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 |
|---|---|---|---|---|---|---|
| Hydrocodone Bitartrate and Homatropine Methylbromide | HYDROCODONE BITARTRATE AND HOMATROPINE METHYLBROMIDE ORAL SOLUTION | KVK-Tech, Inc. | 9a737416-08e0-4df6-897e-cf9d1b5f0b01 | 2026-05-22 | Boxed warning, Warnings, Adverse reactions | NO70W886KK |
| Hydrocodone Bitartrate and Acetaminophen | HYDROCODONE BITARTRATE AND ACETAMINOPHEN | Bryant Ranch Prepack | 080d8fbd-a2c5-45b1-a9cf-2b6dd42ec4c7 | 2026-05-22 | Boxed warning, Warnings, Adverse reactions | NO70W886KK 362O9ITL9D |
| Acetaminophen | ACETAMINOPHEN | Aurohealth LLC | e072e4ab-669d-40ee-b301-0bc15b67792f | 2026-05-21 | Warnings | 362O9ITL9D |
| GOOD NEIGHBOR PHARMACY DAYTIME FLU RELIEF MAX STRENGTH | ACETAMINOPHEN, DEXTROMETHORPHAN HBR | AMERISOURCE BERGEN | 45dc9dd7-134a-4e70-a07e-7bfdf0dc1c4e | 2026-05-21 | Warnings | 362O9ITL9D |
| Extra Strength Tylenol Cold plus Flu Multi-Symptom Nighttime | ACETAMINOPHEN, DEXTROMETHORPHAN HYDROBROMIDE, DOXYLAMINE SUCCINATE | Kenvue Brands LLC | 525467fb-510d-0b4b-e063-6294a90acd36 | 2026-05-21 | Warnings | 362O9ITL9D |
| Mucinex Childrens Multi-Symptom Cold and Flu | ACETAMINOPHEN, DEXTROMETHORPHAN HBR | Reckitt Benckiser LLC | 4a9464cf-0c77-23d0-e063-6394a90a62f1 | 2026-05-21 | Warnings | 362O9ITL9D |
| Mucinex Childrens Night Time Multi-Symptom Cold and Flu | ACETAMINOPHEN, DEXTROMETHORPHAN HBR, TRIPROLIDINE HCL | Reckitt Benckiser LLC | 4ceda68e-c7ce-eb87-e063-6394a90a8ded | 2026-05-21 | Warnings | 362O9ITL9D |
| Acetaminophen PM | ACETAMINOPHEN AND DIPHENHYDRAMINE HYDROCHLORIDE | Grocery Outlet, Inc. | 441d2629-3fff-0bf1-e063-6394a90aa9b6 | 2026-05-21 | Warnings | 362O9ITL9D |
| Acetaminophen | ACETAMINOPHEN | Grocery Outlet, Inc. | 441d1bde-d677-fab7-e063-6394a90aaad4 | 2026-05-21 | Warnings | 362O9ITL9D |
| Acetaminophen | ACETAMINOPHEN | Grocery Outlet, Inc. | 441d3a39-cc55-3c7c-e063-6394a90ad7a7 | 2026-05-21 | Warnings | 362O9ITL9D |
| Arthritis Pain | ACETAMINOPHEN | Grocery Outlet, Inc. | 441d0aa0-9a65-98e9-e063-6294a90a5eb2 | 2026-05-21 | Warnings | 362O9ITL9D |
| ALKA SELTZER COLD Cold and Cough Fast | ACETAMINOPHEN, DEXTROMETHORPHAN HYDROBROMIDE | Bayer HealthCare LLC. | 5241b11a-72c8-5e67-e063-6394a90a4353 | 2026-05-20 | Warnings | 362O9ITL9D |
| Mucinex Fast-Max Cold, Flu and Sore Throat | ACETAMINOPHEN, GUAIFENESIN | Reckitt Benckiser LLC | 50b140ad-aba2-ce6b-e063-6294a90ae2f8 | 2026-05-20 | Warnings | 362O9ITL9D |
| Mucinex Fast-Max Recharge Nighttime Cold and Flu | ACETAMINOPHEN, DEXTROMETHORPHAN HYDROBROMIDE, TRIPROLIDINE HYDROCHLORIDE | Reckitt Benckiser LLC | 4bae240c-70ce-e9c2-e063-6394a90a5f3d | 2026-05-20 | Warnings | 362O9ITL9D |
| HYDROCODONE BITARTRATE AND ACETAMINOPHEN | HYDROCODONE BITARTRATE AND ACETAMINOPHEN | ST. MARY'S MEDICAL PARK PHARMACY | 3d342071-7fdd-d899-e063-6294a90ae782 | 2026-05-20 | Boxed warning, Warnings, Adverse reactions | NO70W886KK 362O9ITL9D |
| Hydrocodone Bitartrate and Acetaminophen | HYDROCODONE BITARTRATE AND ACETAMINOPHEN | Bryant Ranch Prepack | 375c3f81-3276-431e-8773-7b189730e9fd | 2026-05-20 | Boxed warning, Warnings, Adverse reactions | NO70W886KK 362O9ITL9D |
| Chloraseptic Nighttime Sore Throat Hot Relief | ACETAMINOPHEN AND DIPHENHYDRAMINE HYDROCHLORIDE | Prestige Brands Holdings, Inc. | 9c13c052-a5d1-43d2-8d29-4ea011a971ac | 2026-05-20 | Warnings | 362O9ITL9D |
| INFANTS Pain and Fever | ACETAMINOPHEN | Aurohealth LLC | b3f57af5-661f-4534-9eed-76e431f338db | 2026-05-20 | Warnings | 362O9ITL9D |
| Infants Pain and Fever | ACETAMINOPHEN | Aurohealth LLC | e837538d-0515-4f99-b04c-fda63b28777e | 2026-05-20 | Warnings | 362O9ITL9D |
| equate nighttime cold and flu | ACETAMINOPHEN, DEXTROMETHORPHAN HYDROBROMIDE, DOXYLAMINE SUCCINATE, PHENYLEPHRINE HYDROCHLORIDE | WALMART INC. | 61a1beb3-decf-4c8d-a402-93a02ec40a43 | 2026-05-19 | Warnings | 362O9ITL9D |
Reported adverse events (FAERS/openFDA)#
Adverse event summaries are temporarily unavailable. Other product information remains available.