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 |
|---|---|---|---|---|---|---|
| signature care childrens pain relief | ACETAMINOPHEN | Safeway | fccb5aca-5707-491f-beb4-08f568919169 | 2024-09-06 | Warnings | 362O9ITL9D |
| HEADACHE RELIEF | ACETAMINOPHEN-ASPIRIN-CAFFEINE | TARGET CORPORATION | 8e953cef-135e-f1aa-e053-2995a90aaa8b | 2024-09-05 | Warnings | 362O9ITL9D |
| Theraflu Severe Cold Relief Nighttime Soft Chews | ACETAMINOPHEN, DIPHENHYDRAMINE HCL | Haleon US Holdings LLC | 6ba64bbe-7599-406a-9187-737c0f8c1c2a | 2024-09-05 | Warnings | 362O9ITL9D |
| Hydrocodone Bitartrate and Acetaminophen | HYDROCODONE BITARTRATE AND ACETAMINOPHEN | Bryant Ranch Prepack | 42a74abc-bdc7-4ea3-a185-029340111730 | 2024-09-05 | Boxed warning, Warnings, Adverse reactions | NO70W886KK 362O9ITL9D |
| ACETAMINOPHEN | ACETAMINOPHEN | TARGET CORPORATION | 80da2582-1a20-e111-e053-2991aa0acf32 | 2024-09-03 | Warnings | 362O9ITL9D |
| Tramadol Hydrochloride and Acetaminophen | TRAMADOL HYDROCHLORIDE AND ACETAMINOPHEN | Bryant Ranch Prepack | f33fcd05-2c95-48dd-884b-5ed9c25c2ccf | 2024-08-30 | Boxed warning, Warnings, Adverse reactions | 362O9ITL9D |
| Butalbital, Acetaminophen, Caffeine | BUTALBITAL, ACETAMINOPHEN, AND CAFFEINE | Bryant Ranch Prepack | e2978345-826a-47d2-acf3-feb6afb1967e | 2024-08-29 | Boxed warning, Warnings, Adverse reactions | 362O9ITL9D |
| Tylenol PM Extra Strength | ACETAMINOPHEN, DIPHENHYDRAMINE HYDROCHLORIDE | Jones Healthcare Group - Packaging Services, Inc | 639f4e01-9723-a619-e053-2991aa0a549a | 2024-08-27 | Warnings | 362O9ITL9D |
| ENDOCET | OXYCODONE AND ACETAMINOPHEN | Bryant Ranch Prepack | 7dc10b86-c6cd-4012-b7b9-b694ccf4f768 | 2024-08-27 | Boxed warning, Warnings, Adverse reactions | 362O9ITL9D |
| Extra Strength Acetaminohpen Adult Rapid Burst Cherry | ACETAMINOPHEN | Major Pharmaceuticals | 9e7543d9-6249-45b5-b67d-c1b439423b9c | 2024-08-27 | Warnings | 362O9ITL9D |
| Hydrocodone Bitartrate and Acetaminophen | HYDROCODONE BITARTRATE AND ACETAMINOPHEN | Bryant Ranch Prepack | 82b7fd34-02ac-434a-be38-a1f0ec4f3e50 | 2024-08-26 | Boxed warning, Warnings, Adverse reactions | NO70W886KK 362O9ITL9D |
| Up and Up childrens acetaminophen | ACETAMINOPHEN | Target Corporation | 9c3ba4dd-f51b-46ce-91b8-8b617c7b78da | 2024-08-23 | Warnings | 362O9ITL9D |
| Dual Action | ACETAMINOPHEN, IBUPROFEN | BETTER LIVING BRANDS, LLC | f2c096bb-cfed-bfa4-e053-2995a90af2cb | 2024-08-22 | Warnings | 362O9ITL9D |
| ACETAMINOPHEN AND CODEINE PHOSPHATE | ACETAMINOPHEN AND CODEINE PHOSPHATE | Bryant Ranch Prepack | 3f7737d1-ec78-467e-8903-9cb8eba0ab0b | 2024-08-22 | Boxed warning, Warnings, Adverse reactions | 362O9ITL9D |
| ACETAMINOPHEN AND CODEINE PHOSPHATE | ACETAMINOPHEN AND CODEINE PHOSPHATE | Bryant Ranch Prepack | 18315a6f-9e89-46d7-81d3-905b8a51aa79 | 2024-08-22 | Boxed warning, Warnings, Adverse reactions | 362O9ITL9D |
| pain reliever | ACETAMINOPHEN | Walgreen Company | 8255900a-2d58-4261-8df7-f28319883570 | 2024-08-21 | Warnings | 362O9ITL9D |
| Pain and Fever | ACETAMINOPHEN | H E B | 86a072a9-c3b8-47f7-8598-d66e3d30e762 | 2024-08-21 | Warnings | 362O9ITL9D |
| butalbital, acetaminophen and caffeine | BUTALBITAL, ACETAMINOPHEN AND CAFFEINE | Dr. Reddy's Labratories Inc. | 69df02fa-c842-48dc-7ac6-5967b7dc30de | 2024-08-19 | Boxed warning, Warnings, Adverse reactions | 362O9ITL9D |
| Hydrocodone Bitartrate and Acetaminophen | HYDROCODONE BITARTRATE AND ACETAMINOPHEN | Bryant Ranch Prepack | 9698729e-08d0-483c-b157-5a4061d97065 | 2024-08-19 | Boxed warning, Warnings, Adverse reactions | NO70W886KK 362O9ITL9D |
| Cold and Flu Nighttime | ACETAMINOPHEN, DEXTROMETHORPHAN HYDROBROMIDE, DOXYLAMINE SUCCINATE | Walgreens | 8045aef9-22bc-4146-b494-dbb1ffef06df | 2024-08-19 | Warnings | 362O9ITL9D |
Reported adverse events (FAERS/openFDA)#
Adverse event summaries are temporarily unavailable. Other product information remains available.