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 |
|---|---|---|---|---|---|---|
| Midol Complete Gelcaps | MIDOL COMPLETE | Bayer HealthCare LLC | 0a4477ce-0a02-197d-e054-00144ff88e88 | 2025-12-04 | Warnings | 362O9ITL9D |
| Coricidin HBP Maximum Strength Multi Symptom Flu | ACETAMINOPHEN, CHLORPHENIRAMINE MALEATE, DEXTROMETHORPHAN HYDROBROMIDE | Bayer HealthCare LLC. | ae7cf41e-b618-d6bb-e053-2a95a90a6692 | 2025-12-04 | Warnings | 362O9ITL9D |
| Coricidin HBP Maximum Strength Cold Flu And Chest Congestion | ACETAMINOPHEN, GUAIFENESIN | Bayer HealthCare LLC. | de95d2dd-e766-f7ec-e053-2995a90afc5f | 2025-12-04 | Warnings | 362O9ITL9D |
| DayTime Relief, Cold and Flu, 24-7 Life by 7-Eleven | ACETAMINOPHEN, DEXTROMETHORPHAN HBR, PHENYLEPHRINE HCL SOLUTION | Lil' Drug Store Products, Inc. | 450e8974-8ff8-4b82-e063-6394a90a9366 | 2025-12-03 | Warnings | 362O9ITL9D |
| Nighttime Relief, Cold and Flu, 24-7 Life by 7-Eleven | ACETAMINOPHEN, DEXTROMETHORPHAN HBR, DOXYLAMINE SUCCINATE SOLUTION | Lil' Drug Store Products, Inc. | 4510223f-1c88-2796-e063-6394a90a18ac | 2025-12-03 | Warnings | 362O9ITL9D |
| DayTime Severe, Cold and Flu, 24-7 Life by 7-Eleven | ACETAMINOPHEN, DEXTROMETHORPHAN HBR, GUAIFENESIN, PHENYLEPHRINE HCL TABLET, FILM COATED TABLET | Lil' Drug Store Products, Inc. | 44fa0193-2a19-bdc1-e063-6394a90a60e8 | 2025-12-02 | Warnings | 362O9ITL9D |
| Nighttime Severe, Cold and Flu, 24-7 Life by 7-Eleven | ACETAMINOPHEN, DEXTROMETHORPHAN HBR, DOXYLAMINE SUCCINATE, PHENYLEPHRINE HCL TABLET, FILM COATED | Lil' Drug Store Products, Inc. | 44fb9958-d771-f4b3-e063-6294a90a9135 | 2025-12-02 | Warnings | 362O9ITL9D |
| Pain Reliever Extra Strength | ACETAMINOPHEN, ASPIRIN AND CAFFEINE | Rite Aid Corporation | d9caee45-be43-45ec-927f-e7fec5c14f07 | 2025-12-02 | Warnings | 362O9ITL9D |
| Pain Reliever PM Extra Strength | ACETAMINOPHEN, DIPHENHYDRAMINE HCL | Walgreen Company | b4d8860b-d72f-4789-945e-1c6420a8efab | 2025-12-02 | Warnings | 362O9ITL9D |
| Cold and Flu Relief Daytime | ACETAMINOPHEN DEXTROMETHORPHAN HBR PHENYLEPHRINE HCL | CARDINAL HEALTH 110, LLC. DBA LEADER 70000 | ac74be47-30f0-418b-bd07-502feaa9723f | 2025-12-01 | Warnings | 362O9ITL9D |
| Infants Pain and Fever | ACETAMINOPHEN | WALGREEN COMPANY | f7b304d8-e37c-4ac6-b4a2-1797b92cb832 | 2025-12-01 | Warnings | 362O9ITL9D |
| Dye FreeInfants Pain and Fever | ACETAMINOPHEN | WALGREEN COMPANY | 1a304570-88b6-4c16-a8b4-c064bfa5d95a | 2025-12-01 | Warnings | 362O9ITL9D |
| Walgreens High Blood Pressure Cold and Flu | ACETAMINOPHEN, DEXTROMETHORPHAN | WALGREENS CO. | bc83b55e-c3d8-460f-8ef9-ff7b2e4f7272 | 2025-12-01 | Warnings | 362O9ITL9D |
| Walgreen High Blood Pressure Nighttime Cold and Flu | ACETAMINOPHEN, DEXTROMETHORPHAN HYDROBROMIDE, AND DOXYLAMINE SUCCINATE | WALGREENS CO. | f1b7b58f-bbc3-441f-926f-d66e6a9b4e3a | 2025-12-01 | Warnings | 362O9ITL9D |
| Walgreen Severe Multi-Symptom Cough Cold Flu | ACETAMINOPHEN, DEXTROMETHORPHAN HYDROBROMIDE, GUAIFENESIN, PHENYLEPHRINE HYDROCHLORIDE | WALGREENS | b48d93fe-bb60-493f-8d1a-b2dc864203c4 | 2025-12-01 | Warnings | 362O9ITL9D |
| WALGREENS Cold Cough and Flu Relief | ACETAMINOPHEN, DEXTROMETHORPHAN HYDROBROMIDE | WALGREENS CO. | 1e903034-942e-4c6e-9f96-eb097c266580 | 2025-12-01 | Warnings | 362O9ITL9D |
| Advil Dual Action with Acetaminophen, Travel BASIX | IBUPROFEN, ACETAMINOPHEN TABLET, FILM COATED | Lil' Drug Store Products, Inc. | 030d9bca-a934-6ef9-e063-6394a90a8277 | 2025-12-01 | Warnings | 362O9ITL9D |
| CareALL Non Aspirin Extra Strength | ACETAMINOPHEN | New World Imports, Inc | da05a1a1-35b4-4787-8c56-12e369f18ff0 | 2025-12-01 | Warnings | 362O9ITL9D |
| CareALL Acetaminophen Extra Strength | ACETAMINOPHEN | New World Imports, Inc | 80a699b9-bf5c-4765-9e20-ccbc7e3ace7a | 2025-12-01 | Warnings | 362O9ITL9D |
| CareALL Acetaminophen Extra Strength | ACETAMINOPHEN | New World Imports, Inc | 66244cdb-2680-4fa8-890d-32aefd490038 | 2025-12-01 | Warnings | 362O9ITL9D |
Reported adverse events (FAERS/openFDA)#
Adverse event summaries are temporarily unavailable. Other product information remains available.