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 | Kroger Company | bbeebdd6-fe2c-5b8a-e053-2a95a90ab95e | 2024-04-13 | Warnings | 362O9ITL9D |
| infants pain relief | ACETAMINOPHEN | Publix Super Markets Inc | 3d1818a7-d3b2-434c-b3c9-b2713f08ded2 | 2024-04-13 | Warnings | 362O9ITL9D |
| Mommys Bliss Childrens Pain and Fever | ACETAMINOPHEN | Mom Enterprises, LLC. | 08b9eaf7-70d1-640f-e063-6394a90a8d3b | 2024-04-12 | Warnings | 362O9ITL9D |
| Mommys Bliss Infants Pain and Fever | ACETAMINOPHEN | Mom Enterprises, LLC. | 05e26650-81b3-d7b1-e063-6394a90a14ed | 2024-04-11 | Warnings | 362O9ITL9D |
| Childrens Pain Relief | CHILDRENS PAIN RELIEF | Allegiant Health | 7381dd26-c507-4d02-b989-cfd96e02f495 | 2024-04-11 | Warnings | 362O9ITL9D |
| Childrens Pain Relief Dye-Free | ACTEAMINOPHEN | WinCo Foods, LLC | 5ee134b3-b8e9-4621-b0a1-a84d9867ccba | 2024-04-11 | Warnings | 362O9ITL9D |
| Childrens Pain and Fever | ACETAMINOPHEN | WALGREENS | 0b1d086f-7be1-5072-e063-6394a90a11e6 | 2024-04-10 | Warnings | 362O9ITL9D |
| Dye Free Infants Pain and Fever | ACETAMINOPHEN | WALGREENS | 0b1d88d8-56ff-9e9d-e063-6394a90a015c | 2024-04-09 | Warnings | 362O9ITL9D |
| Headache Relief Extra Strength | ACETAMINOPHEN, ASPIRIN, CAFFEINE | H E B | 4d572228-3141-4539-9c3d-2fd06e94eee3 | 2024-04-09 | Warnings | 362O9ITL9D |
| Daytime Cold and Flu Non drowsy | ACETAMINOPHEN, DEXTROMETHORPHAN HYDROBROMIDE, PHENYLEPHRINE HYDROCHLORIDE | Harris Teeter, LLC | 9b0648ac-0ce3-4eaa-8977-26ae864f034d | 2024-04-09 | Warnings | 362O9ITL9D |
| FLONASE Headache and Allergy Relief | ACETAMINOPHEN, CHLORPHENIRAMINE MALEATE, PHENYLEPHRINE HCL | Haleon US Holdings LLC | 282c103c-3888-4a35-a5b1-d492ed6892c1 | 2024-04-08 | Warnings | 362O9ITL9D |
| Robitussin Direct Sore Throat Pain | ACETAMINOPHEN | Haleon US Holdings LLC | 1b512078-24c3-4b80-8f2c-d6824d367f25 | 2024-04-08 | Warnings | 362O9ITL9D |
| Oxycodone and Acetaminophen | OXYCODONE AND ACETAMINOPHEN | Bryant Ranch Prepack | 4da8a7bd-0d2e-452c-afb5-fed4e230a9bd | 2024-04-08 | Boxed warning, Warnings, Adverse reactions | 362O9ITL9D |
| Cold and Flu Relief Daytime | ACETAMINOPHEN, DEXTROMETHORPHAN HYDROBROMIDE, PHENYLEPHRINE HYDROCHLORIDE | H E B | 12ace982-bd47-49b0-ba1b-e0a29d42f1d6 | 2024-04-08 | Warnings | 362O9ITL9D |
| Cold and Flu Relief Daytime | ACETAMINOPHEN, DEXTROMETHORPHAN HYDROBROMIDE, PHENYLEPHRINE HYDROCHLORIDE | H E B | bd19b1f2-d9d3-4dab-8181-605f769ab62f | 2024-04-08 | Warnings | 362O9ITL9D |
| Daytime Severe Cold and Cough | ACETAMINOPHEN, DEXTROMETHORPHAN HBR, PHENYLEPHRINE HCL | H E B | 9f533092-060c-4379-9a77-ecfea8aa46e1 | 2024-04-08 | Warnings | 362O9ITL9D |
| Robitussin Severe Multi-Symptom Cough Cold Flu Nighttime | ACETAMINOPHEN, DIPHENHYDRAMINE HYDROCHLORIDE, PHENYLEPHRINE HYDROCHLORIDE | Haleon US Holdings LLC | 89360fa8-014d-4da8-bb1c-197e3aa52256 | 2024-04-06 | Warnings | 362O9ITL9D |
| Robitussin Severe Multi-Symptom Cough Cold Flu | ACETAMINOPHEN, DEXTROMETHORPHAN HYDROBROMIDE, GUAIFENESIN, PHENYLEPHRINE HYDROCHLORIDE | Haleon US Holdings LLC | 66360295-f364-479a-8b49-c12b21918279 | 2024-04-06 | Warnings | 362O9ITL9D |
| Robitussin Maximum Strength Severe Multi-Symptom 7 in 1 Relief Nighttime | ACETAMINOPHEN, DEXTROMETHORPHAN HYDROBROMIDE, AND DOXYLAMINE SUCCINATE | Haleon US Holdings LLC | e7cf7c5d-5c9a-4201-9e30-1cd616071855 | 2024-04-06 | Warnings | 362O9ITL9D |
| Theraflu Severe Cold Relief Daytime Honey Ginger | ACETAMINOPHEN, DEXTROMETHORPHAN HBR | Haleon US Holdings LLC | 44404c6a-8031-4f4b-a48e-3739a11a0d2c | 2024-04-05 | Warnings | 362O9ITL9D |
Reported adverse events (FAERS/openFDA)#
Adverse event summaries are temporarily unavailable. Other product information remains available.