FDA.reportPublic FDA data

Tinactin

Product NDC
11523-1190
11-digit product format
115231190
Labeler code
11523
Product ID
11523-1190_4536ed2a-2046-b8ad-e063-6394a90ab95c
Type
HUMAN OTC DRUG
Nonproprietary name
Tolnaftate
Dosage form
CREAM
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
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
Tinactin
Listing expiration
2026-12-31

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
103951Internal RxNorm lookup
209651Internal RxNorm lookup

Harmonized SPL set identifiers#

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

Identifier, FDA.report destination table
IdentifierFDA.report destination
c3b715a9-233a-401a-ba60-f78c1ddf1dedAvailable on FDA.report

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
11523-1190-1Tinactin15 g in 1 TUBECREAM1514
11523-1190-1Tinactin1 in 1 CARTONCREAM114
11523-1190-2Tinactin30 g in 1 TUBECREAM3014
11523-1190-2Tinactin1 in 1 CARTONCREAM114

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
11523-1190-1GM - Gram11523-1190250e160b-a93b-44a2-983e-d0affd14699112013-10-17
11523-1190-2GM - Gram11523-11909263e6d1-3890-4317-96ef-fc303226c81c12013-10-17

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
TOLNAFTATEACTIVE INGREDIENT06KB629TKVTINACTIN (TOLNAFTATE) CREAM [BAYER HEALTHCARE LLC]2
TOLNAFTATEACTIVE MOIETY06KB629TKVTINACTIN (TOLNAFTATE) CREAM [BAYER HEALTHCARE LLC]2
CETETH-20INACTIVE INGREDIENTI835H2IHHXTINACTIN (TOLNAFTATE) CREAM [BAYER HEALTHCARE LLC]2
CETOSTEARYL ALCOHOLINACTIVE INGREDIENT2DMT128M1STINACTIN (TOLNAFTATE) CREAM [BAYER HEALTHCARE LLC]2
CHLOROCRESOLINACTIVE INGREDIENT36W53O7109TINACTIN (TOLNAFTATE) CREAM [BAYER HEALTHCARE LLC]2
MINERAL OILINACTIVE INGREDIENTT5L8T28FGPTINACTIN (TOLNAFTATE) CREAM [BAYER HEALTHCARE LLC]2
PETROLATUMINACTIVE INGREDIENT4T6H12BN9UTINACTIN (TOLNAFTATE) CREAM [BAYER HEALTHCARE LLC]2
PROPYLENE GLYCOLINACTIVE INGREDIENT6DC9Q167V3TINACTIN (TOLNAFTATE) CREAM [BAYER HEALTHCARE LLC]2
SODIUM PHOSPHATE, MONOBASICINACTIVE INGREDIENT3980JIH2SWTINACTIN (TOLNAFTATE) CREAM [BAYER HEALTHCARE LLC]2
WATERINACTIVE INGREDIENT059QF0KO0RTINACTIN (TOLNAFTATE) CREAM [BAYER HEALTHCARE LLC]2

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
11523-1190TINACTIN (TOLNAFTATE) CREAM [BAYER HEALTHCARE LLC.]13Current NDC, Legacy NDC, 4 package rows20241208_c3b715a9-233a-401a-ba60-f78c1ddf1ded.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 46 of 49 · 973 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
MICONAZOLE Nitrate 2% Cream ANTIFUNGALMICONAZOLE NITRATEASTONEA LABS PRIVATE LIMITEDe66191a6-0c3c-7319-e053-2a95a90aae842024-06-25WarningsExact identifier
application number: M005
clotrimazoleCLOTRIMAZOLEA-S Medication Solutionsb63a3fe5-5684-41bc-ad6c-69c54e5b942d2024-06-20WarningsExact identifier
application number: M005
THERA Antifungal BodyMICONAZOLE NITRATEMcKesson Medical-Surgical Inc.31096041-28c9-4b16-bbd1-dbadefd375052024-06-14WarningsExact identifier
application number: M005
Antifungal BodyMICONAZOLE NITRATEMcKesson4fb9aece-0baa-475e-e054-00144ff8d46c2024-06-13WarningsExact identifier
application number: M005
Secura ProtectiveZINC OXIDESmith & Nephew Medical Ltdb077aa64-49a3-42ee-abb3-88f833635b932024-06-12WarningsExact identifier
application number: M005
clotrimazoleCLOTRIMAZOLENuCare Pharmaceuticals,Inc.627375fb-2f20-16bc-e053-2a91aa0a15422024-06-06WarningsExact identifier
application number: M005
ClotrimazoleCLOTRIMAZOLECardinal Health 110 dba LEADER199df107-3384-6e03-e063-6294a90afc382024-05-29WarningsExact identifier
application number: M005
FemmesilCLOTRIMAZOLEAidance Skincare & Topical Solutions, LLCefddad82-9dc7-4cd9-b33c-7e85f30d992e2024-05-24WarningsExact identifier
application number: M005
Anti-FungalMICONAZOLE NITRATEUniversal Distribution Center LLC8f316b0d-d308-4ae6-82c4-39bb0d1d474e2024-05-21WarningsExact identifier
application number: M005
CANESPIESTOLNAFTATEOPMX LLCe2f9eedc-3c43-416b-85b5-ba07fb5fb4db2024-05-17WarningsExact identifier
application number: M005
Up and Up AntifungalTOLNAFTATE 1%Target Corporation8f54c8c7-6771-49c3-b429-53aa6df54dc52024-05-08WarningsExact identifier
application number: M005
Up and Up Athletes FootCLOTRIMAZOLE 1%Target Corporation52b61859-11ae-4990-aa0c-9dc1dd00adf42024-05-08WarningsExact identifier
application number: M005
ADI Medical PVP-I Pouch, FoilPOVIDONE-IODINEAsia Dynamics Inc., d/b/a ADI Medical0e8baf24-0c67-5511-e063-6394a90acaa12024-05-02WarningsExact identifier
application number: M005
Caseys Antimicrobial Hand SanitizerETHYL ALCOHOLNavajo Manufacturing Company Inc.78863024-390c-4ff9-8ed6-02af07902a302024-04-29WarningsExact identifier
application number: M005
MQUPIN Liquid Fungal Nail TreatmentLIQUID FUNGAL NAIL TREATMENTZhengzhou Miaoqi Medical Technology Co., Ltd.14782f8c-3b29-1d88-e063-6294a90ac3e42024-03-25WarningsExact identifier
application number: M005
ETADERM Advanced Antifungal SupportUNDECYLENIC ACIDNUEPHASE LLCadb12a1c-ece9-4a59-a62c-89d212c57e6f2024-03-13WarningsExact identifier
application number: M005
Dermachange JockMICONAZOLE NITRATEPrivate label Beauty and Wellness12eef049-76c9-1450-e063-6394a90a00ea2024-03-05WarningsExact identifier
application number: M005
Clotrimazole AntifungalCLOTRIMAZOLETrifecta Pharmaceuticals USA, LLC.11bf50db-552e-0a39-e063-6394a90af60d2024-02-19WarningsExact identifier
application number: M005
TOLNAFTATE ANTIFUNGALTOLNAFTATEBryant Ranch Prepackfbbd159c-217e-46d3-963c-ba0bd1e9bbe82024-01-29WarningsExact identifier
application number: M005
Target Jock ItchCLOTRIMAZOLE 1%Target Corporationf44d4c44-99d1-413f-b9c3-8330bdd21abb2024-01-17WarningsExact identifier
application number: M005

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
209651Tinactin 1 % Topical CreamPSNc3b715a9-233a-401a-ba60-f78c1ddf1ded14
103951tolnaftate 1 % Topical CreamPSNc3b715a9-233a-401a-ba60-f78c1ddf1ded14
209651tolnaftate 10 MG/ML Topical Cream [Tinactin]SBDc3b715a9-233a-401a-ba60-f78c1ddf1ded14
103951tolnaftate 10 MG/ML Topical CreamSCDc3b715a9-233a-401a-ba60-f78c1ddf1ded14
209651Tinactin 1 % Topical CreamSYc3b715a9-233a-401a-ba60-f78c1ddf1ded14
209651Tinactin 10 MG/ML Topical CreamSYc3b715a9-233a-401a-ba60-f78c1ddf1ded14
103951tolnaftate 1 % Topical CreamSYc3b715a9-233a-401a-ba60-f78c1ddf1ded14

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
11523-1190-1115231190011 TUBE in 1 CARTON (11523-1190-1) / 15 g in 1 TUBE1 tube2002-12-120000-00-00NoNoCurrent
11523-1190-2115231190021 TUBE in 1 CARTON (11523-1190-2) / 30 g in 1 TUBE1 tube2002-12-120000-00-00NoNoCurrent