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 44 of 49 · 973 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Dr. Rainer s Vaginal CreamMICONAZOLE NITRATEPlexoris Health Care Products, Llc1f0ee635-c70d-4194-a01d-370ca5c22fcd2024-12-11WarningsExact identifier
application number: M005
BOA VIDA AntifungalMICONAZOLE NITRATECentral Solutions Inc69c5340d-9abd-43bf-a90b-9568d615f06f2024-12-09WarningsExact identifier
application number: M005
BLUESEA DISPOSABLE HAND SANITIZERALCOHOLBLUE SEA AEROSOL & DAILY CARE CO., LTD7a552be2-a9e1-4c6f-b1c2-79113a73bd2f2024-12-06WarningsExact identifier
application number: M005
U HAND SANITIZER CLASSICBENZALKONIUM CHLORIDEBLUE SEA AEROSOL & DAILY CARE CO., LTDfbc27a24-0e81-4907-b24f-881c4fe0ec442024-12-06WarningsExact identifier
application number: M005
BLUESEA INSTANT HAND SANITIZERALCOHOLBLUE SEA AEROSOL & DAILY CARE CO., LTDe6b5ce49-d6d6-4b24-8b40-bfb1fb7005bd2024-12-06WarningsExact identifier
application number: M005
Povidone-IodinePOVIDONE-IODINEMazza Healthcare, LLC31df570a-35ae-41a2-b04a-fce65e9d596d2024-11-21WarningsExact identifier
application number: M005
Povidone-IodinePOVIDONE-IODINEMazza Healthcare, LLC3dc3303f-54b2-4aec-8568-5e0f8eb7cb142024-11-21WarningsExact identifier
application number: M005
WINCO ANTIFUNGALTOLNAFTATE 1%WinCo Foods LLC46b58c71-d62e-4b3d-b2ec-65407032eeea2024-11-21WarningsExact identifier
application number: M005
Dynarex AntifungalANTIFUNGALDynarex Corporationab5b6467-c158-4407-9d52-3c07310306802024-11-20WarningsExact identifier
application number: M005
Terrasil JockItch Treatment Maximum StrengthCLOTRIMAZOLEAidance Scientific, Inc., DBA Aidance Skincare & Topical Solutions8afe11c1-0a85-4255-8eba-e8cbde0759a02024-11-20WarningsExact identifier
application number: M005
Terrasil Ringworm Treatment MAXCLOTRIMAZOLEAidance Scientific, Inc., DBA Aidance Skincare & Topical Solutionsfc2b740a-49c1-4a01-a94c-8cade52a2b822024-11-20WarningsExact identifier
application number: M005
MICONAZOLE NITRATEMICONAZOLE NITRATEALLIED TRADE LINK LLC25520dba-0159-2a3f-e063-6294a90a4c332024-11-12WarningsExact identifier
application number: M005
CLOTRIMAZOLECLOTRIMAZOLEALLIED TRADE LINK LLC266d7b94-2954-4831-e063-6394a90a3f332024-11-08WarningsExact identifier
application number: M005
AntifungalTOLNAFTATE 1%Chain Drug Marketing Association Inc.26303499-dc58-f417-e063-6394a90a0a1b2024-11-05WarningsExact identifier
application number: M005
AZOLENMICONAZOLE NITRATESTRATUS PHARMACEUTICALS INC3264bd0a-c628-404b-8c09-8586682d054e2024-10-31WarningsExact identifier
application number: M005
BACITRACIN ZINCBACITRACIN ZINCSTRATUS PHARMACEUTICALS INCb2cb3a96-b0ca-42ee-8056-91d5450fb3762024-10-31WarningsExact identifier
application number: M005
Premier Value Antifungal Maximum StrengthUNDECYLENIC ACIDPHARMACY VALUE ALLIANCE, LLCf5694ee5-616c-40f6-8da4-c3620dbcd6f72024-10-28WarningsExact identifier
application number: M005
Clotrimazole 1%CLOTRIMAZOLEChain Drug Marketing Association Inc.24ff5ad7-2ff9-b254-e063-6394a90a27a72024-10-21WarningsExact identifier
application number: M005
Micomitin AntifungalTOLNAFTATEPureTek Corporationde9842ba-0254-8ae1-e053-2995a90a06642024-10-16WarningsExact identifier
application number: M005
Ongo - FinTOLNAFTATEEfficient Laboratories Inc.bb5fb71f-bee0-42fa-9c9f-6231b555324c2024-10-14WarningsExact 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