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 |
|---|---|---|---|---|---|---|
| Medique Pain Off | ACETAMINOPHEN, ASPIRIN, CAFFEINE | Sportpharm LLC | 2b35acdc-ff88-46e6-a108-5240aac1d53f | 2026-03-03 | Warnings | 362O9ITL9D |
| Childrens Pain and Fever | ACETAMINOPHEN | Best Choice (Valu Merchandisers Company) | a8a0d9a5-1a36-4ed2-ae9c-7e1a3d674c07 | 2026-03-03 | Warnings | 362O9ITL9D |
| Hydrocodone Bitartrate and Homatropine Methylbromide | HYDROCODONE BITARTRATE AND HOMATROPINE METHYLBROMIDE | PAI Holdings, LLC dba PAI Pharma | 71319a6f-aaf4-4bc5-8b40-a16c6f139be6 | 2026-02-28 | Boxed warning, Warnings, Adverse reactions | NO70W886KK |
| CVS PHARMACY Nighttime MS Flu Relief | ACETAMINOPHEN, CHLORPHENIRAMINE MALEATE AND DEXTROMETHOPHAN HBR | CVS PHARMACY | 23cafaa1-34fe-4cef-960b-5f664ea32cb4 | 2026-02-27 | Warnings | 362O9ITL9D |
| pain relief | ACETAMINOPHEN | HyVee Inc | 6820a515-4004-407b-969b-c4069dc0c3b5 | 2026-02-26 | Warnings | 362O9ITL9D |
| migraine relief | ACETAMINOPHEN, ASPIRIN, CAFFEINE | CVS Pharmacy | e130831a-ec50-467a-9e5c-ba6ebc7bef3c | 2026-02-26 | Warnings | 362O9ITL9D |
| Acetaminophen, Diphenhydramine Hydrochloride | ACETAMINOPHEN, DIPHENHYDRAMINE HYDROCHLORIDE | LEADER/ Cardinal Health 110, Inc. | 7be4d67e-1af9-f059-e053-2991aa0a382e | 2026-02-26 | Warnings | 362O9ITL9D |
| Acetaminophen | ACETAMINOPHEN | NCS HealthCare of KY, LLC dba Vangard Labs | f32fc2e9-c0e3-4a25-8399-9cdba6ae8a16 | 2026-02-26 | Warnings | 362O9ITL9D |
| Acetaminophen | ACETAMINOPHEN | NCS HealthCare of KY, LLC dba Vangard Labs | 1f4ac0e6-e986-4c22-8248-0691d64e1a30 | 2026-02-26 | Warnings | 362O9ITL9D |
| ACETAMINOPHEN | ACETAMINOPHEN | NCS HealthCare of KY, LLC dba Vangard Labs | a3217b48-7482-4cc7-8811-ae75fd9d7805 | 2026-02-26 | Warnings | 362O9ITL9D |
| Childrens Chewable Acetaminophen | ACETAMINOPHEN | Discount Drug Mart | f413a617-1166-4940-b6ec-fae32238a780 | 2026-02-26 | Warnings | 362O9ITL9D |
| Acetaminophen | ACETAMINOPHEN | NCS HealthCare of KY, LLC dba Vangard Labs | 19735691-33f3-4e19-85ad-e5f270251ec5 | 2026-02-26 | Warnings | 362O9ITL9D |
| Multi-Symptom Cold and Fever Childrens | ACETAMINOPHEN, DEXTROMETHORPHAN HBR, GUAIFENESIN, PHENYLEPHRINE HCL | CVS PHARMACY | 2a569e47-3f17-4fc7-83d6-a3dddfd4987e | 2026-02-25 | Warnings | 362O9ITL9D |
| Acetaminophen and Codeine Phosphate | ACETAMINOPHEN AND CODEINE PHOSPHATE | Genus Lifesciences Inc. | 95a5d638-3072-4c37-a4cd-f8550328e2c6 | 2026-02-25 | Boxed warning, Warnings, Adverse reactions | 362O9ITL9D |
| leader tussin cf | ACETAMINOPHEN, DEXTROMETHORPHAN HYDROBROMIDE, GUAIFENESIN, PHENYLEPHRINE HYDROCHLORIDE | Cardinal Health 110, LLC. dba Leader | b3e3699b-b36c-453c-8f3b-0001388c8e82 | 2026-02-25 | Warnings | 362O9ITL9D |
| Childrens Pain and Fever | ACETAMINOPHEN | CVS WOONSOCKET PRESCRIPTION CENTER, INCORPORATED | 12fd643d-7c60-453f-a81f-407ed20e8725 | 2026-02-25 | Warnings | 362O9ITL9D |
| Childrens Pain and Fever | ACETAMINOPHEN | CVS WOONSOCKET PRESCRIPTION CENTER, INCORPORATED | d96a1531-772b-4a5c-89e4-66fff1fa3d78 | 2026-02-25 | Warnings | 362O9ITL9D |
| Sinus Pressure, Pain and Cough | ACETAMINOPHEN, DEXTROMETHORPHAN HBR, GUAIFENESIN, PHENYLEPHRINE HCL | Walgreen Company | 97554f40-f9aa-4dbf-a6f2-de6197236ab4 | 2026-02-25 | Warnings | 362O9ITL9D |
| Cold and Flu Nighttime | ACETAMINOPHEN, DEXTROMETHORPHAN HBR, DOXYLAMINE SUCCINATE | Best Choice (Valu Merchandisers Company) | 64a93715-e7b1-4de1-8099-8ad6c585d517 | 2026-02-24 | Warnings | 362O9ITL9D |
| Equate Childrens Pain and Fever | ACETAMINOPHEN | Wal-Mart Stores Inc | 40eedfe9-54e1-40a2-b4a2-55ff708b89cd | 2026-02-23 | Warnings | 362O9ITL9D |
Reported adverse events (FAERS/openFDA)#
Adverse event summaries are temporarily unavailable. Other product information remains available.