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 |
|---|---|---|---|---|---|---|
| Cold and Flu Relief Multi Symptom Nighttime | ACETAMINOPHEN, DEXTROMETHORPHAN HYDROBROMIDE, DOXYLAMINE SUCCINATE | WinCo Foods, LLC | 89272d2d-5533-4ae8-865b-cb204cec6d65 | 2024-09-17 | Warnings | 362O9ITL9D |
| Cold and Flu Relief Multi Symptom Nighttime | ACETAMINOPHEN, DEXTROMETHORPHAN HYDROBROMIDE, DOXYLAMINE SUCCINATE | WinCo Foods, LLC | 5791c1c7-f614-4940-a45a-6291742e1e22 | 2024-09-17 | Warnings | 362O9ITL9D |
| Oxycodone and Acetaminophen | OXYCODONE AND ACETAMINOPHEN | NuCare Pharmaceuticals,Inc. | 223fe2b4-aa12-81fd-e063-6394a90a6c08 | 2024-09-16 | Boxed warning, Warnings, Adverse reactions | 362O9ITL9D |
| childrens pain and fever | ACETAMINOPHEN | Walgreen Company | 550c4229-c3a3-442c-a9ed-2d04cd4bad51 | 2024-09-14 | Warnings | 362O9ITL9D |
| DAYTIME COLD AND FLU RELIEF SOFTGELS NON-DROWSY | ACETAMINOPHEN, DEXTROMETHORPHAN HBR, PHENYLEPHRINE | Advanced Rx LLC | fa1a4d86-87bb-0c50-e053-6394a90a56e2 | 2024-09-13 | Warnings | 362O9ITL9D |
| NIGHTTIME COLD AND FLU RELIEF SOFTGELS MULTI-SYMPTOM | ACETAMINOPHEN, DEXTROMETHORPHAN HBR, DOXYLAMINE SUCCINATE | Advanced Rx LLC | fa1b60b1-49cb-1211-e053-6394a90a0a46 | 2024-09-13 | Warnings | 362O9ITL9D |
| Hydrocodone Bitartrate and Homatropine Methylbromide | HYDROCODONE BITARTRATE AND HOMATROPINE METHYLBROMIDE | Lupin Pharmaceuticals,Inc. | 41ac90b3-f007-4eb2-9d41-ea626ced2017 | 2024-09-12 | Boxed warning, Warnings, Adverse reactions | NO70W886KK |
| Butalbital, Acetaminophen, Caffeine and Codeine Phosphate | BUTALBITAL, ACETAMINOPHEN, CAFFEINE AND CODEINE PHOSPHATE | Breckenridge Pharmaceutical, Inc. | d74db417-d2de-495b-bb75-46a83745603d | 2024-09-12 | Boxed warning, Warnings, Adverse reactions | 362O9ITL9D |
| rexall pain relief | ACETAMINOPHEN | Dolgencorp, LLC | 9783cf37-3a2b-4ca1-b4eb-6d6ba047a325 | 2024-09-12 | Warnings | 362O9ITL9D |
| meijer Daytime Cold and Flu SOFTGEL | ACETAMINOPHEN, DEXTROMETHORPHAN HYDROBROMIDE, PHENYLEPHRINE HYDROCHLORIDE | Meijer, Inc. | 1bdd7f8a-93ce-5309-e063-6294a90a91f0 | 2024-09-12 | Warnings | 362O9ITL9D |
| pain relief | ACETAMINOPHEN | H E B | 3258ef39-c36e-4a97-8631-89b8d4caf058 | 2024-09-11 | Warnings | 362O9ITL9D |
| Acetaminophen and Diphenhydramine hydrochloride | ACETAMINOPHEN AND DIPHENHYDRAMINE HYDROCHLORIDE | KROGER COMPANY | b9b86755-63ad-e25a-e053-2995a90ad747 | 2024-09-10 | Warnings | 362O9ITL9D |
| Parents Choice Infants Pain and Fever | ACETAMINOPHEN | Wal-Mart Stores Inc | 30a51b90-a565-4e38-82ee-b5af29762977 | 2024-09-10 | Warnings | 362O9ITL9D |
| signature care infants pain relief | ACETAMINOPHEN | Safeway | 236df05a-cf11-42f3-a347-b54f5113680c | 2024-09-10 | Warnings | 362O9ITL9D |
| BUTALBITAL, ACETAMINOPHEN AND CAFFEINE | BUTALBITAL, ACETAMINOPHEN AND CAFFEINE | SOLCO HEALTHCARE US, LLC | 5c9c3407-212a-4ae9-a574-2b0c53f3c5eb | 2024-09-10 | Boxed warning, Warnings, Adverse reactions | 362O9ITL9D |
| TYLENOL 8 HR ARTHRITIS PAIN | ACETAMINOPHEN | Kenvue Brands LLC | 0391963c-022d-1433-e063-6294a90aac90 | 2024-09-09 | Warnings | 362O9ITL9D |
| pain relief | ACETAMINOPHEN | Meijer Distribution Inc | d2759fa6-59cd-417e-8761-d2b129aad8b8 | 2024-09-09 | Warnings | 362O9ITL9D |
| Haben Herb F Cap | ACETAMINOPHEN, DRIED CINNAMON EXTRACT | Lydia Co., Ltd. | 21a5c7c4-5aa3-9337-e063-6394a90a3080 | 2024-09-08 | Warnings | 362O9ITL9D |
| Hydrocodone Bitartrate and Acetaminophen | HYDROCODONE BITARTRATE AND ACETAMINOPHEN | Bryant Ranch Prepack | 2a485efe-a87c-4c55-9e17-7891b2fffb83 | 2024-09-06 | Boxed warning, Warnings, Adverse reactions | NO70W886KK 362O9ITL9D |
| M-PAP | ACETAMINOPHEN | Bryant Ranch Prepack | d344479b-80c1-4592-acc8-3f12690c839c | 2024-09-06 | Warnings | 362O9ITL9D |
Reported adverse events (FAERS/openFDA)#
Adverse event summaries are temporarily unavailable. Other product information remains available.