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 |
|---|---|---|---|---|---|---|
| Nighttime Cold and Flu | ACETAMINOPHEN, DEXTROMETHROPHAN HBR, DOXYLAMINE SUCCINATE | Kroger | 10b08ea8-693e-eb18-e063-6394a90af548 | 2024-05-08 | Warnings | 362O9ITL9D |
| Nighttime Severe Cold and Flu | ACETAMINOPHEN, DEXTROMETHORPHAN HBR, DOXYLAMINE SUCCINATE, PHENYLEPHRINE HCL | Kroger | 10b0bcff-d3bc-f70c-e063-6394a90a35ed | 2024-05-08 | Warnings | 362O9ITL9D |
| Daytime Severe Cold and Flu | ACETAMINOPHEN, DEXTROMETHORPHAN HBR, GUAIFENESIN, PHENYLEPHRINE HCL | Kroger | 10b0e0a0-b878-0a9a-e063-6394a90a20e0 | 2024-05-08 | Warnings | 362O9ITL9D |
| Severe Cold and Flu Daytime Honey | ACETAMINOPHEN, DEXTROMETHROPHAN HBR, GUAIFENESIN, PHENYLEPHRINE HCL | Kroger | 10b0fa3d-d6b2-272a-e063-6394a90a1205 | 2024-05-08 | Warnings | 362O9ITL9D |
| Childrens Plus Multi Symptom Cold | ACETAMINOPHEN, CHLORPHENIRAMINE MALEATE, DEXTROMETHORPHAN HYDROBROMIDE, PHENYLEPHRINE HYDROCHLORIDE | Walgreens | dd967cfb-96b4-4cdc-82e2-a4838001c9e3 | 2024-05-08 | Warnings | 362O9ITL9D |
| Cough Cold and Sore Throat Childrens | ACETAMINOPHEN, DEXTROMETHORPHAN HBR, GUAIFENESIN, PHENYLEPHRINE HCL | Walgreens | 400a0998-e276-4c8d-9b41-145b1b405fff | 2024-05-08 | Warnings | 362O9ITL9D |
| basic care infants pain and fever | ACETAMINOPHEN | Amazon.com Services LLC | 40329d8c-eb3d-4143-b4ae-9bafd0a1cb3c | 2024-05-08 | Warnings | 362O9ITL9D |
| childrens pain and fever | ACETAMINOPHEN | Walgreen Company | 928bb80e-2e14-488c-99ab-abb860cbe7a8 | 2024-05-07 | Warnings | 362O9ITL9D |
| BUTALBITAL, ACETAMINOPHEN AND CAFFEINE | BUTALBITAL, ACETAMINOPHEN AND CAFFEINE | QUAGEN PHARMACEUTICALS LLC | 8438f08f-a32a-4180-9030-e0fd5da4be30 | 2024-05-07 | Boxed warning, Warnings, Adverse reactions | 362O9ITL9D |
| basic care childrens pain and fever | ACETAMINOPHEN | Amazon.com Services LLC | 790d8883-52be-46f2-9838-564b6c5d57f9 | 2024-05-07 | Warnings | 362O9ITL9D |
| Rugby Childrens Acetaminophen | ACETAMINOPHEN | Rugby Laboratories | 304a9aa2-9198-44ca-8627-d41b84ec6cbf | 2024-05-07 | Warnings | 362O9ITL9D |
| careone childrens acetaminophen | ACETAMINOPHEN | American Sales Company | 808f4790-cadd-4285-ae70-25eb547137e2 | 2024-05-07 | Warnings | 362O9ITL9D |
| Severe Cold and Flu Nighttime Honey | ACETAMINOPHEN, DEXTROMETHORPHAN HBR, DOXYLAMINE SUCCINATE, PHENYLEPHRINE HCL | Kroger | 10b12f0e-dba7-fd71-e063-6294a90a42c1 | 2024-05-06 | Warnings | 362O9ITL9D |
| BUTALBITAL and ACETAMINOPHEN | BUTALBITAL AND ACETAMINOPHEN | QUAGEN PHARMACEUTICALS LLC | 1f0dbe62-6aea-4323-ad25-c2211f919253 | 2024-05-06 | Boxed warning, Warnings, Adverse reactions | 362O9ITL9D |
| BUTALBITAL, ACETAMINOPHEN AND CAFFEINE | BUTALBITAL, ACETAMINOPHEN AND CAFFEINE | QUAGEN PHARMACEUTICALS LLC | 24813ec6-0111-4782-9182-a2b93501a2bc | 2024-05-06 | Boxed warning, Warnings, Adverse reactions | 362O9ITL9D |
| Acetaminophen | ACETAMINOPHEN | Baxter Healthcare Corporation | 0f67c1bd-915b-4681-88dd-22f5154a80b3 | 2024-05-06 | Boxed warning, Warnings, Adverse reactions | 362O9ITL9D |
| Basic Care Childrens Pain and Fever | ACETAMINOPHEN | Amazon.com Services LLC | bf8bed5d-7dd4-492c-98ac-c36ff8be8f41 | 2024-05-06 | Warnings | 362O9ITL9D |
| Basic Care Childrens Pain and Fever | ACETAMINOPHEN | Amazon.com Services LLC | 0c133707-a8b8-4105-82f3-e3855ec19617 | 2024-05-06 | Warnings | 362O9ITL9D |
| leader infants pain and fever | ACETAMINOPHEN | Cardinal Health 110, LLC. dba Leader | cfbb8553-f3ac-437d-8f63-caa93f257a77 | 2024-05-06 | Warnings | 362O9ITL9D |
| BUTALBITAL and ACETAMINOPHEN | BUTALBITAL AND ACETAMINOPHEN | QUAGEN PHARMACEUTICALS LLC | 2eb09253-7f59-401e-afbc-70bb9600fedf | 2024-05-06 | Boxed warning, Warnings, Adverse reactions | 362O9ITL9D |
Reported adverse events (FAERS/openFDA)#
Adverse event summaries are temporarily unavailable. Other product information remains available.