3501Available on FDA.report

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 10 of 13 · 242 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
SimethiconeSIMETHICONEHumanwell PuraCap Pharmaceutical (Wuhan) Co., Ltd346df37d-b0fc-4fa5-8c19-492fed58c2392024-11-25WarningsExact identifier
application number: M002
Extra Strength Gas Relief CherrySIMETHICONERetail Business Services, LLC.1e8ed36d-5236-163b-e063-6294a90ad6ec2024-11-22WarningsExact identifier
application number: M002
SimethiconeSIMETHICONEHumanwell PuraCap Pharmaceutical (Wuhan), Ltd.0f9639fa-e1d0-460d-bc46-714a01cd98112024-11-21WarningsExact identifier
application number: M002
SimethiconeSIMETHICONEHumanwell PuraCap Pharmaceutical (Wuhan) Co., Ltd.852cec3b-6564-46b2-afe5-ecef314242372024-11-21WarningsExact identifier
application number: M002
Ultra Strength Gas ReliefSIMETHICONEWalgreen Co.d33e413d-4add-459f-ba46-c23b49cfcc872024-11-21WarningsExact identifier
application number: M002
Gas ReliefSIMETHICONEWalgreen Co.d87a20d4-dd1d-4897-9321-f81df2cfbcc72024-11-21WarningsExact identifier
application number: M002
Ultra Strength Gas ReliefSIMETHICONEWalgreen Co.b14b647f-d729-47df-879d-ca08a30b995e2024-11-21WarningsExact identifier
application number: M002
Ultra Strength Gas ReliefSIMETHICONEWal-Mart Stores Inc206d57ec-c854-496e-af53-7d8b2a208d852024-11-21WarningsExact identifier
application number: M002
SimethiconeSIMETHICONEWALGREEN CO.4d523979-e3ae-47e8-9092-00fdffc8bb0b2024-11-21WarningsExact identifier
application number: M002
Gas ReliefSIMETHICONEWal-Mart Stores Inc69351cf9-3092-45ca-8b84-83e3737fa8d42024-11-21WarningsExact identifier
application number: M002
SimethiconeSIMETHICONEWALMART INC.79a9e0a3-9199-4397-ab29-b8a9c843cdf82024-11-21WarningsExact identifier
application number: M002
Maximum Strength Gas ReliefSIMETHICONEFOODHOLD U.S.A., LLCc37def6e-bb10-41ba-8bce-b06c09edbe9f2024-11-21WarningsExact identifier
application number: M002
Gas Relief Ultra StrengthSIMETHICONE 180 MGHumanwell PuraCap Pharmaceutical (Wuhan), Ltd.2cfb8132-6de4-457d-880b-c870a38862ad2024-11-20WarningsExact identifier
application number: M002
Gas-AidSIMETHICONELeosons Overseas Corpd271bfcb-bf13-4a97-bc03-f1824826f15a2024-11-19WarningsExact identifier
application number: M002
Gas-Aid Drops for infantsSIMETHICONELeosons Overseas Corp06665701-5f1c-4f8f-8775-e0a4a9ef20292024-11-19WarningsExact identifier
application number: M002
Mag-AL Plus XSALUMINUM HYDROXIDE, MAGNESIUM HYDROXIDE, AND DIMETHICONEPAI Holdings, LLC dba PAI Pharmadb0c47ab-5296-4195-9fa6-2e338b6650942024-11-12WarningsExact identifier
application number: M002
basic care gas reliefSIMETHICONEAmazon.com Services LLCab1681df-aded-4b0c-9124-87196606183b2024-11-02WarningsExact identifier
application number: M002
Good Sense Gas Relief Extra StrengthSIMETHICONEL. Perrigo Company6b2d8591-cc58-457e-92b6-c719eee856052024-11-02WarningsExact identifier
application number: M002
premier value infants gas reliefSIMETHICONEChain Drug Consortium7b887e53-a70a-4f33-9472-e1175b24400a2024-10-28WarningsExact identifier
application number: M002
Premier Value Extra StrengthSIMETHICONEPHARMACY VALUE ALLIANCE, LLCdf2b1b62-5bd2-4d02-86c2-537b965a8d202024-10-28WarningsExact identifier
application number: M002

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startSampleExclude flagStatus
85593-105-01855930105012 BAG in 1 BOX (85593-105-01) / 100 g in 1 BAG2 bag2026-07-03NoNoCurrent