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 |
|---|---|---|---|---|---|---|
| Extra Strength Headache, Caseys 4good | ACETAMINOPHEN, ASPIRIN, CAFFEINE TABLET | Lil' Drug Store Products, Inc. | 0425c6a8-a3ea-24ad-e063-6294a90ae15a | 2024-12-16 | Warnings | 362O9ITL9D |
| DayQuil Severe plus VapoCOOL Cold and Flu, Travel BASIX | ACETAMINOPHEN, DEXTROMETHORPHAN HYDROBROMIDE, GUAIFENESIN, AND PHENYLEPHRINE HYDROCHLORIDE | Lil' Drug Store Products, Inc. | cfab9b80-0580-4482-b6e3-0aab875b5797 | 2024-12-16 | Warnings | 362O9ITL9D |
| Cold and Flu Daytime Severe, 24/7 Life | ACETAMINOPHEN, DEXTROMETHORPHAN HBR, GUAIFENESIN, PHENYLEPHRINE HCL TABLET | Lil' Drug Store Products, Inc. | 05cc7185-d49d-82a3-e063-6294a90a568e | 2024-12-16 | Warnings | 362O9ITL9D |
| Cold and Flu Nighttime Severe, 24-7 Life | ACETAMINOPHEN, DEXTROMETHORPHAN HBR, DOXYLAMINE SUCCINATE, PHENYLEPHRINE HCL | Lil' Drug Store products, Inc. | 05d0410f-164e-e7ee-e063-6394a90a2aaa | 2024-12-16 | Warnings | 362O9ITL9D |
| Lil Drug Store Childrens Pain and Fever | ACETAMINOPHEN | Lil' Drug Store Products, Inc. | 5fcd41ad-449f-4090-be19-eae4171de891 | 2024-12-16 | Warnings | 362O9ITL9D |
| Oxycodone and Acetaminophen | OXYCODONE AND ACETAMINOPHEN | Quality Care products LLC | 3f2b939c-2206-469b-85a4-b0ee9ba25be8 | 2024-12-16 | Warnings, Adverse reactions | 362O9ITL9D |
| Acetaminophen 250mg Aspirin 250mg Caffeine 65mg | ACETAMINOPHEN 250MG ASPIRIN 250MG CAFFEINE 65MG | CVS Pharmacy | b9e75551-1e50-9896-e053-2a95a90aafd4 | 2024-12-14 | Warnings | 362O9ITL9D |
| Acetaminophen 250mg Aspirin 250mg Caffeine 65mg | ACETAMINOPHEN 250MG ASPIRIN 250MG CAFFEINE 65MG | CVS Pharmacy | b9e5df0e-06d3-6f72-e053-2995a90a2d07 | 2024-12-14 | Warnings | 362O9ITL9D |
| Excedrin Migraine, TRAVEL BASIX | ACETAMINOPHEN, ASPIRIN, AND CAFFEINE | Lil' Drug Store Products, Inc. | 40aeb2c5-a37b-446d-9918-8378a75ff327 | 2024-12-13 | Warnings | 362O9ITL9D |
| Kroger Daytime Cold and Flu Softgel | ACETAMINOPHEN, DEXTROMETHORPHAN HYDROBROMIDE, PHENYLEPHRINE HYDROCHLORIDE | The Kroger Company | e428dd83-c538-2a92-e053-2a95a90a0e16 | 2024-12-13 | Warnings | 362O9ITL9D |
| Kroger Nighttime Cold and Flu Softgel | ACETAMINOPHEN, DEXTROMETHORPHAN HYDROBROMIDE, DOXYLAMINE SUCCINATE | The Kroger Company | e46291c7-6f4d-46a2-e053-2a95a90a80a1 | 2024-12-13 | Warnings | 362O9ITL9D |
| foster and thrive pain reliever | ACETAMINOPHEN | Strategic Sourcing Services LLC | b8ee568c-80cf-4e35-865e-35516bdab0fd | 2024-12-13 | Warnings | 362O9ITL9D |
| BRONCOCHEM COLD AND FLU TEA | ACETAMINOPHEN-PHENYLEPHRINE HYDROCHLORIDE-CHLORPHENIRAMINE MALEATE | LABORATORIO MAGNACHEM INTERNATIONAL SRL | b7d3f54e-59ef-4b85-a88d-b053058dc1f6 | 2024-12-12 | Warnings | 362O9ITL9D |
| Headache Relief | ACETAMINOPHEN, ASPIRIN, CAFFEINE | Strive Pharmaceuticals Inc. | c0de0bd2-4868-46dc-a20f-3ca02caaa26b | 2024-12-11 | Warnings | 362O9ITL9D |
| EXTRA STRENGTH Headache Relief geltabs | ACETAMINOPHEN, ASPIRIN, CAFFEINE | Strive Pharmaceuticals Inc. | b432771a-4f7d-4d39-a038-d1561d8f6708 | 2024-12-11 | Warnings | 362O9ITL9D |
| HYDROCODONE BITARTRATE AND ACETAMINOPHEN | HYDROCODONE BITARTRATE AND ACETAMINOPHEN | Golden State Medical Supply, Inc. | 87ed3420-1697-6f42-e053-2995a90a1a5b | 2024-12-10 | Boxed warning, Warnings, Adverse reactions | NO70W886KK 362O9ITL9D |
| Pain Relief Childrens | ACETAMINOPHEN | QUALITY CHOICE (Chain Drug Marketing Association) | 223ffb2b-3ee5-4118-955b-bc4fa4e8a2e6 | 2024-12-10 | Warnings | 362O9ITL9D |
| acetaminophen | ACETAMINOPHEN | UNFI | e689c9e3-dd4d-c646-e053-2a95a90a4b6a | 2024-12-09 | Warnings | 362O9ITL9D |
| DrKids Childrens Pain and Fever | ACETAMINOPHEN 80MG/PIECE | CalmCo LLC | ff4b0528-39a0-80d5-e053-6394a90a8a83 | 2024-12-07 | Warnings | 362O9ITL9D |
| Pain Relief | ACETAMINOPHEN | DISCOUNT DRUG MART | 972f09a7-2aa1-4b1b-a6dc-2c4578a07803 | 2024-12-05 | Warnings | 362O9ITL9D |
Reported adverse events (FAERS/openFDA)#
Adverse event summaries are temporarily unavailable. Other product information remains available.