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 |
|---|---|---|---|---|---|---|
| Childrens Chewable Acetaminophen | ACETAMINOPHEN | GERI-CARE PHARMACEUTICAL CORP | 22f63d62-c941-5b8f-e063-6394a90aeecd | 2024-11-28 | Warnings | 362O9ITL9D |
| Extra Strength Acetaminophen | ACETAMINOPHEN | Geri-Care Pharmaceutical Corp | 7a7b6318-b7d6-31b1-e053-2991aa0abf25 | 2024-11-28 | Warnings | 362O9ITL9D |
| Extra Strength Pain Reliever PM | ACETAMINOPHEN, DIPHENHYDRAMINE HCL | INGLES MARKETS, INC. | 27fd288e-c07a-617f-e063-6394a90a17a4 | 2024-11-28 | Warnings | 362O9ITL9D |
| EXCEDRIN MIGRAINE | ACETAMINOPHEN, ASPIRIN (NSAID) AND CAFFEINE | Jones Healthcare Group - Packaging Services, Inc | c4168e4d-3dfc-4e51-a32e-14704cb59c66 | 2024-11-27 | Warnings | 362O9ITL9D |
| Severe Sinus Congestion Allergy and Cough Formula | ACETAMINOPHEN, DEXTROMETHORPHAN HYDROBROMIDE , DOXYLAMINE SUCCINATE, PHENYLEPHRINE HYDROCHLORIDE | PuraCap Pharmaceutical LLC | 36a4ec1f-50c3-4d61-ada9-987ccad3563c | 2024-11-26 | Warnings | 362O9ITL9D |
| First Aid Only Extra-Strength Non-Aspirin | ACETAMINOPHEN | Acme United Corporation | 6891d57a-10a6-53de-e053-2a91aa0ac7c2 | 2024-11-26 | Warnings | 362O9ITL9D |
| BRONCOCHEM COLD AND FLU CAPLETS | ACETAMINOPHEN-DEXTROMETHORPHAN HBR-PHENYLEPHRINE HCL-CHLORPHENIRAMINE MALEATE | LABORATORIO MAGNACHEM INTERNATIONAL SRL | ac4f6a39-e455-4d33-8bb8-ae8dc6ebc2f6 | 2024-11-26 | Warnings | 362O9ITL9D |
| Alka-Seltzer Plus Cold and Flu, CVP | CHLORPHENIRAMINE MALEATE, ACETAMINOPHEN, PHENYLEPHRINE HYDROCHLORIDE, DEXTROMETHORPHAN HYDROBROMIDE TABLET | Lil' Drug Store Products, Inc. | e7a27773-69d6-9e07-e053-2a95a90af8ea | 2024-11-25 | Warnings | 362O9ITL9D |
| ACETAMINOPHEN (RED) | ACETAMINOPHEN | Humanwell PuraCap Pharmaceutical (Wuhan), Ltd. | 06eabf4b-f8c0-439a-acf1-aa6e3075c717 | 2024-11-25 | Warnings | 362O9ITL9D |
| ACETAMINOPHEN (RED) | ACETAMINOPHEN | Humanwell PuraCap Pharmaceutical (Wuhan) Co., Ltd | a352f588-4a70-42b2-8f9c-a73a0629517d | 2024-11-25 | Warnings | 362O9ITL9D |
| DayTime Sinus Relief | ACETAMINOPHEN, PHENYLEPHRINE HYDROCHLORIDE | Humanwell PuraCap Pharmaceutical (Wuhan), Ltd. | 4361912e-4b56-4743-b11d-acfb94482a2e | 2024-11-25 | Warnings | 362O9ITL9D |
| NightTime Sinus Relief | ACETAMINOPHEN, DOXYLAMINE SUCCINATE, PHENYLEPHRINE HYDROCHLORIDE | Humanwell PuraCap Pharmaceutical (Wuhan), Ltd. | 413d82d3-a896-4f15-9fca-c1b7b9a1ee63 | 2024-11-25 | Warnings | 362O9ITL9D |
| Pain Relief Extra Strength | ACETAMINOPHEN | Humanwell PuraCap Pharmaceutical (Wuhan), Ltd. | 5c42dd28-820c-4cc5-9016-11ad5e580616 | 2024-11-25 | Warnings | 362O9ITL9D |
| Night Cold Flu Cough and Allergy | ACETAMINOPHEN, DEXTROMETHORPHAN HYDROBROMIDE, DOXYLAMINE SUCCINATE, PHENYLEPHRINE HYDROCHLORIDE | Humanwell PuraCap Pharmaceutical (Wuhan), Ltd. | 590f4f0d-c8b0-412d-be1e-3eb2ccb29ac0 | 2024-11-25 | Warnings | 362O9ITL9D |
| Daytime Severe Cold and Flu | ACETAMINOPHEN, DEXTROMETHORPHAN HYDROBROMIDE, GUAIFENESIN, PHENYLEPHRINE HYDROCHLORIDE | Humanwell PuraCap Pharmaceutical (Wuhan), Ltd. | cbd3a905-1c41-4cb0-8df6-36784430d627 | 2024-11-25 | Warnings | 362O9ITL9D |
| Nighttime Cold and Flu | ACETAMINOPHEN, DEXTROMETHORPHAN HYDROBROMIDE, DOXYLAMINE SUCCINATE | Humanwell PuraCap Pharmaceutical (Wuhan), Ltd. | 7a28d0fe-0e0a-453a-b604-1cc784dd153c | 2024-11-25 | Warnings | 362O9ITL9D |
| Cough and Cold plus | ACETAMINOPHEN, PHENYLEPHRINE HCL, CHLORPHENIRAMINE MALEATE, DEXTROMETHORPHAN HBR | Humanwell PuraCap Pharmaceutical (Wuhan) Co., Ltd | c483d88f-cb0a-4dd6-b3ae-559521782ba6 | 2024-11-25 | Warnings | 362O9ITL9D |
| DayTime Sinus | ACETAMINOPHEN, PHENYLEPHRINE HYDROCHLORIDE | Humanwell PuraCap Pharmaceutical (Wuhan) Co., Ltd. | a0b01aef-4248-4d41-862c-0c8884dfca5e | 2024-11-25 | Warnings | 362O9ITL9D |
| DayTime Cold and Flu | ACETAMINOPHEN, DEXTROMETHORPHAN HYDROBROMIDE, PHENYLEPHRINE HYDROCHLORIDE | Humanwell PuraCap Pharmaceutical (Wuhan), Ltd. | 3af20739-6794-42e0-b404-3f0401d10a6d | 2024-11-25 | Warnings | 362O9ITL9D |
| NightTime Sinus | ACETAMINOPHEN, DOXYLAMINE SUCCINATE, PHENYLEPHRINE HYDROCHLORIDE | Humanwell PuraCap Pharmaceutical (Wuhan) Co., Ltd. | 0f3b1404-9252-470a-aa8c-b360c85731f3 | 2024-11-25 | Warnings | 362O9ITL9D |
Reported adverse events (FAERS/openFDA)#
Adverse event summaries are temporarily unavailable. Other product information remains available.