OMZOK ANTIFUNGAL PEN

Product NDC
83804-007
11-digit product format
838040007
Labeler code
83804
Product ID
83804-007_38edf699-93b0-e550-e063-6294a90a368c
Type
HUMAN OTC DRUG
Nonproprietary name
UNDECYLENIC ACID 25%
Dosage form
LIQUID
Route
TOPICAL
Labeler
Shenzhen Shandian Jingling Technology Co., Ltd.
Application
M005
Marketing category
OTC MONOGRAPH DRUG
Marketing start
2025-08-04
Substance
UNDECYLENIC ACID
Active strength
25 g/100mL
NDC exclude flag
No
Listing certified through
2026-12-31
Current FDA listing
Yes

Additional Listing Data#

Finished product
Yes
Brand name base
OMZOK ANTIFUNGAL PEN
Listing expiration
2026-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
UNDECYLENIC ACID25 g/100mL

Harmonized Identifiers#

Field, Values table
FieldValues
UniiK3D86KJ24N
Rxcui998329

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
83804-007-01OMZOK ANTIFUNGAL PEN3 mL in 1 APPLICATORLIQUID31
83804-007-01OMZOK ANTIFUNGAL PEN5 in 1 CARTONLIQUID51

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
998329undecylenic acid 25 % Topical SolutionPSN38edf699-93af-e550-e063-6294a90a368c1
998329undecylenic acid 250 MG/ML Topical SolutionSCD38edf699-93af-e550-e063-6294a90a368c1
998329undecylenic acid 25 % Topical SolutionSY38edf699-93af-e550-e063-6294a90a368c1

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startSampleExclude flagStatus
83804-007-01838040007015 APPLICATOR in 1 CARTON (83804-007-01) / 3 mL in 1 APPLICATOR5 applicator2025-08-04NoNoCurrent