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 Tylenol Cold plus Flu Multi-Symptom Daytime | ACETAMINOPHEN, DEXTROMETHORPHAN HYDROBROMIDE | Kenvue Brands LLC | 52291746-2bbf-8f3f-e063-6294a90adcfc | 2026-05-19 | Warnings | 362O9ITL9D |
| Prolate | OXYCODONE AND ACETAMINOPHEN | Forte Bio-Pharma LLC | 9cbbfa94-37b9-9652-e053-2995a90a736b | 2026-05-19 | Boxed warning, Warnings, Adverse reactions | 362O9ITL9D |
| Mucinex Fast-Max Cold and Flu | ACETAMINOPHEN, DEXTROMETHORPHAN HYDROBROMIDE | Reckitt Benckiser LLC | 31ac6883-ffcd-39de-e063-6294a90a52dd | 2026-05-19 | Warnings | 362O9ITL9D |
| Mucinex Fast-Max Cold, Flu and Sore Throat Maximum Strength | ACETAMINOPHEN, DEXTROMETHORPHAN HYDROBROMIDE, GUAIFENESIN, AND PHENYLEPHRINE HYDROCHLORIDE | Reckitt Benckiser LLC | 7050b583-c09b-4457-9a9c-70c0923b62c0 | 2026-05-19 | Warnings | 362O9ITL9D |
| Mucinex Fast-Max Cold and Flu Maximum Strength | ACETAMINOPHEN, DEXTROMETHORPHAN HYDROBROMIDE, GUAIFENESIN, AND PHENYLEPHRINE HYDROCHLORIDE | Reckitt Benckiser LLC | 27312ee4-d1f4-4a95-9c45-91fa5a01f5ba | 2026-05-19 | Warnings | 362O9ITL9D |
| Mucinex Rapid Clear Daytime Pain, Headache, and Cough | ACETAMINOPHEN, DEXTROMETHORPHAN HYDROBROMIDE | Reckitt Benckiser LLC | 37de53a7-5546-3804-e063-6294a90a0fb5 | 2026-05-19 | Warnings | 362O9ITL9D |
| Mucinex Fast-Max Cold and Flu Maximum Strength | ACETAMINOPHEN, DEXTROMETHORPHAN HYDROBROMIDE | Reckitt Benckiser LLC | 36b07e49-c72c-45e5-e063-6394a90a804a | 2026-05-19 | Warnings | 362O9ITL9D |
| Mucinex Fast-Max Congestion and Headache Maximum Strength | ACETAMINOPHEN, DEXTROMETHORPHAN HYDROBROMIDE, AND PHENYLEPHRINE HYDROCHLORIDE | Reckitt Benckiser LLC | d7017328-f8af-4601-9232-dc1104feaa0a | 2026-05-19 | Warnings | 362O9ITL9D |
| Mucinex Rapid Clear Pain Headache and Cough | ACETAMINOPHEN, DEXTROMETHORPHAN HYDROBROMIDE | Reckitt Benckiser LLC | 32375b12-75ed-d605-e063-6294a90ad004 | 2026-05-19 | Warnings | 362O9ITL9D |
| Mucinex Sinus-Max Pressure, Pain and Cough Maximum Strength | ACETAMINOPHEN, DEXTROMETHORPHAN HYDROBROMIDE, GUAIFENESIN, AND PHENYLEPHRINE HYDROCHLORIDE | Reckitt Benckiser LLC | 07da45b5-d05e-41b1-b233-f7034d556a8d | 2026-05-19 | Warnings | 362O9ITL9D |
| Mucinex Sinus-Max Severe Congestion and Pain Maximum Strength | ACETAMINOPHEN, DEXTROMETHORPHAN HYDROBROMIDE, AND PHENYLEPHRINE HYDROCHLORIDE | Reckitt Benckiser LLC | ad4e0e4d-cc1f-4176-835f-3ba76564c634 | 2026-05-19 | Warnings | 362O9ITL9D |
| Mucinex Childrens Mini Melts Cold and Flu | ACETAMINOPHEN AND GUAIFENESIN | Reckitt Benckiser LLC | 401fe0a0-ec97-5248-e063-6394a90af27f | 2026-05-19 | Warnings | 362O9ITL9D |
| Hydrocodone Bitartrate and Acetaminophen | HYDROCODONE BITARTRATE AND ACETAMINOPHEN | ST. MARY'S MEDICAL PARK PHARMACY | 3d347b9b-1b5c-68c8-e063-6294a90aaa9b | 2026-05-19 | Boxed warning, Warnings, Adverse reactions | NO70W886KK 362O9ITL9D |
| Menstrual Complete | ACETAMINOPHEN, CAFFEINE, PYRILAMINE MALEATE | Topco Associates, LLC | 62f03f3c-8475-40bd-a5e4-ec9292b74785 | 2026-05-19 | Warnings | 362O9ITL9D |
| GOOD SENSE DAYTIME | ACETAMINOPHEN, DEXTROMETHORPHAN HYDROBROMIDE | L. Perrigo Company | 2597e84c-18b4-41a9-8e6a-ff0c4c1f0612 | 2026-05-18 | Warnings | 362O9ITL9D |
| Walgreens Headache Relief Extra Strength | ACETAMINOPHEN 250MG, ASPIRIN 250MG AND CAFFEINE 65MG | Walgreens | 52109b65-3bf1-de38-e063-6394a90a9727 | 2026-05-18 | Warnings | 362O9ITL9D |
| Mucinex Childrens Night Time Multi-Symptom Cold | ACETAMINOPHEN, DIPHENHYDRAMINE HYDROCHLORIDE, AND PHENYLEPHRINE HYDROCHLORIDE | Reckitt Benckiser LLC | e048cd53-a3cd-484f-a972-4cb49791dba3 | 2026-05-18 | Warnings | 362O9ITL9D |
| Mucinex Childrens Cold and Flu | ACETAMINOPHEN, DEXTROMETHORPHAN HYDROBROMIDE, GUAIFENESIN, AND PHENYLEPHRINE HYDROCHLORIDE | Reckitt Benckiser LLC | 5bda415d-739f-4ca5-b5b2-07c14a81863b | 2026-05-18 | Warnings | 362O9ITL9D |
| Mucinex Childrens Multi-Symptom Cold and Sore Throat | ACETAMINOPHEN, DEXTROMETHORPHAN HYDROBROMIDE, GUAIFENESIN, AND PHENYLEPHRINE HYDROCHLORIDE | Reckitt Benckiser LLC | 8f3eb5c5-832e-4806-b3da-ef112cf55dcf | 2026-05-18 | Warnings | 362O9ITL9D |
| Mucinex Childrens FreeFrom Multi-Symptom Cold and Flu Nighttime | ACETAMINOPHEN, DEXTROMETHORPHAN HYDROBROMIDE, PHENYLEPHRINE HYDROCHLORIDE, AND TRIPROLIDINE HYDROCHLORIDE | Reckitt Benckiser LLC | 84e7be8f-2785-45ef-9c44-de05394fcd99 | 2026-05-18 | Warnings | 362O9ITL9D |
Reported adverse events (FAERS/openFDA)#
Adverse event summaries are temporarily unavailable. Other product information remains available.