FDA.reportPublic FDA data

TOLNAFTATE ANTIFUNGAL

Product NDC
57896-199
11-digit product format
578960199
Labeler code
57896
Product ID
57896-199_09a769e6-0aed-0a17-e063-6394a90a85d6
Type
HUMAN OTC DRUG
Nonproprietary name
TOLNAFTATE
Dosage form
POWDER
Route
TOPICAL
Labeler
Geri-Care Pharmaceuticals, Corp
Application
M005
Marketing category
OTC MONOGRAPH DRUG
Marketing start
2011-08-01
Substance
TOLNAFTATE
Active strength
1 g/100g
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
TOLNAFTATE ANTIFUNGAL
Listing expiration
2026-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
TOLNAFTATE1 g/100g

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
313422Internal RxNorm lookup

Harmonized SPL set identifiers#

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

Identifier, FDA.report destination table
IdentifierFDA.report destination
f9e60430-eec1-4bc2-9522-eb5aa527d90aAvailable on FDA.report

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
57896-199-45TOLNAFTATE ANTIFUNGAL45 g in 1 BOTTLE, DISPENSINGPOWDER454

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
57896-199-45GM - Gram57896-1998484e728-4ce2-4941-82cd-37c07f868cb412017-12-14

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
TOLNAFTATEACTIVE INGREDIENT06KB629TKVTOLNAFTATE ANTIFUNGAL (TOLNAFTATE) POWDER [GERI-CARE PHARMACEUTICALS, CORP]1
TOLNAFTATEACTIVE MOIETY06KB629TKVTOLNAFTATE ANTIFUNGAL (TOLNAFTATE) POWDER [GERI-CARE PHARMACEUTICALS, CORP]1
STARCH, CORNINACTIVE INGREDIENTO8232NY3SJTOLNAFTATE ANTIFUNGAL (TOLNAFTATE) POWDER [GERI-CARE PHARMACEUTICALS, CORP]1
TALCINACTIVE INGREDIENT7SEV7J4R1UTOLNAFTATE ANTIFUNGAL (TOLNAFTATE) POWDER [GERI-CARE PHARMACEUTICALS, CORP]1

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
57896-199TOLNAFTATE ANTIFUNGAL (TOLNAFTATE) POWDER [GERI-CARE PHARMACEUTICALS, CORP]4Current NDC, Legacy NDC, 1 package rows20231109_f9e60430-eec1-4bc2-9522-eb5aa527d90a.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 47 of 49 · 973 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
FIRST SHIELDBENZALKONIUM CHLORIDE, LIDOCAINE HCIEver Ready First Aidee198aa1-ad0d-9185-e053-2a95a90a65952024-01-15WarningsExact identifier
application number: M005
Ever Ready HAND SANITIZERETHYL ALCOHOLEver Ready First Aidec1af7ef-3c95-9c60-e053-2a95a90acf472024-01-15WarningsExact identifier
application number: M005
MY MEDIC SUPER SANITIZERETHYL ALCOHOLSled Distribution, LLCe7451738-75d5-5dc4-e053-2a95a90a7aee2024-01-15WarningsExact identifier
application number: M005
Medical SuperALCOHOLBeijing HKKY Medical Tech. Co., Ltd.ed2649c6-d971-4338-8745-cd0a40f7b0c22024-01-13WarningsExact identifier
application number: M005
ER Hand Sanitizer PacketsALCOHOLEVER READY FIRST AIDd0b6d09c-26e0-45c7-8d37-7d42143b2e312024-01-11WarningsExact identifier
application number: M005
clotrimazoleCLOTRIMAZOLEProficient Rx LPeeb241a3-93ee-4b74-8cbb-65713d15e7e02024-01-01WarningsExact identifier
application number: M005
ClotrimazoleCLOTRIMAZOLEProficient Rx LPba1dc4a4-073f-4f30-bb9c-9ed0437004312024-01-01WarningsExact identifier
application number: M005
RUGBY ANTIFUNGAL CLOTRIMAZOLECLOTRIMAZOLEProficient Rx LP7c64553b-589c-4e65-a6f0-b2847bbbe8a62024-01-01WarningsExact identifier
application number: M005
Dr. Scholls Instant Cool Athletes foot treatment with MentholTOLNAFTATEScholl's Wellness Companydad00745-e411-35b8-e053-2a95a90a10002023-12-21WarningsExact identifier
application number: M005
TINEACIDETOLNAFTATEBlaine Labs Inc.273eb424-5dc3-40c8-9ea7-2f732cbd11c92023-12-21WarningsExact identifier
application number: M005
TERPENICOL ANTIFUNGALUNDECYLENIC ACIDBlaine Labs Inc.a020334e-aac9-4ea5-a0ea-8e5b021fe2eb2023-12-21WarningsExact identifier
application number: M005
TERPENICOLUNDECYLENIC ACIDBlaine Labs Inc.efd99ed1-07d3-4862-ae47-883f7d1c91c62023-12-21WarningsExact identifier
application number: M005
sunmark antifungalTOLNAFTATEA-S Medication Solutions6f85fbb0-297c-4949-83f2-ed9a521721542023-12-16WarningsExact identifier
application number: M005
Miconazole NitrateMICONAZOLE NITRATEA-S Medication Solutions7a0ef38a-9584-4e67-ba86-c31f86da1ed02023-12-11WarningsExact identifier
application number: M005
Miconazole NitrateMICONAZOLE NITRATEA-S Medication Solutions7d284f6f-a970-49fe-b45a-d5c6c2688bc22023-12-11WarningsExact identifier
application number: M005
Hi VeticTOLNAFTATESato Pharmaceutical Co., Ltd.2096e241-3ed3-49cd-88c4-71db1fd2934a2023-12-06WarningsExact identifier
application number: M005
Undecylenic AcidUNDECYLENIC ACIDChemco Corporation7391b53f-5567-1f45-e053-2991aa0a4fce2023-12-05WarningsExact identifier
application number: M005
Hi VeticTOLNAFTATESato Pharmaceutical Co., Ltd.be92b480-56e8-4371-adbc-40fe74f6747c2023-12-01WarningsExact identifier
application number: M005
Antifungal CreamANTIFUNGALBluePoint Laboratoriesb4c4240f-f84c-ec5e-e053-2a95a90aa0822023-11-17WarningsExact identifier
application number: M005
Antifungal CreamANTIFUNGALBluePoint Laboratoriesb564f971-2a9b-a605-e053-2995a90aee692023-11-17WarningsExact identifier
application number: M005

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
313422tolnaftate 1 % Topical PowderPSNfbbd159c-217e-46d3-963c-ba0bd1e9bbe8100
313422tolnaftate 0.01 MG/MG Topical PowderSCDfbbd159c-217e-46d3-963c-ba0bd1e9bbe8100
313422tolnaftate 1 % Topical PowderSYfbbd159c-217e-46d3-963c-ba0bd1e9bbe8100
313422tolnaftate 1 % Topical PowderPSNf9e60430-eec1-4bc2-9522-eb5aa527d90a4
313422tolnaftate 0.01 MG/MG Topical PowderSCDf9e60430-eec1-4bc2-9522-eb5aa527d90a4
313422tolnaftate 1 % Topical PowderSYf9e60430-eec1-4bc2-9522-eb5aa527d90a4

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
57896-199-455789601994545 g in 1 BOTTLE, DISPENSING (57896-199-45) 45 g2011-08-010000-00-00NoNoCurrent