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 |
|---|---|---|---|---|---|---|
| Methadone Hydrochloride | METHADONE HYDROCHLORIDE | SpecGx LLC | 14f7b1d8-344a-4eaa-a1bf-bc1a00c3ab58 | 2026-07-29 | Boxed warning, Warnings, Adverse reactions | Name/manufacturer search |
| Morphine Sulfate | MORPHINE SULFATE | SpecGx LLC | 242c2512-1d49-486b-a9c3-6905f667799e | 2026-07-28 | Boxed warning, Warnings, Adverse reactions | Name/manufacturer search |
| OXYCODONE AND ACETAMINOPHEN | OXYCODONE HYDROCHLORIDE AND ACETAMINOPHEN | SpecGx LLC | f2137f1a-b49a-40bd-97ac-cd6b36e295f4 | 2026-07-27 | Boxed warning, Warnings, Adverse reactions | Name/manufacturer search |
| Lubiprostone | LUBIPROSTONE | SpecGx LLC | cdf79a5a-6857-4a32-8c54-8c435d1a7535 | 2026-07-10 | Warnings, Adverse reactions | Name/manufacturer search |
| Amitiza | LUBIPROSTONE | SpecGx LLC | 164a2b47-0a52-4bb4-9e71-5342c2e951f4 | 2026-07-10 | Warnings, Adverse reactions | Name/manufacturer search |
| Hydromorphone Hydrochloride | HYDROMORPHONE HYDROCHLORIDE | SpecGx LLC | 4c5c1cc8-c42b-46e3-ad68-8e22f57101f2 | 2026-07-02 | Boxed warning, Warnings, Adverse reactions | Name/manufacturer search |
| ACETAMINOPHEN AND CODEINE PHOSPHATE | ACETAMINOPHEN AND CODEINE PHOSPHATE | SpecGx LLC | eadc80fa-13c3-471a-a22f-6fe7e1ab290f | 2026-06-12 | Boxed warning, Warnings, Adverse reactions | Name/manufacturer search |
| Buprenorphine Hydrochloride and Naloxone Hydrochloride Dihydrate | BUPRENORPHINE HYDROCHLORIDE AND NALOXONE HYDROCHLORIDE DIHYDRATE | SpecGx LLC | 62abde41-46cb-4e90-a798-23d6531bf9aa | 2026-06-10 | Warnings, Adverse reactions | Name/manufacturer search |
| RESTORIL | TEMAZEPAM | SpecGx LLC | bc56f7fd-1aaf-48ff-8aa7-d467e59e1015 | 2026-06-09 | Boxed warning, Warnings, Adverse reactions | Name/manufacturer search |
| TEMAZEPAM | TEMAZEPAM | SpecGx LLC | c9bc61b4-a579-4003-98da-b6f6e381c150 | 2026-06-04 | Boxed warning, Warnings, Adverse reactions | Name/manufacturer search |
| FENTANYL TRANSDERMAL | FENTANYL TRANSDERMAL | SpecGx LLC | e15a7e9b-8025-49dd-9a6d-bafcccf1959f | 2026-04-30 | Boxed warning, Warnings, Adverse reactions | Name/manufacturer search |
| Hydrocodone Bitartrate and Acetaminophen | HYDROCODONE BITARTRATE AND ACETAMINOPHEN | SpecGx LLC | d621b526-4d9a-48a9-9a3e-d29d6aea2f31 | 2026-04-30 | Boxed warning, Warnings, Adverse reactions | Name/manufacturer search |
| METHADONE HYDROCHLORIDE | METHADONE HYDROCHLORIDE | SpecGx LLC | 5baef1bf-8bf0-429c-a4ce-1c93171f3f15 | 2026-04-28 | Boxed warning, Warnings, Adverse reactions | Name/manufacturer search |
| Levorphanol Tartrate | LEVORPHANOL TARTRATE | SpecGx LLC | 759c7040-0be0-4d17-be97-e467e423eaa8 | 2026-04-28 | Boxed warning, Warnings, Adverse reactions | Name/manufacturer search |
| METHADONE HYDROCHLORIDE | METHADONE HYDROCHLORIDE | SpecGx LLC | eddf7077-02fb-4771-9823-31984f4ff2bb | 2026-04-27 | Boxed warning, Warnings, Adverse reactions | Name/manufacturer search |
| METHADOSE | METHADONE HYDROCHLORIDE | SpecGx LLC | 808a9d0b-720b-4034-a862-5122ff514608 | 2026-04-27 | Boxed warning, Warnings, Adverse reactions | Name/manufacturer search |
| Roxicodone | OXYCODONE HYDROCHLORIDE | SpecGx LLC | 5a8157d3-ba20-4abf-b0d4-6ad141b31d63 | 2026-04-24 | Boxed warning, Warnings, Adverse reactions | Name/manufacturer search |
| HYDROCODONE BITARTRATE AND ACETAMINOPHEN | HYDROCODONE BITARTRATE AND ACETAMINOPHEN | SpecGx LLC | 73c1059b-0c7d-42ef-9827-f018858fc447 | 2026-04-20 | Boxed warning, Warnings, Adverse reactions | Name/manufacturer search |
| Prucalopride | PRUCALOPRIDE | SpecGx LLC | 70fced73-c25b-46cb-ad30-19328e6130c3 | 2026-01-23 | Warnings, Adverse reactions | Name/manufacturer search |
| Buprenorphine HCl | BUPRENORPHINE HCL | SpecGx LLC | b60d514d-a88a-4fa2-a5b0-30ac29e04973 | 2025-12-11 | Warnings, Adverse reactions | Name/manufacturer search |
| Dextroamphetamine Sulfate Extended-Release | DEXTROAMPHETAMINE SULFATE | SpecGx LLC | 69c40af8-3710-46bf-bd3d-137fe5eea23e | 2025-12-08 | Boxed warning, Warnings, Adverse reactions | Name/manufacturer search |
| Lisdexamfetamine Dimesylate | LISDEXAMFETAMINE DIMESYLATE | SpecGx LLC | 806a1c15-0842-4787-b2ad-09a21fd96b37 | 2025-12-08 | Boxed warning, Warnings, Adverse reactions | Name/manufacturer search |
| Methylphenidate Hydrochloride Extended-Release | METHYLPHENIDATE HYDROCHLORIDE | SpecGx LLC | 9e11e093-4ff3-4bed-8fe9-3ee460b47303 | 2025-12-01 | Boxed warning, Warnings, Adverse reactions | Name/manufacturer search |
| Dextroamphetamine Saccharate and Amphetamine Aspartate and Dextroamphetamine Sulfate and Amphetamine Sulfate | DEXTROAMPHETAMINE SACCHARATE AND AMPHETAMINE ASPARTATE AND DEXTROAMPHETAMINE SULFATE AND AMPHETAMINE SULFATE | SpecGx LLC | 72ddd1c9-ddbd-4c95-acd9-003189a353a3 | 2025-11-25 | Boxed warning, Warnings, Adverse reactions | Name/manufacturer search |
| Mixed Salts of a Single Entity Amphetamine Product XR | DEXTROAMPHETAMINE SACCHARATE, AMPHETAMINE ASPARTATE MONOHYDRATE, DEXTROAMPHETAMINE SULFATE, AMPHETAMINE SULFATE | SpecGx LLC | 60a2834c-38a2-480e-b89c-563e9cf0c9c3 | 2025-11-25 | Boxed warning, Warnings, Adverse reactions | Name/manufacturer search |
| Lisdexamfetamine Dimesylate | LISDEXAMFETAMINE DIMESYLATE | SpecGx LLC | 3a79b2ab-4131-4978-99a0-0119df57d5fe | 2025-11-24 | Boxed warning, Warnings, Adverse reactions | Name/manufacturer search |
| Methylphenidate Hydrochloride | METHYLPHENIDATE HYDROCHLORIDE | SpecGx LLC | ed004cf0-eb23-43d2-96dc-20c4ad63824f | 2025-10-08 | Boxed warning, Warnings, Adverse reactions | Name/manufacturer search |
| Oxycodone Hydrochloride | OXYCODONE HYDROCHLORIDE | SpecGx LLC | 5451bcaa-0aca-4581-bcea-2f9c2a33b260 | 2025-07-25 | Boxed warning, Warnings, Adverse reactions | Name/manufacturer search |
| DEXTROAMPHETAMINE SULFATE | DEXTROAMPHETAMINE SULFATE | SpecGx LLC | e05cf690-d45a-4696-a1bf-40c9350cc084 | 2025-07-07 | Boxed warning, Warnings, Adverse reactions | Name/manufacturer search |
| POSACONAZOLE | POSACONAZOLE | SpecGx LLC | 8412398b-c696-4f12-ba3a-da74dc8dadaf | 2025-01-15 | Warnings, Adverse reactions | Name/manufacturer search |
| PAMELOR | NORTRIPTYLINE HYDROCHLORIDE | SpecGx LLC | e17dc299-f52d-414d-ab6e-e809bd6f8acb | 2024-12-04 | Boxed warning, Warnings, Adverse reactions | Name/manufacturer search |
| ANAFRANIL | CLOMIPRAMINE HYDROCHLORIDE | SpecGx LLC | 4074b555-7635-41a9-809d-fae3b3610059 | 2024-11-26 | Boxed warning, Warnings, Adverse reactions | Name/manufacturer search |
| CLOMIPRAMINE HYDROCHLORIDE | CLOMIPRAMINE HYDROCHLORIDE | SpecGx LLC | d7cee3fa-d05c-4702-8f75-f446627bdb49 | 2024-11-26 | Boxed warning, Warnings, Adverse reactions | Name/manufacturer search |
| Methylphenidate Hydrochloride Extended-Release | METHYLPHENIDATE HYDROCHLORIDE | SpecGx LLC | b1b0f2ff-d9df-42ab-b471-226ecf97e075 | 2024-09-01 | Boxed warning, Warnings, Adverse reactions | Name/manufacturer search |
| Morphine Sulfate | MORPHINE SULFATE | SpecGx LLC | 8b69f67f-30b3-4982-953e-5a4b87ec6ac6 | 2024-04-02 | Boxed warning, Warnings, Adverse reactions | Name/manufacturer search |
| OXYCODONE HYDROCHLORIDE | OXYCODONE HYDROCHLORIDE | SpecGx LLC | 928227bf-89c5-4c64-9823-0e84cc669388 | 2024-01-01 | Boxed warning, Warnings, Adverse reactions | Name/manufacturer search |
| NALTREXONE HYDROCHLORIDE | NALTREXONE HYDROCHLORIDE | SpecGx LLC | 06ff2d5a-e62b-4fa4-bbdb-01938535bc65 | 2023-12-07 | Warnings, Adverse reactions | Name/manufacturer search |
| MORPHINE SULFATE | MORPHINE SULFATE | SpecGx LLC | 533034fd-c8e7-495b-8874-0db41bd1e65a | 2023-12-01 | Boxed warning, Warnings, Adverse reactions | Name/manufacturer search |
| METHADOSE DISPERSIBLE | METHADONE HYDROCHLORIDE | SpecGx LLC | 544483e6-6f9d-4371-9e93-313e54e0ea05 | 2023-12-01 | Boxed warning, Warnings, Adverse reactions | Name/manufacturer search |
| Mixed Salts of a Single-Entity Amphetamine Product | DEXTROAMPHETAMINE SACCHARATE, AMPHETAMINE ASPARTATE MONOHYDRATE, DEXTROAMPHETAMINE SULFATE, AMPHETAMINE SULFATE | SpecGx LLC | e1b21fd4-8d0b-4e54-a35d-8ad84a7caa78 | 2023-10-01 | Boxed warning, Warnings, Adverse reactions | Name/manufacturer search |