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 |
|---|---|---|---|---|---|---|
| basic care infants pain and fever | ACETAMINOPHEN | Amazon.com Services LLC | dab1f9e6-3875-4d53-a417-c6a78274ee56 | 2024-04-23 | Warnings | 362O9ITL9D |
| Cold and Flu Daytime | ACETAMINOPHEN, DEXTROMETHORPHAN HBR, PHENYLEPHRINE HCL | QUALITY CHOICE (Chain Drug Marketing Association) | fc7954a6-d061-4160-b1d1-a19eb9eabff4 | 2024-04-22 | Warnings | 362O9ITL9D |
| Excedrin Extra Strength Pain Reliever | ACETAMINOPHEN, ASPIRIN (NSAID), AND CAFFEINE | Haleon US Holdings LLC | a71074a6-cc19-4bb3-8c84-4e82a8906801 | 2024-04-22 | Warnings | 362O9ITL9D |
| Pain Relief PM Extra Strength | ACETAMINOPHEN, DIPHENHYDRAMINE HCL | QUALITY CHOICE (Chain Drug Marketing Association) | 47660794-22cc-4863-a183-e694d27e3543 | 2024-04-19 | Warnings | 362O9ITL9D |
| Regular Strength Acetaminophen | ACETAMINOPHEN | KROGER COMPANY | 0fe995cd-f974-db04-e063-6294a90a3355 | 2024-04-18 | Warnings | 362O9ITL9D |
| Nighttime Cold and Flu Relief | ACETAMINOPHEN DEXTROMETHORPHAN HBR DOXYLAMINE SUCCINATE | QUALITY CHOICE (Chain Drug Marketing Association) | f9c08b18-a119-406b-bd96-73572b4445e2 | 2024-04-18 | Warnings | 362O9ITL9D |
| Nighttime Cold and Flu Relief | ACETAMINOPHEN DEXTROMETHORPHAN HBR DOXYLAMINE SUCCINATE | QUALITY CHOICE (Chain Drug Marketing Association) | 025f6622-a6db-4a5c-aebd-5d54172fa4a1 | 2024-04-18 | Warnings | 362O9ITL9D |
| Nighttime Cold and Flu Relief | ACETAMINOPHEN DEXTROMETHORPHAN HBR DOXYLAMINE SUCCINATE | QUALITY CHOICE (Chain Drug Marketing Association) | f9530d55-8226-4659-84f0-2c0b411572be | 2024-04-17 | Warnings | 362O9ITL9D |
| Childrens Pain and Fever Dye Free | ACETAMINOPHEN | KROGER COMPANY | 0fec66b4-3a2a-63d1-e063-6294a90a6d72 | 2024-04-17 | Warnings | 362O9ITL9D |
| MULTI-SYMPTOM COLD AND FLU RELIEF DAYTIME | ACETAMINOPHEN 325 MG DEXTROMETHORPHAN HBR 10 MG PHENYLEPHRINE HCI 5 MG | RITE AID | c92dbbbb-d149-1e7e-e053-2a95a90a6f1a | 2024-04-17 | Warnings | 362O9ITL9D |
| MULTI-SYMPTOM COLD AND FLU RELIEF NIGHTTIME | ACETAMINOPHEN 325 MG DEXTROMETHORPHAN HBR 15 MG DOXYLAMINE SUCCINATE 6.25 MG | RITE AID | c9323799-3505-d6c1-e053-2995a90a6f43 | 2024-04-17 | Warnings | 362O9ITL9D |
| Nighttime Cold and Flu Relief | ACETAMINOPHEN DEXTROMETHORPHAN HBR DOXYLAMINE SUCCINATE | QUALITY CHOICE (Chain Drug Marketing Association) | fac8b01a-9666-43cc-a4ff-3f3ed452c7e4 | 2024-04-17 | Warnings | 362O9ITL9D |
| 8 Hour Pain Relief | ACETAMINOPHEN | KROGER COMPANY | 0fec5c67-8d5d-8e45-e063-6394a90a982a | 2024-04-15 | Warnings | 362O9ITL9D |
| ADVIL DUAL ACTION WITH ACETAMINOPHEN | IBUPROFEN, ACETAMINOPHEN | Navajo Manufacturing Company Inc. | bd0d7812-4e42-b533-e053-2995a90ae1f9 | 2024-04-15 | Warnings | 362O9ITL9D |
| Handy Solutions Headache Pain Relief | ACETAMINOPHEN, ASPIRIN, CAFFEINE | Navajo Manufacturing Company Inc. | e5481abe-6971-2bc5-e053-2995a90ae895 | 2024-04-15 | Warnings | 362O9ITL9D |
| Nighttime Severe Cold and Cough | ACETAMINOPHEN, DIPHENHYDRAMINE HCL, PHENYLEPHRINE HCL | P & L Development, LLC | 8d27b94d-23a1-4e6c-a064-79e2580f7e2e | 2024-04-15 | Warnings | 362O9ITL9D |
| Severe Cold and Cough Relief Daytime | ACETAMINOHPEN, DEXTROMETHORPHAN HBR, PHENYLEPHRINE HCL | P & L Development, LLC | 2af496a1-6fdd-4acf-9944-8b7cdf302275 | 2024-04-15 | Warnings | 362O9ITL9D |
| childrens acetaminophen | ACETAMINOPHEN | Major Pharmaceuticals | 243a5cff-e506-434b-ab19-1a6ac53f8533 | 2024-04-15 | Warnings | 362O9ITL9D |
| Dye Free Pain Reliever Childrens | ACETAMINOPHEN | P & L Development, LLC | 45ddcaad-d416-4d7c-a84a-43548d5c5d3b | 2024-04-15 | Warnings | 362O9ITL9D |
| Tylenol Extra Strength | ACETAMINOPHEN | Navajo Manufacturing Company Inc. | 65bf1556-f25a-9439-e053-2a91aa0a3194 | 2024-04-15 | Warnings | 362O9ITL9D |
Reported adverse events (FAERS/openFDA)#
Adverse event summaries are temporarily unavailable. Other product information remains available.