FDA.reportPublic FDA data

SYLVIRENE FUNGAL NAIL RENEWAL

Product NDC
85248-068
Requested package NDC
85248-068-01
11-digit product format
852480068
Labeler code
85248
Product ID
85248-068_4a363e8e-65bd-82cf-e063-6394a90a2594
Type
HUMAN OTC DRUG
Nonproprietary name
Tolnaftate 1% FUNGAL NAIL RENEWAL
Dosage form
CREAM
Route
TOPICAL
Labeler
Jiangxi Yudexi Pharmaceutical Co., LTD
Application
M028
Marketing category
OTC MONOGRAPH DRUG
Marketing start
2026-02-07
Substance
TOLNAFTATE
Active strength
1 g/100mL
NDC exclude flag
No
Listing certified through
2027-12-31
Current FDA listing
Yes

Additional Listing Data#

Finished product
Yes
Brand name base
SYLVIRENE FUNGAL NAIL RENEWAL
Listing expiration
2027-12-31

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 · 1 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
103951Internal RxNorm lookup

Harmonized SPL set identifiers#

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

Identifier, FDA.report destination table
IdentifierFDA.report destination
4a363e8e-65bc-82cf-e063-6394a90a2594Available on FDA.report

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
85248-068-01SYLVIRENE FUNGAL NAIL RENEWAL30 mL in 1 BOTTLECREAM301

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 1 of 14 · 264 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Wart Remover PatchesSALICYLIC ACIDGuangzhou Hechuang Commercial Service Co.,Ltd.57c063f3-a7ae-d8aa-e063-6294a90af0322026-07-29WarningsExact identifier
application number: M028
NERAXIVA Wart RemoverSALICYLIC ACIDGuangzhou Xinhongda Trading Service Co., Ltd.5793ff70-9cd7-1aa8-e063-6394a90ae48c2026-07-27WarningsExact identifier
application number: M028
DERMFREE Liquid Wart Corn Callus RemoverSALICYLIC ACID 17% LIQUID WART CORN CALLUS REMOVERJiangxi Yudexi Pharmaceutical Co., LTD4a5affb7-d674-3b1a-e063-6294a90a19392026-07-23WarningsExact identifier
application number: M028
Equate One Step Wart Remover StripsSALICYLIC ACIDWalmart Inc.0aef23f0-d337-46b9-b1d5-72ce7fc2b86a2026-07-23WarningsExact identifier
application number: M028
SANUSCODE WART CORN REMOVERSALICYLIC ACID 40% WART CORN REMOVERJiangxi Yudexi Pharmaceutical Co., LTD4a0a7a7b-91e9-49f4-e063-6394a90a24622026-07-21WarningsExact identifier
application number: M028
SANUSCODE WART REMOVERSALICYLIC ACID 17% WART REMOVERJiangxi Yudexi Pharmaceutical Co., LTD4a0df8d0-d230-7c43-e063-6294a90a54bf2026-07-21WarningsExact identifier
application number: M028
Ouamvh SKIN TAG REMOVERSALICYLIC ACID 20% SKIN TAG REMOVERJiangxi Yudexi Pharmaceutical Co., LTD .50915164-112a-bf71-e063-6294a90a07542026-07-21WarningsExact identifier
application number: M028
wart remover patchesWART REMOVER PATCHESShenzhen Hengdasheng Technology Co., Ltd571f815a-e448-6c41-e063-6394a90a6e112026-07-21WarningsExact identifier
application number: M028
Pureskin wart removerSALICYLIC ACIDBENLONG HALL LLC57271ece-36ef-1fa7-e063-6294a90a727a2026-07-21WarningsExact identifier
application number: M028
SYLVIRENE FUNGAL NAIL RENEWALTOLNAFTATE 1% FUNGAL NAIL RENEWALJiangxi Yudexi Pharmaceutical Co., LTD4a363e8e-65bc-82cf-e063-6394a90a25942026-07-21WarningsExact identifier
application number: M028
ndc (package): 85248-068-01
ndc (product): 85248-068
ndc11 (package): 85248006801
SYLVIRENE Liquid Wart Corn Callus RemoverSALICYLIC ACID 17% LIQUID WART CORN CALLUS REMOVERJiangxi Yudexi Pharmaceutical Co., LTD4a367127-8b5a-4f55-e063-6294a90a1a7e2026-07-21WarningsExact identifier
application number: M028
REINREUDE WART REMOVAERSALICYLIC ACID 17% WART REMOVAERJiangxi Yudexi Pharmaceutical Co., LTD4a38ac58-27fe-d26c-e063-6294a90a4efc2026-07-21WarningsExact identifier
application number: M028
REINREUDE WART REMOVERSALICYLIC ACID 17% WART REMOVERJiangxi Yudexi Pharmaceutical Co., LTD4a39b608-8789-cbbc-e063-6394a90add562026-07-21WarningsExact identifier
application number: M028
REINREUDE TAG WART REMOVERSALICYLIC ACID 40% TAG WART REMOVERJiangxi Yudexi Pharmaceutical Co., LTD4a45b165-5fcd-04f2-e063-6294a90ab0d42026-07-21WarningsExact identifier
application number: M028
SERYNTH Liquid WART CORN REMOVERSALICYLIC ACID 17% LIQUID WART CORN REMOVERJiangxi Yudexi Pharmaceutical Co., LTD4a4b5f08-3265-ecb2-e063-6294a90a3edf2026-07-21WarningsExact identifier
application number: M028
SERYNTH GENITAL WARTS REMOVERSALICYLIC ACID 17% GENITAL WARTS REMOVERJiangxi Yudexi Pharmaceutical Co., LTD4a4b8c9d-a9c0-f0a1-e063-6294a90ad9dd2026-07-21WarningsExact identifier
application number: M028
SERYNTH ECZEMA RELIEFHYDROCORTISONE 1% ECZEMA RELIEFJiangxi Yudexi Pharmaceutical Co., LTD4a4bbb5d-09b1-2c5c-e063-6394a90a832c2026-07-21WarningsExact identifier
application number: M028
WART REMOVER PATCHSSALICYLIC ACID 17%Guangxi Keyun E-commerce Co., Ltd.572b71cc-6af0-4a49-e063-6394a90afed22026-07-21WarningsExact identifier
application number: M028
NATUHEAL WART REMOVERSALICYLIC ACID 17% WART REMOVERJiangxi Yudexi Pharmaceutical Co., LTD4a46ca4f-19df-f148-e063-6394a90a63e62026-07-20WarningsExact identifier
application number: M028
OURUI ONE WART COMPLETE Care Kit CORN WART REMOVERSALICYLIC ACID 17% WART COMPLETE CARE KIT CORN WART REMOVERJiangxi Yudexi Pharmaceutical Co., LTD4a47a2ff-4924-eedc-e063-6394a90ab0722026-07-20WarningsExact identifier
application number: M028

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
103951tolnaftate 1 % Topical CreamPSN4a363e8e-65bc-82cf-e063-6394a90a25941
103951tolnaftate 10 MG/ML Topical CreamSCD4a363e8e-65bc-82cf-e063-6394a90a25941
103951tolnaftate 1 % Topical CreamSY4a363e8e-65bc-82cf-e063-6394a90a25941

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startSampleExclude flagStatus
85248-068-018524800680130 mL in 1 BOTTLE (85248-068-01) 30 ml2026-02-07NoNoCurrent