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 |
|---|---|---|---|---|---|---|
| Leader Daytime Severe Cold and Flu | ACETAMINOPHEN, DEXTROMETHORPHAN HBR, GUAIFENESIN, PHENYLEPHRINE HCL | Cardinal Health 110, LLC. dba Leader | d38537c6-9553-4e93-a83e-11ed48c955ab | 2024-10-28 | Warnings | 362O9ITL9D |
| Severe Daytime | ACETAMINOPHEN, DEXTROMETHORPHAN HBR, GUAIFENESIN, PHENYLEPHRINE HCL | CVS Pharmacy | 2b3a1997-f382-4843-a44b-d80d1ad21a90 | 2024-10-28 | Warnings | 362O9ITL9D |
| daytime cold flu | ACETAMINOPHEN, DEXTROMETHORPHAN HYDROBROMIDE, GUAIFENESIN, PHENYLEPHRINE HYDROCHLORIDE | Meijer, Inc. | 1740ccfc-6e68-46f4-a1ba-48fe092f0aa0 | 2024-10-28 | Warnings | 362O9ITL9D |
| night time cold and flu | ACETAMINOPHEN, DEXTROMETHORPHAN HYDROBROMIDE, DOXYLAMINE SUCCINATE, PHENYLEPHRINE HYDROCHLORIDE | Meijer, Inc. | d3bd0632-328c-4ad7-bb44-8383e1e51b8c | 2024-10-28 | Warnings | 362O9ITL9D |
| Clear Eyes Triple Relief | POLYVINYL ALCOHOL AND POVIDONE AND TETRAHYDROZOLINE HYDROCHLORIDE | Prestige Brands Holdings, Inc. | 1269a1a6-843d-4d08-bb3c-c1f3d2e7080d | 2024-10-25 | Warnings | FZ989GH94E |
| leader Acetaminophen | ACETAMINOPHEN | Cardinal Health 110, LLC. dba Leader | 36bdcac9-eed4-40f9-a6f2-4c1e773a6b50 | 2024-10-25 | Warnings | 362O9ITL9D |
| nighttime | ACETAMINOPHEN, DEXTROMETHORPHAN HBR, DOXYLAMINE SUCCINATE | CVS Pharmacy | 1c341cf5-ac33-4a6e-b023-a23d280d496c | 2024-10-25 | Warnings | 362O9ITL9D |
| GOODYS PM | ACETAMINOPHEN AND DIPHENHYDRAMINE CITRATE | Medtech Products Inc. | db5d6c2b-688e-4e88-a42d-0fa2b0d8140b | 2024-10-25 | Warnings | 362O9ITL9D |
| Cold and Flu | ACETAMINOPHEN, DEXTROMETHORPHAN HBR, DOXYLAMINE SUCCINATE | Walgreen Company | b6d9f421-b236-4660-be7f-85a878f2fc61 | 2024-10-25 | Warnings | 362O9ITL9D |
| Goodys Extra Strength | ACETAMINOPHEN, ASPIRIN, AND CAFFEINE | Medtech Products Inc. | 16d774cc-4247-4bf8-9b5a-c338ffebda3d | 2024-10-25 | Warnings | 362O9ITL9D |
| NIGHTTIME COLD AND FLU RELIEF | ACETAMINOPHEN, DEXTROMETHORPHAN HBR AND DOXYLAMINE SUCCINATE | Chain Drug Consortium, LLC | 1deb60f3-e9be-4756-b0c1-527ef00dc741 | 2024-10-24 | Warnings | 362O9ITL9D |
| Cold Medicine XL3 FORTE | ACETAMINOPHEN CHLORPHENIRAMINE MALEATE PHENYLEPHERINE HYDROCHLORIDE | Selder, S.A. de C.V. | 51dd467b-aae8-41fa-e054-00144ff8d46c | 2024-10-24 | Warnings | 362O9ITL9D |
| Cold Flu and Sore Throat | ACETAMINOPHEN, DEXTROMETHORPHAN HYDROBROMIDE, GUAIFENESIN, AND PHENYLEPHRINE HYDROCHLORIDE | PUBLIX SUPER MARKETS INC | 68a5930b-37db-439d-8fb9-7d7de07d8465 | 2024-10-24 | Warnings | 362O9ITL9D |
| sinus pressure pain and cough | ACETAMINOPHEN, DEXTROMETHORPHAN HYDROBROMIDE, GUAIFENESIN, AND PHENYLEPHRINE HYDROCHLORIDE | PUBLIX SUPER MARKETS INC | bb0225d5-6c32-2c64-e053-2995a90a829b | 2024-10-24 | Warnings | 362O9ITL9D |
| Cold and Flu | ACETAMINOPHEN, DEXTROMETHORPHAN HYDROBROMIDE, GUAIFENESIN, AND PHENYLEPHRINE HYDROCHLORIDE | PUBLIX SUPER MARKETS INC | 01e1ad15-0ef5-4d6a-a9c1-19a5f2b20148 | 2024-10-24 | Warnings | 362O9ITL9D |
| Acetaminophen | ACETAMINOPHEN | Kroger Company | 5bfd9841-c781-43be-b823-d334893ae6ed | 2024-10-24 | Warnings | 362O9ITL9D |
| Pain Relief | ACETAMINOPHEN | H E B | add6952e-9dd5-487c-93e6-337e9d6a4872 | 2024-10-24 | Warnings | 362O9ITL9D |
| Dye Free Pain Reliever Childrens | ACETAMINOPHEN | Safeway, Inc. | 7d55cb42-295f-473a-941d-71825b44a3c0 | 2024-10-24 | Warnings | 362O9ITL9D |
| rapid release pain relief | ACETAMINOPHEN | Publix Super Markets Inc | d0b34133-d69d-47db-bf51-be942769c612 | 2024-10-24 | Warnings | 362O9ITL9D |
| basic care acetaminophen | ACETAMINOPHEN | Amazon.com Services LLC | 00146b91-008d-4b16-95b0-6077f98821be | 2024-10-24 | Warnings | 362O9ITL9D |
Reported adverse events (FAERS/openFDA)#
Adverse event summaries are temporarily unavailable. Other product information remains available.