NDC 00591-0385 - HYDROCODONE BITARTRATE AND ACETAMINOPHEN
This NDC is not currently matched to an FDA NDC product listing in FDA.report, but it is a valid NDC-form code. FDA.report is showing the available DailyMed label context for the product root.
- Product NDC
- 00591-0385
- Manufacturer
- Keltman Pharmaceuticals Inc.
- Effective date
- 2010-12-10
- Current FDA listing
- Not matched in FDA.report NDC product tables
DailyMed Labels#
| Label | Manufacturer | Effective date | Type |
|---|---|---|---|
| hydrocodone bitartrate and acetaminophen tablet | Keltman Pharmaceuticals Inc. | 2010-12-10 | HUMAN PRESCRIPTION DRUG LABEL |
DailyMed Socrata Ingredients#
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.
| Brand | Generic | Manufacturer | SPL set ID | Effective date | Available safety fields | Join |
|---|---|---|---|---|---|---|
| Acetaminophen | ACETAMINOPHEN | Solupharm Pharmazeutische Erzeugnisse GmbH | adeebc6c-c82f-40dc-b813-1b02244984ce | 2023-02-13 | Warnings, Adverse reactions | 362O9ITL9D |
| Butalbital, Acetaminophen and Caffeine | BUTALBITAL, ACETAMINOPHEN AND CAFFEINE | Granules Pharmaceuticals Inc. | 74e27dab-9790-47e4-b4f1-3b9df4bce184 | 2023-01-27 | Boxed warning, Warnings, Adverse reactions | 362O9ITL9D |
| Nightime | ACETAMINOPHEN DEXTROMETHORPHAN HBR DOXYLAMINE SUCCINATE | H-E-B | db44560b-da02-74c9-e053-2a95a90af0b6 | 2023-01-13 | Warnings | 362O9ITL9D |
| Migraine Relief | ACETAMINOPHEN, ASPIRIN AND CAFFEINE | FSA STORE INC. | ec6b7017-cf12-09a7-e053-2995a90a2db9 | 2023-01-12 | Warnings | 362O9ITL9D |
| DAYTIME COLD AND FLU Maximum Strength | ACETAMINOPHEN, DEXTROMETHORPHAN HBR,GUAIFENESIN, PHENYLEPHRINE HCL | Walgreens | dbf5656b-9105-871b-e053-2995a90a4941 | 2023-01-03 | Warnings | 362O9ITL9D |
| Pain Relief 8 HR | ACETAMINOPHEN | H E B | b5c7e93b-e626-49c3-a7d4-773475f945ae | 2022-11-12 | Warnings | 362O9ITL9D |
| Oxycodone and Acetaminophen | OXYCODONE AND ACETAMINOPHEN | Proficient Rx LP | 78933d4a-d78a-43bc-9052-a032901ee050 | 2022-11-01 | Boxed warning, Warnings, Adverse reactions | 362O9ITL9D |
| Oxycodone and Acetaminophen | OXYCODONE AND ACETAMINOPHEN | Proficient Rx LP | 5df7c033-0f31-45bc-8c34-3da45635e66d | 2022-11-01 | Boxed warning, Warnings, Adverse reactions | 362O9ITL9D |
| arthritis pain relief | ACETAMINOPHEN | Meijer Distribution Inc | c388f3a5-03bb-4fed-b81a-bb876bc260f0 | 2022-10-27 | Warnings | 362O9ITL9D |
| Pain Relief | ACETAMINOPHEN | Meijer Distribution Inc | bfe37210-b322-4edb-8ff2-aff9b3e66be0 | 2022-10-27 | Warnings | 362O9ITL9D |
| Equate 8HR Arthritis Pain Relief | ACETAMINOPHEN | Wal-Mart Stores Inc | ca7f0f68-2862-4265-bf4a-3a89994b4d6b | 2022-10-13 | Warnings | 362O9ITL9D |
| Arthritis Pain Relief | ACETAMINOPHEN | TOPCO ASSOCIATES LLC | e60aa992-f5f7-3506-e053-2995a90a7abd | 2022-10-04 | Warnings | 362O9ITL9D |
| Hydrocodone Bitartrate and Acetaminophen | HYDROCODONE BITARTRATE AND ACETAMINOPHEN | Proficient Rx LP | e6711f26-a01d-43e8-882a-d58561e4b67f | 2022-10-01 | Boxed warning, Warnings, Adverse reactions | NO70W886KK 362O9ITL9D |
| Oxycodone and Acetaminophen | OXYCODONE AND ACETAMINOPHEN | Proficient Rx LP | ad03068c-1af4-46ce-bdea-c2745b1c1e52 | 2022-10-01 | Boxed warning, Warnings, Adverse reactions | 362O9ITL9D |
| acetaminophen for children | ACETAMINOPHEN | Proficient Rx LP | 43fd900c-50c8-49c4-9f07-4fef924d533c | 2022-09-01 | Warnings | 362O9ITL9D |
| Oxycodone and Acetaminophen | OXYCODONE AND ACETAMINOPHEN | Proficient Rx LP | 484a4323-0758-439d-844f-f04d7e5ef6f3 | 2022-08-01 | Boxed warning, Warnings, Adverse reactions | 362O9ITL9D |
| basic care migraine relief | ACETAMINOPHEN, ASPIRIN, CAFFEINE | Amazon.com Services LLC | a19798b3-1b2e-4e4f-b595-2a156bd52ee5 | 2022-07-28 | Warnings | 362O9ITL9D |
| Hydrocodone Bitartrate and Acetaminophen | HYDROCODONE BITARTRATE AND ACETAMINOPHEN | Asclemed USA, Inc. | 23dde6b8-3655-49ee-ac2c-28f80cf6b3c2 | 2022-07-20 | Boxed warning, Warnings, Adverse reactions | NO70W886KK 362O9ITL9D |
| Acetaminophen | ACETAMINOPHEN | Hikma Pharmaceuticals USA Inc. | b466c989-f7aa-e476-e053-2a95a90a8e55 | 2022-07-18 | Boxed warning, Warnings, Adverse reactions | 362O9ITL9D |
| topcare migraine relief | ACETAMINOPHEN, ASPIRIN, CAFFEINE | Topco Associates LLC | 9163ecfe-6493-46eb-a08d-b4134d84b0ab | 2022-06-28 | Warnings | 362O9ITL9D |
Reported adverse events (FAERS/openFDA)#
Adverse event summaries are temporarily unavailable. Other product information remains available.