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 Identifiers#

Field, Values table
FieldValues
Unii06KB629TKV
Rxcui103951

DailyMed Package Descriptions#

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

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