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 |
|---|---|---|---|---|---|---|
| Nighttime SEVERE | ACETAMINOPHEN, DEXTROMETHORPHAN HYDROBROMIDE, DOXYLAMINE SUCCINATE, PHENYLEPHRINE HYDROCHLORIDE | H E B | 0a178114-0748-4a92-9b60-a7a0a8b72287 | 2025-08-26 | Warnings | 362O9ITL9D |
| good neighbor pharmacy migraine relief | ACETAMINOPHEN, ASPIRIN, CAFFEINE | Amerisource Bergen | 201f101a-3b53-4349-896c-6b86cdd9b831 | 2025-08-26 | Warnings | 362O9ITL9D |
| Hydrocodone Bitartrate and Acetaminophen | HYDROCODONE BITARTRATE AND ACETAMINOPHEN | Camber Pharmaceuticals, Inc. | 4d5bfd3a-3793-4d24-aedd-c04fa34ea736 | 2025-08-26 | Boxed warning, Warnings, Adverse reactions | NO70W886KK 362O9ITL9D |
| pain relief | ACETAMINOPHEN | Safeway | 0e0a73f9-8c18-41fd-812e-8be20287e77a | 2025-08-26 | Warnings | 362O9ITL9D |
| good sense pain relief arthritis pain | ACETAMINOPHEN | Bryant Ranch Prepack | 7b0b07f6-242a-4e1a-ab39-84f0334d4716 | 2025-08-26 | Warnings | 362O9ITL9D |
| CAREONE DUAL ACTION | ACETAMINOPHEN, IBUPROFEN | Retail Business Services, LLC | 76302cb3-0371-49ce-85d8-5f3785c370b0 | 2025-08-25 | Warnings | 362O9ITL9D |
| Topcare Pain Relief | ACETAMINOPHEN | Sixarp, LLC | 2e20be17-2b6c-1a07-e063-6394a90acdd3 | 2025-08-25 | Warnings | 362O9ITL9D |
| Pain Reliever PM Extra Strength | ACETAMINOPHEN, DIPHENHYDRAMINE HCL | Strategic Sourcing Services LLC | 997eb228-09cb-47ad-acbb-363b05c67635 | 2025-08-25 | Warnings | 362O9ITL9D |
| SanaTos Multi Symptom | ACETAMINOPHEN, DEXTROMETHORPHAN HBR, GUAIFENESIN, PHENYLEPHRINE HCI | Pharmadel LLC | df260190-89e7-b338-e053-2995a90a32cb | 2025-08-22 | Warnings | 362O9ITL9D |
| Hydrocodone Bitartrate and Acetaminophen | HYDROCODONE BITARTRATE AND ACETAMINOPHEN | Camber Pharmaceuticals, Inc. | ed6af366-753c-4f3b-a6a2-c9a183c50035 | 2025-08-21 | Boxed warning, Warnings, Adverse reactions | NO70W886KK 362O9ITL9D |
| Severe Cold Daytime | ACETAMINOPHEN, DEXTROMETHORPHAN HBR, GUAIFENESIN, PHENYLEPHRINE HCL | CVS Pharmacy | 258d27a9-fea6-4076-8dfa-77c7e982d250 | 2025-08-20 | Warnings | 362O9ITL9D |
| Daytime Cold and Flu Non Drowsy | ACETAMINOPHEN, DEXTROMETHORPHAN HBR, PHENYLEPHRINE HCL | Rite Aid Corporation | 09bd88ec-ff84-4640-b561-243fda727043 | 2025-08-19 | Warnings | 362O9ITL9D |
| pain relief | ACETAMINOPHEN | Publix Super Markets Inc | 6b691dc1-09e4-46d3-b199-8917e42848a6 | 2025-08-19 | Warnings | 362O9ITL9D |
| Menstrual Complete | ACETAMINOPHEN, CAFFEINE, PYRILAMINE MALEATE | L.N.K. International, Inc. | c4a28f8f-030d-4487-b74f-13998482e72d | 2025-08-18 | Warnings | 362O9ITL9D |
| Night Time Cold and Flu Relief Multi Symptom | ACETAMINOPHEN, DEXTROMETHORPHAN HBR, DOXYLAMINE SUCCINATE | Rite Aid Corporation | 28785677-2e80-4d6e-8997-bf5ac2ffb5a2 | 2025-08-18 | Warnings | 362O9ITL9D |
| Pain Relief Extra Strength | ACETAMINOPHEN | P & L Development, LLC | 59eb14a5-40b0-4331-beb5-7166e6cdf411 | 2025-08-18 | Warnings | 362O9ITL9D |
| ACTIDOGESIC | DEXBROMPHENIRAMINE MALEATE, ACETAMINOPHEN | ACTIPHARMA, LLC | 697da3f9-9888-4d41-ba83-87ca9bf1e54b | 2025-08-18 | Warnings | 362O9ITL9D |
| Acetaminophen | ACETAMINOPHEN | PAI Holdings, LLC dba PAI Pharma | caf5daea-409e-5dd2-e053-2995a90acb12 | 2025-08-18 | Warnings | 362O9ITL9D |
| Night Time Cold and Flu Relief Multi Symptom | ACETAMINOPHEN, DEXTROMETHORPHAN HBR, DOXYLAMINE SUCCINATE | Rite Aid Corporation | 5f9c9c48-4e8f-4ace-a6fb-1c1bccaf02a0 | 2025-08-18 | Warnings | 362O9ITL9D |
| Acetaminophen | ACETAMINOPHEN | Hikma Pharmaceuticals USA Inc. | 88c29438-3648-4b09-bd43-70ad7a35bcb5 | 2025-08-18 | Boxed warning, Warnings, Adverse reactions | 362O9ITL9D |
Reported adverse events (FAERS/openFDA)#
Adverse event summaries are temporarily unavailable. Other product information remains available.