FDA.reportPublic FDA data

TOLAK

Product NDC
28105-421
11-digit product format
281050421
Labeler code
28105
Product ID
28105-421_db3a1489-fcb1-4442-b309-4eb8ad9b9f46
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
FLUOROURACIL
Dosage form
CREAM
Route
TOPICAL
Labeler
HILL DERMACEUTICALS, INC.
Application
NDA022259
Marketing category
NDA
Marketing start
2015-09-18
Substance
FLUOROURACIL
Active strength
.04 g/g
Pharmacologic classes
Nucleic Acid Synthesis Inhibitors [MoA], Nucleoside Metabolic Inhibitor [EPC]
NDC exclude flag
No
Listing certified through
2026-12-31
Current FDA listing
Yes

Additional Listing Data#

Finished product
Yes
Brand name base
TOLAK
Listing expiration
2026-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
FLUOROURACIL.04 g/g

Harmonized Identifiers#

Field, Values table
FieldValues
UniiU3P01618RT
Rxcui1669868, 1669873

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
7dc9482d-9b87-4471-9708-4f1b4585846bProduct name220250723
a2ca0bf8-8306-49cc-93a3-3e6e4137c7cbProduct name520250630
dc0d2364-4811-4665-a3ee-7ed8c7301465Product name220171219
62fb8671-1693-49d8-8aab-0c1bfdd6794eProduct name120151005
878ca466-81fd-9d24-1349-31baf36065c6Product name220150506
630d1bc2-ae6b-fd31-1264-c4733e788193Product name120140508

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
28105-421-40TOLAK40 g in 1 TUBECREAM406
28105-421-40TOLAK1 in 1 CARTONCREAM16

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
28105-421-40GM - Gram28105-421a526fc93-dc05-4ff7-bcef-bfc2b380452e12015-11-12

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
FLUOROURACILACTIVE INGREDIENTU3P01618RTTOLAK (FLUOROURACIL) CREAM [HILL DERMACEUTICALS, INC.]2
FLUOROURACILACTIVE MOIETYU3P01618RTTOLAK (FLUOROURACIL) CREAM [HILL DERMACEUTICALS, INC.]2
Anhydrous Citric AcidINACTIVE INGREDIENTXF417D3PSLTOLAK (FLUOROURACIL) CREAM [HILL DERMACEUTICALS, INC.]2
Butylated HydroxytolueneINACTIVE INGREDIENT1P9D0Z171KTOLAK (FLUOROURACIL) CREAM [HILL DERMACEUTICALS, INC.]2
Cetyl AlcoholINACTIVE INGREDIENT936JST6JCNTOLAK (FLUOROURACIL) CREAM [HILL DERMACEUTICALS, INC.]2
GlycerinINACTIVE INGREDIENTPDC6A3C0OXTOLAK (FLUOROURACIL) CREAM [HILL DERMACEUTICALS, INC.]2
Glyceryl MonostearateINACTIVE INGREDIENT230OU9XXE4TOLAK (FLUOROURACIL) CREAM [HILL DERMACEUTICALS, INC.]2
Isopropyl MyristateINACTIVE INGREDIENT0RE8K4LNJSTOLAK (FLUOROURACIL) CREAM [HILL DERMACEUTICALS, INC.]2
Methyl Gluceth-10INACTIVE INGREDIENTN0MWT4C7WHTOLAK (FLUOROURACIL) CREAM [HILL DERMACEUTICALS, INC.]2
MethylparabenINACTIVE INGREDIENTA2I8C7HI9TTOLAK (FLUOROURACIL) CREAM [HILL DERMACEUTICALS, INC.]2
Peanut OilINACTIVE INGREDIENT5TL50QU0W4TOLAK (FLUOROURACIL) CREAM [HILL DERMACEUTICALS, INC.]2
Polyethylene Glycol 4500INACTIVE INGREDIENTTVH7653921TOLAK (FLUOROURACIL) CREAM [HILL DERMACEUTICALS, INC.]2
PropylparabenINACTIVE INGREDIENTZ8IX2SC1OHTOLAK (FLUOROURACIL) CREAM [HILL DERMACEUTICALS, INC.]2
Sodium HydroxideINACTIVE INGREDIENT55X04QC32ITOLAK (FLUOROURACIL) CREAM [HILL DERMACEUTICALS, INC.]2
Stearic acidINACTIVE INGREDIENT4ELV7Z65APTOLAK (FLUOROURACIL) CREAM [HILL DERMACEUTICALS, INC.]2
Stearyl AlcoholINACTIVE INGREDIENT2KR89I4H1YTOLAK (FLUOROURACIL) CREAM [HILL DERMACEUTICALS, INC.]2
WaterINACTIVE INGREDIENT059QF0KO0RTOLAK (FLUOROURACIL) CREAM [HILL DERMACEUTICALS, INC.]2

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
28105-421TOLAK (FLUOROURACIL) CREAM [HILL DERMACEUTICALS, INC.]6Current NDC, Legacy NDC, 2 package rows20220928_59de2709-00b8-4f0a-867c-f0dfeb947192.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
1669868fluorouracil 4 % Topical CreamPSN59de2709-00b8-4f0a-867c-f0dfeb9471926
1669873Tolak 4 % Topical CreamPSN59de2709-00b8-4f0a-867c-f0dfeb9471926
1669873fluorouracil 40 MG/ML Topical Cream [Tolak]SBD59de2709-00b8-4f0a-867c-f0dfeb9471926
1669868fluorouracil 40 MG/ML Topical CreamSCD59de2709-00b8-4f0a-867c-f0dfeb9471926
16698685-5-fluorouracil 40 MG/ML Topical CreamSY59de2709-00b8-4f0a-867c-f0dfeb9471926
16698735-5-fluorouracil 40 MG/ML Topical Cream [Tolak]SY59de2709-00b8-4f0a-867c-f0dfeb9471926
16698685-FU 40 MG/ML Topical CreamSY59de2709-00b8-4f0a-867c-f0dfeb9471926
16698735-FU 40 MG/ML Topical Cream [Tolak]SY59de2709-00b8-4f0a-867c-f0dfeb9471926
1669868fluorouracil 4 % Topical CreamSY59de2709-00b8-4f0a-867c-f0dfeb9471926
1669873Tolak 4 % Topical CreamSY59de2709-00b8-4f0a-867c-f0dfeb9471926
1669873Tolak 40 MG/ML Topical CreamSY59de2709-00b8-4f0a-867c-f0dfeb9471926

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
28105-421-40281050421401 TUBE in 1 CARTON (28105-421-40) / 40 g in 1 TUBE1 tube2015-09-180000-00-00NoNoCurrent