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 |
|---|---|---|---|---|---|---|
| Acetaminophen | ACETAMINOPHEN | Aurohealth LLC | a4ff94b9-c248-4cd3-8491-38e9555cc22e | 2023-11-29 | Warnings | 362O9ITL9D |
| Aurophen Extra Strength for Adults | ACETAMINOPHEN | Aurohealth LLC | d59c5f04-4bcc-4a52-a42f-e049506f00de | 2023-11-29 | Warnings | 362O9ITL9D |
| Aurophen Extra Strength for Adults | ACETAMINOPHEN | Aurohealth LLC | a769094b-1e91-4ca7-ba67-21aa7e312910 | 2023-11-29 | Warnings | 362O9ITL9D |
| Acetaminophen | ACETAMINOPHEN | Aurohealth LLC | 30756257-f748-4a5d-b031-dd267d0f91ad | 2023-11-29 | Warnings | 362O9ITL9D |
| Aurophen Regular Strength | ACETAMINOPHEN | Aurohealth LLC | 8eda893f-5266-4b7a-95b9-2e194973cf06 | 2023-11-29 | Warnings | 362O9ITL9D |
| Childrens Pain Relief | ACETAMINOPHEN | Aurohealth LLC | 00ec6518-b5e3-49d1-a342-139381c3bfd2 | 2023-11-29 | Warnings | 362O9ITL9D |
| CHILDRENS PAIN RELIEF | ACETAMINOPHEN | Better Living Brands, LLC | fadb4c09-071f-56c0-e053-6294a90ae6c1 | 2023-11-28 | Warnings | 362O9ITL9D |
| Acetaminophen and Diphenhydramine hydrochloride | ACETAMINOPHEN AND DIPHENHYDRAMINE HYDROCHLORIDE | Better Living Brands, LLC | fc07d516-9ffe-9989-e053-6294a90ae1a5 | 2023-11-28 | Warnings | 362O9ITL9D |
| Stona | ACETAMINOPHEN, CHLORPHENIRAMINE MALEATE, DEXTROMETHORPHAN HYDROBROMIDE, PHENYLEPHRINE HYDROCHLORIDE | Sato Pharmaceutical Co., Ltd. | 8b89f50d-88f8-4773-92ea-5ada61766056 | 2023-11-28 | Warnings | 362O9ITL9D |
| NOTTS - Tension Headache | ACETAMINOPHEN, CAFFEINE | VIVUNT PHARMA LLC | 08f2ae03-967b-ad7e-e063-6294a90a8484 | 2023-11-24 | Warnings | 362O9ITL9D |
| Sanatos Multi Symptoms Nighttime | ACETAMINOPHEN, DEXTROMETHORPHAN HBR, DOXYLAMINE SUCCINATE | Pharmadel LLC | 0a60326a-a17b-e843-e063-6394a90ac211 | 2023-11-22 | Warnings | 362O9ITL9D |
| Sanatos Nighttime Multi Symptoms | ACETAMINOPHEN, DEXTROMETHORPHAN HBR, DOXYLAMINE SUCCINATE | Pharmadel LLC | 0ab188f3-f7f9-d665-e063-6294a90a198a | 2023-11-22 | Warnings | 362O9ITL9D |
| Acetaminophen, Aspirin and Caffeine | ACETAMINOPHEN, ASPIRIN AND CAFFEINE | Safrel Pharmaceuticals, LLC. | 0ac07846-5f04-dc4b-e063-6394a90ac8ca | 2023-11-22 | Warnings | 362O9ITL9D |
| Rugby Regular Strength Acetaminophen | ACETAMINOPHEN | A-S Medication Solutions | 400d4a29-9e39-4e74-8272-37be5d789924 | 2023-11-22 | Warnings | 362O9ITL9D |
| RIGHT REMEDIES Pain Relief Extra Strength Caplet | ACETAMINOPHEN | Strive Pharmaceuticals Inc. | dcce28d9-8528-489e-b995-1d98e9d0e6ad | 2023-11-21 | Warnings | 362O9ITL9D |
| Hydrocodone Polistirex and Chlorpheniramine Polistirex extended-release | HYDROCODONE POLISTIREX AND CHLORPHENIRAMINE POLISTIREX | Bryant Ranch Prepack | eecaa52b-f636-4ae4-a60f-d5e2503ab53b | 2023-11-20 | Boxed warning, Warnings, Adverse reactions | NO70W886KK |
| Sanatos Multi Symptom Daytime | ACETAMINOPHEN, DEXTROMETHORPHAN HBR, PHENYLEPHRINE HCI | Pharmadel LLC | 0ab11691-5b29-55fc-e063-6394a90aa328 | 2023-11-17 | Warnings | 362O9ITL9D |
| Acetaminophen | ACETAMINOPHEN | A-S Medication Solutions | 1e223faa-f6d0-4235-bc4c-6cfca84a5b0a | 2023-11-17 | Warnings | 362O9ITL9D |
| SanaTos X | ACETAMINOPHEN, DEXTROMETHORPHAN HBR,GUAIFENESIN, PHENYLEPHRINE HCI | Pharmadel LLC | 85b8ef3d-7318-7f3b-e053-2991aa0a0777 | 2023-11-14 | Warnings | 362O9ITL9D |
| Daytime Cold and Flu Severe, Caseys 4goog | ACETAMINOPHEN, PHENYLEPHRINE, DEXTROMETHORPHAN HBR, GUAIFENESIN TABLET, FILM COATED | Lil' Drug Store Products, Inc. | 0334259d-587e-b2d5-e063-6394a90a3e56 | 2023-11-14 | Warnings | 362O9ITL9D |
Reported adverse events (FAERS/openFDA)#
Adverse event summaries are temporarily unavailable. Other product information remains available.