Home NDC 28105-421 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 Source provenance: Browse the complete Orange Book source catalog · source snapshot 42 .
Orange Book products# Current product rows page 1 of 1 · 1 matching rows.
Application-product, Trade name, Ingredient table Application-product Trade name Ingredient Strength Dosage form / route TE codes RLD / RS Approval date N022259-001 TOLAK FLUOROURACIL 4% CREAM / TOPICAL RLD, RS 2015-09-18
Observed Orange Book product history# Observed FDA ZIP history: Each table is queried independently by exact application/product key from successfully parsed Orange Book snapshots. Capture times identify archived source observations; absence or a change between snapshots is not inferred. FDA publication files that were not recoverable as structured ZIP data are not represented as states.
Product history page 1 of 2 · 42 observed states.
Captured, Edition, Application-product table Captured Edition Application-product Trade name Strength Dosage form / route Product TE source text RLD / RS Approval date Source SHA-256 2026-08-18 06:07:40 2026-07 N022259-001 TOLAK 4% CREAM / TOPICAL RLD, RS 2015-09-18 caaa826d4ba7…2026-02-19 14:30 UTC 2026-02 N022259-001 TOLAK 4% CREAM / TOPICAL RLD, RS 2015-09-18 011fe1cb6892…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 N022259-001 TOLAK 4% CREAM / TOPICAL RLD, RS 2015-09-18 31067a03dcf5…2025-08-23 18:47 UTC 2025-08 N022259-001 TOLAK 4% CREAM / TOPICAL RLD, RS 2015-09-18 6a471c1ec25d…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 N022259-001 TOLAK 4% CREAM / TOPICAL RLD, RS 2015-09-18 fd3edfee7708…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 N022259-001 TOLAK 4% CREAM / TOPICAL RLD, RS 2015-09-18 b8a1b40f171c…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 N022259-001 TOLAK 4% CREAM / TOPICAL RLD, RS 2015-09-18 03ed91905a0d…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 N022259-001 TOLAK 4% CREAM / TOPICAL RLD, RS 2015-09-18 2680178bc6a6…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 N022259-001 TOLAK 4% CREAM / TOPICAL RLD, RS 2015-09-18 5bbf6a4d5a75…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 N022259-001 TOLAK 4% CREAM / TOPICAL RLD, RS 2015-09-18 d8e5a09893c0…2024-10-29 15:01 UTC 2024-10 N022259-001 TOLAK 4% CREAM / TOPICAL RLD, RS 2015-09-18 d06236e962d9…2024-08-13 05:28 UTC · 3 captures of this ZIP 2024-08 N022259-001 TOLAK 4% CREAM / TOPICAL RLD, RS 2015-09-18 79d66fd596c7…2024-07-13 05:37 UTC · 2 captures of this ZIP 2024-07 N022259-001 TOLAK 4% CREAM / TOPICAL RLD, RS 2015-09-18 301d65b070ca…2024-06-18 03:08 UTC · 5 captures of this ZIP 2024-06 N022259-001 TOLAK 4% CREAM / TOPICAL RLD, RS 2015-09-18 1e350fbaab3a…2024-05-31 18:47 UTC 2024-05 N022259-001 TOLAK 4% CREAM / TOPICAL RLD, RS 2015-09-18 8072bd15b7f6…2022-06-29 02:47 UTC · 2 captures of this ZIP 2022-06 N022259-001 TOLAK 4% CREAM / TOPICAL RLD, RS 2015-09-18 5c6f7cd8ea54…2022-04-08 23:34 UTC 2022-04 N022259-001 TOLAK 4% CREAM / TOPICAL RLD, RS 2015-09-18 5d02ea3f76ae…2022-04-04 05:41 UTC 2022-04 N022259-001 TOLAK 4% CREAM / TOPICAL RLD, RS 2015-09-18 4b0b4de00fa7…2019-12-13 00:20 UTC 2019-12 N022259-001 TOLAK 4% CREAM / TOPICAL RLD, RS 2015-09-18 74a2ff9319b5…2022-03-09 01:35 UTC 2022-03 N022259-001 TOLAK 4% CREAM / TOPICAL RLD, RS 2015-09-18 bb7c543d1eb4…2021-12-28 21:50 UTC 2021-12 N022259-001 TOLAK 4% CREAM / TOPICAL RLD, RS 2015-09-18 782e0a99824c…2021-05-05 16:15 UTC · 3 captures of this ZIP 2021-05 N022259-001 TOLAK 4% CREAM / TOPICAL RLD, RS 2015-09-18 87673890dc5c…2021-03-12 10:30 UTC 2021-03 N022259-001 TOLAK 4% CREAM / TOPICAL RLD, RS 2015-09-18 5aa47cf7b7d7…2020-12-22 03:56 UTC 2020-12 N022259-001 TOLAK 4% CREAM / TOPICAL RLD, RS 2015-09-18 8869cabd3fbd…2020-11-12 02:37 UTC 2020-11 N022259-001 TOLAK 4% CREAM / TOPICAL RLD, RS 2015-09-18 c0c555d07b60…2019-12-14 00:12 UTC 2019-12 N022259-001 TOLAK 4% CREAM / TOPICAL RLD, RS 2015-09-18 3f01610625f2…2019-09-15 20:21 UTC 2019-09 N022259-001 TOLAK 4% CREAM / TOPICAL RLD, RS 2015-09-18 b00525d2431f…2019-07-19 19:46 UTC 2019-07 N022259-001 TOLAK 4% CREAM / TOPICAL RLD, RS 2015-09-18 ea99ee380514…2024-03-16 18:09 UTC · 4 captures of this ZIP 2024-03 N022259-001 TOLAK 4% CREAM / TOPICAL RLD, RS 2015-09-18 6a51e52b5d6a…2024-02-18 07:12 UTC 2024-02 N022259-001 TOLAK 4% CREAM / TOPICAL RLD, RS 2015-09-18 1c564ffb4f44…2023-12-20 04:57 UTC 2023-12 N022259-001 TOLAK 4% CREAM / TOPICAL RLD, RS 2015-09-18 ea1830bbd6c7…2023-11-28 05:40 UTC · 2 captures of this ZIP 2023-11 N022259-001 TOLAK 4% CREAM / TOPICAL RLD, RS 2015-09-18 a72a2bbeb626…2023-10-25 00:34 UTC · 2 captures of this ZIP 2023-10 N022259-001 TOLAK 4% CREAM / TOPICAL RLD, RS 2015-09-18 9b2671bbb829…2023-07-15 15:27 UTC · 2 captures of this ZIP 2023-07 N022259-001 TOLAK 4% CREAM / TOPICAL RLD, RS 2015-09-18 a67488948f0b…2023-06-13 01:57 UTC · 3 captures of this ZIP 2023-06 N022259-001 TOLAK 4% CREAM / TOPICAL RLD, RS 2015-09-18 3f0d92c62455…2023-05-13 08:27 UTC 2023-05 N022259-001 TOLAK 4% CREAM / TOPICAL RLD, RS 2015-09-18 053a50430f4f…2023-01-26 05:58 UTC 2023-01 N022259-001 TOLAK 4% CREAM / TOPICAL RLD, RS 2015-09-18 3bdfa0b2c4d7…2022-11-12 20:34 UTC · 5 captures of this ZIP 2022-11 N022259-001 TOLAK 4% CREAM / TOPICAL RLD, RS 2015-09-18 3a93d1ddd44b…2022-10-28 04:53 UTC 2022-10 N022259-001 TOLAK 4% CREAM / TOPICAL RLD, RS 2015-09-18 f41ea6bd6efb…2022-09-29 23:25 UTC 2022-09 N022259-001 TOLAK 4% CREAM / TOPICAL RLD, RS 2015-09-18 e64feba35796…
Observed Orange Book patent history# Captured, Edition, Application-product table Captured Edition Application-product Patent Expiration Use code Coverage / status Submission date Source SHA-256 2022-06-29 02:47 UTC · 2 captures of this ZIP 2022-06 N022259-001 7169401 2023-07-18 Drug product 2015-11-04 5c6f7cd8ea54…2022-04-08 23:34 UTC 2022-04 N022259-001 7169401 2023-07-18 Drug product 2015-11-04 5d02ea3f76ae…2022-04-04 05:41 UTC 2022-04 N022259-001 7169401 2023-07-18 Drug product 2015-11-04 4b0b4de00fa7…2019-12-13 00:20 UTC 2019-12 N022259-001 7169401 2023-07-18 Drug product 2015-11-04 74a2ff9319b5…2022-03-09 01:35 UTC 2022-03 N022259-001 7169401 2023-07-18 Drug product 2015-11-04 bb7c543d1eb4…2021-12-28 21:50 UTC 2021-12 N022259-001 7169401 2023-07-18 Drug product 2015-11-04 782e0a99824c…2021-05-05 16:15 UTC · 3 captures of this ZIP 2021-05 N022259-001 7169401 2023-07-18 Drug product 2015-11-04 87673890dc5c…2021-03-12 10:30 UTC 2021-03 N022259-001 7169401 2023-07-18 Drug product 2015-11-04 5aa47cf7b7d7…2020-12-22 03:56 UTC 2020-12 N022259-001 7169401 2023-07-18 Drug product 2015-11-04 8869cabd3fbd…2020-11-12 02:37 UTC 2020-11 N022259-001 7169401 2023-07-18 Drug product 2015-11-04 c0c555d07b60…2019-12-14 00:12 UTC 2019-12 N022259-001 7169401 2023-07-18 Drug product 2015-11-04 3f01610625f2…2019-09-15 20:21 UTC 2019-09 N022259-001 7169401 2023-07-18 Drug product 2015-11-04 b00525d2431f…2019-07-19 19:46 UTC 2019-07 N022259-001 7169401 2023-07-18 Drug product 2015-11-04 ea99ee380514…2023-12-20 04:57 UTC 2023-12 N022259-001 7169401 2023-07-18 Drug product 2015-11-04 ea1830bbd6c7…2023-11-28 05:40 UTC · 2 captures of this ZIP 2023-11 N022259-001 7169401 2023-07-18 Drug product 2015-11-04 a72a2bbeb626…2023-10-25 00:34 UTC · 2 captures of this ZIP 2023-10 N022259-001 7169401 2023-07-18 Drug product 2015-11-04 9b2671bbb829…2023-07-15 15:27 UTC · 2 captures of this ZIP 2023-07 N022259-001 7169401 2023-07-18 Drug product 2015-11-04 a67488948f0b…2023-06-13 01:57 UTC · 3 captures of this ZIP 2023-06 N022259-001 7169401 2023-07-18 Drug product 2015-11-04 3f0d92c62455…2023-05-13 08:27 UTC 2023-05 N022259-001 7169401 2023-07-18 Drug product 2015-11-04 053a50430f4f…2023-01-26 05:58 UTC 2023-01 N022259-001 7169401 2023-07-18 Drug product 2015-11-04 3bdfa0b2c4d7…2022-11-12 20:34 UTC · 5 captures of this ZIP 2022-11 N022259-001 7169401 2023-07-18 Drug product 2015-11-04 3a93d1ddd44b…2022-10-28 04:53 UTC 2022-10 N022259-001 7169401 2023-07-18 Drug product 2015-11-04 f41ea6bd6efb…2022-09-29 23:25 UTC 2022-09 N022259-001 7169401 2023-07-18 Drug product 2015-11-04 e64feba35796…2022-07-09 03:26 UTC · 3 captures of this ZIP 2022-07 N022259-001 7169401 2023-07-18 Drug product 2015-11-04 cb3db0bc1861…
Additional Listing Data#
Finished product Yes
Brand name base TOLAK
Listing expiration 2026-12-31 Active Ingredients# Ingredient, Strength table Ingredient Strength FLUOROURACIL .04 g/g
Harmonized UNII identifiers# UNII identifiers page 1 of 1 · 1 matching rows.
Identifier, FDA.report destination table Identifier FDA.report destination U3P01618RT Internal UNII lookup
Harmonized RxCUI identifiers# RxCUI identifiers page 1 of 1 · 2 matching rows.
Identifier, FDA.report destination table Identifier FDA.report destination 1669868 Internal RxNorm lookup 1669873 Internal RxNorm lookup
Harmonized SPL set identifiers# SPL set identifiers page 1 of 1 · 1 matching rows.
DailyMed Product Concepts# DailyMed Package Descriptions# Package NDC, Product, Description table Package NDC Product Description Form Quantity Strength SPL version 28105-421-40 TOLAK 40 g in 1 TUBE CREAM 40 6 28105-421-40 TOLAK 1 in 1 CARTON CREAM 1 6
DailyMed Socrata Ingredients# Ingredient, Type, UNII table Ingredient Type UNII DailyMed label SPL version Uploaded FLUOROURACIL ACTIVE INGREDIENT U3P01618RT TOLAK (FLUOROURACIL) CREAM [HILL DERMACEUTICALS, INC.] 2 FLUOROURACIL ACTIVE MOIETY U3P01618RT TOLAK (FLUOROURACIL) CREAM [HILL DERMACEUTICALS, INC.] 2 Anhydrous Citric Acid INACTIVE INGREDIENT XF417D3PSL TOLAK (FLUOROURACIL) CREAM [HILL DERMACEUTICALS, INC.] 2 Butylated Hydroxytoluene INACTIVE INGREDIENT 1P9D0Z171K TOLAK (FLUOROURACIL) CREAM [HILL DERMACEUTICALS, INC.] 2 Cetyl Alcohol INACTIVE INGREDIENT 936JST6JCN TOLAK (FLUOROURACIL) CREAM [HILL DERMACEUTICALS, INC.] 2 Glycerin INACTIVE INGREDIENT PDC6A3C0OX TOLAK (FLUOROURACIL) CREAM [HILL DERMACEUTICALS, INC.] 2 Glyceryl Monostearate INACTIVE INGREDIENT 230OU9XXE4 TOLAK (FLUOROURACIL) CREAM [HILL DERMACEUTICALS, INC.] 2 Isopropyl Myristate INACTIVE INGREDIENT 0RE8K4LNJS TOLAK (FLUOROURACIL) CREAM [HILL DERMACEUTICALS, INC.] 2 Methyl Gluceth-10 INACTIVE INGREDIENT N0MWT4C7WH TOLAK (FLUOROURACIL) CREAM [HILL DERMACEUTICALS, INC.] 2 Methylparaben INACTIVE INGREDIENT A2I8C7HI9T TOLAK (FLUOROURACIL) CREAM [HILL DERMACEUTICALS, INC.] 2 Peanut Oil INACTIVE INGREDIENT 5TL50QU0W4 TOLAK (FLUOROURACIL) CREAM [HILL DERMACEUTICALS, INC.] 2 Polyethylene Glycol 4500 INACTIVE INGREDIENT TVH7653921 TOLAK (FLUOROURACIL) CREAM [HILL DERMACEUTICALS, INC.] 2 Propylparaben INACTIVE INGREDIENT Z8IX2SC1OH TOLAK (FLUOROURACIL) CREAM [HILL DERMACEUTICALS, INC.] 2 Sodium Hydroxide INACTIVE INGREDIENT 55X04QC32I TOLAK (FLUOROURACIL) CREAM [HILL DERMACEUTICALS, INC.] 2 Stearic acid INACTIVE INGREDIENT 4ELV7Z65AP TOLAK (FLUOROURACIL) CREAM [HILL DERMACEUTICALS, INC.] 2 Stearyl Alcohol INACTIVE INGREDIENT 2KR89I4H1Y TOLAK (FLUOROURACIL) CREAM [HILL DERMACEUTICALS, INC.] 2 Water INACTIVE INGREDIENT 059QF0KO0R TOLAK (FLUOROURACIL) CREAM [HILL DERMACEUTICALS, INC.] 2
DailyMed Dashboard NDC Coverage# NDC, Dashboard title, SPL version table NDC Dashboard title SPL version Validation Dashboard ZIP 28105-421 TOLAK (FLUOROURACIL) CREAM [HILL DERMACEUTICALS, INC.] 6 Current NDC, Legacy NDC, 2 package rows 20220928_59de2709-00b8-4f0a-867c-f0dfeb947192.zip
openFDA label cross-check# OpenFDA label data provides additional search and identifier links. DailyMed’s Structured Product Label is the canonical label on FDA.report. Matching records are deduplicated before they are shown below.
Matched openFDA labels page 1 of 1 · 1 matching rows.
Brand, Generic, Manufacturer table Brand Generic Manufacturer SPL set ID Effective date Available safety fields Join TOLAK FLUOROURACIL HILL DERMACEUTICALS, INC. 59de2709-00b8-4f0a-867c-f0dfeb947192 2022-09-06 Warnings, Adverse reactions Exact identifier application applno (NDA): 022259 application number: NDA022259 ndc (product): 28105-421
DailyMed RxNorm Mappings# Packages# Package NDC, 11-digit format, Description table Package NDC 11-digit format Description Units Marketing start Marketing end Sample Exclude flag Status 28105-421-40 28105042140 1 TUBE in 1 CARTON (28105-421-40) / 40 g in 1 TUBE 1 tube 2015-09-18 0000-00-00 No No Current