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 3 of 49 · 973 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
WISH HAND SANITIZER Strawberry MuskALCOHOL HAND SANITIZERPT SUPER HOME PRODUCT INDONESIA59143edb-41fe-0a1f-e063-6394a90a81a52026-08-15WarningsExact identifier
application number: M005
WISH HAND SANITIZER Rose WoodsALCOHOL HAND SANITIZERPT SUPER HOME PRODUCT INDONESIA58fb4491-2918-c486-e063-6394a90a621f2026-08-14WarningsExact identifier
application number: M005
VXGXO antifungal with tea tree oilTOLNAFTATEGuangdong Aimu Biological Technology Co., Ltd58fd67c5-c985-13a7-e063-6294a90a40fb2026-08-14WarningsExact identifier
application number: M005
Charmpoo ANTIFUNGAL BODY CreamMICONAZOLE NITRATE 2% ANTIFUNGAL BODY CREAMWenzhou Yuyuan Pharmaceutical Co., Ltd.58ff4779-83a7-afe2-e063-6294a90a9f9a2026-08-14WarningsExact identifier
application number: M005
TEATREEOILANTIFUNGALUNDECYLENIC ACID AND ZINC UNDECYLENATEFoshan Chancheng District Xuntou Electronic Commerce Co., Ltd5900904f-cf51-4398-e063-6394a90aca6c2026-08-14WarningsExact identifier
application number: M005
ClotrimazoleCLOTRIMAZOLEYYBA CORP58f1707a-579b-1e06-e063-6294a90a5a9f2026-08-13WarningsExact identifier
application number: M005
WISH HAND SANITIZER Mango Coconut CreamALCOHOL HAND SANITIZERPT SUPER HOME PRODUCT INDONESIA58faa781-520b-92fa-e063-6294a90a9ecf2026-08-13WarningsExact identifier
application number: M005
Hecila ANTIFUNGAL NAILUNDECYLENIC ACID 25% ANTIFUNGAL NAILWenzhou Yuyuan Pharmaceutical Co., Ltd.58c117cc-e039-86f6-e063-6394a90af18f2026-08-12WarningsExact identifier
application number: M005
TOTCLEAR NAIL RENEWALUNDECYLENIC ACIDGOOD BRIDGE LLC93605e22-920d-43c3-bb2b-6e3116a19f5e2026-08-12WarningsExact identifier
application number: M005
TOTCLEAR NAIL RENEWALUNDECYLENIC ACIDGOOD BRIDGE LLCfde7d6ea-1b44-4a88-820a-0f2e033727e12026-08-11WarningsExact identifier
application number: M005
XBOFPEN MULTI-PURPOSE TREATMENTTOLNAFTATE 1% MULTI-PURPOSE TREATMENTWenzhou Yuyuan Pharmaceutical Co., Ltd.58c2f50c-9c9e-4989-e063-6394a90abb212026-08-11WarningsExact identifier
application number: M005
RoyceDerm Athletes foot antifungal .cream.MICONAZOLE NITRATE 2%RoyceDerm LLC58d23aa0-497e-4ece-e063-6294a90aef662026-08-11WarningsExact identifier
application number: M005
QualiLife persimmon foot and shoeUNDECYLENIC ACIDGuangdong Aimu Biological Technology Co., Ltd584966c7-ceae-91af-e063-6294a90ac1eb2026-08-10WarningsExact identifier
application number: M005
Persiancat ANTIFUNGAL PENUNDECYLENIC ACIDGuangzhou ChuanMa International Trading Co.,Ltd.58affb96-6cfc-b1fb-e063-6294a90a340c2026-08-10WarningsExact identifier
application number: M005
Dryello Tolnaftate 1% AntifungalTOLNAFTATEProPedix, Inc.58b6820c-f601-5921-e063-6294a90aa5e92026-08-10WarningsExact identifier
application number: M005
MedlineMICONAZOLE NITRATEMedline Industries, LP3c43ef91-bbd2-5e58-e063-6294a90a00d32026-08-05WarningsExact identifier
application number: M005
Antifungal LiquidTOLNAFTATEFamily Dollar Services, Inc57c20748-fdad-b73b-e063-6294a90a1c172026-08-04WarningsExact identifier
application number: M005
Lyssera Fungal Nail RenewalUNDECYLENIC ACID 25% FUNGAL NAIL RENEWALWenzhou Yuyuan Pharmaceutical Co., Ltd.5843c1a0-ab60-bd64-e063-6294a90af8582026-08-04WarningsExact identifier
application number: M005
YAMANGU FUNGAL NAIL RENEWALUNDECYLENIC ACID 25% FUNGAL NAIL RENEWALWenzhou Yuyuan Pharmaceutical Co., Ltd.5843cc12-de66-ca47-e063-6294a90ae55b2026-08-04WarningsExact identifier
application number: M005
Antifungal LiquidTOLNAFTATEAmerisourceBergen Drug Corporation58dffd8e-49ef-e03e-e063-6394a90abf5d2026-08-04WarningsExact 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