FDA.reportPublic FDA data

Tinactin

Product NDC
11523-0165
11-digit product format
115230165
Labeler code
11523
Product ID
11523-0165_4526e2eb-ee8c-3ac4-e063-6394a90a133f
Type
HUMAN OTC DRUG
Nonproprietary name
Tolnaftate
Dosage form
AEROSOL, SPRAY
Route
TOPICAL
Labeler
Bayer HealthCare LLC
Application
M005
Marketing category
OTC MONOGRAPH DRUG
Marketing start
1993-09-23
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
Tinactin
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
209674Internal RxNorm lookup
313421Internal RxNorm lookup

Harmonized SPL set identifiers#

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

Identifier, FDA.report destination table
IdentifierFDA.report destination
bb878f31-2189-4427-aacf-5bce96d75978Available on FDA.report

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
11523-0165-3Tinactin150 g in 1 CANAEROSOL, SPRAY15011

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
11523-0165-3GM - Gram11523-01657b490cc7-f5e9-43ac-9a65-28807e26d7cc12013-02-13

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
TolnaftateACTIVE INGREDIENT06KB629TKVTINACTIN (TOLNAFTATE) AEROSOL, SPRAY [MSD CONSUMER CARE, INC.]1
TolnaftateACTIVE MOIETY06KB629TKVTINACTIN (TOLNAFTATE) AEROSOL, SPRAY [MSD CONSUMER CARE, INC.]1
butylated hydroxytolueneINACTIVE INGREDIENT1P9D0Z171KTINACTIN (TOLNAFTATE) AEROSOL, SPRAY [MSD CONSUMER CARE, INC.]1
isobutaneINACTIVE INGREDIENTBXR49TP611TINACTIN (TOLNAFTATE) AEROSOL, SPRAY [MSD CONSUMER CARE, INC.]1
PPG-12-buteth-16INACTIVE INGREDIENT58CG7042J1TINACTIN (TOLNAFTATE) AEROSOL, SPRAY [MSD CONSUMER CARE, INC.]1

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
11523-0165TINACTIN (TOLNAFTATE) AEROSOL, SPRAY [BAYER HEALTHCARE LLC]10Current NDC, Legacy NDC, 1 package rows20241208_bb878f31-2189-4427-aacf-5bce96d75978.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 17 of 49 · 973 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Velloryn ANTIFUNGAL CreamZINC UNDECYLENATE, UNDECYLENIC ACIDGuangdong Quadrant Ecological Technology Co., Ltd.4e38e1f1-0466-5b91-e063-6294a90a66c42026-03-30WarningsExact identifier
application number: M005
APUREE Nailtific Extra-Max Strength Daytime AntigungalAPUREE NAILTIFIC EXTRA-MAX STRENGTH DAYTIME ANTIGUNGALGuangzhou Meixi Biotechnology Co., Ltd.4e3d226b-57f1-75a6-e063-6394a90a96cd2026-03-30WarningsExact identifier
application number: M005
APUREE Nailtific Extra-Max Strength Nighttime AntifungalAPUREE NAILTIFIC EXTRA-MAX STRENGTH NIGHTTIME ANTIFUNGALGuangzhou Meixi Biotechnology Co., Ltd.4e3e8895-34b4-de69-e063-6294a90a55322026-03-30Exact identifier
application number: M005
Miconazole NitrateATHLETES FOOT POWDER SPRAY TALC FREECVS Pharmacy3380263d-ee7b-4946-a467-35a24789a9012026-03-27WarningsExact identifier
application number: M005
Micro-Guard (AF)MICONAZOLE NITRATEColoplast Corpa43a94d0-fec0-470f-bdb4-535dcce6d1e02026-03-27WarningsExact identifier
application number: M005
Suave Antibacterial Hand Wash Fresh CitrusLIQUID HAND WASH ANTIBACTERIALSuave Brands Co, LLC41d77ec6-a1d1-13dc-e063-6394a90a95f42026-03-26WarningsExact identifier
application number: M005
Suave Antibacterial Hand Wash Deeply CleanLIQUID HAND WASH ANTIBACTERIALSuave Brands Co, LLC41d83736-66da-abb9-e063-6294a90a3d672026-03-26WarningsExact identifier
application number: M005
Suave Antibacterial Hand Wash Sea Minerals and Aloe VeraLIQUID HAND WASH ANTIBACTERIALSuave Brands Co, LLC41d8848c-d157-6e2c-e063-6294a90aa2592026-03-26WarningsExact identifier
application number: M005
Hermon Jock Itch Antifungal Treatment Kit Antifungal Cream and .Soap. for Jock ItchANTIFUNGAL TREATMENT KITBeautivity LLC4800a93b-7042-827b-e063-6294a90acd952026-03-25WarningsExact identifier
application number: M005
Toenail Fungus TreatmentTERBINAFINEShenzhen Wankelai E-commerce Co., Ltd.4dc1d7f7-e4ae-c54b-e063-6394a90aa4202026-03-24WarningsExact identifier
application number: M005
Lasolex Liquid SolutionCLOTRIMAZOLE 1%PureTek Corporation4dc9e64d-8235-b218-e063-6394a90a01572026-03-24WarningsExact identifier
application number: M005
Hermon Jock Itch Antifungal Treatment .Soap. BarTOLNAFTATE 1%Beautivity LLC4dbbf09b-5bc1-501b-e063-6394a90a2a9d2026-03-23WarningsExact identifier
application number: M005
Hermon Jock Itch Antifungal Treatment CreamMICONAZOLE NITRATE 2%Beautivity LLC4dbc521c-2f5f-9736-e063-6294a90ad85d2026-03-23WarningsExact identifier
application number: M005
seebeellar clotrimazole 1% antifungal creamSEEBEELLAR CLOTRIMAZOLE 1% ANTIFUNGAL CREAMGUANGZHOU YUSONG FINE CHEMICLS Co., Ltd4d80e551-76c2-150a-e063-6394a90a79962026-03-20WarningsExact identifier
application number: M005
Nail Fungal PenUNDECYLENIC ACIDGuangzhou Hechuang Commercial Service Co.,Ltd.4d5b5c22-4781-6391-e063-6294a90a70102026-03-19WarningsExact identifier
application number: M005
HAND SANITIZER MADRID MUSEALCOHOL HAND SANITIZERCROWN (YANGZHOU) HEALTH & BEAUTY CO., LTD.4d5cecf6-c232-6cd9-e063-6394a90a03e92026-03-19WarningsExact identifier
application number: M005
HAND SANITIZER VALENCIA VIBESALCOHOL HAND SANITIZERCROWN (YANGZHOU) HEALTH & BEAUTY CO., LTD.4d5de4d6-4c58-f393-e063-6294a90a323a2026-03-19WarningsExact identifier
application number: M005
Toenail Fungus PenUNDECYLENIC ACIDGuangzhou Hechuang Commercial Service Co.,Ltd.4d5e256f-7fd5-f903-e063-6394a90a11602026-03-19WarningsExact identifier
application number: M005
HAND SANITIZER MALLORCA BREEZEALCOHOL HAND SANITIZERCROWN (YANGZHOU) HEALTH & BEAUTY CO., LTD.4d5e50de-62fd-f9e9-e063-6394a90af0bd2026-03-19WarningsExact identifier
application number: M005
HAND SANITIZER MAR BELLAALCOHOL HAND SANITIZERCROWN (YANGZHOU) HEALTH & BEAUTY CO., LTD.4d6005d9-5d4d-033e-e063-6294a90ad36f2026-03-19WarningsExact identifier
application number: M005

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
209674Tinactin 1 % Topical SprayPSNbb878f31-2189-4427-aacf-5bce96d7597811
313421tolnaftate 1 % Topical SprayPSNbb878f31-2189-4427-aacf-5bce96d7597811
209674tolnaftate 10 MG/ML Topical Spray [Tinactin]SBDbb878f31-2189-4427-aacf-5bce96d7597811
313421tolnaftate 10 MG/ML Topical SpraySCDbb878f31-2189-4427-aacf-5bce96d7597811
209674Tinactin 1 % Topical SpraySYbb878f31-2189-4427-aacf-5bce96d7597811
209674Tinactin 10 MG/ML Topical SpraySYbb878f31-2189-4427-aacf-5bce96d7597811
313421tolnaftate 1 % Topical SpraySYbb878f31-2189-4427-aacf-5bce96d7597811

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
11523-0165-311523016503150 g in 1 CAN (11523-0165-3) 150 g1993-09-230000-00-00NoNoCurrent