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 |
|---|---|---|---|---|---|---|
| Excedrin Extra Strength Pain Reliever | ACETAMINOPHEN, ASPIRIN (NSAID), AND CAFFEINE | Haleon US Holdings LLC | 1b5ff867-5442-4cf8-bd1e-530093cc88f8 | 2024-04-05 | Warnings | 362O9ITL9D |
| Activcin | ACETAMINOPHEN, DEXTROMETHORPHAN HYDROBROMIDE, PHENYLEPHRINE HYDROCHLORIDE | OPMX LLC. | e06a4d72-cc8d-fd9d-e053-2995a90a7a76 | 2024-04-05 | Warnings | 362O9ITL9D |
| Coldtac Plus Softgels | ACETAMINOPHEN, DEXTROMETHORPHAN HYDROBROMIDE, PHENYLEPHRINE HYDROCHLORIDE | OPMX LLC. | ff5ce5c6-a03f-2ad3-e053-6394a90a99f6 | 2024-04-05 | Warnings | 362O9ITL9D |
| Desresfriol-DX Softgels | ACETAMINOPHEN, DEXTROMETHORPHAN HYDROBROMIDE, PHENYLEPHRINE HYDROCHLORIDE | OPMX LLC. | ff5e0e0f-bfd2-b02b-e053-6394a90afe8a | 2024-04-05 | Warnings | 362O9ITL9D |
| Excedrin Extra Strength Pain Reliever | ACETAMINOPHEN, ASPIRIN (NSAID), AND CAFFEINE | Haleon US Holdings LLC | 0faa3592-4d56-4645-9a0e-066e0bdfebb6 | 2024-04-05 | Warnings | 362O9ITL9D |
| Acetaminophen | ACETAMINOPHEN TABLET EXTENDED RELEASE | Bryant Ranch Prepack | 61ea1796-b9c7-4cb9-9a36-60943f884875 | 2024-04-05 | Warnings | 362O9ITL9D |
| Butalbital, Acetaminophen, Caffeine and Codeine Phosphate | BUTALBITAL, ACETAMINOPHEN, CAFFEINE AND CODEINE PHOSPHATE | Bryant Ranch Prepack | 215e2a6f-ec32-4836-8fad-22c8b40ba1f1 | 2024-04-04 | Boxed warning, Warnings, Adverse reactions | 362O9ITL9D |
| Pain Relief Childrens Dye Free | ACETAMINOPHEN | H E B | 3f9beeeb-5e27-4b81-a647-20e65f0e9fc9 | 2024-04-03 | Warnings | 362O9ITL9D |
| Butalbital, Acetaminophen and Caffeine | BUTALBITAL, ACETAMINOPHEN AND CAFFEINE | Bryant Ranch Prepack | e9dffed5-d615-4e63-9860-c0f6f23848a1 | 2024-04-03 | Boxed warning, Warnings, Adverse reactions | 362O9ITL9D |
| Childrens Pain Relief | ACETAMINOPHEN | H E B | a0c0277e-50aa-4328-8f93-ab20c6176b2b | 2024-04-03 | Warnings | 362O9ITL9D |
| Clear Eyes Natural Tears | POLYVINYL ALCOHOL AND POVIDONE | Prestige Brands Holdings, Inc. | efba3eb0-798d-4635-b19b-4970e45b3cc9 | 2024-04-01 | Warnings | FZ989GH94E |
| DAYTIME COLD AND FLU RELIEF | ACETAMINOPHEN, DEXTROMETHORPHAN HYDROBROMIDE, AND PHENYLEPHRINE HYDROCHLORIDE | Advanced Rx LLC | 38299cf3-e884-4676-8cc4-6dd64e7d023c | 2024-03-30 | Warnings | 362O9ITL9D |
| NIGHTTIME COLD AND FLU RELIEF | ACETAMINOPHEN, DEXTROMETHORPHAN HYDROBROMIDE, AND DOXYLAMINE SUCCINATE | Advanced Rx LLC | d1542362-19c5-4470-89e8-87d26e2ca8ed | 2024-03-30 | Warnings | 362O9ITL9D |
| Dual Action Pain Relief | DUAL ACTION PAIN RELIEF | Allegiant Health | fb4fc347-0f90-429f-9ca8-903e736f5496 | 2024-03-29 | Warnings | 362O9ITL9D |
| Hydrocodone Bitartrate and Acetaminophen | HYDROCODONE BITARTRATE AND ACETAMINOPHEN | NuCare Pharmaceuticals,Inc. | c8d65aab-d6ae-bc69-e053-2a95a90a7b5e | 2024-03-27 | Boxed warning, Warnings, Adverse reactions | NO70W886KK 362O9ITL9D |
| ANTIGRIP Nighttime | ACETAMINOPHEN, DEXTROMETHORPHAN HBR, DOXYLAMINE SUCCINATE, PHENYLEPHRINE HCL | Pharmadel LLC | 12de30fd-95b6-f16d-e063-6294a90aeba2 | 2024-03-27 | Warnings | 362O9ITL9D |
| Signature Care Migraine Relief | ACETAMINOPHEN, ASPIRIN, CAFFEINE | Safeway | 66695667-97a3-4329-8ce0-0fffa8628951 | 2024-03-27 | Warnings | 362O9ITL9D |
| Daytime Cold and Flu | ACETAMINOPHEN, DEXTROMETHORPHAN HBR, PHENYLEPHRINE HCL | Family Dollar (FAMILY WELLNESS) | 0044c53c-11dd-41a9-a5d9-622dd8b1c144 | 2024-03-27 | Warnings | 362O9ITL9D |
| Headache Relief Extra Strength | ACETAMINOPHEN, ASPIRIN, CAFFEINE | Family Dollar (FAMILY WELLNESS) | 650cb15e-c448-4df3-b0f8-4398be05d841 | 2024-03-27 | Warnings | 362O9ITL9D |
| Pure Cornstarch Baby | CORN STARCH | Walgreen Company | d0e9bd13-b568-4f7e-b036-8d23e71ad8bf | 2024-03-25 | Warnings | O8232NY3SJ |
Reported adverse events (FAERS/openFDA)#
Adverse event summaries are temporarily unavailable. Other product information remains available.