FDA.reportPublic FDA data

SYLVIRENE FUNGAL NAIL RENEWAL

Product NDC
85248-068
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 16 · 319 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Dcsily Liquid Wart Corn RemoverLIQUID WART CORN REMOVERShenzhen Xinxin Yunhai Technology Co., Ltd.5b1bf2f7-422f-8713-e063-6394a90adee32026-09-10WarningsExact identifier
application number: M028
OJIOG WART REMOVER CreamSALICYLIC ACID 40% WART REMOVER CREAMWenzhou Yuyuan Pharmaceutical Co., Ltd.5b1cff55-0478-62d2-e063-6394a90abfc72026-09-10WarningsExact identifier
application number: M028
Ronxiva WART REMOVERSALICYLIC ACID 40% WART REMOVERWenzhou Yuyuan Pharmaceutical Co., Ltd.5b181d86-6f28-890a-e063-6294a90a34392026-09-09WarningsExact identifier
application number: M028
TepidSun WART REMOVERSALICYLIC ACID 40%Guangzhou Huixue Biotechnology Co., Ltd.5a181d19-86e2-97b1-e063-6394a90a19f12026-09-08WarningsExact identifier
application number: M028
TRLYC WART REMOVERSALICYLIC ACID 40%Guangzhou Huixue Biotechnology Co., Ltd.59b4d4a2-f7c5-a73a-e063-6294a90ae8c02026-09-08WarningsExact identifier
application number: M028
Aiilo WART REMOVERSALICYLIC ACID 40%Guangzhou Huixue Biotechnology Co., Ltd.58ad9307-a9f9-4de8-e063-6394a90adaa62026-09-08WarningsExact identifier
application number: M028
Aiilo WART REMOVER PATCHESSALICYLIC ACID 40%Guangzhou Huixue Biotechnology Co., Ltd.58af5ac2-75a7-246d-e063-6394a90ae9662026-09-08WarningsExact identifier
application number: M028
Youggle WART REMOVERSALICYLIC ACIDGuangzhou Huixue Biotechnology Co., Ltd.57a3744e-316c-8a3d-e063-6294a90a15d12026-09-08WarningsExact identifier
application number: M028
GPPEE WART REMOVERSALICYLIC ACID 40%Guangzhou Huixue Biotechnology Co., Ltd.5715c122-8ba8-6f1e-e063-6294a90a805f2026-09-08WarningsExact identifier
application number: M028
DVO WART REMOVERSALICYLIC ACIDGuangzhou Huixue Biotechnology Co., Ltd.57028c23-e012-9066-e063-6394a90a910b2026-09-08WarningsExact identifier
application number: M028
OMPLEN WART REMOVERSALICYLIC ACID 40%Guangzhou Huixue Biotechnology Co., Ltd.56e118b3-c27f-c14a-e063-6394a90ab75e2026-09-08WarningsExact identifier
application number: M028
GPPEE WART REMOVER PATCHESSALICYLIC ACID 40%Guangzhou Huixue Biotechnology Co., Ltd.568a84eb-c0f7-6ce6-e063-6294a90a15b42026-09-08WarningsExact identifier
application number: M028
OMPLEN WART REMOVERSALICYLIC ACID 40%Guangzhou Huixue Biotechnology Co., Ltd.5652eb70-23f2-91cb-e063-6294a90a11962026-09-08WarningsExact identifier
application number: M028
Jorvinl WART REMOVERSALICYLIC ACID 40%Guangzhou Huixue Biotechnology Co., Ltd.55c66a49-9d89-84a2-e063-6294a90a114e2026-09-08WarningsExact identifier
application number: M028
Youggle WART REMOVERSALICYLIC ACID 40%Guangzhou Huixue Biotechnology Co., Ltd.54e97ada-b3fa-0411-e063-6294a90a6ecd2026-09-08WarningsExact identifier
application number: M028
OCSINL WART REMOVERSALICYLIC ACID 40%Guangzhou Huixue Biotechnology Co., Ltd.54c206b9-758e-4baf-e063-6394a90afa992026-09-08WarningsExact identifier
application number: M028
DVO WART REMOVERSALICYLIC ACID 40%Guangzhou Huixue Biotechnology Co., Ltd.53e389a6-722c-dc65-e063-6294a90ac7dc2026-09-08WarningsExact identifier
application number: M028
Flyleaf WART REMOVERSALICYLIC ACID 40%Guangzhou Huixue Biotechnology Co., Ltd.53f1ca40-e909-e9df-e063-6294a90a97912026-09-08WarningsExact identifier
application number: M028
QKEKL WART REMOVERSALICYLIC ACID 45%Guangzhou Huixue Biotechnology Co., Ltd.5aeeafa6-4167-dcc3-e063-6294a90a26bb2026-09-07WarningsExact identifier
application number: M028
WOPRES WART REMOVERSALICYLIC ACID 45%Guangzhou Huixue Biotechnology Co., Ltd.5aef5afe-d3f3-4af8-e063-6394a90a28cb2026-09-07WarningsExact 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