FDA.reportPublic FDA data

Signature Black Bottle Tea Tree Antifungal Foot and Body Wash

Product NDC
69882-726
11-digit product format
698820726
Labeler code
69882
Product ID
69882-726_09d75c0c-2944-98b9-e063-6394a90aa287
Type
HUMAN OTC DRUG
Nonproprietary name
TOLNAFTATE
Dosage form
LOTION
Route
TOPICAL
Labeler
Restoration Rockstar, Llc (dba: Kroning Signature Black Bottle)
Application
M005
Marketing category
OTC MONOGRAPH DRUG
Marketing start
2016-02-10
Substance
TOLNAFTATE
Active strength
10 mg/mL
NDC exclude flag
No
Listing certified through
2026-12-31
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
Signature Black Bottle Tea Tree Antifungal Foot and Body Wash
Listing expiration
2026-12-31

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 · 1 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
283693Internal RxNorm lookup

Harmonized SPL set identifiers#

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

Identifier, FDA.report destination table
IdentifierFDA.report destination
2c966d97-30f5-4942-b64d-742884ce6a2fAvailable on FDA.report

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
69882-726-01Signature Black Bottle Tea Tree Antifungal Foot and Body Wash266.16 mL in 1 BOTTLELOTION266.164

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
69882-726SIGNATURE BLACK BOTTLE TEA TREE ANTIFUNGAL FOOT AND BODY WASH (TOLNAFTATE) LOTION [RESTORATION ROCKSTAR, LLC (DBA: KRONING SIGNATURE BLACK BOTTLE)]4Current NDC, Legacy NDC, 1 package rows20231111_2c966d97-30f5-4942-b64d-742884ce6a2f.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 20 of 49 · 973 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
PHARMBANNER TINEA VERSICOLOR CreamTINEA VERSICOLOR CREAMShenzhen Xinxin Yunhai Technology Co., Ltd.3db832f4-630d-72a2-e063-6394a90a08dc2026-02-12WarningsExact identifier
application number: M005
TolnafateTOLNAFTATE JOCK ITCH POWDER SPRAY - TALC FREEChain Drug Consortium, LLC5f9edcf9-b99e-65a2-e053-2a91aa0af5652026-02-12WarningsExact identifier
application number: M005
TolnafateTOLNAFTATE POWDER SPRAYChain Drug Consortium, LLC5fafc16d-7257-fc88-e053-2991aa0a67c42026-02-12WarningsExact identifier
application number: M005
Kerova Miconazole NitrateMICONAZOLE NITRATEGuangzhou Bixiaoyu Trading Co., Ltd.3b8b5547-f8d1-9e48-e063-6294a90af4292026-02-12WarningsExact identifier
application number: M005
natouchMICONAZOLENatouch LLCa980ff33-2b6d-3065-e053-2995a90ae9742026-02-11WarningsExact identifier
application number: M005
Tuymec Antifungal Medicated BarANTIFUNGAL MEDICATED BARGuangzhou Jingliang Cosmetics Co., Ltd.4a8265c5-9c69-a36a-e063-6294a90ab2922026-02-11WarningsExact identifier
application number: M005
Tuymec FUNGAL NAIL TREATMENT KitFUNGAL NAIL TREATMENT KITGuangzhou Jingliang Cosmetics Co., Ltd.4a983b42-9723-7a3a-e063-6394a90ae7b22026-02-11WarningsExact identifier
application number: M005
Miconazole NitrateATHLETES FOOT SPRAYCVS Pharmacy1f5e3bfb-b6b9-4b22-9c34-71112bcf0c3c2026-02-10WarningsExact identifier
application number: M005
Kerova ANTIFUNGALCLOTRIMAZOLEGuangzhou Bixiaoyu Trading Co., Ltd.4a7b48cf-72c3-be63-e063-6394a90a1efe2026-02-10WarningsExact identifier
application number: M005
Kerova ClotrimazoleANTIFUNGALGuangzhou Bixiaoyu Trading Co., Ltd.4a7b9658-f411-299d-e063-6394a90af9ce2026-02-10WarningsExact identifier
application number: M005
natouchMICONAZOLENatouch LLC3b1209fc-9d6b-2f55-e063-6394a90ac2ad2026-02-10WarningsExact identifier
application number: M005
Nabrace Wipes for Ringworm, Jockitch and Athlete FeetNABRACE WIPES FOR RINGWORM, JOCKITCH AND ATHLETE FEETNabrace LLC0fdd1658-5759-8a42-e063-6394a90a72712026-02-10WarningsExact identifier
application number: M005
APUREE Nailtific Extra-Max Strength AntigungalAPUREE NAILTIFIC EXTRA-MAX STRENGTH ANTIGUNGALGuangzhou Meixi Biotechnology Co., Ltd.4a633da8-dcba-349c-e063-6294a90a77022026-02-09WarningsExact identifier
application number: M005
Fungus Master Antifungal TreatmentMICONAZOLE NITRATEEbanel Laboratories, Incf7b011b2-11e5-46f1-afed-89f438985e002026-02-09WarningsExact identifier
application number: M005
OSIMOON Toenail Fungus TreatmentTOENAIL FUNGUS TREATMENTGuangzhou Jingliang Cosmetics Co., Ltd.4a7061a9-8ba2-72b8-e063-6294a90a4d9a2026-02-09WarningsExact identifier
application number: M005
CLOTRIMAZOLE 1%CLOTRIMAZOLEPHARMACY CHOICE INC43852cfb-6d28-e54f-e063-6394a90aa0902026-02-08WarningsExact identifier
application number: M005
ASSIELF ANTIFUNGAL PENUNDECYLENIC ACIDShenzhen Yuanbang International Logistics Co., Ltd4a5d8e86-6401-7556-e063-6394a90acce12026-02-08WarningsExact identifier
application number: M005
Dryello Dual Action Relief for Athlete FootTOLNAFTATEProPedix, Inc.359478dd-02c9-05e5-e063-6294a90a41ed2026-02-06WarningsExact identifier
application number: M005
HEALMUSZ ClotrimazoleCLOTRIMAZOLE1% MICONAZOLE1% CLOTRIMAZOLEJiangxi Yudexi Pharmaceutical Co., LTD4a326159-a6a7-c1d6-e063-6294a90a3b892026-02-06WarningsExact identifier
application number: M005
Antifungal LiquidTOLNAFTATEWal-Mart Stores, Inc.17d0486e-e8b5-3afe-e063-6394a90aa3842026-02-04WarningsExact identifier
application number: M005

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
283693tolnaftate 1 % Topical LotionPSN2c966d97-30f5-4942-b64d-742884ce6a2f4
283693tolnaftate 10 MG/ML Topical LotionSCD2c966d97-30f5-4942-b64d-742884ce6a2f4
283693tolnaftate 1 % Topical LotionSY2c966d97-30f5-4942-b64d-742884ce6a2f4

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
69882-726-0169882072601266.16 mL in 1 BOTTLE (69882-726-01) 266.16 ml2016-02-100000-00-00NoNoCurrent