FDA.reportPublic FDA data

Hi Vetic

Product NDC
49873-050
11-digit product format
498730050
Labeler code
49873
Product ID
49873-050_0b7d0c0b-2732-36f6-e063-6294a90a7c17
Type
HUMAN OTC DRUG
Nonproprietary name
tolnaftate
Dosage form
SOLUTION
Route
TOPICAL
Labeler
Sato Pharmaceutical Co., Ltd.
Application
M005
Marketing category
OTC MONOGRAPH DRUG
Marketing start
1990-08-14
Substance
TOLNAFTATE
Active strength
1 g/100mL
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
Hi Vetic
Listing expiration
2026-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
TOLNAFTATE1 g/100mL

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
313423Internal RxNorm lookup
1236109Internal RxNorm lookup

Harmonized SPL set identifiers#

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

Identifier, FDA.report destination table
IdentifierFDA.report destination
be92b480-56e8-4371-adbc-40fe74f6747cAvailable on FDA.report

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
2d2ef081-4f0c-4669-81e8-32b263669a0aProduct name120230801
af534dc0-c9e5-19a6-693c-e7ad53714660Product name120140508

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
49873-050-02Hi Vetic20 mL in 1 BOTTLESOLUTION207
49873-050-02Hi Vetic1 in 1 CARTONSOLUTION17

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
tolnaftateACTIVE INGREDIENT06KB629TKVHI VETIC (TOLNAFTATE) SOLUTION [SATO PHARMACEUTICAL CO., LTD.]4
tolnaftateACTIVE MOIETY06KB629TKVHI VETIC (TOLNAFTATE) SOLUTION [SATO PHARMACEUTICAL CO., LTD.]4
acetoneINACTIVE INGREDIENT1364PS73AFHI VETIC (TOLNAFTATE) SOLUTION [SATO PHARMACEUTICAL CO., LTD.]4
citric acid monohydrateINACTIVE INGREDIENT2968PHW8QPHI VETIC (TOLNAFTATE) SOLUTION [SATO PHARMACEUTICAL CO., LTD.]4
diethyl sebacateINACTIVE INGREDIENTI41B9FJK6VHI VETIC (TOLNAFTATE) SOLUTION [SATO PHARMACEUTICAL CO., LTD.]4
isopropyl alcoholINACTIVE INGREDIENTND2M416302HI VETIC (TOLNAFTATE) SOLUTION [SATO PHARMACEUTICAL CO., LTD.]4
POLIDOCANOLINACTIVE INGREDIENT0AWH8BFG9AHI VETIC (TOLNAFTATE) SOLUTION [SATO PHARMACEUTICAL CO., LTD.]4
propyl gallateINACTIVE INGREDIENT8D4SNN7V92HI VETIC (TOLNAFTATE) SOLUTION [SATO PHARMACEUTICAL CO., LTD.]4
waterINACTIVE INGREDIENT059QF0KO0RHI VETIC (TOLNAFTATE) SOLUTION [SATO PHARMACEUTICAL CO., LTD.]4

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
49873-050HI VETIC (TOLNAFTATE) SOLUTION [SATO PHARMACEUTICAL CO., LTD.]7Current NDC, Legacy NDC, 2 package rows20231202_be92b480-56e8-4371-adbc-40fe74f6747c.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 35 of 49 · 973 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
ONIADBA Fungal Nail Treatment SwabsTOLNAFTATE,UNDECYLENIC ACIDShenzhen Boyimei Technology Co., Ltd.3baa99ab-6d22-8d7d-e063-6294a90af3e82025-08-05WarningsExact identifier
application number: M005
MICONAZOLE Nitrate 2% Cream ANTIFUNGALMICONAZOLE NITRATEPreferred Pharmaceuticals Inc.cca84334-2e2d-4991-9d1e-d5b7c9ffd3922025-08-01WarningsExact identifier
application number: M005
RoyceDerm CoolDefense Refreshing Shower GelTOLNAFTATE 1.0%RoyceDerm LLC3b3216d6-8cc8-ea89-e063-6294a90ab6912025-07-31WarningsExact identifier
application number: M005
SUNMARK MICONAZOLE NITRATE antifungalMICONAZOLE NITRATEStrategic Sourcing Services LLC7c15d95a-5b89-4789-8c91-3f61d7ec77072025-07-30WarningsExact identifier
application number: M005
AntifungalMICONAZOLE NITRATEAdvanced Rx LLCe13eb653-3916-444a-ae86-1738c0308b792025-07-28WarningsExact identifier
application number: M005
Meridian Unwrapped Antibacterial DeodorantBENZETHONIUM CHLORIDEYangzhou Hongshengding Chemical Co.,Ltd.a2b9570f-312c-4f46-994d-efe057b247aa2025-07-28WarningsExact identifier
application number: M005
Meridian Antibacterial DeodorantBENZETHONIUM CHLORIDEYangzhou Hongshengding Chemical Co.,Ltd.b41b130f-48fd-47d4-a94e-74433ae44de22025-07-28WarningsExact identifier
application number: M005
Rugby Clotrimazole Antifungal CreamCLOTRIMAZOLEPreferred Pharmaceuticals Inc.bd567e91-7152-4612-83e0-8e8a00c2d2c52025-07-25WarningsExact identifier
application number: M005
HongocuraUNDECYLENIC ACID, ZINC UNDECYLENATEMENPER DISTRIBUTORS, INC.c69b735e-0ffe-4328-bd9f-3c1ac6798c082025-07-22WarningsExact identifier
application number: M005
Hongocura PinceladasUNDECYLENIC ACIDMenper Distributors, Inc.4b9a3a70-d646-47c6-b969-5c4d759d23a42025-07-22WarningsExact identifier
application number: M005
Hongocura MUNDECYLENIC ACIDMENPER DISTRIBUTORS, INC.b4adb7b0-59b4-4b3c-9b0e-1869bb5431742025-07-22WarningsExact identifier
application number: M005
Hongocura SUNDECYLENIC ACIDMENPER DISTRIBUTORS, INC.4a21f371-bfc1-4e66-af16-55b3283872b72025-07-22WarningsExact identifier
application number: M005
FifthPulse Miconazole Nitrate Cream 1ozMICONAZOLE NITRATEFront Pharmaceutical PLC3a37a3a8-9d05-926c-e063-6294a90a9ed82025-07-18WarningsExact identifier
application number: M005
FifthPulse Miconazole Nitrate Cream 4ozMICONAZOLE NITRATEFront Pharmaceutical PLC3a382b79-dde9-dde0-e063-6294a90a53bb2025-07-18WarningsExact identifier
application number: M005
FifthPulse clotrimazole cream 4ozCLOTRIMAZOLE 1%Front Pharmaceutical PLC3a389093-48f2-29cb-e063-6294a90ada372025-07-18WarningsExact identifier
application number: M005
PHARMBANNER Tea Tree Oil Antifungal Soap.TEA TREE OIL ANTIFUNGAL SOAP.Shenzhen Xinxin Yunhai Technology Co., Ltd.3a0860b0-346e-7024-e063-6394a90ace812025-07-16WarningsExact identifier
application number: M005
TopCare AntifungalCLOTRIMAZOLETopco Associates LLC6757eb2a-73e0-4bd0-a332-5713fdf3445d2025-07-16WarningsExact identifier
application number: M005
UpandUp ClotrimazoleCLOTRIMAZOLETarget Corporationcb2b7d38-9988-493b-9843-56c2f59eed2f2025-07-16WarningsExact identifier
application number: M005
Jock ItchCLOTRIMAZOLETARGET Corporation1ae551e7-69de-4eef-b4f7-5e1a880e631d2025-07-16WarningsExact identifier
application number: M005
Athletes FootCLOTRIMAZOLEFRED'S, INC.d2d8f44e-2dfa-446b-855e-86e0d6d2d0df2025-07-15WarningsExact identifier
application number: M005

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
1236109hiVETIC 1 % Topical SolutionPSNbe92b480-56e8-4371-adbc-40fe74f6747c7
313423tolnaftate 1 % Topical SolutionPSNbe92b480-56e8-4371-adbc-40fe74f6747c7
1236109tolnaftate 10 MG/ML Topical Solution [hiVETIC]SBDbe92b480-56e8-4371-adbc-40fe74f6747c7
313423tolnaftate 10 MG/ML Topical SolutionSCDbe92b480-56e8-4371-adbc-40fe74f6747c7
1236109hiVETIC 1 % Topical SolutionSYbe92b480-56e8-4371-adbc-40fe74f6747c7
1236109hiVETIC 10 MG/ML Topical SolutionSYbe92b480-56e8-4371-adbc-40fe74f6747c7
313423tolnaftate 1 % Topical SolutionSYbe92b480-56e8-4371-adbc-40fe74f6747c7

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
49873-050-02498730050021 BOTTLE in 1 CARTON (49873-050-02) / 20 mL in 1 BOTTLE1 bottle1990-08-140000-00-00NoNoCurrent