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 |
|---|---|---|---|---|---|---|
| EXTRA STRENGTH HEADACHE RELIEF | ACETAMINOPHEN, ASPIRIN, CAFFEINE | WALGREENS | 7d8f8389-730d-494e-a0af-5a91a3c99e17 | 2026-01-16 | Warnings | 362O9ITL9D |
| TENSION HEADACHE RELIEF | ACETAMINOPHEN AND CAFFEINE | WALGREENS | 54aff6a0-2778-472f-90ba-375d6bce6ee8 | 2026-01-16 | Warnings | 362O9ITL9D |
| EXTRA STRENGTH HEADACHE RELIEF | ACETAMINOPHEN, ASPIRIN, CAFFEINE | WALGREENS | 097fbab7-3886-4e75-b037-f03adcf3859f | 2026-01-16 | Warnings | 362O9ITL9D |
| Maximum Strength Congestion and Headache | ACETAMINOPHEN, DEXTROMETHORPHAN HYDROBROMIDE, AND PHENYLEPHRINE HYDROCHLORIDE | Walgreens | 88da92d2-92c2-445a-9b70-58996e086014 | 2026-01-16 | Warnings | 362O9ITL9D |
| Pain Reliever | ACETAMINOPHEN | WALGREENS CO. | bdb09e15-8e17-4987-99d0-bab8856a2109 | 2026-01-16 | Warnings | 362O9ITL9D |
| Maximum Strength Cold and Flu | ACETAMINOPHEN, GUAIFENESIN, DEXTROMETHORPHAN HYDROBROMIDE, AND PHENYLEPHRINE HYDROCHLORIDE | Walgreens | 5f638bca-55c2-4ead-8c47-3f15713495da | 2026-01-16 | Warnings | 362O9ITL9D |
| COLD, Flu and Sore Throat | ACETAMINOPHEN, GUAIFENESIN, DEXTROMETHORPHAN HYDROBROMIDE, AND PHENYLEPHRINE HYDROCHLORIDE | Walgreens | 190175bb-c08a-4050-aacf-29a130cbe05c | 2026-01-16 | Warnings | 362O9ITL9D |
| Night Time Cold and Flu Relief | ACETAMINOPHEN, DEXTROMETHORPHAN HBR, DOXYLAMINE SUCCINATE | FSA Store Inc. (Caring Mills) | a9bd1efc-51c7-40d0-a4f8-f130ce5b45ff | 2026-01-16 | Warnings | 362O9ITL9D |
| Relief-PE | ACETAMINOPHEN, PHENYLEPHRINE, CHLORPHENIRAMINE | HART Health | 9475fb51-931b-4a89-be6b-62e715d0883e | 2026-01-15 | Warnings | 362O9ITL9D |
| Allergy Multi-Symptom | ACETAMINOPHEN, CHLORPHENIRAMINE MALEATE, PHENYLEPHRINE HCL | L.N.K. International, Inc. | 99147338-f459-4423-ae54-f96fffc1728d | 2026-01-15 | Warnings | 362O9ITL9D |
| acetaminophen | ACETAMINOPHEN | HF Acquisition Co LLC, DBA HealthFirst | 4870ff00-f727-814d-e063-6394a90a6c8e | 2026-01-15 | Warnings | 362O9ITL9D |
| SanaTos Severe Cold Relief Nighttime | ACETAMINOPHEN, DIPHENHYDRAMINE HYDROCHLORIDE, AND PHENYLEPHRINE HYDROCHLORIDE | Pharmadel LLC | 144aafcc-6ec2-a322-e063-6294a90afc27 | 2026-01-15 | Warnings | 362O9ITL9D |
| SanaTos Severe Cold and Cough Daytime | ACETAMINOPHEN, DEXTROMETHORPHAN HYDROBROMIDE, AND PHENYLEPHRINE HYDROCHLORIDE | Pharmadel LLC | 14484bf5-ff45-b859-e063-6394a90a9a0f | 2026-01-15 | Warnings | 362O9ITL9D |
| ACETAMINOPHEN AND CODEINE PHOSPHATE | ACETAMINOPHEN AND CODEINE PHOSPHATE | Preferred Pharmaceuticals Inc. | 55d494b1-c828-4841-8f64-75b92cd54cb6 | 2026-01-14 | Boxed warning, Warnings, Adverse reactions | 362O9ITL9D |
| Leader Vapor Ice Cold and Flu | ACETAMINOPHEN, DEXTROMETHORPHAN HYDROBROMIDE | Cardinal Health 110, LLC. dba Leader | f27bf0b2-25cc-474c-ab6b-f227ed3525fa | 2026-01-14 | Warnings | 362O9ITL9D |
| Unisom PM Pain Nighttime Sleep Aid and Pain Reliever | ACETAMINOPHEN AND DIPHENHYDRAMINE HYDROCHLORIDE | Chattem, Inc. | 451daeeb-88a9-44b1-9a2d-1ff0b0ec41cb | 2026-01-14 | Warnings | 362O9ITL9D |
| ACETAMINOPHEN AND CODEINE PHOSPHATE | ACETAMINOPHEN AND CODEINE PHOSPHATE | Preferred Pharmaceuticals Inc. | 2453d635-989d-4569-96b3-4efaf61cca71 | 2026-01-14 | Boxed warning, Warnings, Adverse reactions | 362O9ITL9D |
| Nighttime Cold and Flu | ACETAMINOPHEN, DEXTROMETHORPHAN HBR, DOXYLAMINE SUCCINATE | BETTER LIVING BRANDS LLC. | 41f4bf6d-f83c-92e4-e063-6394a90aebab | 2026-01-13 | Warnings | 362O9ITL9D |
| Severe Cold and Flu | ACETAMINOPHEN, DEXTROMETHORPHAN HYDROBROMIDE, GUAIFENESIN, AND PHENYLEPHRINE HYDROCHLORIDE | HYVEE INC | 462cbf3d-51b1-dab9-e063-6394a90a70ba | 2026-01-13 | Warnings | 362O9ITL9D |
| Pain Terminator Extra Strength Pain Relief | CAFFEINE, ACETAMINOPHEN, ASPIRIN | Wildman Business Group | 8ffb02d9-92df-4d2f-a367-1c71490807fb | 2026-01-12 | Warnings | 362O9ITL9D |
Reported adverse events (FAERS/openFDA)#
Adverse event summaries are temporarily unavailable. Other product information remains available.