FDA labels
Search the openFDA drug-label export by label identifier, NDC, application, RxCUI, UNII, product name, or manufacturer.
OpenFDA label data provides additional search and identifier links. DailyMed’s Structured Product Label is the canonical label on FDA.report.
Label matches#
| Label | Generic name | Manufacturer | SPL set ID | Effective date | Safety fields | Match |
|---|---|---|---|---|---|---|
| Fluorouracil | FLUOROURACIL | Sun Pharmaceutical Industries, Inc. | 1b2f6145-b338-42ed-88a7-f4da65c59164 | 2026-07-15 | Warnings, Adverse reactions | Name/manufacturer search |
| Fluorouracil | FLUOROURACIL | Fresenius Kabi USA, LLC | beb8c6c5-4b6e-4770-b6d4-718e33c7a2ff | 2026-07-15 | Boxed warning, Warnings, Adverse reactions | Name/manufacturer search |
| Fluorouracil | FLUOROURACIL | BluePoint Laboratories | c612b05f-f37d-47fa-9c1e-b2d876dd7093 | 2026-07-14 | Boxed warning, Warnings, Adverse reactions | Name/manufacturer search |
| Fluorouracil | FLUOROURACIL | BluePoint Laboratories | cdf07a8b-91ee-424f-8c04-34f53dfb82be | 2026-07-14 | Boxed warning, Warnings, Adverse reactions | Name/manufacturer search |
| Fluorouracil | FLUOROURACIL | Sun Pharmaceutical Industries, Inc. | acca0036-f19c-459b-9dfc-9592f1cd588d | 2026-07-14 | Warnings, Adverse reactions | Name/manufacturer search |
| Fluorouracil | FLUOROURACIL | NORTHSTAR RX LLC | 52ef5f41-2312-4b55-aa86-abd5bb28b9d3 | 2026-07-08 | Warnings, Adverse reactions | Name/manufacturer search |
| Fluorouracil | FLUOROURACIL | Fresenius Kabi USA, LLC | b4328ae3-f48f-40b1-9719-1c1aced7c734 | 2026-06-10 | Boxed warning, Warnings, Adverse reactions | Name/manufacturer search |
| Fluorouracil | FLUOROURACIL | Fresenius Kabi USA, LLC | a85ab26a-05ea-498f-8f34-564a925fa9d9 | 2026-06-09 | Boxed warning, Warnings, Adverse reactions | Name/manufacturer search |
| Fluorouracil | FLUOROURACIL | Fresenius Kabi USA, LLC | 21af1777-87f7-4e40-9917-f1677e7ff1a5 | 2026-06-08 | Boxed warning, Warnings, Adverse reactions | Name/manufacturer search |
| Fluorouracil | FLUOROURACIL | Meitheal Pharmaceuticals Inc. | de8a3fce-85a9-4a77-a3cd-e50179b93098 | 2026-04-08 | Boxed warning, Warnings, Adverse reactions | Name/manufacturer search |
| Fluorouracil | FLUOROURACIL | Meitheal Pharmaceuticals Inc. | a0cd6301-c6e0-4b62-8683-39c99913db24 | 2026-04-08 | Boxed warning, Warnings, Adverse reactions | Name/manufacturer search |
| Fluorouracil | FLUOROURACIL | Fresenius Kabi USA, LLC | c45f5286-a52b-43e5-8a6f-d0312e7da0c8 | 2026-03-19 | Boxed warning, Warnings, Adverse reactions | Name/manufacturer search |
| Fluorouracil | FLUOROURACIL | BluePoint Laboratories | 300304fa-4791-4455-962c-493ae467f504 | 2026-02-26 | Boxed warning, Warnings, Adverse reactions | Name/manufacturer search |
| Fluorouracil | FLUOROURACIL | BluePoint Laboratories | 9c42eeff-ab0c-4820-94d7-e1a3df9fda74 | 2026-02-26 | Boxed warning, Warnings, Adverse reactions | Name/manufacturer search |
| Fluorouracil | FLUOROURACIL | Xiromed LLC | 19735014-c6fb-0a05-c330-2e9389c71216 | 2026-02-19 | Warnings, Adverse reactions | Name/manufacturer search |
| Fluorouracil | FLUOROURACIL | Xiromed LLC | f4b0cae1-a2fc-2991-d663-3b729503cd1c | 2026-02-19 | Warnings, Adverse reactions | Name/manufacturer search |
| Fluorouracil | FLUOROURACIL | Accord Healthcare, Inc. | 8eff167f-203a-4a81-b2fc-d8773bc3555e | 2026-02-09 | Boxed warning, Warnings, Adverse reactions | Name/manufacturer search |
| Fluorouracil | FLUOROURACIL | Accord Healthcare, Inc. | 66d451fe-2436-494c-80c5-4528c8e34369 | 2026-02-09 | Boxed warning, Warnings, Adverse reactions | Name/manufacturer search |
| fluorouracil | FLUOROURACIL | Sagent Pharmaceuticals | 37e35e8c-5d51-413b-a3a0-b72a18caaf65 | 2026-02-09 | Boxed warning, Warnings, Adverse reactions | Name/manufacturer search |
| FLUOROURACIL | FLUOROURACIL | Eugia US LLC | 697816ce-dc05-4943-b7f0-2f0b125e93b7 | 2026-01-19 | Boxed warning, Warnings, Adverse reactions | Name/manufacturer search |
| FLUOROURACIL | FLUOROURACIL | Eugia US LLC | 199ef964-8a9b-403e-a2ae-759280b3d1d1 | 2026-01-19 | Boxed warning, Warnings, Adverse reactions | Name/manufacturer search |
| Fluorouracil | FLUOROURACIL | Alembic Pharmaceuticals Inc. | fdee9255-9447-4ae7-951d-b694802b5966 | 2025-11-12 | Boxed warning, Warnings, Adverse reactions | Name/manufacturer search |
| Fluorouracil | FLUOROURACIL | Alembic Pharmaceuticals Inc. | 6b34cbf2-66f9-48a4-b41f-deb84ba8e8c4 | 2025-11-12 | Boxed warning, Warnings, Adverse reactions | Name/manufacturer search |
| Fluorouracil | FLUOROURACIL | Gland Pharma Limited | 572b710e-8e2b-46eb-bd80-648ad769d34d | 2025-11-10 | Boxed warning, Warnings, Adverse reactions | Name/manufacturer search |
| Fluorouracil | FLUOROURACIL | Gland Pharma Limited | ea3497db-23b9-4ace-9a6f-b54853d04a82 | 2025-11-10 | Boxed warning, Warnings, Adverse reactions | Name/manufacturer search |
| Fluorouracil | FLUOROURACIL | ProPharma Distribution | 43057fcd-1f87-cc1a-e063-6294a90a8d24 | 2025-11-07 | Warnings, Adverse reactions | Name/manufacturer search |
| Fluorouracil | FLUOROURACIL | Encube Ethicals, Inc. | 2c631ce7-ea15-4b51-b5bc-4962e3c315cd | 2025-10-09 | Warnings, Adverse reactions | Name/manufacturer search |
| FLUOROURACIL | FLUOROURACIL | Encube Ethicals, Inc. | 30294dd2-40fb-420d-b838-376343308895 | 2025-09-09 | Warnings, Adverse reactions | Name/manufacturer search |
| FLUOROURACIL | FLUOROURACIL CREAM, 0.5% | Dr. Reddy's Laboratories Inc. | 37dcfb83-0e7d-d23d-9cd5-afa5bdc30628 | 2025-07-11 | Warnings, Adverse reactions | Name/manufacturer search |
| Fluorouracil | FLUOROURACIL | Fresenius Kabi USA, LLC | fdf2a165-2ca4-48be-89c1-570e6010b47c | 2025-06-11 | Warnings, Adverse reactions | Name/manufacturer search |
| Fluorouracil | FLUOROURACIL | Accord Healthcare Inc. | 667d4059-de90-4d3f-86c2-c2573def2ecb | 2024-10-04 | Warnings, Adverse reactions | Name/manufacturer search |
| FLUOROURACIL | FLUOROURACIL | Dr. Reddy's Labratories Inc. | e137c766-1f7f-0251-90b9-450c3d4d78b9 | 2024-04-01 | Warnings, Adverse reactions | Name/manufacturer search |
| Fluorouracil | FLUOROURACIL | Alembic Pharmaceuticals Limited | b6b0d9e2-c6f0-4523-a33b-b958d32d3a28 | 2023-11-16 | Warnings, Adverse reactions | Name/manufacturer search |
| Fluorouracil | FLUOROURACIL | Alembic Pharmaceuticals Limited | d10f12a2-7b38-4351-93df-1e8444d2a9e4 | 2023-05-10 | Warnings, Adverse reactions | Name/manufacturer search |
| FLUOROURACIL | FLUOROURACIL | Mayne Pharma Inc. | 06475bd8-66d9-4f88-90e4-b367480dab39 | 2021-11-04 | Warnings, Adverse reactions | Name/manufacturer search |
| Fluorouracil | FLUOROURACIL | Mylan Pharmaceuticals Inc. | 744737c5-0d96-4214-82ab-6cff016b1ea0 | 2021-06-30 | Warnings, Adverse reactions | Name/manufacturer search |
| FAVLYXA | FLUOROURACIL | Avyxa Pharma, LLC | 1daf714b-704c-4bcc-b6e0-6f0eb2bfe66b | 2026-07-23 | Boxed warning, Warnings, Adverse reactions | Name/manufacturer search |
| Efudex | FLUOROURACIL | Bausch Health US, LLC | 35de1c1c-bef5-46c5-b6f8-ea032147411c | 2025-04-23 | Name/manufacturer search | |
| TOLAK | FLUOROURACIL | HILL DERMACEUTICALS, INC. | 59de2709-00b8-4f0a-867c-f0dfeb947192 | 2022-09-06 | Warnings, Adverse reactions | Name/manufacturer search |