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 |
|---|---|---|---|---|---|---|
| equaline dual action pain reliever | ACETAMINOPHEN, IBUPROFEN | United Natural Foods, Inc. dba UNFI | ae0dc3f1-ee6f-4347-af5d-70f45dd68bdb | 2026-08-27 | Warnings | 362O9ITL9D |
| Daytime Cold and Flu mini Softgels | ACETAMINOPHEN, DEXTROMETHORPHAN HBR, PHENYLEPHRINE HCL | Shield Pharmaceuticals Corp | dfb0fe2e-b0c7-409a-bd1a-fd12485665ba | 2026-08-26 | Warnings | 362O9ITL9D |
| Nighttime Severe Cold and Flu Maximum Strength mini softgels | ACETAMINOPHEN, DEXTROMETHORPHAN HBR, DOXYLAMINE SUCCINATE, PHENYLEPHRINE HCL | Shield Pharmaceuticals Corp | 70c5517d-be4e-4317-b4f4-df660c71c699 | 2026-08-26 | Warnings | 362O9ITL9D |
| Childrens Pain and Fever | ACETAMINOPHEN | FSA STORE INC. | 5502ef15-9f40-db56-e063-6394a90a2de4 | 2026-08-26 | Warnings | 362O9ITL9D |
| foster and thrive dual action | ACETAMINOPHEN, IBUPROFEN | Strategic Sourcing Services LLC | f970d423-1d92-40c0-8358-91d1f963505c | 2026-08-26 | Warnings | 362O9ITL9D |
| DG Health 8 Hour Pain Relief | ACETAMINOPHEN | Dolgencorp Inc | d102e8a2-2fff-48cb-9864-7582fde956ed | 2026-08-26 | Warnings | 362O9ITL9D |
| Cold and Flu | ACETAMINOPHEN, DEXTROMETHORPHAN HBR, GUAIFENESIN, PHENYLEPHRINE HCL | Meijer Distribution, Inc. | c1f9ec75-7eb2-405c-8cdc-097cbf2cf87d | 2026-08-26 | Warnings | 362O9ITL9D |
| Pain Reliever | ACETAMINOPHEN, IBUPROFEN | CVS Pharmacy | 9126e680-d5ff-4189-9f9a-d797822ce670 | 2026-08-26 | Warnings | 362O9ITL9D |
| Leader Dual Action Pain Reliever | ACETAMINOPHEN, IBUPROFEN | Cardinal Health 110, LLC. dba Leader | 2bb1f616-48af-4fe1-9aa9-32fcb2dba50c | 2026-08-26 | Warnings | 362O9ITL9D |
| Dye Free Pain and Fever Childrens | ACETAMINOPHEN | Walgreens | 3ea217dd-e5b9-4d4b-861a-76ce61ba3a1d | 2026-08-26 | Warnings | 362O9ITL9D |
| dual pain reliever | ACETAMINOPHEN, IBUPROFEN | Walgreen Company | 5cb3b0b4-5b47-4ed4-a5e3-f14dbbcb46df | 2026-08-26 | Warnings | 362O9ITL9D |
| Childrens TYLENOL COLD plus COUGH plus RUNNY NOSE | ACETAMINOPHEN, CHLORPHENIRAMINE MALEATE, AND DEXTROMETHORPHAN HYDROBROMIDE | Kenvue Brands LLC | 5b95905e-b729-4caf-921a-fc4ef815289c | 2026-08-25 | Warnings | 362O9ITL9D |
| Hydrocodone Bitartrate and Homatropine Methylbromide | HYDROCODONE BITARTRATE AND HOMATROPINE METHYLBROMIDE | KVK-Tech, Inc. | 26d7c90c-5e6b-4bdb-b06f-c76173a01c21 | 2026-08-25 | Boxed warning, Warnings, Adverse reactions | NO70W886KK |
| HyVee Extra Strength Headache Relief CAPLET | ACETAMINOPHEN, ASPIRIN, CAFFEINE | HyVee Inc | 495c75bf-c09a-accd-e063-6294a90a75ec | 2026-08-24 | Warnings | 362O9ITL9D |
| Feverall Childrens | ACETAMINOPHEN | Sun Pharmaceutical Industries, Inc. | 861e2987-5473-45b0-b2a6-f980a9b0e809 | 2026-08-24 | Warnings | 362O9ITL9D |
| Acetaminophen | ACETAMINOPHEN | Walgreens | 543f93d1-df14-0bd2-e063-6294a90a4413 | 2026-08-24 | Warnings | 362O9ITL9D |
| ACETAMINOPHEN | ACETAMINOPHEN | Akron Pharma Inc. | ab79fd60-8315-4c63-8045-1b0511ac268f | 2026-08-24 | Warnings | 362O9ITL9D |
| migraine relief | ACETAMINOPHEN, ASPIRIN, CAFFEINE | Walgreen Company | 36503181-0fda-4127-b3f0-bdb1b56bb0ed | 2026-08-24 | Warnings | 362O9ITL9D |
| Cold, Flu and Sore Throat | ACETAMINOPHEN, DEXTROMETHORPHAN HBR, GUAIFENESIN, PHENYLEPHRINE HCL | Meijer Distribution, Inc. | 9be8437c-6053-4ed4-bdd2-97f556b5289e | 2026-08-24 | Warnings | 362O9ITL9D |
| Genexa Infants Pain and Fever | ACETAMINOPHEN | Genexa Inc. | 4fd048c3-70bc-2ea7-e063-6394a90a55f2 | 2026-08-22 | Warnings | 362O9ITL9D |
Reported adverse events (FAERS/openFDA)#
Adverse event summaries are temporarily unavailable. Other product information remains available.