Derman antifungal cream

Product NDC
81929-004
11-digit product format
819290004
Labeler code
81929
Product ID
81929-004_3bc695a0-b9ba-240a-e063-6394a90a15a9
Type
HUMAN OTC DRUG
Nonproprietary name
TOLNAFTATE
Dosage form
CREAM
Route
TOPICAL
Labeler
Taisho Pharmaceutical California Inc.
Application
M005
Marketing category
OTC MONOGRAPH DRUG
Marketing start
2022-07-01
Marketing end
2027-10-28
Substance
TOLNAFTATE
Active strength
10 mg/g
NDC exclude flag
No
Current FDA listing
Yes

Additional Listing Data#

Finished product
Yes
Brand name base
Derman antifungal cream

Active Ingredients#

Ingredient, Strength table
IngredientStrength
TOLNAFTATE10 mg/g

Harmonized Identifiers#

Field, Values table
FieldValues
Unii06KB629TKV
Rxcui103951

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
81929-004-01Derman antifungal cream1 in 1 CARTONCREAM14
81929-004-01Derman antifungal cream50 g in 1 TUBECREAM504
81929-004-02Derman antifungal cream25 g in 1 TUBECREAM254
81929-004-02Derman antifungal cream1 in 1 CARTONCREAM14

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
81929-004DERMAN ANTIFUNGAL CREAM (TOLNAFTATE) CREAM [TAISHO PHARMACEUTICAL CALIFORNIA INC.]3Current NDC, Legacy NDC, 4 package rows20231111_15d9b3c9-01af-4083-a1bc-014505d8798d.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
103951tolnaftate 1 % Topical CreamPSN15d9b3c9-01af-4083-a1bc-014505d8798d4
103951tolnaftate 10 MG/ML Topical CreamSCD15d9b3c9-01af-4083-a1bc-014505d8798d4
103951tolnaftate 1 % Topical CreamSY15d9b3c9-01af-4083-a1bc-014505d8798d4

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
81929-004-01819290004011 TUBE in 1 CARTON (81929-004-01) / 50 g in 1 TUBE1 tube2022-07-012027-05-24NoNoCurrent
81929-004-02819290004021 TUBE in 1 CARTON (81929-004-02) / 25 g in 1 TUBE1 tube2022-07-012027-10-28NoNoCurrent