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 |
|---|---|---|---|---|---|---|
| RIGHT REMEDIES EXTRA STRENGTH PM Pain Relief | ACETAMINOPHEN, DIPHENHYDRAMINE HYDROCHLORIDE | Strive Pharmaceuticals Inc. | 8badbaad-eb35-4251-a779-00474819360d | 2023-11-13 | Warnings | 362O9ITL9D |
| TopCare EXTRA STRENGTH Headache Relief | ACETAMINOPHEN, ASPIRIN, CAFFEINE | Topco Associates LLC | e5c21b3a-d8a0-4978-ae6c-4ce0cc9cebe4 | 2023-11-09 | Warnings | 362O9ITL9D |
| Acetaminophen | ACETAMINOPHEN | Trifecta Pharmaceuticals USA LLC | 09935a74-34b0-0e7c-e063-6294a90a7c83 | 2023-11-07 | Warnings | 362O9ITL9D |
| Tylenol Sinus Severe | ACETAMINOPHEN, GUAIFENESIN, PHENYLEPHRINE HYDROCHLORIDE | Jones Healthcare Group - Packaging Services, Inc | 6c90b415-4c5f-49e5-beb6-4cf225797b21 | 2023-11-06 | Warnings | 362O9ITL9D |
| Tylenol Cold Plus Flu Severe Severe | ACETAMINOPHEN, DEXTROMETHORPHAN HYDROBROMIDE, GUAIFENESIN, PHENYLEPHRINE HYDROCHLORIDE | Jones Healthcare Group - Packaging Services, Inc | 8b8582c0-8aef-482f-9738-2f1d4e325d64 | 2023-11-06 | Warnings | 362O9ITL9D |
| TopCare Nite Time SEVERE Cold and Flu | ACETAMINOPHEN, DEXTROMETHORPHAN HYDROBROMIDE, DOXYLAMINE SUCCINATE, PHENYLEPHRINE HYDROCHLORIDE | Topco Associates LLC | adc8edf5-ebbe-4d94-9018-aa0dbe118112 | 2023-11-03 | Warnings | 362O9ITL9D |
| Pain Relief PM | ACETAMINOPHEN AND DIPHENHYDRAMINE HYDROCHLORIDE | AMERIFOODS TRADING COMPANY | f6dd6396-93e9-1096-e053-6394a90af06d | 2023-11-02 | Warnings | 362O9ITL9D |
| Acetaminophen | ACETAMINOPHEN | RETAIL BUSINESS SERVICES , LLC. | eb644e9e-36dc-5f84-e053-2a95a90affa5 | 2023-11-02 | Warnings | 362O9ITL9D |
| Sinus Pressure plus Pain PE | ACETAMINOPHEN AND PHENYLEPHRINE HYDROCHLORIDE | RETAIL BUSINESS SERVICES , LLC. | eb64750f-19ac-655f-e053-2995a90a33b5 | 2023-11-02 | Warnings | 362O9ITL9D |
| 8 Hour Arthritis Pain | ACETAMINOPHEN | MARC GLASSMAN, INC. | e2387b9c-94c0-397a-e053-2995a90a444c | 2023-11-02 | Warnings | 362O9ITL9D |
| Good Sense Childrens Pain and Fever | ACETAMINOPHEN | Proficient Rx LP | 46527b1f-7515-44ce-b5cb-9d24223b9af1 | 2023-11-01 | Warnings | 362O9ITL9D |
| Multi-Symptom Mapap Cold Formula | ACETAMINOPHEN, DEXTROMETHORPHAN HBR, PHENYLEPHRINE HCL | Proficient Rx LP | 9bf81b26-38b4-486c-ae89-222119ce1a4f | 2023-11-01 | Warnings | 362O9ITL9D |
| Acetaminophen, Aspirin, Caffeine | ACETAMINOPHEN, ASPIRIN, CAFFEINE | Proficient Rx LP | af8b30a0-7a56-4557-8404-cc8059fcd6bc | 2023-11-01 | Warnings | 362O9ITL9D |
| Acetaminophen | ACETAMINOPHEN | B. Braun Medical Inc. | 9744d804-2857-47ef-a27a-bca27db9394c | 2023-11-01 | Boxed warning, Warnings, Adverse reactions | 362O9ITL9D |
| 8 Hour Arthritis Pain | ACETAMINOPHEN | AMERISOURCE BERGEN | 7888eff3-3030-4aa0-89e3-9795aa214659 | 2023-10-31 | Warnings | 362O9ITL9D |
| Acetaminophen | ACETAMINOPHEN | AMERIFOODS TRADING COMPANY | f6dd387d-c768-9443-e053-6394a90aca14 | 2023-10-31 | Warnings | 362O9ITL9D |
| Daytime Cold and Flu Relief | DAYTIME COLD AND FLU RELIEF | TopCo Associates, LLC | d592fbb8-d4bf-444e-982e-edf6fe97dce4 | 2023-10-31 | Warnings | 362O9ITL9D |
| Nite Time Cold and Flu Relief | NITE TIME COLD AND FLU RELIEF | TopCo Associates, LLC | 407dc4ae-882d-4a49-8884-ef048bb404cf | 2023-10-31 | Warnings | 362O9ITL9D |
| SafeTynadol | ACETAMINOPHEN | Sinew Pharma Inc. | b956d527-7ea7-e084-e053-2a95a90a866d | 2023-10-28 | Warnings | 362O9ITL9D |
| Dual Action Pain Relief | ACETAMINOPHEN, IBUPROFEN | TIME CAP LABORATORIES, INC. | 08acd3bf-ad0c-f693-e063-6394a90ad8c2 | 2023-10-27 | Warnings | 362O9ITL9D |
Reported adverse events (FAERS/openFDA)#
Adverse event summaries are temporarily unavailable. Other product information remains available.