OURUI ONE FUNGAL NAIL TREATMENT

Product NDC
85248-084
11-digit product format
852480084
Labeler code
85248
Product ID
85248-084_4a60503b-e94b-3fba-e063-6394a90ae113
Type
HUMAN OTC DRUG
Nonproprietary name
Tolnaftate 1% FUNGAL NAIL TREATMENT
Dosage form
LIQUID
Route
TOPICAL
Labeler
Jiangxi Yudexi Pharmaceutical Co., LTD
Application
M005
Marketing category
OTC MONOGRAPH DRUG
Marketing start
2026-02-08
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
OURUI ONE FUNGAL NAIL TREATMENT
Listing expiration
2027-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
TOLNAFTATE1 g/100mL

Harmonized Identifiers#

Field, Values table
FieldValues
Unii06KB629TKV
Rxcui313423

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
85248-084-01OURUI ONE FUNGAL NAIL TREATMENT2 in 1 BOXLIQUID22
85248-084-01OURUI ONE FUNGAL NAIL TREATMENT15 mL in 1 BOTTLELIQUID152

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
313423tolnaftate 1 % Topical SolutionPSN4a473f03-f4cc-74ef-e063-6394a90ac7072
313423tolnaftate 10 MG/ML Topical SolutionSCD4a473f03-f4cc-74ef-e063-6394a90ac7072
313423tolnaftate 1 % Topical SolutionSY4a473f03-f4cc-74ef-e063-6394a90ac7072

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startSampleExclude flagStatus
85248-084-01852480084012 BOTTLE in 1 BOX (85248-084-01) / 15 mL in 1 BOTTLE2 bottle2026-02-08NoNoCurrent