FDA.reportPublic FDA data

Hi Vetic

Product NDC
49873-056
11-digit product format
498730056
Labeler code
49873
Product ID
49873-056_0bde5831-2b16-2948-e063-6394a90ad473
Type
HUMAN OTC DRUG
Nonproprietary name
tolnaftate
Dosage form
OINTMENT
Route
TOPICAL
Labeler
Sato Pharmaceutical Co., Ltd.
Application
M005
Marketing category
OTC MONOGRAPH DRUG
Marketing start
1996-10-25
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
Hi Vetic
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 · 2 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
199126Internal RxNorm lookup
1236105Internal RxNorm lookup

Harmonized SPL set identifiers#

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

Identifier, FDA.report destination table
IdentifierFDA.report destination
2096e241-3ed3-49cd-88c4-71db1fd2934aAvailable 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
49873-056-01Hi Vetic1 in 1 CARTONOINTMENT17
49873-056-01Hi Vetic15 g in 1 TUBEOINTMENT157

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
tolnaftateACTIVE INGREDIENT06KB629TKVHI VETIC (TOLNAFTATE) OINTMENT [SATO PHARMACEUTICAL CO., LTD.]4
tolnaftateACTIVE MOIETY06KB629TKVHI VETIC (TOLNAFTATE) OINTMENT [SATO PHARMACEUTICAL CO., LTD.]4
CARBOXYMETHYLCELLULOSE SODIUMINACTIVE INGREDIENTK679OBS311HI VETIC (TOLNAFTATE) OINTMENT [SATO PHARMACEUTICAL CO., LTD.]4
CETETH-20INACTIVE INGREDIENTI835H2IHHXHI VETIC (TOLNAFTATE) OINTMENT [SATO PHARMACEUTICAL CO., LTD.]4
diethyl sebacateINACTIVE INGREDIENTI41B9FJK6VHI VETIC (TOLNAFTATE) OINTMENT [SATO PHARMACEUTICAL CO., LTD.]4
dimethiconeINACTIVE INGREDIENT92RU3N3Y1OHI VETIC (TOLNAFTATE) OINTMENT [SATO PHARMACEUTICAL CO., LTD.]4
glyceryl monostearateINACTIVE INGREDIENT230OU9XXE4HI VETIC (TOLNAFTATE) OINTMENT [SATO PHARMACEUTICAL CO., LTD.]4
light mineral oilINACTIVE INGREDIENTN6K5787QVPHI VETIC (TOLNAFTATE) OINTMENT [SATO PHARMACEUTICAL CO., LTD.]4
POLIDOCANOLINACTIVE INGREDIENT0AWH8BFG9AHI VETIC (TOLNAFTATE) OINTMENT [SATO PHARMACEUTICAL CO., LTD.]4
potassium stearateINACTIVE INGREDIENT17V812XK50HI VETIC (TOLNAFTATE) OINTMENT [SATO PHARMACEUTICAL CO., LTD.]4
propylene glycolINACTIVE INGREDIENT6DC9Q167V3HI VETIC (TOLNAFTATE) OINTMENT [SATO PHARMACEUTICAL CO., LTD.]4
siliconINACTIVE INGREDIENTZ4152N8IUIHI VETIC (TOLNAFTATE) OINTMENT [SATO PHARMACEUTICAL CO., LTD.]4
sodium lauryl sulfateINACTIVE INGREDIENT368GB5141JHI VETIC (TOLNAFTATE) OINTMENT [SATO PHARMACEUTICAL CO., LTD.]4
stearyl alcoholINACTIVE INGREDIENT2KR89I4H1YHI VETIC (TOLNAFTATE) OINTMENT [SATO PHARMACEUTICAL CO., LTD.]4
ureaINACTIVE INGREDIENT8W8T17847WHI VETIC (TOLNAFTATE) OINTMENT [SATO PHARMACEUTICAL CO., LTD.]4
waterINACTIVE INGREDIENT059QF0KO0RHI VETIC (TOLNAFTATE) OINTMENT [SATO PHARMACEUTICAL CO., LTD.]4
white waxINACTIVE INGREDIENT7G1J5DA97FHI VETIC (TOLNAFTATE) OINTMENT [SATO PHARMACEUTICAL CO., LTD.]4
zinc oxideINACTIVE INGREDIENTSOI2LOH54ZHI VETIC (TOLNAFTATE) OINTMENT [SATO PHARMACEUTICAL CO., LTD.]4

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
49873-056HI VETIC (TOLNAFTATE) OINTMENT [SATO PHARMACEUTICAL CO., LTD.]7Current NDC, Legacy NDC, 2 package rows20231207_2096e241-3ed3-49cd-88c4-71db1fd2934a.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 9 of 49 · 973 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
FIobow FUNGAL NAIL TREATMENTTOLNAFTATE 1% FUNGAL NAIL TREATMENTJiangxi Yudexi Pharmaceutical Co., LTD4a49db2b-e45a-57c5-e063-6294a90a065c2026-06-23WarningsExact identifier
application number: M005
RoyceDerm Antifungal .spray.CLOTRIMAZOLE 1%RoyceDerm LLC54d3ae29-8919-4868-e063-6294a90a587e2026-06-22WarningsExact identifier
application number: M005
Miconazole NitrateATHLETES FOOT LIQUIDWalgreens Company94f4f656-e8a3-4439-b53c-12be59dc8eac2026-06-20WarningsExact identifier
application number: M005
VTROUY Fungal Nail Renewal PenFUNGAL NAIL RENEWAL PENGuangzhou Jingliang Cosmetics Co., Ltd.549bf490-99c2-c800-e063-6394a90a672b2026-06-19WarningsExact identifier
application number: M005
Terramed Just Think Comfort Armor Antifungal Body Wash Tea TreeTOLNAFTATERida LLC0c7a3b2d-8b1c-4130-86ad-892a591574802026-06-19WarningsExact identifier
application number: M005
Terramed Just Think Comfort Clotrimazole Antifungal Topical SolutionCLOTRIMAZOLERida LLC83a9c5dc-c969-43a7-a763-44783710d5d02026-06-18WarningsExact identifier
application number: M005
Anytalk FUNGAL NAIL TREATMENTTOLNAFTATE 1%Guangzhou Huixue Biotechnology Co., Ltd.54718558-376f-ed31-e063-6294a90a52202026-06-17WarningsExact identifier
application number: M005
KLIPP FUNGAL NAIL TREATMENTKLIPP FUNGAL NAIL TREATMENTGUANGZHOU YUSONG FINE CHEMICLS Co., Ltd547f2fbe-a2de-057d-e063-6394a90ac7422026-06-17WarningsExact identifier
application number: M005
GeriGentle Miconazole nitrateANTIFUNGALGERI-GENTLE CORPORATION0ae03b4a-06c8-ddf9-e063-6294a90ad1052026-06-16WarningsExact identifier
application number: M005
WKPIKI FUNGAL NAIL REPAIR PENUNDECYLENIC ACID 25% FUNGAL NAIL REPAIR PENWenzhou Yuyuan Pharmaceutical Co., Ltd.54472c44-93de-d4b9-e063-6394a90adde12026-06-15WarningsExact identifier
application number: M005
BIOSHUGA Dermomucosal Antibacterial GelBIOSHUGA DERMOMUCOSAL ANTIBACTERIAL GELGuangxi Rise Biological Technology Co.,Ltd.5456574a-dda4-9c67-e063-6294a90ac2222026-06-15WarningsExact identifier
application number: M005
BIOSHUGA CUTANEOUS MUCOSAL ANTIMICROBIAL SolutionBIOSHUGA CUTANEOUS MUCOSAL ANTIMICROBIAL SOLUTIONGuangxi Rise Biological Technology Co.,Ltd.5457a623-7812-e516-e063-6394a90a8bfd2026-06-15WarningsExact identifier
application number: M005
TOYKNIER MULTI-PURPOSE TREATMENTUNDECYLENIC ACID 25% MULTI-PURPOSE TREATMENTJiangxi Yudexi Pharmaceutical Co., LTD4f8eb3a3-8f26-50dd-e063-6294a90ad9f82026-06-14WarningsExact identifier
application number: M005
CYYZROSE ANTIFUNGAL NAILUNDECYLENIC ACID 25% ANTIFUNGAL NAILJiangxi Yudexi Pharmaceutical Co., LTD527765d4-6988-ed4e-e063-6394a90a2f232026-06-14WarningsExact identifier
application number: M005
HEALMUSZ FUNGAL NAILTOLNAFTATE 1% FUNGAL NAILJiangxi Yudexi Pharmaceutical Co., LTD4a2317d2-e45b-1fe2-e063-6394a90a940d2026-06-14WarningsExact identifier
application number: M005
HEALMUSZ FUNGI NAILTOLNAFTATE 1% FUNGI NAILJiangxi Yudexi Pharmaceutical Co., LTD4a23c01b-492d-324b-e063-6394a90a73b12026-06-14WarningsExact identifier
application number: M005
HEALMUSZ Multi-PurposeTreatmentTOLNAFTATE 1% MULTI-PURPOSETREATMENTJiangxi Yudexi Pharmaceutical Co., LTD4a2421d8-a543-abb1-e063-6394a90afaa72026-06-14WarningsExact identifier
application number: M005
HEALMUSZ FOOT ODOR PROBIOTICTOLNAFTATE 1% FOOT ODOR PROBIOTICJiangxi Yudexi Pharmaceutical Co., LTD4a24b5ae-f86c-459f-e063-6394a90ac5c32026-06-14WarningsExact identifier
application number: M005
PUVIDA Helps WITH NAGELPILZTOLNAFTATE 1% HELPS WITH NAGELPILZJiangxi Yudexi Pharmaceutical Co., LTD4a4828d7-091b-7c8e-e063-6294a90af1362026-06-14WarningsExact identifier
application number: M005
PUVIDA FUNGAL NAIL RENEWALUNDECYLENIC ACID 25% FUNGAL NAIL RENEWALJiangxi Yudexi Pharmaceutical Co., LTD4a484e3d-d653-2689-e063-6394a90a64ef2026-06-14WarningsExact identifier
application number: M005

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
1236105hiVETIC 1 % Topical OintmentPSN2096e241-3ed3-49cd-88c4-71db1fd2934a7
199126tolnaftate 1 % Topical OintmentPSN2096e241-3ed3-49cd-88c4-71db1fd2934a7
1236105tolnaftate 0.01 MG/MG Topical Ointment [hiVETIC]SBD2096e241-3ed3-49cd-88c4-71db1fd2934a7
199126tolnaftate 0.01 MG/MG Topical OintmentSCD2096e241-3ed3-49cd-88c4-71db1fd2934a7
1236105hiVETIC 0.01 MG/MG Topical OintmentSY2096e241-3ed3-49cd-88c4-71db1fd2934a7
1236105hiVETIC 1 % Topical OintmentSY2096e241-3ed3-49cd-88c4-71db1fd2934a7
199126tolnaftate 1 % Topical OintmentSY2096e241-3ed3-49cd-88c4-71db1fd2934a7

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
49873-056-01498730056011 TUBE in 1 CARTON (49873-056-01) / 15 g in 1 TUBE1 tube1996-10-250000-00-00NoNoCurrent