HTRCSW FUNGAL NAIL RENEWAL

Product NDC
85248-217
11-digit product format
852480217
Labeler code
85248
Product ID
85248-217_523bc484-511d-b603-e063-6394a90a55ae
Type
HUMAN OTC DRUG
Nonproprietary name
Undecylenic Acid 25% TOENAIL FUNGUS PEN
Dosage form
LIQUID
Route
TOPICAL
Labeler
Jiangxi Yudexi Pharmaceutical Co., LTD
Application
M005
Marketing category
OTC MONOGRAPH DRUG
Marketing start
2026-05-20
Substance
TOLNAFTATE; UNDECYLENIC ACID
Active strength
1; 25 g/100mL; g/100mL
NDC exclude flag
No
Listing certified through
2027-12-31
Current FDA listing
Yes

Related Records

Related UNII Ingredients

UNIIPreferred termRegistry numberMatched term
06KB629TKVTOLNAFTATE2398-96-1TOLNAFTATE
K3D86KJ24NUNDECYLENIC ACID112-38-9UNDECYLENIC ACID

Packages

Package NDC11-digit formatDescriptionUnitsMarketing startSampleExclude flagStatus
85248-217-01852480217013 TUBE in 1 BOX (85248-217-01) / 5 mL in 1 TUBE3 tube2026-05-20NoNoHistorical
85248-217-02852480217022 TUBE in 1 BOX (85248-217-02) / 10 mL in 1 TUBE2 tube2026-05-20NoNoHistorical

Related DailyMed Labels

TitleManufacturerEffective dateTypeVersion
85248-217Jiangxi Yudexi Pharmaceutical Co., LTD2026-05-20HUMAN OTC DRUG LABEL1